PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria

Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma in Children And Young Adult

Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

 Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC

Sanofi Signs a License Agreement with Biond for BND-22

Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV

Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders

Kamada to Commercialize Three Biosimilar Products in Israel

Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19

Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D

Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D

UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus

GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer

Bluebird bio to Spin Off its Oncology Business into Independent Company

Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio

 Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline

BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors

Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies,  Solid Tumors

Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases

Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases

Sanofi to Acquire Kymab for ~$1.45B

Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease

Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)

The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Shots:

  • The companies plan to initiate a P-II study assessing selgantolimod + VIR-2218 in treatment-experienced and treatment-naïve people living with HBV. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy
  • The 1EPs of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of HBsAg and HBV DNA from the serum. The study is the first P-II study that combines immunomodulation and Ag suppression approaches in HBV cure research
  • Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the P-II study

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Revenues & Profits

The post Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus first appeared on PharmaShots.

Top 20 Biopharma M&A of 2020 by Total Deal Value

  • Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years.
  • AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% strengthening its capabilities in immunology, neurology, metabolic cardiovascular, nephrology, and rare disease.
  • This article is based on the 2020 deals data as provided by the DealForma database. Our team at PharmaShots compiled a list of the top 20 acquisitions of 2020 based on total deal value.

Deal Date: Dec 17, 2020

Deal Value: $0.77B 

Novartis acquired Cadent Therapeutics. The acquisition strengthens Novartis’ neuroscience portfolio with the addition of Cadent’s NMDAr program, including CAD-9303, an NMDAr positive allosteric modulator in Phase I for schizophrenia, and MIJ-821, an NMDAr negative allosteric modulator in Phase I for treatment-resistant depression. CAD-9303 and MIJ-821 were licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical-stage SK channel positive allosteric modulator for movement disorders. Cadent Therapeutics received $210M up front and is eligible for up to $560M in milestones.

Deal Date: Aug 11, 2020

Deal Value: $0.87B

Bayer acquired KaNDy Therapeutics with its Phase IIb compound, NT-814, a small molecule for menopause and vasomotor symptoms. The acquisition strengthens Bayer’s drug development portfolio in women’s healthcare. KaNDy Therapeutics received $425M up front and is eligible for up to $450M in R&D milestones and additional undisclosed sales-based milestones.

Deal Date: Aug 25, 2020

Deal Value: $0.93B

ACADIA Pharmaceuticals acquired CerSci Therapeutics with its lead candidate, ACP-044, a Phase I small molecule for acute & chronic pain. The acquisition strengthens ACADIA’s non-opioid pain therapies portfolio. CerSci shareholders received $52.5M up front and are eligible for up to $887M in development and sales-based milestones.

Deal Date: Dec 15, 2020

Deal Value: $1.04B

Eli Lilly acquired Prevail Therapeutics. The acquisition strengthens Eli Lilly’s gene therapies portfolio with Prevail’s clinical and preclinical disease-modifying AAV9 gene therapy assets in neuroscience. Prevail’s pipeline includes PR001 in Phase I/II for Parkinson’s disease and in preclinical studies for neuronopathic Gaucher disease, and PR006 in Phase I/II for frontotemporal dementia with GRN mutations. Prevail shareholders received $880M up front at a purchase price of $22.50 per share which represents a premium of approximately 117% plus 1 non-tradable CVR worth up to $4.00 per share in cash (or an aggregate of approximately $160M), for a deal total of up to $26.50 per share in cash, approximately $1.04B. The CVR is payable upon the first regulatory approval for the commercial sale of a Prevail product in one of the countries, including the US, Japan, UK, Germany, France, Italy, or Spain.

Deal Date: Jan 10, 2020

Deal Value: $1.1B     

Eli Lilly acquired Dermira with its IL-13 inhibitor antibody lebrikizumab, which is in Phase III for moderate-to-severe atopic dermatitis, and its marketed QBREXZA (glycopyrronium) medicated cloth for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). Dermira licensed lebrikizumab from Genentech/Roche, which acquired the compound when it acquired Tanox, the originator. Dermira shareholders received $18.75 per share in cash at a 1-day premium of 2.2% for approximately $1.1B.

Deal Date: Oct 15, 2020

Deal Value: $1.3B

Lilly acquired Disarm Therapeutics. The acquisition strengthens Lilly’s neurology portfolio with the addition of preclinical SARM1 inhibitors, a small molecule for peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm shareholders received $135M up front and are eligible for up to $1.225B in development, regulatory, and commercial milestones if Lilly develops and commercializes new medicines based on Disarm’s approach.

Deal Date: May 5, 2020

Deal Value: $1.3B     

Alexion Pharmaceuticals acquired Portola Pharmaceuticals including its balance sheet and debt of approximately $215M. The acquisition expands Alexion’s hematology, neurology, and critical care portfolio. Portola shareholders received $18 per share in cash at a premium of 130% for a total of $1.38B.

Deal Date: Dec 10, 2020

Deal Value: $1.4B     

Boehringer Ingelheim acquired NBE-Therapeutics. The acquisition strengthens Boehringer Ingelheim’s oncology pipeline with NBE-002, Phase I immunoconjugates for TNBC, lung, and ovarian cancers. NBE-Therapeutics is eligible to receive up to EUR 1.18B ($1.428B).

Deal Date: Dec 10, 2020

Deal Value: $1.7B

Gilead Sciences acquired MYR. The acquisition strengthens Gilead’s infectious disease and liver disease portfolio with the addition of hepcludex, a lipoprotein approved for Hepatitis D in Europe and in Phase III for Hepatitis D, in Phase II for Hepatitis B, in Phase I for dyslipidemia, and in preclinical studies for NASH and primary biliary cholangitis. MYR shareholders received EUR 1.15B ($1.39B) up front and are eligible for up to EUR 300M ($363.7M) in milestones.

Deal Date: Nov 6, 2020

Deal Value: $1.8B     

Novo Nordisk acquired Emisphere Technologies for $1.8B. The acquisition strengthens Novo Nordisk’s biologics segment with the addition of Eligen SNAC drug delivery technology. Additionally, Novo Nordisk will buy out its Eligen SNAC royalty stream obligations with MHR Fund Management, Emisphere’s largest shareholder. Novo Nordisk partnered with Emisphere in 2007 to develop oral biologics by applying Eligen SNAC. Emisphere shareholders received $7.82 per share in cash representing a 15% 1-day premium at approximately $1.35B. Additionally, Novo Nordisk will pay $450M to MHR Fund in connection with its royalty stream obligations.

Deal Date: June 11, 2020

Deal Value: $2.1B

Novo Nordisk acquired Corvidia Therapeutics. The acquisition strengthens Novo Nordisk’s cardiovascular disease portfolio with Phase II ziltivekimab, an antibody for inflammatory cardiovascular risk in CKD patients. Corvidia received $725M up front and is eligible for up to $1.375B in regulatory and sales-based milestones.

Deal Date: Aug 31, 2020

Deal Value: $2.6B

Nestle acquired Aimmune Therapeutics. The acquisition strengthens Nestle’s food allergy portfolio with Palforzia, an approved protein for peanut allergy. Aimmune Therapeutics received $2.6B at $34.50 per share at a 1-day premium of 174%. Nestle previously acquired 25% of the company starting with their 2016 partnership.

Deal Date: Nov 5, 2020

Deal Value: $2.7B     

Merck acquired VelosBio. The acquisition strengthens Merck’s oncology pipeline with the addition of Phase II VLS-101 antibody-drug conjugate targeting ROR1 for hematologic malignancies and solid tumors plus preclinical ADCs and bispecific antibodies. VelosBio shareholders will receive $2.75B.

Deal Date: Aug 17, 2020

Deal Value: $3.6B     

Sanofi acquired Principia Biopharma. The acquisition strengthens Sanofi’s autoimmune and allergic diseases portfolio with tolebrutinib (SAR442168), a small molecule in Phase III for multiple sclerosis and in Phase II for CNS disorders. Principia Biopharma received $3.6B at a purchase price of $100 per share at a premium of 10%. In 2017, Sanofi and Principia partnered on the development and commercialization of SAR442168, which was in Phase IIb for multiple sclerosis. Principia’s lead compound was rilzabrutinib, which was in Phase III for pemphigus.

Deal Date: Oct 26, 2020

Deal Value: $4B

Bayer acquired Asklepios BioPharmaceutical for $4B. The acquisition strengthens Bayer’s cell and gene therapy portfolio with the addition of AskBio’s AAV technology platform, CDMO facilities, and preclinical and clinical compounds for neuromuscular, CNS, cardiovascular, and metabolic diseases. Its leading gene therapy is in Phase I/II for Pompe disease. This also complements Bayer’s 2019 acquisition of BlueRock Therapeutics. Asklepios is eligible to receive 75% of the milestone payments in the next five years.

Deal Date: Mar 2, 2020

Deal Value: $4.9B

Gilead acquired Forty-Seven with its lead product magrolimab, a monoclonal antibody targeting CD47 in Phase Ib for acute myeloid leukemia (AML). The company is also studying myelodysplastic syndrome (MDS) and diffuse large B-cell lymphoma (DLBCL). The acquisition strengthens Gilead’s oncology portfolio. Forty-Seven received $4.9B at $95.50 per share at a premium of 65%.

Deal Date: Aug 19, 2020

Deal Value: $6.5B     

Johnson & Johnson acquired Momenta Pharmaceuticals for $6.5B at $52.50 per share at a premium of 79%. The acquisition strengthens Johnson & Johnson’s portfolio of autoimmune disease therapies with Phase III nipocalimab (M281), an anti-FcRn antibody for warm autoimmune hemolytic anemia, which is also in Phase II for myasthenia gravis among other indications. Momenta’s potential pipeline may have indications in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology, and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation.

Deal Date: Oct 05, 2020

Deal Value: $13.1B 

Bristol Myers Squibb acquired MyoKardia for $13.1B at $225 per share at a 1-day premium of 61%. MyoKardia’s mavacamten, a small molecule in Phase III for obstructive hypertrophic cardiomyopathy (HCM), has an NDA submission expected in Q1 2021 and is in Phase II for Non-obstructive Hypertrophic Cardiomyopathy. MyoKardia also has 2 clinical compounds, danicamtiv (MYK-491) in Phase II for genetic dilated cardiomyopathy, systolic dysfunction, and atrial fibrillation, and MYK-224, a Phase I small molecule for hypertrophic cardiomyopathy.

Deal Date: Sep 13, 2020

Deal Value: $21B

Gilead acquired Immunomedics for $21B at $88.00 per share at a premium of 108%. The acquisition gives Gilead trodelvy, an antibody-drug conjugate approved for mTNBC. Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, which received accelerated approval for mTNBC in the US. Trodelvy is also being studied in Phase III for 3L HR+/HER2- breast cancer and Phase II for bladder cancer, NSCLC, and other solid tumors.

Deal Date: Dec 12, 2020

Deal Value: $39B     

AstraZeneca acquired Alexion for $39B including its drugs Soliris, Ultomiris, and 11 pipeline molecules in 20 different clinical programs. Soliris is an anti-complement component 5 mAb approved for paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder and is in Phase III for Guillain-Barre syndrome. Ultomiris is an approved antibody for Paroxysmal nocturnal hemoglobinuria and Hemolytic uremic syndrome and is in Phase III for generalized Myasthenia gravis, neuromyelitis optica spectrum disorder (NOSMD), hematopoietic stem cell transplant-associated thrombotic microangiopathy, Amyotrophic lateral sclerosis, complement-mediated thrombotic microangiopathy, severe pneumonia or acute respiratory distress syndrome in COVID-19. Alexion’s expertise in the complement cascade beyond C5 and additional modalities, including the pathway of the complement system, will strengthen AstraZeneca’s portfolio including immunology, neurology, metabolic cardiovascular, nephrology, and rare disease. Alexion shareholders received $60 per share in cash and 2.1243 ADS shares of AstraZeneca valued at $175 per share at a premium of 45%, or approximately $39B. Upon completion, Alexion will own 15% of the combined company.

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High hopes as Inventiva takes NASH contender into phase 3

Analysts are continuing to back Inventiva’s lanifibranor as a potential “best-in-class” drug for the fatty liver disease NASH, as the company prepares for the launch of a phase 3 trial in spring.

A team of analysts from Jefferies led by Lucy Codrington noted the design of the trial, which will have a dual goal measuring both liver inflammation and scarring could give an edge over potential competitors.

There are no approved drugs for NASH – full name non-alcoholic steatohepatitis – after the FDA rejected Intercept’s obeticholic acid last year.

The regulator said it wanted more long-term safety and efficacy data from the REGENERATE study before making a final decision on the drug, which had been expected to be the first entrant into a likely multi-billion dollar market niche.

According to the latest analysis from Jefferies the design for the phase 3 NATIVE3 study from Inventiva has been okayed by regulators and the case for lanifribanor has already been boosted by “stellar” results in phase 2.

The decision to include two endpoints of inflammation and scarring is important because improvements in both these measures are likely to lead to an improved prognosis.

Lanifibranor is also taken orally, making it convenient for patients and Inventiva is hoping to offer a choice of two doses offering doctors the ability lower the strength of the medication to control side-effects such as oedema.

The trial will take a while however, with results not due until the second half of 2023, with sales forecast to peak at around $2.6 billion annually if approved.

The Jefferies team also noted that the French biotech is also partnered with AbbVie to develop an oral successor to its inflammatory diseases blockbuster Humira (adalimumab).

Proof-of-concept phase 1b data is due from the drug codenamed ABBV-157 is due this quarter, which will help AbbVie decide on whether to continue development.

A host of other pharma companies including Gilead, Novo Nordisk, Merck & Co are also developing potential NASH drugs.

Only this morning, Novo Nordisk selected the first candidate from a project with Dicerna to find new gene-silencing drugs to treat liver-related diseases including NASH.

 

 

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Why cell therapy manufacture is a team sport

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work

This thought leadership series has been paid and developed by Kite, a Gilead Company.

In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer.

Roll on two years and the team has achieved what at the time appeared a major challenge, putting 1,000 tonnes of steel, 1,800 solar panels and 176km of network cable into the creation of a centre of excellence for cell therapy near Amsterdam in the Netherlands.

In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years. Our ambition was always to do this within two years, a goal we achieved despite the unprecedented challenge of a global coronavirus pandemic.

Indeed, while undoubtedly putting new hurdles in our path, the arrival of COVID-19 into our lives has transformed our business and operations by presenting an opportunity to be adaptable, flexible and responsive – and to continually evaluate and mitigate risk.

“There is huge complexity involved in cell therapy manufacture, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells”

It’s been a complex process that’s required highly technical and skilled personnel. Not only did we build a specialised facility from the ground up, but we built an organisation, from 10-15 people two years ago to more than 400 now. We put energy and emphasis into creating the right team and a culture where everyone understands the values and drivers, allowing us to operate in a collaborative and cohesive way.

Now the new €130 million, 19,000m2 manufacturing facility near Amsterdam is able to support delivery of up to 4,000 cell therapies each year for eligible cancer patients across Europe.

But backtrack to August 2018 and the very first European patients were also receiving treatment, part of an expertly crafted operation that ran in parallel to the build. Our supply chain group worked with the existing US team to manage the shipment of patients’ cells to the US for modification and their return for treatment.

Having a fully operational site in Europe versus the US has several advantages; reducing transportation time, strengthening the chain of custody and, potentially, cutting lead time to the patient by approximately one week. This allows us to potentially provide the therapy quicker for eligible cancer patients who have stopped responding to or have progressed despite other treatments. At this stage of their disease, for patients who have no other options, a week can make a difference.

The journey of the cell

The very nature of cell therapy manufacture means employees work in tightly controlled environments to ensure adherence to good manufacturing practice standards and, ultimately, to ensure the quality and integrity of the product.

Ultimately, it’s a team sport between Kite and Gilead and the 100-plus qualifying hospitals across Europe, all of which have been individually trained and assessed to ensure they are fully compliant with the necessary procedures and meet exacting standards.

So, what does the journey of the cell look like?

To achieve consistent, timely delivery of a high-quality product requires a robust and efficient approach to engineering patient’s own T cells, which in itself encompasses apheresis, cell modification and final formulation – coupled with rigorous quality control testing throughout – reflecting the highly complex nature of the manufacturing process.

Understandably, teamwork is vital and requires an integrated network and seamless communication between Kite and the treating hospital. The journey starts with the hospital making a treatment reservation through KiteKonnect and shipping of the apheresis kit to enable the process of extracting the patient’s own white blood cells, kickstarting both the chain of identity and chain of custody.

Here, our quality and supply chain experts are integral to every stage of the cell therapy manufacturing continuum to ensure the product is returned to the patient in a timely manner.

As soon as apheresis has completed, the cells are shipped in temperature-controlled conditions to our facility near Amsterdam where they are assessed for quality and condition. One patient equals one individual treatment, so it is critical to preserve the chain of custody and chain of identity to ensure the product comes back to the same patient.

Why chain of custody and identity is critical

The chain of custody and chain of identity must, therefore, go hand-in-hand. In this way, not only do we know which cells belong to which patient, but we have precise location and up-to-the-minute feedback on storage conditions to ensure quality and safety is paramount at all times.

Once the cells have completed this first stage, the manufacturing process can begin, with T cell selection, activation, and genetic modification using viral vector technology to ensure the ability to recognise the patient’s cancer cells. Cell expansion follows to multiply the modified cells into their millions.

Further critical quality testing then takes place to ensure the cells are of a required standard and to create a finished purified product, which will be stored and returned to the originator hospital in temperature-controlled conditions (see diagram below).

Several quality attributes will be tested at this stage and the cells must meet these rigorous criteria and specifications. There is huge complexity involved in cell therapy manufacturing, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells.

As part of this process, the supply chain team simultaneously coordinate with the hospital to prepare the individual so when the cells are infused back to the patient they are primed to potentially fight the cancer.

Individualising the approach

In stark contrast to basic biopharmaceutical products with a robust starting material, the cells of a patient with cancer who has already undergone multiple treatments will not have the same quality. Consequently, there can be unforeseen hurdles during the process and I am proud that the team has managed each situation to safeguard the patient’s cells and ensure they receive treatment in an efficient and timely way.

This is particularly important when you consider the turnaround for each individualised product from starting material to the patient is typically four weeks – versus months or even years for a standard biopharmaceutical product.

Additionally, each patient equals one product batch – we do not keep inventory – and the potential impact on the patient if something happens to that batch is why we are so passionate. From quality manufacturing, facility engineering, supply chain, we’re driven to make sure the batch is returned to the patient safely and effectively.

What of the future? For me, it’s all about leadership, clarity, direction, and commitment of the entire team. It’s about the opportunity to be involved in an innovative field of cancer therapy where the body is stimulated to fight cancer cells. It’s about optimising the manufacturing process to become more effective and efficient. But, most of all, it’s about the patients, their care partners and families

 

This was supported by Kite, a Gilead Company
UK-CTH-2020-11-0075 | Date of preparation: December 2020

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PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020.

1. Bayer Signs an Exclusive Option to License Agreement with Dare Biosciences to Commercialize Ovaprene in the US

  • Dare to receive up front, $20M as option exercise fee, $310M as commercial milestones, royalties on sales of the product along with access to Bayer’s clinical and market capabilities and remain responsible for development & regulatory activities of Ovaprene
  • Bayer to get exclusive right to commercialize Ovaprene in the US, once approved by the FDA. Dare is expected to file IDE for the therapy in H1’20 and the initiation of its clinical study in H2’20 following FDA’s review and clearance of the IDE
  • Ovaprene is an investigational hormone-free monthly vaginal contraceptive, currently in development for the prevention of pregnancy and if approved, will be the first monthly non-hormonal contraceptive therapy

2. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints

  • Theramax acquires commercialization rights of Zoely, allowing it to commercialize the therapy in 50+ countries globally. Earlier, Theramax has right to commercialize Zoely in eleven countries in the EU while MSD retains rights in the US and Canada
  • The acquisition of further rights of Zoely expands Theramex global footprints by providing innovative therapies to maintain the healthcare of women
  • Zoely is a combined oral contraceptive therapy consisting of two steroid hormones: 17-beta estradiol and nomegestrol acetate

3. Gilead Signs an Exclusive License Agreement with Rockefeller University for its Portfolio of HIV Abs

  • Rockfeller to receive up front, milestones plus royalties on sales and will retain rights to perform non-clinical and early-stage clinical research on the portfolio of HIV Abs. Gilead to get exclusive rights to develop and commercialize Rockefeller’s full portfolio of HIV bNAbs
  • The focus of the agreement is to enhance Gilead’s HIV pipeline and will advance academic programs into potential future products
  • 3BNC117 and 10-1074 are clinical-stage products with the ability to be used as HIV long-acting therapies for treatment and prevention

4. Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

  • Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software EW10-EC01 and the compatible expansion unit EX-1 in combination with the ELUXEO 7000 system
  • CAD EYE utilizes FUJIFILM’s REiLi AI technology and can perform complex segmentation of 2D/3D images, spot lesions & is compatible with various imaging modalities. It automatically engages with white light or LCI mode to improve the accuracy of lesion detection
  • CAD EYE is customized detection support used with the ELUXEO system, aimed to improve lesion detection in the colon at the expert level and is expected to be available with EX-1 in Mar’2020

5. GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

  • The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process
  • The submission is based on P-III PRIMA study assessing Zejula vs PBO in women in a ratio (2:1) as 1L therapy for stage III/ IV platinum-responsive advanced OC. The study demonstrated clinical outcomes of Zejula
  • Zejula (PO, qd) is a PARP inhibitor, indicated as a monothx. for the maintenance treatment of patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based CT

6. Esperion’s Nexlizet (bempedoic acid and ezetimibe) Tablet Receives the US FDA’s Approval as LDL-Cholesterol Lowering Medicine

  • The approval is based on P-III trial Fixed Combination Drug Product LDL-C Lowering program, involves assessing of Nexlizet vs PBO when added on to maximally tolerated statins
  • The study resulted in well-tolerated data and lowered LDL-C by 38%, when added on to maximally tolerated statins. Also, the results are published in The European Journal of Preventative Cardiology
  • Nexlizet is an oral qd, non-statin LDL-cholesterol lowering medicine approved by the US FDA on Feb 21, 2020 and will be available in Jul 2020. Nexletol (bempedoic acid) is a novel ATP Citrate Lyase inhibitor involves lowering of LDL-C by cholesterol biosynthesis and up-regulating the LDL receptors, will be available from Mar 30, 2020

7. AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

  • The P-III CASPIAN study involves assessing of Imfinzi + SOC (etoposide and carboplatin/ cisplatin CT) or Imfinzi + Tremelimumab vs CT as monothx. as a 1L treatment for 805 patients with ES-SCLC in 200+ centers across 23 countries
  • The first arm (Imfinzi + SOC) has met its 1EPs of OS in Jun’2019 while the second arm (Imfinzi + tremelimumab) did not meet its 1EPs of OS. The safety profile of each therapy is consistent with the known safety profiles
  • Imfinzi (durvalumab) is mAb targeting PD-L1, acts by blocking the interaction of PD-L1 with PD-1 & CD80 and is currently under review in combination with etoposide and carboplatin/cisplatin as 1L treatment for ES-SCLC in the US, EU and Japan with its anticipated PDUFA date in 2021

8. Novo Nordisk’s Fiasp (insulin aspart injection) Receives Health Canada’s Approval for Children with Diabetes

  • Health Canada has expanded the approval of Fiasp (10mL vials) to include use in insulin infusion pumps for the improvement of glycemic control in pediatric patients aged ≥2yrs with diabetes (T1D/T2D both)
  • The approval is based on data from 7 clinical studies that verified the safety & efficacy of Fiasp in children. The label change for use in insulin infusion pumps is based on Health Canada’s review of data from 5 clinical studies which demonstrated the efficacy of Fiasp used in insulin infusion pumps in adults with diabetes
  • Fiasp is the first and only fast-acting mealtime insulin injection, administered at the beginning of a meal or within 20 minutes after starting a meal and has received FDA’s approval as an IV infusion or SC MDI in adults with diabetes

9. Merck KGaA’s ERBITUX (cetuximab) Receives NMPA’s Approval as a 1L treatment for Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

  • The approval is based on P-III CHANGE II study assessing extreme regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX as maintenance therapy) vs Pt. based CT (cisplatin + 5-FU) in 243 patients aged ≥18 yrs. with R/M SCCHN, prior not treated with any systemic therapy in China
  • The P-III CHANGE II study results: improvement in PFS (5.5 vs 4.2mos.); OS (10.2 vs 8.4mos.), ORR (50% vs 27%) with no new safety findings
  • ERBITUX is an IgG1 mAb targeting the EGFR and is an approved therapy in 100+ countries for RAS wild-type m-CRC and for HNSCC

10. Bausch Health to Initiate Clinical Study Evaluating Virazole (Ribavirin for Inhalation Solution, USP) in Patients with COVID-19 in Canada

  • The clinical study will evaluate the safety and efficacy of Virazole + SOC in hospitalized patients aged ≥18yrs. with respiratory distress due to COVID-19
  • The clinical study has been approved by Health Canada and is expected to initiate within the next few weeks. The company is working with multiple health authorities including the US FDA regarding additional studies to assess Virazole as a treatment for COVID-19 infection
  • Virazole (ribavirin for inhalation solution, USP) aerosol is indicated only for lower respiratory tract infection due to RSV. The Bausch Foundation is working with health authorities in Italy to make Virazole for inhalation available free of charge in compassionate use in hospitals

11. Amgen Signs a Partnership with Adaptive Biotechnologies to Develop Abs for COVID-19

  • Adaptive to expand its platform for selection of B cell receptors of recovered patients from COVID-19. Amgen will utilize its Ab engineering and drug development capabilities to select and develop Abs designed to bind and neutralize SARS-CoV-2. Additionally, Amgen ‘s subsidiary DeCODE Genetics located in Iceland, will provide genetic information from patients infected with COVID-19
  • The focus of the collaboration is to combine expertise to discover and develop fully human neutralizing Abs for SARS-CoV-2 virus to treat COVID-19 where Adaptive’s immunological medicine platform will help in identification of virus neutralizing Abs
  • Additionally, the Abs can be used to treat patients with COVID-19 and can be administered to patients with who are at increased risk of exposure to SARS-CoV-2

12. BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany

  • The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US
  • The dose-escalation portion of the P-I/II study will include ~200 healthy participants aged 18-55yrs. and will target a dose range of 1-100 µg, focusing on determining the optimal dose for further studies and to evaluate the safety and immunogenicity of the vaccine
  • The study will evaluate the effects of repeated vaccination following a prime injection for 3 vaccine candidates that contain uRNA or modRNA. The fourth vaccine candidate contains saRNA will be evaluated following a single dose of vaccine. Additionally, BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct clinical studies

13. Fresenius Kabi Signs an Agreement with Medec to Commercialize IDACIO (adalimumab, biosimilar) in Germany

  • Fresenius Kabi and Medec collaborated to offer IDACIO as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From Jun 01, 2020, Medec’s will market the biosimilar therapy
  • Last year, Fresenius Kabi launched IDACIO in the EU for arthritis and psoriasis. The collaboration offers patients and doctors new benefits and synergies in therapy offerings as well as consulting
  • Medac provides methotrexate (metex PEN, metex FS) as the parenteral treatment of patients with chronic inflammatory diseases, the affected patients are treated with a combination of methotrexate and adalimumab

14. Neurocrine Biosciences Exercises its Option with Idorsia for ACT-709478

  • Idorsia to receive $45M upfront in cash, $365M for development & regulatory milestone, one-time sales threshold and royalties on sales. Additionally, will receive $7M in funding to discover, identify and develop additional novel T-type calcium channel blockers
  • Neurocrine exercises its option to license rights for ACT-709478 (post IND acceptance from the US FDA on Apr 30, 2020) for rare pediatric epilepsy. In 2019, Neurocrine and Idorsia signed a preclinical research collaboraion for ACT-709478 to treat rare pediatric epilepsy
  • ACT-709478 is an selective, orally-active and brain penetrating T-type calcium channel blocker also received the US FDA’s Rare Pediatric Disease designation for rare pediatric epilepsy with completion of P-I in 2019 and expected P-II initiation in in H2’20

15. Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19

  • The companies intend to establish manufacturing suites at Lonza’s facilities in the US and Switzerland to manufacture mRNA-1273 at both sites. The collaboration will deploy Lonza’s global expertise in technology transfer and manufacturing while the technology transfer expected to begin in Jun’2020
  • The focus of the collaboration is to enable the manufacturing of mRNA-1273 up to 1B doses/year and anticipates the manufacturing of the first batches of mRNA-1273 at Lonza US site in Jul’2020, assuming the currently expected dose of 50µg
  • Manufacturing operations at Lonza US site is covered by Moderna’s agreement with BARDA under which BARDA will support late-stage clinical development programs of mRNA-1273. On Apr 27, 2020, Moderna has submitted IND to the US FDA for P-II studies with its expected initiation in Q2’20

16. Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

  • The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 & 13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • In overall population: reduction in the risk of relapse (62% & 55%); In the pre-specified subgroup of AQP4-IgG seropositive patients: reduction in the risk of relapse (79% & 74%) respectively
  • Enspryng is a mAb targeting IL-6 and is under PR in Canada for NMOSD patients who are AQP4-IgG seropositive. In Oct’2019, the FDA & EMA has accepted the MAA for the therapy with expected CHMP & FDA’s decision in 2020

17. Cipla Launches Cipremi (remdesivir lyophilized powder for injection 100 mg) to Treat Patients with Severe COVID-19

  • The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s Remedisvir called CIPREMI
  • Cipla has received DCGI’s approval for restricted emergency use in India as part of the accelerated approval process. Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a P-IV clinical trial on Indian patients
  • As per ACTT-1 study, 1063 patients were treated with Remdesivir vs PBO over 60 centers across the US, EU and Asia demonstrated faster time to clinical recovery in hospitalized patients with the mortality rate as (7.1% vs 11.9%)

18. Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

  • Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus
  • Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. The assay develops three clear lines that confirm the assay validity and the qualitative detection & differentiation of IgM and IgG Abs to the COVID-19
  • Sorrento has secured manufacturing capacity to ramp up the production of up to 5M test kits/ month with the availability of results in ≤8mins. The assay showed specificity > 97% and diagnostic sensitivity of > 94% in an analytical validation

19. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside the Japan

  •  Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India
  • Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s and GRA for utilizing it in clinical studies targeting COVID-19. Moreover, Dr. Reddy’s will get right to use Avigan’s patents of formulation and manufacturing method and will establish a setup for developing drug-like Avigan and utilizes the GRA’s global sales network to supply the manufactured drugs
  • Fujifilm is currently conducting a clinical study on Avigan targeting COVID-19 patients in the US and Japan and is collaborating with multiple companies to increase the drug’s production

20. ViiV Healthcare’s Rukobia (fostemsavir) Receives the US FDA’s Approval for HIV in Patients with Limited Treatment Options

  • The approval is based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
  • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively
  • In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

21. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patient

22. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

  • J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in the key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

23.  Novartis’ Beovu (brolucizumab) Receives EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of an update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) that enhances tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors, and mitigation of AEs

24. Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

25. Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

26. Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

27. AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

28. Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

  • The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs
  • It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is used at the POC to test individuals <14yrs. The test is currently authorized for prescription use only
  • Lucira plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a website to arrange a prescription and overnight delivery of the test kit by Q2’21

29. UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

30. Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

Related Post: PharmaShots’ Most Read News of 2019

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The top 5 pharma M&A deals of 2020

2020’s M&A activity hasn’t quite reached the heights of last year’s, where two pharma mega-mergers – BMS’ buyout of Celegne and AbbVie’s acquisition of Allergan – accounted for almost 40% of total M&A deal values.

That said, there were still some interesting moves indicating new directions of travel for big pharma players – with most deals focused on specific drugs from biotechs, particularly in cancer (though we did get rumours of an AstraZeneca-Gilead merger, which would have been the biggest pharma M&A deal of all time).

Here we take a look at the biggest mergers and acquisitions of 2020 and what they might mean for the companies involved.

AstraZeneca & Alexion

By far the biggest pharma deal of the year is AstraZeneca’s late-breaking offer to buy Alexion for $39 billion.

Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and with the purchase, AZ will bolster its immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.

It marks something of a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.

While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.

In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.

Meanwhile, AZ will also pick up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.

Gilead & Immunomedics

The AZ-Alexion deal is likely to be the only big pharma merger this year, but Gilead’s purchase of US biotech Immunomedics and its potential cancer blockbuster Trodelvy isn’t far off it in terms of value, with the deal totalling $21 billion.

California-based Gilead announced its strong intentions in oncology in 2017 with its $11.9 billion buy of Kite Pharma and followed that earlier this year by acquiring immuno-oncology firm Forty Seven for $4.9 billion (see below). Shoring up its assets in a wider range of disease areas will help the company weather the storm as the pool of patients eligible to receive its hepatitis C drugs such as Sovaldi shrinks.

Trodelvy (sacituzumab govitecan) is a first-in-class TROP2 antibody-drug conjugate drug that was granted accelerated approval by the FDA in April for adults with metastatic triple-negative breast cancer (TNBC), who have received at least two previous therapies for metastatic disease.

Data from trials of the drug wowed ESMO in September – Trodelvy was shown to significantly extend overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared with standard chemotherapy in TNBC patients with brain metastases treated with at least two therapies.

The 500-plus patients in ASCENT had received a median of four previous anticancer treatments, but Trodelvy significantly improved OS with a median of 12.1 months, compared with 6.7 months in patients treated with chemotherapy.

Johnson and Johnson & Momenta

This $6.5 billion deal means that J&J has added potential inflammatory disease blockbuster nipocalimab to the pipeline at its Janssen pharmaceuticals unit.

J&J thinks that Momenta’s lead drug nipocalimab could be a kind of Swiss army knife drug that could be used across a range of inflammatory diseases including maternal-foetal disorders, neuro-inflammatory disorders, rheumatology, and autoimmune haematology.

The success of AbbVie’s Humira (adalimumab), which peaked at almost $20 billion in sales in 2018, demonstrates the potential of inflammatory diseases drugs to make mega-bucks.

Johnson & Johnson’s own Remicade (infliximab) was also a blockbuster several times over thanks to approvals in a range of inflammatory diseases including Crohn’s, rheumatoid arthritis and psoriasis.

But like the rest of this first generation of antibody-based drugs, Remicade has been hit by cheaper competition from biosimilars and the hunt is on for newer drugs that outperform standard therapy in terms of safety and efficacy.

Whether nipocalimab achieves the astronomical figures seen from Humira and Remicade remains to be seen – but the price J&J has paid shows the big pharma thinks it has considerable potential.

Momenta is best known for producing a generic version of Teva’s multiple sclerosis drug Copaxone (glatiramer), but nipocalimab is the company’s lead pipeline asset and the main rationale behind the acquisition.

“The first wave had disproportionate health, economic and social impacts on people in lower socioeconomic groups and those with black, Asian and minority ethnic backgrounds”

Gilead & Forty Seven

Further cementing Gilead’s ambitions in cancer, this $4.9 billion deal adds an antibody targeting several blood cancers to the company’s research pipeline.

Forty Seven is based in Menlo Park, a short drive away from Gilead’s base in Foster City, and is developing magrolimab, which is targeting myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML), and diffuse large B-cell lymphoma (DLBCL).

A potential first-in-class therapy, magrolimab targets CD47, which produces a “do not eat me” signal that allows cancer cells to avoid destruction (an area AbbVie has almost invested significantly in).

By targeting CD47 it’s hoped that magrolimab will allow the patient’s own innate system to engulf and eradicate cancer cells.

The company presented promising results from a phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology meeting in December.

Sanofi & Principia Biopharma

Sanofi added a potential multiple sclerosis drug to its pipeline when it bought Principia Biopharma for up to $3.68 billion in August.

The French pharma paid $100 per share in cash for San Francisco-based Principia, which specialises in Bruton’s kinase (BTK) inhibitor drugs, after the deal was unanimously agreed by both boards of directors.

Sanofi’s acquisition builds on a partnership to develop central nervous system drugs that began in late 2017.

In a statement Sanofi said that the acquisition will give it full control of the brain-penetrant BTK inhibitor SAR442168, making marketing more efficient and eliminating any royalty payments due under the 2017 agreement.

The drug known for short as ‘168 reduced multiple sclerosis brain lesions by 85% compared with placebo in a phase 2b trial.

Phase 3 development has begun and will comprise four pivotal trials across the MS disease spectrum.

Another of Principia’s BTK inhibitors, rilzabrutinib, is being tested in phase 3 for patients with moderate to severe pemphigus, a rare and debilitating autoimmune disease that causes blistering of the skin and mucous membranes.

Principia also has a topical BTK inhibitor, PRN473, which is in phase 1 development for immune diseases that could benefit from local application to the skin.

The deal follows Sanofi’s announcement late last year that it is rethinking its R&D operations, turning its back on diabetes and focusing on badly needed “transformative” therapies and maximising the potential of its asthma and eczema drug Dupixent.

CEO Paul Hudson, who was appointed to the role in June last year, has already acquired the oncology firm Synthorx and signed a potential $2 billion collaboration with Kymera Therapeutics to develop immune-inflammatory drugs.

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PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, Us FDA

NOWDiagnostics Receives CE Mark for its ADEXUSDx COVID-19 Antibody Fingerstick Test

Published: Dec 17, 2020 | Tags: ADEXUSDx COVID-19, Antibody Fingerstick Test, COVID-19, Launches, NOWDiagnostics

GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

Published: Dec 17, 2020 | Tags: (belimumab), Active, Benlysta, GSK, Lupus Nephritis (LN), Recieves, US, US FDA’s Approval

GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813

Published: Dec 17, 2020 | Tags: Commercialize, Develop, Exclusive License Agreement, GSK, Signs, SRF813, Surface Oncology

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Published: Dec 17, 2020 | Tags: Advisory, Against, Committee, COVID-19, EUA, Moderna, receives, Supporting, US, Us FDA, vaccine, Vote

Novartis to Acquire Cadent Therapeutics for ~$770M

Published: Dec 17, 2020 | Tags: $770M, Acquire, Cadent, Novartis, therapeutics

Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

Published: Dec 16, 2020 | Tags: (KTE-X19), EC’s Conditional Marketing Authorization, Europe, Kite, receives, Relapsed or Refractory Mantle Cell Lymphoma, Tecartus, ZUMA-2 Study

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Published: Dec 16, 2020 | Tags: Advanced, Amgen, KRAS G12C, Metastatic, Mutation, NDA, NSCLC, reports, Sotorasib, Submission, Us FDA

Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Published: Dec 16, 2020 | Tags: approval, Health Canada, Novartis, One-Time Gene Therapy, receives, Spinal Muscular Atrophy (SMA), Zolgensma

Novo Nordisk to Initiate a P-lll Study of Semaglutide to Treat Alzheimer Disease

Published: Dec 16, 2020 | Tags:  Alzheimer Disease, Novo Nordisk, P-lll Development, Semaglutide, Start

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Published: Dec 15, 2020 | Tags: Advisory, Committee, Entresto, HFpEF, Novartis, patients, Positive, receives, Recommendation, Treat, USFDA

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Published: Dec 15, 2020 | Tags: Abbott, antibody, Blood, CE Mark, COVID-19, IgG, Quantitative, receives, Test

Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

Published: Dec 15, 2020 | Tags: Antigen, COVID-19, Ellume, EUA, receives, Test, Us FDA

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Published: Dec 15, 2020 | Tags: Belt, Bone Health Technologies, Breakthrough, Designation, Device, OsteoBoost, receives, USFDA, Vibration

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Published: Dec 15, 2020 | Tags: (budesonide oral suspension), Eosinophilic Esophagitis (EoE), NDA, reports, TAK-721, Takeda, US FDA’s Acceptance

Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

Published: Dec 15, 2020 | Tags: (tirbanibulin), Actinic Keratosis, Athenex’s, Face, Klisyri, receives, Scalp, US FDA’s Approval

Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

Published: Dec 15, 2020 | Tags: Agreement, Commercialization, Development, Filgotinib, Galapagos, Gilead, Jyseleca, Signs

Lilly to Acquire Prevail Therapeutics for ~$1.04B

Published: Dec 15, 2020 | Tags: ~$1.04B, Acquire, Lilly, Prevail Therapeutics

EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

Published: Dec 15, 2020 | Tags: approval, AstraZeneca, CHMP, EU, Imfinzi, NSCLC, Recommended, Unresectable

CureVac Commences P-llb/lll Trial of CVnCoV for COVID-19

Published: Dec 14, 2020 | Tags: Commences, COVID-19, CureVac, CVnCoV, P-llb/lll Trial

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Published: Dec 15, 2020 | Tags: Advanced, breast, Cancer, Cobas, Launch, Metastatic, Mutation, patients, PIK3CA, Roche, Test

Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Dec 14, 2020 | Tags: (Denosumab), Initiates, P-Ill Study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

Published: Dec 14, 2020 | Tags: Agreement, Commercialization, Develop, Genentech, Relay Therapeutics, RLY-1971, Signs, Worldwide License

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Published: Dec 14, 2020 | Tags: approval, Genentech, Multiple Sclerosis, ocrelizumab, Ocrevus, Primary, Progressive, receives, Relapsing, Us FDA

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

Published: Dec 11, 2020 | Tags: approval, AstraZeneca, breast, Cancer, CHMP, Daiichi Sankyo, Deruxtecan, EU, HER2, Metastatic, Positive, Recommended, trastuzumab

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Published: Dec 14, 2020 | Tags: COVID-19, Novartis, P-lll, reports, results, RUXCOVID Study, ruxolitinib

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Published: Dec 14, 2020 | Tags: AstraZeneca’s, China, EU’s Approval, Japan, moderate to severe chronic obstructive pulmonary disease (COPD), receives, Trixeo Aerosphere, US

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

Published: Dec 10, 2020 | Tags: Agreement, Alvotech, Biosimilar, Commercialization, Extends, Four, Fuji Pharma, Japan, Medicines

Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Date: Dec 11, 2020 | Tags: BioNTech, BLA, BNT162b2, COVID-19, EUA, files, Pfizer, Prevent, receives, Us FDA

AstraZeneca to Acquire Alexion for $39B

Published: Dec 12, 2020 | Tags: $39B, Acquires, Alexion, AstraZeneca

Related News: PharmaShots Weekly Snapshots (Dec 7-11, 2020)

The post PharmaShots Weekly Snapshots (Dec 14-18, 2020) first appeared on PharmaShots.

Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

Shots:

  • Following the FDA Type A meeting, Gilead will not pursue the approval of Jyseleca for RA in the US. Galapagos will be solely responsible in EU for Jyseleca (200/100mg) in RA and UC + all future indications for which Gilead will receive royalties on EU sales initiating in 2024
  • Galapagos to receive $194.6M, which will be split b/w $133.7M in 2021 & $60.8M in 2022 for the ongoing development and accelerated commercial buildout in the EU
  • Additionally, Galapagos will assume responsibility for ongoing clinical trials evaluating filgotinib in RA. Gilead will retain commercial rights for filgotinib outside the EU, including in Japan where filgotinib has recently been approved and is co-marketed with Eisai

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Canva

The post Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib) first appeared on PharmaShots.

Evolution in Hepatitis B and C Virus: Can we expect success similar to Hepatitis C in Hepatitis B as well?

Hepatitis is an infection that causes inflammation of the liver. The condition can be self-limiting or can progress to fibrosis (scarring), cirrhosis, or liver cancer. Hepatitis viruses are the most common cause of hepatitis; however, other infections such as toxic substances (e.g., alcohol, certain drugs) and autoimmune diseases can also cause hepatitis. The hepatitis viruses fall into five different types: A, B, C, D, and E. The most common types in the United States are Hepatitis B and C viruses. Both hepatitis B and C viruses are blood-borne pathogens, which means that their primary mode of transmission is through direct blood-to-blood contact with an infected person. Also, both hepatitis B and C viruses can cause chronic, lifelong infections that can lead to severe liver disease.

As per the Centers for Disease Control and Prevention (CDC) estimates, approximately 2.0–2.5 million US residents were living with chronic Hepatitis C in the year 2016, and an estimated 50,300 new infections occurred in 2018. In contrast, approximately 850,000–2.2 million people were living with chronic Hepatitis B in the United States in the year 2016. Due to hepatitis C, most people develop cirrhosis, or scarring of the liver, before liver cancer; about 5–25% of patients with chronic hepatitis C develop cirrhosis over 10–20 years. People with hepatitis C and cirrhosis have a 1–4% annual risk for hepatocellular carcinoma. However, most people with acute HBV infection recover with no lasting liver damage, and about 15–25% of people with chronic HBV infection develop chronic liver disease, including cirrhosis, liver failure, or liver cancer.

Hurdles in the Hepatitis treatment

As the new HCV infections are usually asymptomatic, few people are diagnosed when the infection is recent. For those who develop chronic HCV infection, the infection is often undiagnosed because it remains asymptomatic until decades and also not all the patients are aware of their condition so as to approach treatment. Hence, WHO is working toward eliminating chronic HCV as a public health threat by 2030, for which WHO has set a target of 90% diagnosis and 80% treatment coverage under “Global Health Sector Strategy on Viral Hepatitis, 2016-2021.”

Research and development in Hepatitis

In the 1960s, Baruch Blumberg determined that one form of blood-borne hepatitis was caused by a virus that became known as the hepatitis B virus. This discovery led to the development of diagnostic tests and an effective vaccine, and Blumberg was awarded the Nobel Prize in Physiology or Medicine in 1976 for this discovery. In comparison, HCV was initially isolated from the serum of a person with non-A, non-B hepatitis viruses in 1989. Shortly after HCV cloning, this newfound virus was discovered to cause approximately 90% of non-A, non-B hepatitis virus in the US. Harvey J. Alter, Michael Houghton, and Charles M. Rice were awarded the Nobel Prize in 2020 for their seminal discoveries that led to the identification of a novel Hepatitis C virus. However, there is still a need for further research on HCV and the risk factors that lead to the progression of fibrosis, cirrhosis, and Hepatocellular carcinoma (HCC). Identification of additional viral, host, and external factors would help develop means of prevention, early detection, and treatment.

Hepatitis Treatment pattern

The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. When used alone, response rates for IFNa were relatively low, helping only one-third of the hepatitis C patients, and the relapse rate was very high. Frequent side effects and average sustained viral response (SVR) was observed with IFNa treatment. Pegylated INF-α2b (PegINF-α2b) was developed to maintain a steady level of an active drug and reduce the frequency of administration. Following clinical studies showed that PegINF-α2b was superior to the unpegylated IFN, and a new combination of PegINF-α2b and ribavirin became the standard choice of hepatitis C treatment for the next 10 years. 

However, the side effects and negative interactions with other drugs outweighed the benefits. Some of the more serious side effects, such as congenital disabilities and rectal pain, led to the discontinuation of both the drugs.

A better understanding of HCV structure, enzymes, and lifecycle led to the introduction of new drug targets and the discovery of Direct-Acting Antivirals (DAAs). These DAA treatments are much better than the previously available treatment because they have fewer side effects and do not need to be injected.  DAA therapies for HCV have shown initial cure rates of 95–99% and re-treatment cure rates of 95%. First DAAs (telaprevir and boceprevir), used in combination with PegINF-α and ribavirin, were officially approved for HCV GT1 treatment. Both drugs resulted in inhibition of HCV replication. Even though clinical trial results were promising, adverse events and serious complications were observed. In 2013, Sofosbuvir – an NS5B polymerase inhibitor – was developed and proven effective against all HCV GTs. It was approved as a part of therapy for HCV GT1 and GT4 with PegINF-α and GT2 and GT3 with ribavirin.

Hepatitis C treatment options, without a doubt, have improved significantly, including pan-genotypic medications that are used to treat all genotypes and subtypes. Typically, pan-genotypic treatments have high cure rates, few side effects, and short treatment durations (usually 8–12 weeks). For hepatitis C, a cure is defined as a sustained virologic response (SVR), which means that the virus is not detected in a person’s blood 3 months after treatment has been completed. In 2016, sofosbuvir/velpatasvir‎ (Epclusa) was developed as the first drug therapy to treat all hepatitis C genotypes. The side effects were considered low, and the cure rate was as high as 98% in those without severe liver scarring (cirrhosis) and 86% in those with cirrhosis. In July 2017, the US FDA approved sofosbuvir/velpatasvir/voxilaprevir‎ (Vosevi) to treat adult chronic hepatitis C of all genotypes previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. In the United States, an affordable, generic version of Epclusa and Harvoni was released by Gilead Sciences, Inc. in January 2019. In August 2017, the US FDA approved glecaprevir/pibrentasvir (Mavyret) to treat adults with HCV genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.

The treatment outcomes of HCV infection in children has also greatly improved. Earlier, the standard therapy was a combination of pegylated interferon (PEG–IFN) α-2a or 2b and ribavirin, and the duration of therapy depended on the HCV genotype. In 2020, the US FDA approved Epclusa (sofosbuvir and velpatasvir) to treat HCV in children ages 6 years and older with any of the six HCV genotypes.

Chronic hepatitis B infection is treated with medicines, including oral antiviral agents. Treatments that are effective in suppressing HBV replication are interferons (IFNs) and nucleos(t)ide analogs (NAs). Interferon has a low functional cure rate, but the rate varies according to the host phase of infection.  After interferon therapy, the functional cure rate is, at most, 20%. Furthermore, the other class of medicine for current HBV treatment consists of HBV polymerase inhibitors, often called nucleoside or nucleotide analogs. These include oral treatments such as tenofovir or entecavir. Tenofovir, approved in 2008 by the US FDA, is recommended by WHO as a potent drug to suppress the hepatitis B virus. These agents are very effective by blocking the viral enzyme needed for the virus to replicate itself. However, they do not act directly to the host immune system, and their functional cure rate is lower than that of interferon (<10%). However, the treatment does not cure hepatitis B infection but only suppresses the replication of the virus. Therefore, most people who start hepatitis B treatment have to continue it for life.

Future of Hepatitis treatment

The major barrier to eliminating HBV is the persistence of cccDNA and its ability to self‐replenish and the lack of direct effects of current therapies on cccDNA. Unlike a typical virus, hepatitis B’s cccDNA permanently integrates itself into a healthy cell’s DNA. The complex nature and integration process of cccDNA contributes to the difficulties of finding a cure for hepatitis B. There are additional barriers to eliminating HBV. HBV DNA can be integrated into the host genome. Hence, the persistence of cccDNA, the presence of integrated HBV DNA, and impaired innate and adaptive immune responses make it difficult to eliminate HBV from chronically infected patients. Currently, no curative therapy is available. The therapies available to date inhibit virus replication but need to be given long-term.

New antiviral drugs in clinical trials include entry receptor inhibitors, capsid assembly modifiers, RNA interference, and nucleic acid polymers. Several novel therapies are also coming up in the future, such as JNJ-64300535 or Selgantolimod, which will be helpful for the high global burden of hepatitis B, the desire to achieve a cure with a finite course of therapy, and the need to effectively control HBV replication at an early stage of chronic HBV infection.

In the case of HCV, the hepatitis C market is set to experience a steady decline. Declining patient populations and unusually high DAA treatment rates are expected to reduce the disease prevalence to a more sustainable level. Gilead, one of the leading pharmaceutical companies for HCV, had announced that combined sales for Harvoni, Sovaldi, Epclusa, and Vosevi declined due to fewer patients initiating treatment and increased drug competition. Similar to HCV, companies active in HBV space are also trying the cocktail of drugs with a different mechanism of actions and if these therapies are expected to lift the cure rate bar compared to current antiviral drugs if launched successfully. Although hepatitis B virus discovered earlier to hepatitis C, there is still a long way to go in HBV space in terms of cure rate and we might witness revolutions in treatment similar to HCV space in upcoming years. 

The post Evolution in Hepatitis B and C Virus: Can we expect success similar to Hepatitis C in Hepatitis B as well? appeared first on DelveInsight Business Research.

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

Lilly’s baricitinib granted US emergency use in COVID-19

Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib.

Baricitinib is the active ingredient in Lilly’s rheumatoid arthritis drug Olumiant and is the latest example of a drug being repurposed to combat COVID-19.

Most of the drugs attempt to tackle the inflammation that can cause complications in patients with severe disease.

While not all the attempts to get existing drugs to work in COVID-19 have been successful, the FDA said there is enough evidence to justify the emergency use for baricitinib in adults and children aged over two who are hospitalised with the disease and require oxygen therapy or invasive mechanical ventilation.

This temporary authorisation, which only applies during the COVID-19 crisis, is based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2) conducted by the National Institute of Allergy and Infectious Diseases, part of the government funded National Institutes of Health.

Patients treated with baricitinib in combination with Gilead’s remdesivir had a significant reduction in median time to recovery from eight to seven days (12.5% improvement) compared to remdesivir.

The FDA’s decision came as the World Health Organization has advised against using Gilead’s Veklury (remdesivir) to treat hospitalised patients with COVID-19, no matter how severe their illness, after saying new evidence no longer supports its use.

The update is in contrast to the FDA, which has approved remdesivir to treat patients hospitalised with COVID-19 last month, after it was granted and Emergency Use Authorization earlier in the year.

But in the new guidance published in the BMJ, the WHO’s experts recommend against using remdesivir in non-severe, severe, or critical patients, citing weak evidence.

However the panel said there is strong evidence in favour of using corticosteroids in patients with severe or critical disease.

The latest guidance was produced using a systematic review of latest evidence.

According to the panel of experts who drew up the guideline, the evidence suggests that remdesivir has no important effect on mortality, need for mechanical intervention, time to clinical improvement and other outcomes.

The guidance was triggered by findings of the WHO’s SOLIDARITY trial last month, which reported results treating hospitalised COVID-19 patients with remdesivir, the steroid hydroxychloroquine, and the antiviral combination lopinavir-ritonavir.

Findings of SOLIDARITY diverged from evidence gathered in the US – last month data from the National Institutes of Health-backed ACTT-1 trial study showed Veklury resulted in five days’ faster recovery in patients hospitalised with COVID-19.

There was a non-statistically significant trend towards a reduction in mortality, with the effect being more pronounced in patients who were on low-flow oxygen at baseline.

In a statement, Gilead noted that Veklury has been included in guidelines from the NIH and Infectious Diseases Society of America, as well as in national guidelines in Japan, the UK, and Germany.

Gilead added: “These recommendations are based on the robust evidence from multiple randomised, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury, such as significantly faster recovery, which can free up limited hospital resources.

“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries.”

 

The post Lilly’s baricitinib granted US emergency use in COVID-19 appeared first on .

Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 5 new drugs approved by the US FDA in Oct 2020.

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Received the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: Approval, Atoltivimab, Ebolavirus, Firs,t Inmazeb, Maftivimab, Odesivimab, Receives, Regeneron, Treatment, US FDA

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

Nevakar’s Ephedrine Sulfate Injection Received the US FDA’s Approval as Ready-To-Use Vials

Published: Oct 22, 2020 | Tags: Nevakar, Ephedrine Sulfate, Injection, Receives, US FDA, Approval, Ready to Use, Vials

  • Nevakar received US FDA’s approval to market Ephedrine Sulfate Injection (50mg/10 ml) in a ready to use vial presentation and it is the 1st approval under collaboration bw Nevakar and Endo for the development of sterile injectable product in the US and Canada
  • Nevakar to develop and obtain FDA approval for these products and Par Pharmaceuticals Sterile Products division will launch and distribute the products
  • The company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patient care and quality of life

Gilead’s Veklury (remdesivir) Received the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 23, 2020 | Tags: COVID-19, Gilead, Receives, Remdesivir, US FDA, Approval, Veklury

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the 1st and only approved COVID-19 treatment in the US

Kala Pharmaceuticals’ Eysuvis (loteprednol etabonate ophthalmic suspension) Received US FDA’s Approval for Dry Eye Disease

Published: Oct 27, 2020 | Tags: Kala Pharmaceuticals, Eysuvis, Loteprednol, Etabonate, Ophthalmic, Suspension, US FDA, Dry Eye Disease

  • The approval is based on results from four clinical trials, including three P-III trials and one P-II trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease
  • The approval has made Eysuvis, the 1st ocular corticosteroid for the treatment of dry eye disease and the 1st drug approved specifically for the short-term (up to 2 wks.) treatment of the signs and symptoms of dry eye disease
  • Eysuvis utilizes Kala’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance penetration of loteprednol etabonate into target tissue on the ocular surface. The company plans to launch Eysuvis in the US by the end of the year 2020

Chiesi’s Bronchitol (mannitol) Inhalation Powder Received US FDA’s Approval for Cystic Fibrosis

Published: Oct 30, 2020 | Tags: Chiesi, Bronchitol, Mannitol, Inhalation, Powder, Receives, US FDA, Approval, Cystic Fibrosis, Pulmonary

  • In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed
  • Bronchitol is currently approved and marketed in Australia, Italy, Germany, Russia, and several other countries. Additionally, the company anticipates launching Bronchitol in the US in Mar 2021
  • Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older

Related Post: Insights+: The US FDA New Drug Approvals in September 2020

The post Insights+: The US FDA New Drug Approvals in October 2020 first appeared on PharmaShots.

ViiV could challenge Gilead with long-acting HIV PrEP shot

GlaxoSmithKline’s HIV joint venture ViiV Healthcare could mount a challenge to Gilead’s HIV pre-exposure prophylaxis (PrEP) medicines after the FDA granted Breakthrough Therapy Designation for its long-acting injectable drug cabotegravir.

In the trial cabotegravir was injected every eight weeks in a formulation that the company hopes will be more appealing than Gilead’s daily Truvada pill.

Offering patients the option of an injection every eight weeks would allow them to take the medicine more discreetly. Trial results show that cabotegravir is more effective at preventing infections than Truvada.

PrEP drugs are taken by HIV-negative people before they have sex and reduce the risk of getting HIV.

The FDA granted the status based on efficacy and safety results of a trial comparing cabotegravir with emtricitabine+tenofovir disoproxil fumarate (FTC/TDF) – the active ingredients in Gilead’s Truvada – in high-risk individuals.

HPTN 08 is, a phase IIb/III randomised, multicentre, double-blinded, clinical trial comparing the two drugs for HIV prevention among 4,566 men who have sex with men and transgender women who have sex with men.

ViiV said the final analysis of HPTN 083 showed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral Truvada tablets.

Results of the trial were presented at the AIDS 2020 conference in July and the blinded phase of a prevention study in 3,223 sub-Saharan African women was stopped earlier this month after an analysis by the independent safety monitoring board showed cabotegravir was superior to oral FTC/TDF.

Viiv, which is majority owned by GSK with Pfizer and Shionogi as shareholders, plans to use the data from both studies for future filings with regulators.

Breakthrough Therapy status is intended to expedite the development and review of drugs for serious or life-threatening diseases, which may be better than available therapies.

The FDA requires preliminary clinical evidence showing a drug may be a substantial improvement on at least one clinically significant endpoint over available therapies.

It may allow more frequent collaboration with the FDA to discuss a development plan and could pave the way for a faster Priority Review lasting six months.

Gilead has also produced a follow-up to Truvada – Descovy (emtricitabine+tenofovir alafenamide) which is approved by the FDA in PrEP and to help keep the virus at bay in those infected with the virus.

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Gilead and Novo Nordisk plot next steps after encouraging data from NASH combo

Gilead and Novo Nordisk have announced drug combinations for the fatty liver disease known as NASH involving the GLP-1 class drug semaglutide have checked out in a mid-stage proof-of-concept study.

The companies said that the trial met its primary safety goal in people with non-alcoholic steatohepatitis (NASH) but stopped short of announcing any further plans for clinical development.

Instead they are “carefully evaluating next steps based on a thorough assessment of data,” according to Novo Nordisk’s senior vice president of global development, Martin Holst Lange.

The five-arm trial tested combinations of Novo’s semaglutide GLP-1 agonist, in various combinations with two Gilead pipeline drugs:  the FXR agonist cilofexor and the investigational ACC inhibitor firsocostat.

Semaglutide is the active ingredient in Novo’s weekly injection Ozempic and its daily pill Rybelsus, which are both approved to treat type 2 diabetes.

Results of the 24-week trial involving 108 people with NASH were presented at The Liver Meeting Digital Experience over the weekend.

The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis, all regimens were well tolerated.

The most common adverse events (AEs) were gastrointestinal. Minimal pruritus (itching) was observed in people treated with cilofexor.

Across all groups, 5–14% of people discontinued any trial treatment due to AEs.

Exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks in post-hoc analyses showed statistically significant improvements in liver fat levels and liver injury in the combination arms versus semaglutide alone.

Although liver stiffness measured and enhanced liver fibrosis score declined in all groups, statistically significant differences between groups were not observed.

Gilead and Novo are among a group of companies searching for therapies for NASH, which has for years been predicted to be a source of billions of dollars in revenue for big pharma.

But finding a drug that works against the disease has proved tricky: the FDA rejected Intercept Pharmaceuticals’ FXR agonist obeticholic acid in NASH in July after deciding its benefits would not outweigh its risks.

Although the REGENERATE study showed obeticholic acid increased the likelihood of at least a one-stage improvement in fibrosis without worsening of NASH, it failed to meet another endpoint of improvement in NASH without worsening fibrosis.

Gilead added frisocostat and cilofexor to its pipeline after acquiring them from Nimbus Therapeutics and Phenex Pharmaceuticals, respectively.

The California biotech’s other big hope in NASH selonsertib is yet to produce convincing results in late stage clinical trials.

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PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart from acquisitions, big alliances were the highlights of the quarter which include Biogen collaboration with Denali on LRRK2 program for Parkinson’s Disease worth ~$2.125B, Sanofi’s agreement with Kymera to advance novel protein degrader therapies, Roche & UCB’s collaboration to develop UCB0107 for AD, Merck’s $4.5B oncology deal with Seattle Genetics. The third quarter of the year also showcases multiple approvals of the therapies which include Roche’s FDA’s approval for the VENTANA HER2 Dual ISH test as CDx, Genentech’ Gavreto (pralsetinib) got the US FDA’s approval for metastatic RET fusion-positive NSCLC. Meanwhile, AstraZeneca, J&J, and Novavax initiated the P-III development of their COVID-19 vaccine candidates. Our team at PharmaShots has summarized and complied with the insights of Q3’20.

Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK

Date – Sept 25, 2020

Product – NVX-CoV2373

  • Novavax has initiated P-III study assessing the efficacy, safety and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks.
  • Half the participants will receive two IM injections of vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive PBO
  • The 1EPs & 2EPs is the first occurrence of PCR-confirmed symptomatic COVID-19 & PCR-confirmed symptomatic mod. to sev. COVID-19 with the onset at least 7 days after second study vaccination in volunteers prior not infected with SARS-CoV-2 respectively. Novavax has continued to scale-up its manufacturing capacity, currently up to 2B annually

J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine

Date- Sept 24, 2020

Product- JNJ-78436735

  • The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
  • The P-III ENSEMBLE study is design to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60,000 adults aged ≥18yrs., including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
  • The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021, if proven to be safe and effective

Illumina Acquired GRAIL for ~$8B

Date – Sept 22, 2020

Deal Value – ~$8B

  • Illumina to acquire GRAIL in cash & stock transaction for $8B including ~$3.5B in cash and $4.5B in shares of Illumina common stock. Illumina founded GRAIL in 2016 and later spun out it to develop state-of-the-art data science, ML and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests
  • GRAIL to receive CVR and future payments representing a pro rata portion of certain GRAIL-related revenues/ year for 12yrs., reflecting a 2.5% payment right to the first $1B of revenue each year for 12yrs. and 9% CVR if revenue is above $1B. Additionally, GRAIL to get the option to receive additional cash and/or stock consideration, prior to closing, in lieu of the CVR
  • The acquisition will transform cancer care using genomics and NGS platform and accelerates commercialization and adoption of transformative multi-cancer screening test with potential to detect cancer. GRAIL expects to launch Galleri in 2021 which can detect 50+ cancer indications

Fitbit to Launch ECG App in the US and EU in October 2020

Date – Sept 15, 2020

Product – ECG App

  • Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The Fitbit ECG app will be available in Oct’2020 to the users on Fitbit Sense smartwatch
  • The company has launched a multi-site clinical trial across the US, to detect AFib from normal sinus rhythm and to generate an ECG trace, recording of a heart’s electrical rhythm, that is qualitatively like Lead I ECG. The study demonstrated that algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
  • Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel

Novartis’ Beovu (brolucizumab) Received EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

Date – Sept 15, 2020

Product – Beovu (brolucizumab)

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) which enhances tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of AEs

Gilead Acquired Immunomedics for ~$21B

Date – Sept 14, 2020

Deal Value – ~$21B

  • Gilead to acquire Immunomedics for $88.00/ share representing a 108% premium to Immunomedics’ closing price on Sept 11, 2020, making a total deal value $21B. The transaction is expected to be completed in Q4’20
  • The acquisition will add Immunomedic’s s Trodelvy to Gilead’s portfolio, expanding its oncology pipeline and accelerated its revenue and EPS growth. Additionally, the Trodelvy is being studied in an ongoing P-III study for 3L HR+/HER2- BC and a registrational P-II study in bladder cancer, NSCLC, and other solid tumors
  • Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, received accelerated approved for mTNBC in the US while the company plans to submit the sBLA for the full approval of the therapy in Q4’20. Immunomedics is on track to file for regulatory approval in EU in the H1’21

Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics

Date – Sept 14, 2020

Deal Value – ~$4.5B

  • Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, $2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs
  • The companies will co-commercialize the therapy in the US and EU. Seattle Genetics will be responsible for approval in the US & Canada and will record sales in the US, Canada, and EU while Merck will be responsible for approval in EU & outside the US & Canada, and will record sales in countries outside the US, EU, and Canada
  • Additionally, companies enter exclusive license and co-development agreement to accelerate the global reach of Tukysa for HER2+ cancers in regions outside the US, EU & Canada. As per the agreement, Seattle Genetics to receive $125M as upfront and is eligible to receive up to $65M as progress-dependent milestones, $85M as research and development milestones, and royalties on sales of Tukysa in Merck’s territory

Novartis’ Kisqali (ribociclib) Received Highest Score on the ESMO Magnitude of Clinical Benefit Scale

Date – Sept 11, 2020

Product – Kisqali (ribociclib)

  • Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 score on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study
  • Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with fulvestrant  for 1L postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained QoL observed in P-III MONALEESA-3. Additionally, Kisqali + fulvestrant receive a score of 4 out of 5 in 2L setting based on the MONALEEA-3 study
  • New data presented at ESMO 2020 add to the substantial body of evidence further differentiating Kisqali as the only CDK 4/6 inhibitor that improves OS in two P- III trials, with consistent results across patient subgroups, and with QoL benefits. Kisqali in patients with endocrine resistance led to a 30% & 41% reduction in the risk of death in the MONALEESA-3 & -7 studies over standard endocrine therapy respectively

AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B

Date – Sept 09, 2020

Deal Value – ~$2B

  • I-Mab to receive $180M upfront, $20M on P-I results and is eligible to receive $1.74B which include $840M as development & regulatory milestones while remaining as commercial milestones along with royalties on sales of the therapy outside China
  • AbbVie to get an exclusive global license (Ex-greater China) to develop and commercialize lemzoparlimab while I-Mab retain its right in China. Both the companies will conduct clinical trials to evaluate lemzoparlimab in multiple cancers while each partner have the potential to expand the collaboration to additional transformative therapies
  • The companies will have the opportunity to further licenses to explore each other’s related programs in their respective territories. Lemzoparlimab is an anti-CD47 mAb, designed to minimize inherent binding to normal RBCs while preserving its strong anti-tumor activity

Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Date – Sept 07, 2020

Product – Gavreto (pralsetinib)

  • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors
  • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer
  • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb, 2021

AstraZeneca Expanded the Development of AZD1222 into P-III Study in the US Across All Adult Age Groups

Date- Sept 01, 2020

Product- AZD1222

  • AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess it safety, efficacy and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine
  • The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. in a ratio (2:1) across ~100 trial centers in and outside the US. Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4wks. apart, with twice as many participants receiving the potential vaccine than the saline control
  • The company is evaluating the AZD1222 globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, while the trials are planned to start in Japan and Russia

GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19

Date- Sept 01, 2020

Product- VIR-7831

  • The first patient has been dosed last week in a P-II/III COMET-ICE study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization
  • The study will enroll ~ 1,300 patients globally who have early symptomatic infection. The P-II/III study comprises of two parts: The Lead-In phase will assess the safety and tolerability of VIR-7831 (IV, 500mg) vs PBO over a 14-day period in non-hospitalized patients and aims to recruit 20 patients across the US
  • Following this initial safety assessment, the Expansion phase will assess the safety and efficacy VIR-7831 (IV) vs PBO in ~1,300 non-hospitalized participants globally. The company expects the results in Q1’21 and early access to the Ab treatment in H1’21

World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan

Date – Aug 31, 2020

Product – CureApp

  • On Aug 21, 2020, CureApp receive MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020
  • CureApp SC is a prescription medical device designed to aid patients receiving outpatient smoking cessation treatment and supports patients to quit smoking in a home setting. The product consists of three components – a patient app, a doctor app, and a portable CO Checker
  • The patient app can provide personalized guidance and is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of CO in their breath at home. The patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app

GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma

Date – Aug 27, 2020

Product – Blenrep (belantamab mafodotin-blmf)

  • The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
  • The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
  • Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017

Novartis’ Kesimpta (ofatumumab) Received the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Date – Aug 21, 2020

Product – Kesimpta (ofatumumab)

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22 & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B

Date – Aug 19, 2020

Deal Value – ~$6.5B

  • J&J acquires Momenta in all cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

Sanofi Acquired Principia Biopharma for ~$3.68B

Date – Aug 17, 2020

Deal Value – ~$3.6B

  • Sanofi to acquire Principia Biopharma in all stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20
  • The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of SAR442168 development program into CNS disorders. Additionally, the deal also adds rilzabrutinib to Sanofi’s portfolio of immunology and inflammation indications
  • The Principia’s BTK inhibitor ‘168 is developed using its Tailored Covalency platform and was evaluated in P-IIb study for MS leading reduction of 85% Gd-enhancing T1 hyperintense lesions vs PBO. In 2017, Sanofi signed exclusive WW license agreement with Principia to develop and commercialize BTK inhibitor ‘168 in MS and other CNS diseases

Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India

Date – Aug 13, 2020

Product – Remdesivir

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patients

Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Date – Aug 07, 2020

Deal Value – ~$2.125B

  • Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s pro-forma outstanding stock along with $1.125B as milestones.
  • The two companies will codevelop Denali’ LRRK2 inhibitor for PD and co-commercialize it the US and China while Biogen have the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
  • Denali’ LRRK2 inhibitor (DNL151) has been progressed into late stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid beta + right of first negotiation for two additional unnamed TV platform programs

Siemens Healthineers Acquired Varian for $16.4B

Date – Aug 04, 2020

Deal Value – ~$16.4B

  • Siemens Healthineers to acquire Varian in all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B
  • The transaction is expected to be closed in H1’21. The combined company will offer an integrated platform of end-to-end oncology solutions to addressing the complete continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship
  • Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide

Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Date – Aug 03, 2020

Value – $2.1B

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Roche’s Actemra/RoActemra (tocilizumab) Failed to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Date – Jul 29, 2020

Product – Actemra/RoActemra (tocilizumab)

  • The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post randomization
  • The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
  • Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both in IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral

Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease

Date- Jul 29, 2020

Deal Value- ~$2B+

  • UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development and commercial milestones as well as royalties on sales of the therapies, if Roche proceed the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
  • UCB to fund and perform a POC study in AD and, upon availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
  • UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21

AstraZeneca Signed an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Date – Jul 27, 2020

Deal Value – ~$6B

  • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
  • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
  • Daiichi Sankyo is expected to book sales in US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B

Date – Jul 10, 2020

Deal Value – ~$2.1B

  • Kymera to receive $150M up front, $2B as development, regulatory and commercial milestones along with royalties on sales of therapies. Additionally, the company has an option to develop and commercialize the two programs in the US while retaining global rights to its IRAK4 program in oncology indications.
  • Sanofi will get a global right to develop and commercialize protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases and a second undisclosed preclinical program
  • Kymera will advance the IRAK4 program through P-I study, afterwards Sanofi will be further responsible for its development and will lead all clinical development activities for the second program. IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs

Bausch Health Spun off its Eye Health Business

Date – July 08, 2020

Product – N/A

  • Bausch Health spin off its leading eye health business into an independent publicly traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21
  • The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a diversified company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals
  • Bausch + Lomb will consist of Bausch Health’s global vision care, surgical, consumer and ophthalmic Rx businesses which had generated $3.7B revenue in 2019. The other company would comprise brands across the Salix, International Rx, neurology, and medical dermatology businesses that generated a revenue of ~$4.9B in 2019

Roche Signed a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Date – Jul 07, 2020

Deal Value – ~$1B

  • Blueprint Medicine to receive $675M as up front, $100M as equity investment and is eligible to receive up to $927M as development, regulatory and commercial milestones along with royalties on sales of therapy outside the US
  • Roche to get an exclusive right to co-develop globally and commercialize pralsetinib outside the US, excluding Greater China. In the US, Roche will get co-commercialization rights to pralsetinib. The companies will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US
  • Pralsetinib (qd, PO) is precision therapy for the treatment of patients with RET-altered NSCLC, MTC and other types of thyroid cancer, and solid tumors and has demonstrated tumour-agnostic potential with its PDUFA date as Nov 23, 2020

Merck KGaA and Pfizer’s Bavencio (avelumab) Received the US FDA’s Approval as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Date – Jul 01, 2020

Product – Bavencio (avelumab)

  • The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
  • Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population, in PD-L1+ patients (44% reduction in risk of death), in an exploratory analysis of patients with PD L1 negative tumors, OS hazard ratio (0.85)
  • Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following the receipt of BT designation. In 2017, the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval

The post PharmaShots’ Key Highlights of Third Quarter 2020 first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

Published: Oct 22, 2020 | Tags: 2020, ASN Calcification, Kidney, reports, results, Sanifit, SNF472, Treatment, Vascular, Week

Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors

Published: Oct 22,2020 | Tags: Activated, Daiichi, DS-1055, GARP, Immuno, Initiates, Oncology, P-I, Regulatory, T Cells, Targeting, therapy, Trial

UCB’s Vimpat (lacosamide) Receives CHMP’s Positive Opinion for Primary Generalized Tonic-Clonic Seizures

Published: Oct 22,2020 | Tags: CHMP’s Positive Opinion, EU Approval, lacosamide, Primary Generalised Tonic-Clonic Seizure, receives, UCB’s, Vimpat

Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020

Published: Oct 22,2020 | Tags: ASN Week 2020, Dicerna, Evaluating, Nedosiran, New Interim Data, PHYOX 3 OLE, Presents, Primary Hyperoxaluria, study

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 22,2020 | Tags: COVID-19, Gilead, receives, Remdesivir, US FDA Approval, Veklury

ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020

Published: Oct 21, 2020 | Tags: Antiretroviral Therapy, ATLAS, ATLAS-2M, Cabenuva, Cabotegravir, COVID-19, CUSTOMIZE, FLAIR, LATTE-2, P-IIb/IIIb, POLAR, reports, Result, Rilpivirine, ViiV Healthcare

Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19

Published: Oct 22, 2020 | Tags: AT-527, Atea Pharmaceuticals, Collaborates, COVID-19, Develop, Roche

Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Published: Oct 21, 2020 | Tags: Branaplam, Designation, Disease, Drug, Huntington, LMI070, Novartis, Orphan, receives, U.S.FDA

AWS and Onica Collaborate with Teva to Support its Digihaler Portfolio

Published: Oct 21, 2020 | Tags: AWS, Collaborate, Digihaler, Portfolio, Onica, Teva

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Published: Oct 21, 2020 | Tags: Adults, Candidate, Clinical, GSK, Maternal, Older, Positive, reports, results, RSV, Vaccines

Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies

Published: Oct 21, 2020 | Tags: Antibody Engineering Technologies, Chugai, License Agreement, Novo Nordisk, Signs

NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Published: Oct 20, 2020 | Tags: Biosimilar, Crohn Disease, NeuClone, P-l Trial, Positive Result, reports, Stelara, ustekinumab

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Published: Oct 20, 2020 | Tags: Cataplexy, EDS, Jazz, Narcolepsy, Oral, P-III, patients, publication, reports, results, Sleep, Solution, study

Samsung Biologics Collaborates with Dinona to Develop DNP-019 for COVID-19

Published: Oct 20,2020 | Tags: Collaborates, COVID-19, Develop, Dinona, DNP-019, Samsung Biologics

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Published: Oct 21, 2020 | Tags: Advances, Clinical, Development, Disease, Late, Parkinson, Prasinezumab, Prothena, Roche, Stage, study

Lilly’s Taltz (ixekizumab) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

Published: Oct 20, 2020 | Tags: Health Canada Approval, ixekizumab, Lilly, Non-Radiographic Axial Spondyloarthritis, receives, Taltz

StageBio Acquires TPL Path Labs to Expand its Footprints Globally

Published: Oct 20, 2020 | Tags: Acquisition, Expands, Global Presence, StageBio, TPL Path Labs

Endo to Acquire BioSpecifics for ~ $540M

Published: Oct 19, 2020 | Tags: $ 540 M, Acquire, BioSpecifics, Endo

Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

Published: Oct 19, 2020 | Tags: 111, Bayer, China, Extend, Inc., Vast Blue Ocean of Online Healthcare

Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery

Published: Oct 19, 2020 | Tags: AI-Driven, Collaborates, Drug Discovery, Genesis Therapeutics, Roche

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: Oct 20, 2020 | Tags: Adjuvant, AstraZeneca, Cancer, Early, EGFR, Lung, Mutated, osimertinib, reports, results, Stage, Tagrisso, Treatment, US

AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Atopic Dermatitis

Published: Oct 19, 2020 | Tags: AbbVie, Atopic Dermatitis, P-lll Study, Rinvoq, Submit Regulatory Application, Upadacitinib, US FDA and EMA

ImmunoGen Signs an Agreement with Huadong to Develop & Commercialize Mirvetuximab Soravtansine in Greater China

Published: Oct 19, 2020 | Tags: Collaboration, Commercialize, Develop, Greater China, Huadong, ImmunoGen, Mirvetuximab Soravtansine, Signs

Henlius Signs a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases

Published: Oct 18, 2020 | Tags: $43M, Agreement, bevacizumab, Develop, Diseases, Essex, Henlius, Jointly, License, Ophthalmic, Signs, Treat

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

Published: Oct 18, 2020 | Tags: FAD, Isatuximab, Multiple Myeloma, NICE, patients, receives, Recommendation, Sanofi, Sarclisa

Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

Published: Oct 18, 2020 | Tags: approval, CHMP Positive Opinion, guselkumab, Janseen, PsA, receives, Tremfya

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

Published: Oct 19, 2020 | Tags: approval, AstraZeneca, CHMP, COPD, EU, Maintenance, Recommendation, Treatment, Trixeo, Aerosphere

AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

Published: Oct 19, 2020 | Tags: AbbVie, Acute Myeloid Leukemia, receives, US FDA, Approval, Venclexta, venetoclax

Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Published: Oct 17, 2020 | Tags: (inclisiran), approval, CHMP, Hypercholesterolemia, Leqvio, Novartis, Positive, Opinion, receives, Treat

Related Post: PharmaShots Weekly Snapshot (Oct 12-16, 2020)

The post PharmaShots Weekly Snapshot (Oct 19 – 23, 2020) first appeared on PharmaShots.

Gilead’s remdesivir finally gets US approval

Gilead’s Veklury (remdesivir) has become the first COVID-19 drug approved in the US following a nod from the FDA.

As an antiviral drug, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19.

Originally intended as a treatment for Ebola virus, remdesivir made headlines early on in the pandemic as the first drug to show significant improvements in recovery time in patients.

Until now, the drug – which will be marketed under the brand name Veklury – was only available to US patients under an Emergency Use Authorisation for the treatment of hospitalised patients with severe COVID.

In the meantime, it has been subject to a ‘rolling submission’ with the FDA that began in April. This has allowed Gilead to submit its application in small chunks as they were completed.

The approval is supported by data from two randomised, open-label, multi-centre phase 3 clinical studies of Veklury conducted by Gilead.

It also includes the phase 3 randomised, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

Data from the studies showed treatment with Veklury led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement.

Across studies, Veklury was generally well tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified.

The drug has already been approved by several other regulators across the world, including in the European Union and Japan.

There are ongoing phase 3 trials testing its safety and efficacy in patients infected by the SARS-CoV-2 coronavirus that causes COVID-19, including combination trials with other drugs.

Last month a trial found that combining the drug with Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) reduces recovery time in COVID-19 patients compared to Veklury alone.

It hasn’t always been plain sailing in Veklury’s development journey, though, and some trials have shown more mixed results.

Earlier this month preliminary results from the World Health Organization’s large Solidarity trial suggested that the drug had failed to produce an effect on hospital stay and mortality.

Several other drugs are being tested as a treatment for COVID-19: one of the most promising is the off-patent steroid dexamethasone, which lowered mortality in a UK-based phase 3 trial and is considerably cheaper than Veklury.

Meanwhile, Roche announced this week that it will team up with Atea Pharmaceuticals to co-develop a rival to Veklury that can be taken orally outside of a hospital setting.

The post Gilead’s remdesivir finally gets US approval appeared first on .

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Shots:

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the first and only approved COVID-19 treatment in the United States.

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Los Angeles Times

The post Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19 first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA

Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab

Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs

Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020

Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result

Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19  

Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission

Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer

Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives

Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19

Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment

Linnaeus Reports First Patients Dosing with LNS8801 + Keytruda (pembrolizumab) in P-I/II Study for Advanced Cancer

Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports

J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

Published: Oct 14, 2020 | Tags: COVID-19, Dosing, J&J, Pauses, Unexplained Illness, Vaccine, Studies

Roche to Launch Elecsys SARS-CoV-2 Antigen Test for Suspected COVID-19 Patients

Published: Oct 13, 2020 | Tags: Antigen, COVID-19, Laboratory, Launch, patients, Roche, SARS-CoV-2, Suspected, Test

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA VOYAGE Study in Children with Asthma

Published: Oct 13, 2020 | Tags: Asthma, attacks, Biologic, Children, children’s, Demonstrate, dupilumab, Dupixent, Function, Improvement, Lung, P-III Trial, Reduced, reports, results, Sanofi, Severe

Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION Study for Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Filgotinib, Galapagos, Gilead, P-2B/3, reports, results, SELECTION Study, Ulcerative Colitis (UC)

Lilly Reports Results of Mirikizumab in P-ll SERENITY Study for Crohn’s Disease

Published: Oct 13, 2020 | Tags: Crohn Disease, Improvement and Reduction of Intestinal Inflammation, Lilly, Mirikizumab, P-ll, reports, results, SERENITY Study

Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from VISIBLE OLE Study for Moderately to Severely Active Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Active, During, Entyvio, Long-Term, Maintenance, Moderately, reports, results, Severely, Takeda, therapy, Vedolizumab

Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA for COVID-19

Published: Oct 13, 2020 | Tags: Abbott, antibody, Authorization, Blood, Test, COVID-19, Emergency, IgM, New, receives, Test, U.S.FDA, Use

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 12, 2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA Granted Marketing Approval, Rituximab

Janssen Reports Five-Year Data of Stelara (ustekinumab) in P-lll LTE Study for Severe Crohn’s Disease

Published: Oct 12, 2020 | Tags: Five-Year, Janssen Pharmaceutical, LTE Study, P-lll, Report, results, Severe Crohn’s Disease, Stelara, ustekinumab

AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for COVID-19

Published: Oct 12,2020 | Tags: Acting, antibody, AstraZeneca, AZD7442, COVID-19, Long, P-III, Test, Treatment, Trials

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 Study for Moderately to Severely Active Crohn’s Disease

Published: Oct 12,2020 | Tags: Active Crohn’s Disease, guselkumab, Interim, Janssen, P-II, patients, reports, Result, study, Tremfya

Pfizer’s Ibrance (palbociclib) Fails to Meet its Primary Endpoint in P-lll PENELOPE-B Study for Early Breast Cancer

Published: Oct 12,2020 | Tags: Breast Cancer, German Breast Group, Ibrance, P-lll, Palbociclib, PENELOPE-B Study, Pfizer Inc., Report, results

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 10,2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA, Granted, Marketing Approval, Rituximab

Related Post: PharmaShots Weekly Snapshot (Oct 5-9, 2020)

The post PharmaShots Weekly Snapshot (Oct 12-16, 2020) first appeared on PharmaShots.

Gilead’s COVID-19 drug Veklury falls short in WHO’s global trial

Gilead’s Veklury (remdesivir) has failed to produce an effect on hospital stay and mortality in COVID-19 patients in a large global trial, casting doubt on previous supportive study findings.

The results from the World Health Organization’s large Solidarity trial are yet to be peer reviewed but were posted online on a preprint server.

Interim findings from Solidarity, which involved more than 11,000 patients in more than 30 countries, contradict those from the manufacturer in a US study.

Solidarity is testing the effects of four potential drug regimens including remdesivir, hydroxychloroquine, the anti-HIV combination lopinavir and ritonavir, and interferon.

According to the study the regimens have little or no effect on length of hospital stay or 28-day mortality, the WHO said.

All other three options have already been shown to be ineffective, but the data from remdesivir is a surprise given the previous trial results used to support its Emergency Use Authorization from the FDA.

Earlier this month data from the US-based ACTT-1 trial study showed Veklury resulted in five days’ faster recovery in patients hospitalised with COVID-19.

There was a non-statistically significant trend towards a reduction in mortality, with the effect being more pronounced in patients who were on low-flow oxygen at baseline.

A spokesperson for Gilead told Reuters: “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomised, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir.

“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”

The WHO said that Solidarity provides a platform that could be used to quickly test emerging treatments.

WHO chief scientist Soumya Swaminathan said that the trial model could be used to test new therapies including monoclonal antibodies and newer antiviral drugs.

In a separate development, Spain’s Pharmamar said it is planning a phase 3 pivotal trial of its Aplidin (plitidepsin) in COVID-19, after an early stage study showed the drug seems to be safe and reduces viral load in infected patients.

Pharmamar specialises in developing medicines that take their inspiration from compounds found in the sea and had been focused on oncology until the pandemic began.

 

 

The post Gilead’s COVID-19 drug Veklury falls short in WHO’s global trial appeared first on .

Eli Lilly and Gilead’s combination cuts COVID-19 recovery time

Eli Lilly’s Olumiant (baricitinib) has a significant effect on recovery from COVID-19 when combined with Gilead Veklury (remdesivir), according to a large trial backed by funding from the US government.

The findings came from additional safety and efficacy data harvested from the US National Institute of Allergy and Infectious Diseases’ (NIAID) ACCT-2 trial.

Results in hospitalised adults with COVID-19 infection also showed a numerical decrease in death – 35% – in patients treated with the combination therapy, which was more pronounced in patients receiving oxygen.

Lilly said that mortality rate seen on the combination was 5.1%, compared with 7.8% in patients treated with remdesivir alone.

In patients receiving oxygen the combination reduced mortality rate by 60% at day 29, was 43% in certain subgroups.

No new safety signals were observed for patients treated with Olumiant and results will be peer reviewed soon, the company added.

Lilly is continuing talks with the FDA around the potential for an Emergency Use Authorisation for Olumiant, which has been approved since 2018 in the US to treat rheumatoid arthritis.

However because of the well-known side effects associated with Olumiant, which may increase the risk of blood clots that can cause deep vein thrombosis and pulmonary embolism, it’s likely that the drug will be reserved for use in only very sick COVID-19 patients.

The drug works by inhibiting janus kinase (JAK1 and JAK2), which has the effect of reducing the activity of the immune system.

This is important because the more extreme symptoms seen in serious cases of COVID-19 are caused when the virus causes the body’s immune system to over-react.

Several drugs have been trialled to counter the inflammation and damage to organs that this can cause, such as dexamethasone, a cheap steroid that was found to work against COVID-19 in the UK’s large RECOVERY trial.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post Eli Lilly and Gilead’s combination cuts COVID-19 recovery time appeared first on .

PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis

2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Published: Aug 28, 2020 | Tags:  Bayer, Reports, NDA, Submission, NMPA, Chronic Heart Failure, China, Vericiguat

3. Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Published: Aug 27, 2020 | Tags: Galecto, GB0139, Receives, US, FDA, EMA, Orphan Drug Designations, Idiopathic Pulmonary Fibrosis

4. Philips to Acquire Intact Vascular for $360M

Published: Aug 27, 2020 | Tags: Philips, Acquire, Intact Vascular, $360M

5. BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Published: Aug 27, 2020 | Tags: BioNTech, Fosun Pharma,  Supply, ~10M, Doses, COVID-19 Vaccine, Hong Kong, Macao

6. Amazon Enters into Fitness Space with the Launch of Halo Band and App

Published: Aug 27, 2020 | Tags: Amazon, Enters, Fitness Space, Launch, Halo Band

7. BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

Published: Aug 27, 2020 | Tags: BeiGene, Signs, Exclusive, License Agreement, Singlomics, Neutralizing, COVID-19, Antibodies

8. Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect COVID-19

Published: Aug 27, 2020 | Tags: Abbott, BinaxNOW COVID-19 Ag Card, Receives, US, FDA, EUA, Detect, COVID-19

9. FDC Launches Two Variants of Favipiravir for COVID-19 in India

Published: Aug 26, 2020 | Tags:  FDC, Launches, Two Variants, Favipiravir, COVID-19, India

10. Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Published: Aug 26, 2020 | Tags:  Celltrion, Initiates, P-I, Study, CT-P59, COVID-19, Korea

11. GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

Published: Aug 26, 2020 | Tags:  GSK, Blenrep, (belantamab mafodotin), Receives, EC’s, Approval, R/R, Multiple Myeloma

12. Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany

Published: Aug 26, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases

Published: Aug 26, 2020 | Tags: Takeda, Collaborates, Engitix, Target, Fibrotic Liver Diseases

14. Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Published: Aug 25, 2020 | Tags: Philips, B. Braun, Onvision Needle Tip Tracking Technology, Receive, US, FDA, 510 (k) Clearance, Regional Anesthesia

15. Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

Published: Aug 25, 2020 | Tags: Qiagen, Launch, Digital Test, Detecting, SARS-CoV-2, Antibodies, US

16. Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Published: Aug 26, 2020 | Tags: Novartis, Reports, Results, Asciminib, (ABL001), P-III, ASCEMBL Study, Chronic Myeloid Leukemia

17. Takeda and OVID Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Published: Aug 25, 2020 | Tags: Takeda, OVID, Report, Results, Soticlestat, TAK-935/OV935, P-II, ELEKTRA Study, Dravet Syndrome, Lennox-Gastaut Syndrome

18. ACADIA Acquires CerSci Therapeutics for $52.5M

Published: Aug 25, 2020 | Tags: ACADIA, Acquires, CerSci Therapeutics, $52.5M

19. AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

Published: Aug 25, 2020 | Tags: AbbVie, Harvard University, Collaborate, Develop, Novel Therapies, Against, Emergent Viral Diseases

20. AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

Published: Aug 24, 2020 | Tags: AbbVie, Exercises, License, Option, Morphosys, αvβ6 Integrin, Inhibitor Program, Fibrotic Disease

21. BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Published: Aug 24, 2020 | Tags: BeiGene, Signs, License, Supply, Agreement, Bio-Thera, BAT1706, biosimilar, bevacizumab, China

22. AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Published: Aug 25, 2020 | Tags: AstraZeneca, Initiates, P-I, Study, AZD7442, Against, COVID-19

23. Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Published: Aug 24, 2020 | Tags: Merck, Keytruda, (pembrolizumab), Receives, PMDA, Approvals, Japan

24. Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

Published: Aug 24, 2020 | Tags: Bionano, Genomics, Acquires, Lineagen, Facilitate, Clinical Adoption, Saphyr, Digital Cytogenetics

26. Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

Published: Aug 24, 2020 | Tags:  Bayer, One Drop, Collaborate, Develop, Digital Therapies, Across, Multiple, Therapeutic Areas

27. BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

Published: Aug 24, 2020 | Tags: BMS, Acquire, Forbius, Adding, TGF-beta Inhibitor, Portfolio

28.  Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Published: Aug 23, 2020 | Tags: Novartis, Triple Regimen, Fails, Meet, Primary Endpoint, P-III, COMBI-I, Study, Advanced Melanoma

29. ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Published: Aug 24, 2020 | Tags: ReiThera, Reports, First, Patient Dosing, COVID-19, Vaccine Candidate, Italy

30. Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

Published: Aug 24, 2020 | Tags:  Takeda, Divest, Consumer Health Unit, Blackstone,  $2.3B, Japan

31. Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Published: Aug 23, 2020 | Tags: Chugai, Kadcyla, (trastuzumab emtansine), Receives, MHLW, Approval, Adjuvant Therapy, HER2-Positive, Early Breast Cancer

32. Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

Published: Aug 22, 2020 | Tags: Vertex, Kaftrio, Ivacaftor, Receive, EC, Approval, Cystic Fibrosis, Aged, 12 Years, Older

32. AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

Published: Aug 22, 2020 | Tags: AstraZeneca, Collaborates, RenalytixAI, Develop, Precision Medicine, Chronic Diseases

PharmaShots Weekly Snapshot (Aug 17 -21 2020)

1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia

2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China

Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, Senaparib, IMP4297, China

3. The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R MM

Published: Aug 20, 2020 | Tags: US, FDA, Approves, Kyprolis, carfilzomib, Darzalex, (daratumumab), Dexamethasone, Two Dosing, Regimens, RRMM

4. AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Published: Aug 21, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, MHLW, Approval, Extensive-Stage, Small Cell lung Cancer

5.  Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Published: Aug 20, 2020 | Tags: Pfizer, BioNTech, Regulatory Review, COVID-19, Vaccine,  October, 2020

6. Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis 

Published: Aug 20, 2020 | Tags: Novartis, Kesimpta, (ofatumumab), Receives, US ,FDA, Approval, First, Self-Administered Therapy, Relapsing, Multiple Sclerosis

7. Evotec and Centogene Expand their Collaboration to Target Gaucher Disease

Published: Aug 20, 2020 | Tags: Evotec, Centogene, Expand, Collaboration, Target, Gaucher Disease

8. BioSymetrics Signs an Agreement with Janssen and Sema4 to Utilize AI for the Prediction of COVID-19

Published: Aug 19, 2020 | Tags: BioSymetrics, Signs, Agreement, Janssen, Sema4, Utilize AI, COVID-19

9. Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

Published: Aug 19, 2020 | Tags:  Precision BioSciences, Receives, US, FDA, Fast Track Disease Designation, PBCAR0191, Treat, Advanced, B-cell Precursor Acute Lymphoblastic Leukemia

10. Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

Published: Aug 18, 2020 | Tags:  Qiagen, Launches, QIAseq SARS-CoV-2, Primer Panel, Tracking, COVID-19, Mutations, Strains

11. Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with COVID-19

Published: Aug 19, 2020 | Tags:  Sorrento, Files, IND, STI-1499, COVI-GUARD, Patients, Hospitalized, COVID-19

12. Fitbit Reports Results of its COVID-19 Study for Early Detection of Diseases

Published: Aug 19, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Published: Aug 19, 2020 | Tags: Roche, Tecentriq, Bevacizumab, Receive, Health Canada, Approval, 1L, Treatment,  Unresectable,  Metastatic, Hepatocellular Carcinoma

14. The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues   

Published: Aug 19, 2020 | Tags: The US, FDA, Rejects, Gilead, Filgotinib, Toxicity Issues

15. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

Published: Aug 19, 2020 | Tags: Johnson & Johnson, Acquire, Momenta Pharmaceuticals,  $6.5B

16. Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Published: Aug 18, 2020 | Tags: Sanofi, Dupixent, dupilumab, Receives,  Health Canada, Approval,  Severe, Chronic Rhinosinusitis,  Nasal Polyposis

17. Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease 

Published: Aug 18, 2020 | Tags: Novo Nordisk, Collaborates, Evotec, Develop Therapies, Targeting, Chronic Kidney Disease

18. Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Published: Aug 19, 2020 | Tags: Regeneron, Collaborates, Roche, Improve, Global Supply, REGN-COV2, Against, COVID-19

19. Lilly and Innovent Report the Global Expansion of their Alliance for Tyvyt (sintilimab)

Published: Aug 18, 2020 | Tags: Lilly, Innovent, Report, Global Expansion, Alliance, Tyvyt, sintilimab

20. G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Published: Aug 17, 2020 | Tags: G1 Therapeutics, Reports, US, FDA, Acceptance, Priority Review, NDA, Trilaciclib, SCLC

21.PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

Published: Aug 17, 2020 | Tags: PTC, Reports, EMA, Acceptance, MAA, Evrysdi, risdiplam, SMA

22. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B   

Published: Aug 17, 2020 | Tags: Gilead, Expand, Oncology Collaboration, Tango, $6.3B

23. AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Published: Aug 19, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, US, FDA, Priority Review, Less Frequent, Fixed-Dose Use, NSCLC, Bladder Cancer

24. AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

Published: Aug 17, 2020 | Tags: AstraZeneca, Collaborates, mAbxience, Produce, Covid-19, Vaccine, Latin America

26. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B

Published: Aug 17, 2020 | Tags:  Gilead, Expand, Oncology Collaboration, Tango, Worth, ~$6.3B

27. Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Published: Aug 17, 2020 | Tags: Roche, Enspryng, (satralizumab-mwge), Receives,  US, FDA, Approval,  Neuromyelitis Optica Spectrum Disorder

28. Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Published: Aug 17, 2020 | Tags: Henlius, HLX02, Receives, NMPA, Approval, First, Trastuzumab, Biosimilar, China

29.Abeona Signs a License and Inventory Purchase Agreements with Taysha for ABO-202 to Treat CLN1 Disease (Infantile Batten disease)

Published: Aug 17, 2020 | Tags: Abeona Therapeutics, Signs, License, Inventory Purchase, Agreements, Taysha Gene Therapies, ABO-202, CLN1 Disease

30.BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

Published: Aug 17, 2020 | Tags:  BMS, Signs, Exclusive, Worldwide, License Agreement, Dragonfly Therapeutics, DF6002

31. Sanofi to Acquire Principia Biopharma for ~$3.68B

Published: Aug 17, 2020 | Tags: Sanofi, Acquire, Principia Biopharma, $3.68B

The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues

Shots:

  • The US FDA has issued a complete response letter for the NDA of filgotinib to treat moderately to severely active RA. FDA has requested data from two ongoing clinical trials, MANTA and MANTA-Ray assessing the effect of filgotinib (200mg) on sperm parameter
  • The authority has expressed concerns regarding the overall benefit/risk profile of the filgotinib (200mg). The company will evaluate the points raised in the CRL for discussion with the FDA and will continue to believe in the results of P-III FINCH clinical program
  • The company anticipates the study of MANTA and MANTA-RAy studies in H1’21. Filgotinib is currently under review by regulatory authorities across the globe and has received the CHMP’s positive opinion, recommending MAA for filgotinib in the EU to treat mod. to sev. RA who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs

Click here ­to­ read full press release/ article | Ref: Gilead | Image: New York Post

Analysts question Gilead’s commitment to arthritis drug after FDA setback

The FDA has rejected Gilead and Galapagos’ rheumatoid arthritis (RA) pill filgotinib over concerns that it could damage male fertility, prompting speculation that the big US pharma could become disillusioned with the project.

Filgotinib needs to be good: it is the fourth Janus kinase (JAK) inhibitor to market after Eli Lilly’s Olumiant (baricitinib), Pfizer’s Xeljanz (tofacitinib), and AbbVie’s Rinvoq (upadacitinib).

There have been safety issues including thrombotic events in all of the drugs approved in the class so far and the developers hoped that filgotinib would be able to offer the convenience of an oral medicine without the boxed warnings that appear on already-approved rivals.

But the FDA has rejected a filing in rheumatoid arthritis, saying in a dreaded Complete Response Letter that it required data from the ongoing MANTA and MANTA-Ray studies before completing its review.

The studies are designed to assess whether filgotinib has an impact on sperm count, and the FDA has concerns about the overall risk/benefit profile of filgotinib at its highest 200 mg dose.

Data from toxicology studies in rats and dogs suggested this could be an issue, but there has been evidence of it occurring in human trials to date.

However analysts from Jefferies said the unexpected development is a “significant” setback for a drug that could be worth up to $6 billion in annual sales if approved in all its potential indications such as ulcerative colitis and Crohn’s disease.

In a broker note a team led by Peter Welford said: “We understand approval of the 200 mg dose for RA is viewed as important for partner Gilead, likely needed as a differentiating factor given fourth JAKi to market.”

Data from the phase 3 FINCH study suggested filgotinib’s safety profile could be best-in-class, but the Jefferies team said that Gilead’s “commitment may now be shaken”.

A disappointing efficacy readout in ulcerative colitis in May will hardly have helped matters, particularly as Gilead has already invested billions in Galapagos, signing $5.1 billion in a deal with Galapagos last year to develop rheumatoid arthritis and inflammatory diseases drugs.

This is on top of $2 billion when it signed a partnership over filgotinib in 2015.

Jefferies still expects approval in Europe and Japan later this year but investor confidence was hit by the news as a sizeable chunk of sales are expected to come from the US.

Shares in Galapagos fell by 25% on the Euronext market in Amsterdam following the announcement, while Gilead’s fell almost 6% in pre-market trading on the Nasdaq.

The post Analysts question Gilead’s commitment to arthritis drug after FDA setback appeared first on .

Gilead Expands its Oncology Collaboration with Tango for ~$6.3B

Shots:

  • Tango to receive $125M up front, $20M as equity investment, up to $410M/ program as an opt-in, extension, and milestones along with royalties on sales of the products. If Tango opts to co-develop and co-promote the product, the parties will equally split profits/losses and development costs in the US and will receive milestones and royalties on ex-US sales
  • Gilead will have an option for the global rights of up to 15 programs over the next 7yrs. and will pay option extension fees for Tango to lead activities through early clinical development, to which Gilead will retain its option rights. Additionally, Tango get an option to co-develop and co-promote the lead products for up to five programs in the US
  • Tango will continue to leverage its CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The agreement excludes Tango’s lead programs, including one which is expected to be in IND application-enabling studies in 2021

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Touch Oncology

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

 3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8.  Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9.  Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13.  Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA,  Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

17.   Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

Published: Aug 13, 2020 | Tags:  Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18.   Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19.  Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20.   Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients,  Advanced Solid Tumors

21.  AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags:  AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23.  SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses,  NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan

Related Post: PharmaShots Weekly Snapshot (Aug 03- 07, 2020)

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots:

  • The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe, including the EU and Japan

Click here ­to­ read full press release/ article | Ref: Gilead  | Image: The Wire Science

Pfizer signs deal with Gilead to manufacture COVID-19 antiviral remdesivir

Pfizer has signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic.

Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.

Pfizer will provide contract manufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead.

It is part of a five-point plan by Pfizer launched in March that urged all pharma companies and biotechs to work together with government agencies and academic institutions to tackle the COVID-19 pandemic.

Remdesivir has not yet been approved in the US to treat COVID-19, although it can be used to treat the disease under an Emergency Use Authorization issued by the FDA.

Remdesivir was the first drug to show activity against the SARS-CoV-2 coronavirus earlier this year and is a broad-spectrum antiviral drug that was originally developed as a potential agent against the Ebola virus.

After the initial first success as a monotherapy, scientists are now trialling it in combination with other drugs to see if the antiviral effect is enhanced.

Earlier this week the US-government backed National Institutes of Health begun a trial testing remdesivir in combination with interferon beta-1a – Merck KGaA’s Rebif – against COVID-19.

The Adaptive COVID-19 Treatment Trial 3 (ACTT 3) study is run by the National Institute of Allergy and Infectious Diseases and is expected to recruit more than 1,000 hospitalised adults with COVID-19 at as many as 100 sites in the US and abroad.

Rebif has the same amino acid sequence as a naturally occurring protein called interferon beta, which is part of a class of proteins called type 1 interferons.

Infected cells normally produce type 1 interferons to help the immune system fight pathogens, especially viruses. Interferon beta has both antiviral and anti-inflammatory properties.

This is the third iteration of the ACTT trial. Results from the first part of the trial published at the end of May found that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo.

Feature image courtesy of Rocky Mountain Laboratories/NIH

 

The post Pfizer signs deal with Gilead to manufacture COVID-19 antiviral remdesivir appeared first on .

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease 

Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease

2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Published: Jul 30, 2020 | Tags: Johnson & Johnson, Initiates, P-I/IIa, Study,  Ad26,  US, Belgium

 3. Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Published: Jul 31, 2020 | Tags: Roche, Receives, US, FDA, Approval, VENTANA HER2 Dual ISH Test, CDx, Identify, Breast Cancer

4. Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Published: Jul 31, 2020 | Tags: Takeda, Pevonedistat, Receives, US, FDA, Breakthrough Therapy Designation, Patients, Higher-Risk Myelodysplastic Syndromes, HR-MDS

5. Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Published: Jul 31, 2020 | Tags: Roche, Tecentriq, Cotellic, Zelboraf, Receives, US, FDA, Approval, Patients, Advanced, Melanoma

6. Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Published: Jul 30, 2020 | Tags: Sangamo, Signs, Worldwide, License Agreement, Novartis, Develop, Genomic Therapies, Three, Neurodevelopmental Targets

7.  Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Published: Jul 30, 2020 | Tags: Eli Lilly, Reports, Results, Jardiance, empagliflozin, P-III, EMPEROR Trial, Heart Failure, Patients, Reduced Ejection Fraction, with and without, Diabetes

8.  AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Published: Jul 29, 2020 | Tags: AstraZeneca, Tagrisso, Osimertinib, Receives, US, FDA, BT, Designation, Adjuvant Treatment, Patients, Stage IB-IIIA EGFR-Mutated, Lung Cancer

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Published: Jul 30, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Published: Jul 29, 2020 | Tags: UCB Canada, Brivlera, brivaracetam, Receives, Health Canada, Approval, Treat, Partial-Onset Seizures, Pediatric, Epilepsy Patients

11. BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Published: Jul 23, 2020 | Tags: BARDA, Signs, Multi-Year Agreement, Regeneron, REGN-EB3, National Preparedness

13.  Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Published: Jul 29, 2020 | Tags: Baxter, Ayogo, Expand, Partnership, Advance, Digital, Health Solution, Home Dialysis

14.  Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Published: Jul 29, 2020 | Tags: Merck, MK-6482, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Patients, Von Hippel-Lindau Disease- Associated, Renal Cell Carcinoma

15AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Published: Jul 28, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, P-III, AD Up, Study, Patients, Atopic Dermatitis

16.   Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Published: Jul 29, 2020 | Tags: Roche, Actemra/RoActemra, tocilizumab, Fails, Meet, Primary Endpoint, P-III, COVACTA Study, Patients, COVID-19, Associated Pneumonia

17.  Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Published: Jul 28, 2020 | Tags: Sanofi, GSK, Sign, Agreement, UK, Government, Supply, ~60M, Doses, COVID-19, Vaccine

18.  Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Published: Jul 29, 2020 | Tags: Eli Lilly, P-tau217, Blood Test, Demonstrate, High Accuracy, Diagnosis, Alzheimer’s Disease

19.  Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Published: Jul 28, 2020 | Tags: Roche, UCB, Collaborate, Develop, UCB0107,  Alzheimer’s Disease

20.  Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Published: Jul 27, 2020 | Tags: Zebra Medical, Receives, US, FDA, Approval, HealthMammo, Mammography Tool, Oncology, Breast Cancer

21.   AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Published: Jul 27, 2020 | Tags: AstraZeneca, Reports, Results, Farxiga, P-III, DAPA-CKD, Study, Patients, Chronic Kidney Disease

22.  Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Published: Jul 28, 2020 | Tags: Eli Lilly, Amends, 2013, Agreement, Chi-Med, Commercialize, Elunate, Fruquintinib, China

23. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Emergent BioSolutions, Expand, Manufacturing, AZD1222, COVID-19

24.  Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Published: Jul 28, 2020 | Tags: Pfizer, BioNTech, Initiate, P-II/III, Global Study, Lead, mRNA, Vaccine, Candidate, Against, COVID-19

25.  Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Published: Jul 26, 2020 | Tags:  Three, Pharma, Companies, Launch, Favipiravir, COVID-19, India

26. Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Published: Jul 27, 2020 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Receives, US, FDA, Approval, First, Cell-Based, Gene Therapy, Relapsed, Refractory, MCL

27.   Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Published: Jul 26, 2020 | Tags: Centus Biotherapeutics, Equidacent, (bevacizumab, biosimilar, Receives, CHMP, Positive Opinion, Treatment, Multiple Cancer Indications

28.   AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Daichii Sankyo, Develop, Commercialize, DS-1062, Worth, Up to, $6B, Global, Oncology,

29. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

Published: Jul 27, 2020 | Tags: Sorrento, Acquire, SmartPharm, Develop, Pipeline, Gene-Encoded, Therapeutic Antibodies, Targeting, COVID-19, Cancer, Oncology, Global




Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




Gilead loses $3.3bn in Q2, blaming COVID-19 and cancer drugs firm acquisition

Gilead has blamed a $3.3 billion loss in Q2 on its acquisition of immune-oncology company Forty Seven – but revenues are declining as the pandemic bit into sales of its hepatitis C drugs.

Product sales in Q2 were down nearly 10% compared with last year to just over $5 billion, and the company recorded a net loss of $3.3 billion.

The overall trend in Gilead’s hepatitis C franchise is down as the market is shrinking as patients are cured by its drugs and those of rivals such as AbbVie.

Gilead said COVID-19 has made things worse because fewer patients have been visiting clinics and hospitals for visits and screenings.

Sales of HIV drugs were down 1% to $4 billion in Q2, although over the first half they increased by 6% to $8 billion.

Hypertension drug Letairis and chest pain drug Ranexa have also been hit by generic competition in the US in the first half of the year.

In the second quarter of last year Gilead also benefited from rebate adjustments worth around $160 million, related to sales of its HIV and hepatitis C drugs in Europe.

These favourable adjustments did not reoccur in this year’s Q2, further impacting the company’s underlying performance.

Other factors were lower sales of HIV drugs such as Truvada, and COVID-10 affecting demand for HIV pre-exposure prophylaxis (PrEP) drugs.

However the company said that this was partially offset by continued uptake of its newer PrEP drugs Biktarvy and Descovy.

CAR-T cancer therapy Yescarta generated sales of $156 million in Q2, up from $120 million in the same period last year driven by continued uptake in Europe.

On top of all this Gilead also took a charge of $4.5 billion following its acquisition of cancer immunotherapy Forty Seven.

R&D expenses have also increased because of Gilead’s focus on developing remdesivir as an antiviral against COVID-19, and donations to the US healthcare system in June.

Gilead expects to have manufactured more than two million remdesivir treatment courses by the end of 2020, and several million more treatment courses in 2021.

Investment in remdesivir research will continue, the company plans to test the drug early in the disease and has already launched a phase 1a study testing an inhaled solution.

It also plans to test remdesivir in combination with Eli Lilly’s Olumiant (baricitinib), a JAK inhibitor already used in inflammatory diseases, and Roche’s IL-6 drug Actemra (tocilizumab).

The company is sticking by full-year guidance announced in February of product sales in a range of $21.8 – $22.2 billion and earnings per share of between $5.15 and $5.55.

The post Gilead loses $3.3bn in Q2, blaming COVID-19 and cancer drugs firm acquisition appeared first on .

PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis 

Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis

2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Published: Jul 24, 2020 | Tags: Synaffix, Expands, Existing Collaboration, ADC, Explore, Two Additional Programs

 3. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Published: Jul 23, 2020 | Tags: Zydus, Initiate, Clinical Study, Desidustat, Patients, Chemotherapy Induced Anemia, CIA

4. AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Receives, US, FDA, Approval, Maintenance Treatment, COPD

5. Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Published: Jul 17, 2020 | Tags: Abbott, IOS-Compatible App, Receives, US, FDA, Approval, Patients, Neurological Disorder

6. BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Published: Jul 23, 2020 | Tags: BioMarin, Reports, Submission, MAA, EMA, Vosoritide, Treat, Children, Achondroplasia

7.  Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Published: Jul 22, 2020 | Tags: Ovid Therapeutics, University of Connecticut, Collaborate, Accelerate, Development, OV101, gaboxadol, Angelman Syndrome

8.  Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Published: Jul 22, 2020 | Tags: Genentech, Reports, Results, Port Delivery System, Ranibizumab, P-III, Archway Study, Neovascular Age-Related Macular Degeneration

9. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Published: Jul 22, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Published: Jul 23, 2020 | Tags: Daiichi Sankyo, Signs, Research Agreement, Gustave Roussy, DS-1062, Patritumab Deruxtecan, Treat, Lung, Breast Cancer

11. Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

Published: Jul 23, 2020 | Tags: Chugai, Biofourmis, Collaborate, Develop, Solutions, Digitally Measuring, Endometriosis Pain

13.  AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Published: Jul 22, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, Monotherapy, P-III, Measure Up 2, Study, Atopic Dermatitis

14.  Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Published: Jul 22, 2020 | Tags: Evotec, Collaborates, Quantro Therapeutics, Discover, Develop, Novel, Therapies, Cancer, Other Diseases

15Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Published: Jul 20, 2020 | Tags: Boston Scientific, Receives, US, FDA, Approval, Next-Generation, WATCHMAN FLX, Left Atrial, Appendage Closure Device

16.   Gilead to Acquire Tizona’s Stakes for $300M

Published: Jul 22, 2020 | Tags: Gilead, Acquire, Tizona, Stake, $300M, AbbVie, TTX-080, TTX-03

17.  Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Published: Jul 21, 2020 | Tags: Biocon, Collaborates, Voluntis, Digital Therapeutics, Insulins

18.  Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Published: Jul 22, 2020 | Tags: Paige, Receives, US, FDA, 510(k), Clearance, FullFocus Viewer, Use, Digital Pathology

19.  The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

Published: Jul 21, 2020 | Tags: The UK, Government, Launch, AbC-19, Lateral Flow, Free Finger-Prick Test, COVID-19

20.  Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Published: Jul 21, 2020 | Tags: Roche, Collaborates, Jnana Therapeutics, Discover, Novel Therapies, Treat, Immune-Mediated, Neurological Diseases

21.   Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Published: Jul 20, 2020 | Tags: Mylan, Launches, Remdesivir, Under, Brand Name, Desrem, COVID-19, India

22.  Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Published: Jul 21, 2020 | Tags: Pfizer, BioNTech, Elicits, Strong, T-cell, Response, P-I/II, Study, Against, COVID-19, Germany

23. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Published: Jul 20, 2020 | Tags: AstraZeneca, Oxford University, AZD1222, Delivers, Strong, Immune Response, P-II/III, COV001, Study, Against, COVID-19  

24.  Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M

Published: Jul 19, 2020 | Tags: Royalty Pharma, Acquires, PTC, Royalty Interest, Risdiplam,  $650M

25.  Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Published: Jul 19, 2020 | Tags:  Quest Diagnostic, Receives, US, FDA, First, EUA, Sample Pooling, COVID-19

26. Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Published: Jul 19, 2020 | Tags: Roche, Signs, RWD, Collaboration, PicnicHealth, Create, Personalized Treatment, Patients, Multiple Sclerosis

27.   Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Published: Jul 19, 2020 | Tags: Celltrion, Initiates, P-I, Study, COVID-19, Antibody Treatment, South Korea

28.   GSK to Acquire 10% stake in CureVac for $163M

Published: Jul 20, 2020 | Tags: GSK, Acquire, 10%, Stake, CureVac, $163M




Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Shots:

  • Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs
  •  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage assessed by mTSS compared with PBO
  • Across the FINCH and DARWIN trials, filgotinib(qd) demonstrated a clinical safety profile when administered as monothx./ in combination with MTX. The company expects the EC’s decision in Q3’20

Click here to read full press release/ article | Ref: Businesswire | Image: Pharmashots




Gilead to Acquire Tizona’s Stakes for $300M

Shots:

  • Gilead invests $300M to obtain 49.9% equity interest in Tizona and receives an exclusive option to acquire remaining stakes of Tizona for up to an additional $1.25B that includes an option exercise fee and milestones. The transaction is expected to be closed in Q3’20
  • Gilead can exercise its option following the results of a P-Ib study of Tizona’s TTX-080, or earlier if it chooses and provides funding to support Tizona’s ongoing research and development to advance its novel pipeline
  • Additionally, Tizona will spin-off TTX-03 into a separate entity prior to the closing of this transaction, as a part of its collaboration with AbbVie under which Tizona has received $105M as upfront & an undisclosed equity investment

Click here to read full press release/ article | Ref: Gilead | Image: Pharmacy Business




PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis

2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Published: Jul 16, 2020 | Tags: Oncorus, Initiates, P-I, ONCR-177, Patients, Advanced, Refractory, Cutaneous, Subcutaneous, Metastatic, Nodal Solid Tumors

 3. Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

Published: Jul 16, 2020 | Tags: Thermo Fisher Scientific, Amends, Agreement, Acquire, QIAGEN

4.  Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Published: Jul 16, 2020 | Tags: Kiniksa, Rilonacept, Receives, US, FDA, Orphan Drug Designation, Treat, Pericarditis

5. Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

Published: Jul 17, 2020 | Tags: Merck KGaA, Takes, Early Option, Existing, Immuno-Oncology, Collaboration, F-star

6. Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

Published: Jul 17, 2020 | Tags: Kronos Bio, Acquire, Gilead, SYK Inhibitor, Portfolio, Entospletinib, Lanraplenib

7.  Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Published: Jul 16, 2020 | Tags: Merck, Bayer, Receive, US, FDA, Priority Review, Vericiguat, Reduce, Risk, CV Death, Patients, Symptomatic Chronic Heart Failure, HFrEF

8.  MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Published: Jul 15, 2020 | Tags: MSD, Collaborates, Novocure, Evaluate, Tumor Treating Fields, Together, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer

9. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Published: Jul 15, 2020 | Tags: Zydus, Initiates, Adaptive, P-I/II, Clinical Study, Evaluating, ZyCoV-D, Against, COVID-19, India

10.  NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology

Published: Jul 16, 2020 | Tags: NCCN, Collaborates, Pfizer, Explore, Adoption, Biosimilars, Oncology

11.  AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Published: Jul 16, 2020 | Tags: AstraZeneca, Report, Results, Brilinta, ticagrelor, P-III, THALES Study, Patients, Acute Ischemic Stroke, Transient Ischemic Attack

12.  Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Published: Jul 16, 2020 | Tags: Novartis, Launches, Zero Profit, Portfolio, Symptomatic Treatment, COVID-19

13.  Medtronic to Acquire Medicrea to Boost its Spine Offerings

Published: Jul 15, 2020 | Tags: Medtronic, Acquire, Medicrea, Boost, Spine Offerings

14.   AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Published: Jul 15, 2020 | Tags: AstraZeneca, University of Oxford, Share, Positive News, COVID-19 Vaccine, Imminently

15.   GSK’s Belantamab Mafodotin Receives the US FDA Advisory Committee’s Recommendation to Treat Relapsed/Refractory Multiple Myeloma

Published: Jul 14, 2020 | Tags: GSK, Belantamab Mafodotin, Receives, US, FDA, Advisory Committee, Recommendation, Treat, Relapsed/Refractory, Multiple Myeloma

16.  3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Published: Jul 14, 2020 | Tags: 3M, Collaborates, MIT, Develop, Paper-Based, Diagnostic Test, COVID-19

17.  Samsung Biologics Signs Multi-Product Development and Manufacturing Agreement with ImmuneOncia

Published: Jul 15, 2020 | Tags: Samsung Biologics, Signs, Multi-Product, Development, Manufacturing, Agreement, ImmuneOncia

18.  Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Published: Jul 14, 2020 | Tags: Moderna, Anticipate, Initiate, Late-stage, COVID-19, Vaccine, Trial, 27 July, 2020

19.   Sanofi and MD Anderson Sign a Five-Year Pact to Expedite Oncology Research and Development

Published: Jul 14, 2020 | Tags: Sanofi, MD Anderson, Sign, Five-Year, Pact, Expedite, Oncology, Research, Development

20.  Merck Signs an Exclusive Agreement with Dewpoint Therapeutics to Develop Curative Treatment for HIV

Published: Jul 13, 2020 | Tags: Merck, Signs, Exclusive Agreement, Dewpoint Therapeutics, Develop, Curative Treatment, HIV

21.  Roche’s Mosunetuzumab Receives the US FDA’s Breakthrough Therapy Designation to Treat Relapsed or Refractory Follicular Lymphoma

Published: Jul 14, 2020 | Tags: Roche, Mosunetuzumab, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Relapsed, Refractory, Follicular Lymphoma

22.  Roche Expands its Collaboration with Immunomedics to Evaluate Tecentriq Based Combination Therapy in Urothelial and Non-Small Cell Lung Cancers

Published: Jul 13, 2020 | Tags: Roche, Expands, Collaboration, Immunomedics, Evaluate, Tecentriq, Based, Combination Therapy, Urothelial, Non-Small Cell Lung Cancers

23.  Roche Signs a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Published: Jul 14, 2020 | Tags:  Roche, Signs, ~$1B, Agreement, Blueprint Medicines, Precision Therapy, Patients, RET-Altered, Cancer Indications

24. Paige Secures Funding from Goldman Sachs to Continue Innovation in Digital Pathology

Published: Jul 13, 2020 | Tags: Paige, Secures, Funding, Goldman Sachs, Continue, Innovation, Digital Pathology

25.   Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Published: Jul 10, 2020 | Tags: Gilead, Veklury, remdesivir, Receives, the TGA, Approval, Treat, Adults, Adolescent, Severe, COVID-19 Symptoms

26.   Pfizer with its Partner BioNTech Receives the US FDA’s Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

Published: Jul 13, 2020 | Tags: Pfizer, Partner, BioNTech,, Receives, the US FDA, Fast Track Designation, Two, mRNA, Based, Therapies, Treat, COVID-19

25. Samsung Biologics Expands its Development Partnership with STCube for STM418

Published: Jul 13, 2020 | Tags: Samsung Biologics, Expands, Development, Partnership, STCube, STM418

26.   Roche’s Reports Results of Tecentriq in P-III IMagyn050 Study for Women with 1L Newly Diagnosed Advanced Stage Ovarian Cancer

Published: Jul 13, 2020 | Tags: Roche, Reports, Results, Tecentriq, P-III, IMagyn050 Study, Women, 1L, Newly, Diagnosed, Advanced, Stage, Ovarian Cancer

27.  Biocon’s ALZUMAb (Itolizumab) Receives the DCGI’s Approval for Emergency Use to Treat Patients with Moderate to Severe COVID-19

Published: Jun 11, 2020 | Tags: Biocon, ALZUMAb, Itolizumab, Receives, the DCGI, Approval, Emergency, Use, Treat, Patients, Moderate, Severe, COVID-19




Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

Shots:

  • Gilead to receive an up front in cash and convertible notes into Kronos equity, regulatory & commercial milestones along with royalties on sales of products emerges from the acquired programs
  • Kronos to acquire the two clinical-phase assets along with the rest of Gilead’s portfolio of SYK inhibitors. The portfolio includes entospletinib, being evaluated in P-I & II study in oncology patients, and lanraplenib that has been evaluated in P-II trials for autoimmune diseases
  • Kronos plans to initially focus on a biomarker-defined subset of AML patients. The focus indicates that SYK inhibition showed promising clinical activity in AML patients with cancers that overexpress the HOXA9 and MEIS1 transcription factors. Additionally, Entospletinib demonstrated positive clinical data in its early studies

Click here to read full press release/ article | Ref: Kronos Bio | Image: PharmaLive