PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Published: Jan 22, 2020 | Tags: MTPA, Aquestive ,Sign ,License ,Supply Agreement, Exservan (riluzole) ,Treat, ALS ,US

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Published: Jan 22, 2020 | Tags: ViiV ,Cabenuva (cabotegravir and rilpivirine), Receives ,US, FDA Approval, First and Only Complete, Long-Acting ,Regimen, HIV, treatment

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Published: Jan 22, 2020 | Tags: Eli Lilly, Reports, Results, Bamlanivimab (LY-CoV555), P-III, BLAZE-2 Study, Preventing, COVID-19, Nursing Homes

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Published: Jan 22, 2020 | Tags: Servier , MiNA Therapeutics, Collaborate ,Develop ,saRNA Therapies ,Neurological Diseases

Boston Scientific to Acquire Preventice for ~$1.2B

Published: Jan 22, 2020 | Tags: Boston, Scientific, Acquire, Preventice ,~$1.2B

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Published: Jan 21, 2020 | Tags: Roche, Reports, US, FDA, Acceptance ,sNDA ,Granted ,Priority Review ,Esbriet (pirfenidone),Treat ,UILD

Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Published: Jan 21, 2020 | Tags: Qiagen’s, PCR Tests, Demonstrate ,Effectiveness ,Detecting Mutations ,SARS-CoV-2 Virus

Haemonetics to Acquire Cardiva Medical for ~$510M

Published: Jan 21, 2020 | Tags: Haemonetics, Acquire ,Cardiva Medical,  ~$510M

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Published: Jan 21, 2020 | Tags: Bayer, Merck, Verquvo (vericiguat) ,Receives ,US ,FDA, Approval, Treat, Chronic Heart Failure

MacroGenics’ Margenza (margetuximab-cmkb) Receives the US FDA’s Patients with Pretreated Metastatic HER2-Positive Breast

Published: Jan 21, 2020 | Tags: MacroGenics, Margenza (margetuximab-cmkb), Receives, US, FDA, Pretreated, Metastatic HER2-Positive Breast

Urovant’s Gemtesa (Vibegron) Receives the US FDA’s Approval for Overactive Bladder 

Published: Jan 21, 2020 | Tags: Urovant, Gemtesa (Vibegron) ,Receives, US, FDA, Approval, Overactive Bladder

Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Published: Jan 21, 2020 | Tags: Merck KGaA, GSK, Bintrafusp Alfa, Fails, Meet, Co-Primary Endpoints, Lung Cancer, Study

Vanda’s Hetlioz (tasimelteon) Receives the US FDA’s Approval for Nighttime Sleep Disturbances in Smith-Magenis Syndrome

Published: Jan 21, 2020 | Tags: Vanda,Hetlioz (tasimelteon) ,Receives, US, FDA, Approval, Nighttime Sleep Disturbances ,Smith-Magenis Syndrome

Ridgeback’s Ebanga (mAb114) Receives the US FDA’s Approval for the Treatment of Ebola

Published: Jan 21, 2020 | Tags: Ridgeback, Ebanga (mAb114), Receives, US, FDA, Approval , Treatment, Ebola

Sorrento Presents Preliminary Results of STI-2020 Against COVID-19

Published: Jan 20, 2020 | Tags: Sorrento, Presents, Preliminary, Results, STI-2020, COVID-19

Biohaven’s Troriluzole Fails to Meet its Co-Primary Endpoints in P-II/III Study for Alzheimer’s Disease

Published: Jan 20, 2020 | Tags: Biohaven, Troriluzole, Fails, Meet, Co-Primary Endpoints, P-II/III, Study, Alzheimer’s Disease

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer

Published: Jan 20, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu (trastuzumab deruxtecan), Receives, EU, Approval, HER2 Positive, Metastatic Breast Cancer

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Published: Jan 20, 2020 | Tags: Omeros, Reports, US, FDA, Acceptance ,Priority Review , BLA Narsoplimab (OMS721) ,Treat, HSCT-TMA

Thermo Fisher to Acquire Mesa Biotech for $450M

Published: Jan 20, 2020 | Tags: Thermo Fisher, Acquire, Mesa Biotech, $450M

Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Published: Jan 20, 2020 | Tags: Lilly, Merus ,Collaborate ,Discover, Novel T-Cell, Re-Directing, Bispecific Antibodies

Biocryst’s Orladeyo (berotralstat) Receives the US FDA’s Approval to Prevent Attacks of Hereditary Angioedema (HAE)

Published: Jan 20, 2020 | Tags: Biocryst, Orladeyo (berotralstat), Receives, US, FDA, Approval, Prevent ,Attacks, Hereditary Angioedema (HAE)

Myovant’s Orgovyx (relugolix) Receives the US FDA’s Approval as the First Oral GnRH Receptor Antagonist for Advanced Prostate Cancer

Published: Jan 20, 2020 | Tags: Myovant, Orgovyx (relugolix), Receives, US, FDA, Approval, First Oral, GnRH Receptor Antagonist, Advanced, Prostate Cancer

Philips to Acquire Capsule Technologies for ~$635M

Published: Jan 19, 2020 | Tags: Philips, Acquire, Capsule Technologies, ~$635M

Innovent Out Licenses Byvasda’s (biosimilar, bevacizumab) Development and Commercialization Rights to PT Etana in Indonesia

Published: Jan 19, 2020 | Tags: Innovent, Out Licenses, Byvasda’s (biosimilar, bevacizumab), Development, Commercialization Rights, PT Etana, Indonesia

Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Published: Jan 19, 2020 | Tags: Grifols, Evaluate, New Immunoglobulin Therapy, COVID-19, Spain

Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases

Published: Jan 19, 2020 | Tags: Janssen, Signs, Research Agreement, TenNor, Develop, Treatments, Nontuberculous Mycobacteria Diseases

Tessa’s CD30 CAR-T Therapy Receives EMA’s PRIME Designation for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Jan 19, 2020 | Tags: Tessa, CD30 CAR-T Therapy, Receives, EMA, PRIME Designation, Relapsed or Refractory Classical Hodgkin Lymphoma

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Published: Jan 19, 2020 | Tags: Boehringer Ingelheim, Collaborates, Genetics, Develop, Next-Generation, Liver-Targeted, Gene Therapy

Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

Published: Jan 18, 2020 | Tags: Nanobiotix, Presents, Results, NBTXR3 (PEP503), P-Ib/II , Study, Rectal Cancer, ASCO-GI 2021

Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

Published: Jan 18, 2020 | Tags: Cardiff Oncology, Report, Results, Onvansertib, P- Ib/II, Study, KRAS-Mutated, Metastatic, Colorectal Cancer

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Published: Jan 18, 2020 | Tags: Genmab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), Receives, US, FDA, Approval, Patients, Newly Diagnosed, Light-chain,(AL) Amyloidosis

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Published: Jan 18, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, Receive, US, FDA, Approval, Previously, Treated, HER2-Positive, Advanced, Gastric Cancer

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Published: Jan 18, 2020 | Tags: AstraZeneca, Imfinzi (durvalumab), New Dosing Option, Receives, Approval, NSCLC, EU, UK

GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

Published: Jan 18, 2020 | Tags: GSK, Presents, Results, Dostarlimab, P-I, GARNET, Study,dMMR, Solid Cancers, ASCO GI

Related Post: PharmaShots Weekly Snapshots (Jan 11- 15, 2021)

The post PharmaShots Weekly Snapshots (Jan 18 – 22, 2021) first appeared on PharmaShots.

Health literacy needs support, now more than ever

The COVID-19 pandemic has brought healthcare guidelines and scientific advances front-of-mind on a global scale, in the process highlighting long-standing gaps in health literacy as well as an opportunity for pharma.

It’s long been known that many people struggle to access, understand and use health information and services to make decisions about their health.

As the WHO noted in 2013: “Knowledge societies in the 21st century confront a health decision-making paradox. People are increasingly challenged to make healthy lifestyle choices and manage their personal and family journeys through complex environments and health care systems but are not being prepared or supported well in addressing these tasks.”

Just how unprepared people are has been laid bare time after time. According to the 2012 European Health Literacy Survey, 29% to 62% of people across eight EU member states had inadequate or problematic health literacy.

And that’s before national television briefings began on COVID’s ‘R number’, an ever-mutating set of restrictive rules and an evolving understanding of the science behind a novel coronavirus first identified on 7 January 2020.

Alongside COVID’s devastating effects, 2020 also saw a raging misinformation pandemic as fake science and conspiracy theories spread rampantly online, often peddled by those in power, such as the former US president Donald Trump.

“In times of uncertainty and ‘fake news’, it is our responsibility to provide guidance and clarity to our patients and consumers”

A challenge to self-care

The spread of health misinformation at a time when we are increasingly expected to practice self-care wherever possible has been a particularly pernicious modern development and has turbo-charged dangerous ‘anti-vax’ ideas.

Filippo Lanzi is EMEA regional head for GSK Consumer Healthcare. His company is one of those in pharma looking to help improve health literacy and support people to manage their everyday health.

“In times of uncertainty and ‘fake news’, it is our responsibility to provide guidance and clarity to our patients and consumers,” he said.

“If we want to overcome misinformation and improve health literacy, we need to explain science to people in a way they understand, using the right channel, at the right time, so they can make informed decisions and find the products and sources of information they know they can trust.”

However, a GSK-commissioned study on the health-economic benefits of self-care in Europe published last month found that poor health literacy continues to pose a major challenge to self-care.

It revealed that 80% of Europeans accept that it is their responsibility to manage their own health and are willing to do so, but only 2 in 10 feel very confident in managing their own health.

Discussing the study’s findings Professor Lieven Annemans, senior full professor health economics at Ghent University, said: “Better health literacy creates empowered individuals who can take better control of their own health and make the right choices. There is a clear opportunity for governments, health systems, regulators and healthcare professionals to work together to remove this barrier in order to enable people to engage in self-care with confidence.”

An ‘infodemic’ of misinformation and fake news

Alongside pharma efforts to highlight the scale of the health literacy problem and work towards solutions, it’s clear that the problem of misinformation requires action from both governments and the tech giants that have allowed it to spread almost unchecked.

Facebook said in March it had been “taking aggressive steps to stop misinformation and harmful content from spreading” ever since the WHO declared COVID-19 to be a global public health emergency at the beginning of 2020.

In a sign that more concerted action was needed, in April the social network started displaying messages in people’s News Feeds if they had interacted with COVID-related posts subsequently deemed to have violated its policies. In June it started providing more context to COVID-related links and in September it introduced a forwarding limit to its Messenger service.

Those steps were followed in October with a new global policy that banned any adverts that would discourage people from getting vaccinated, whether for COVID, the flu or anything else. “We don’t want these ads on our platform,” the company noted, somewhat belatedly.

Meanwhile, Google started this year with the launch of a $3 million fund to tackle misinformation about COVID-19 vaccines.

Alexios Mantzarlis, news and information credibility lead at Google News Lab, said: “The uncertainty and developing nature of the coronavirus pandemic continues to generate related misinformation. The global rollout of COVID-19 vaccines is exacerbating a perennial problem of misinformation about immunisation.”

The company’s new fund is global in scope and open to news organisations with a proven track record in fact-checking and debunking activities as it aims to broaden the audience of fact checks, particularly to those who may be disproportionately affected by misinformation.

Individuals too have an important role to play, and the WHO has seven tips to help people flatten what it calls the ‘infodemic’ curve.

Pharma’s chance to help

Starting with prescribing information and packaging leaflets, there is a huge opportunity to make health information clearer and easier to understand.

Efforts are afoot to do so and it’s something the Patient Information Forum (PIF) aims to support through the health information accreditation scheme it launched last year.

“One of the things that COVID-19 has really highlighted is how important health literacy is. Materials don’t just need to be evidence based, they also need to be easy to use and understand,” Sophie Randall, PFI’s head of strategy and partnership told pharmaphorum.

“Industry has been under pressure from the EMA to improve the health literacy of prescribing information and packaging leaflets. We know that is complicated because of regulation, but we also think they can rise to the challenge.”

Beyond that pharma companies could be looking to harness their decades of experience in disease awareness for health literacy materials or easy-to-understand vaccine information. This could build on the industry’s already sterling efforts in working against COVID and there’s certainly a clear need for it.

About the author

Dominic-TyerDominic Tyer is a journalist and editor specialising in the pharmaceutical and healthcare industries. He is currently pharmaphorum’s interim managing editor and is also creative and editorial director at the company’s specialist healthcare content consultancy pharmaphorum connect. Connect with Dominic on LinkedIn or Twitter

The post Health literacy needs support, now more than ever appeared first on .

Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Shots:

  • Merck KgaA provides an update on its P-III [email protected] Lung 037 study and the extensive [email protected] clinical trial program assessing bintrafusp alfa for patients with BTC and cervical cancer
  • Based on the IDMC’s recommendation, Merck will discontinue the [email protected] Lung 037 study as it fails to meet its co-1EPs, specifically PFS. The ongoing clinical trial [email protected] Lung 037 includes 1L treatment of patients with stage IV NSCLS having PD-L1 expression
  • The company will further evaluate bintrafusp alfa in other studies. GSK has high hopes with the drug as it has paid $4.2B+ in the collaboration signed in 2019

Click here ­to­ read full press release/ article | Ref: Merck KgaA | Image: GMP News

The post Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study first appeared on PharmaShots.

GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

Shots:

  • The ongoing P-I GARNET study involves assessing dostarlimab as monothx. in patients with advanced solid tumors. Cohort F of the GARNET trial enrolled patients with dMMR non-endometrial solid cancers in which patients received dostarlimab (500mg, q3w) for four doses and dostarlimab (1000mg, q6w) thereafter for ~2yrs. or until disease progression or discontinuation
  • The study demonstrated ORR (38.7%). Additionally, after a median follow-up of 12.4mos., mDoR had not yet been reached and responses were durable across tumor types
  • Dostarlimab is a PD-1 mAb targeting PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2 and is under review in the US and EU

Click here ­to­ read full press release/ article | Ref: GSK | Image: BBC

The post GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI first appeared on PharmaShots.

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.

GSK’s Neale Belson on building trust with employees and society

Pharma’s reputation is currently riding high as the industry comes together to tackle COVID-19, but GSK’s UK general manager Neale Belson says there is always more companies can do to build their culture and make sure employees and customers trust they are doing the right thing.

When we spoke with Belson about the GSK’s response to COVID-19, he pointed out how the pandemic has allowed him to get to know his colleagues even better than he anticipated. Now, speaking to him as the first vaccines are deployed in the UK, he highlights the importance of GSK’s employees and culture to the future of the company post-COVID.

Despite becoming UK GM at a difficult time – right before lockdowns came into effect in March – Belson says he was excited to start the role, which he describes as his “dream job”.

“It’s an incredibly humbling experience. When I was young, I had a strong desire to make a difference, and making a difference is right at the heart of GSK’s mission.”

As GSK’s UK lead, Belson is responsible for promoting and implementing the company’s three core priorities – Innovation, Trust and Performance – in the country. He believes the most important aspect of doing this is to develop the business by building its people.

“Our employees’ friends and colleagues understand the great work we’re doing, which has changed how they feel about working for GSK and how they are engaged in our mission”

“To me that’s all about the environment we create,” he says. “We want people to enjoy working for GSK in the UK, to feel valuable, and to feel excited about being part of something.

“What we do as an industry is really special, and it’s important to me that people feel proud of what we do and see that we can achieve an awful lot together.”

The COVID-19 pandemic, he says, has been a key catalyst in helping people both outside and inside the company understand its purpose and build on the Trust agenda.

“People now recognise what the industry has done to help tackle COVID. Our employees’ friends and colleagues understand the great work we’re doing, which has changed how they feel about working for GSK and how they are engaged in our mission. It’s been lovely to see that.

“There’s never been a better time to be in pharma. If we build on that, our Trust agenda can have a very strong future.”

Trust and Performance

Building this trust among employees involves improving a company’s culture from the ground up, Belson says.

“We are looking to build a purpose-led, performance-driven culture to enable us to make the biggest difference possible. To us, that means making a difference to what matters to people.

“We want to focus on things like development, diversity, health and wellbeing – and all of that underpins our goal to be one of the most innovative, high-performing, and trusted companies in the healthcare space.”

The same is true for the company’s Performance agenda.

“Our performance agenda is all about investing in our people and our capabilities,” Belson says. “At the beginning of the pandemic we ramped up our training, and our capabilities developed significantly as a result. We wanted to get people match-fit, and they really enjoyed and appreciated that.

“As part of that we also sought to understand the challenges people were having and how we could help them. This is not only good for health and wellbeing, but also for overall performance.”

Sustainability and joint working

But Belson notes that building trust must go beyond internal projects and involve external efforts as well.

He highlights GSK’s recently announced sustainability ambitions as an example of how the company is aiming to “do the right thing” for wider society.

With the new goals, GSK aims to have a net zero impact on climate and a net positive impact on nature by 2030.

Underpinning these goals, the company has set new targets across its different businesses, including: 100% renewable electricity usage and good water stewardship at all GSK sites; 100% of materials sustainably sourced and deforestation free and transitioning to 100% usage of electric vehicles by sales reps worldwide.

“We’re investing in restoration projects where we can and are looking to put back into nature more than we take out,” Belson explains.

“We don’t have all the answers yet, but I’m proud of the agenda and the ambition.”

Similarly, Belson believes it is important to make sure that GSK is “part of the solution” in addressing patient needs in the UK through joint working initiatives with the NHS.

Some examples where GSK have done this include a collaboration with Health Innovation Manchester to deliver asthma care to patients within a pharmacy community setting, and an initiative with the Federation of Family Practices in Belfast to help improve the care of COPD patients who remain symptomatic.

“It’s also important that we continue to learn and understand what patients need throughout the ecosystem, from early drug development all the way through to how patients are diagnosed and treated and their journey through these processes.”

Overall, Belson says the Trust agenda is about making sure people genuinely feel that GSK is doing the right thing.

“I think people are proud to work for a company that has that as one of the core pillars of its strategy. Fundamentally, I want to lead an organisation where people genuinely feel they are connected with our purpose.”

He says he would like to see employees become even more connected to this purpose in the future.

“We’re trying to drive a culture where people feel valued and respected, and where they’re genuinely part of the solutions we’re providing.

“That involves listening, understanding and making sure they have a voice and feel confident about speaking up – as well as making sure they can feel part of where we’re going as an organisation.”

About the interviewee

Neale Belson is senior vice president and general manager UK and Ireland at GSK, and leader of the GSK Pharmaceuticals affiliate in the UK. Neale has performed several significant leadership roles encompassing many therapeutic areas working in the United States, Europe and most recently as vice president and area director GSK Nordic and Baltic Cluster, based in Copenhagen, Denmark. Prior to GSK, Neale held senior commercial roles at AstraZeneca.

About the author

George Underwood is pharmaphorum’s Deep Dive magazine editor, leading the content for the bi-monthly magazine. He has been reporting on the industry for seven years and has worked at a number of leading publications in the UK.

The post GSK’s Neale Belson on building trust with employees and society appeared first on .

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

Shots:

  • The companies signed an agreement with to evaluate VIR-7832 vs PBO in P-Ib/IIa AGILE study in patients with mild to mod. COVID-19. The trial is expected to be initiated in Q1’21 across up to five sites in the UK
  • The preclinical data demonstrated that VIR-7832 enhanced ability to clear infected cells and enhance virus-specific T cell function, treating or prevent COVID-19 infection
  • VIR-7832 is a dual-action mAb, currently being evaluated in two global P-III studies for the early treatment of COVID-19 in patients who are at high risk of hospitalization, and for hospitalized patients with COVID-19

Click here ­to­ read full press release/ article | Ref: GSK | Image: Medical Dialogues

The post GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19 first appeared on PharmaShots.

ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs

In a recent interview with PharmaShots, Dr. Riju Ray, MD, PhD, Senior Medical Lead at GSK, leading US medical affairs across asthma and COPD shared his views on how community-based pulmonologists are improving COPD management and education among referring PCPs.

Shots:

  • Pulmonologists identified 12 strong to moderate predictors of future COPD exacerbations, some of which were evaluated less frequently. COPD is frequently underdiagnosed, and this may be partially due to a lack of adequate knowledge and testing at the primary care level, highlighting the need for further education improve patient care
  • When evaluating COPD traits, pulmonologists were most likely to evaluate behavioral traits, exacerbation history and recovery time rather than traits that require testing, as acknowledged by the standard of care (GOLD guidelines). Failure to evaluate testing-based traits creates an overdependence on physician-patient communication, which is already a recognized key challenge
  • Community-based pulmonologists play an important role in the management of COPD, and the majority of respondents were also in a position to influence COPD management practices of colleagues. However, the opportunity to educate primary care physicians on COPD management and exacerbation prevention was not utilized by the majority of survey respondents, suggesting a need to more strongly engage specialists in education efforts

Tuba: Please discuss the epidemiology of the chronic obstructive pulmonary disease (COPD)?

Riju: COPD, or chronic obstructive pulmonary disease, is a progressive lung disease. There are more than 16.4 million people in the U.S. that are diagnosed with COPD, and it is one of the leading causes of death worldwide. While there is no cure for COPD, it is treatable, and with daily management, those with the disease can maintain good quality of life.

Tuba: Can we have a key point of the whitepaper published in Chest Clinical Perspectives in a non-scientific way?

Riju: In the recent study funded by GSK and co-developed by CHEST and GSK, we assessed the approaches pulmonary specialists take when they think of managing COPD exacerbations (or flare-ups) and what clinical perspectives come to mind when they consider future risk of these COPD exacerbations for their patients. These COPD exacerbations, or COPD flare-ups, speed up lung function decline and often lead to hospitalizations, which impact the health and quality of life for people with COPD. Research shows that frequent exacerbations that require hospitalization are also associated with higher mortality. Hospitalizations also lead to greater impact on daily life, decreased ability to work and increased burden on family caregivers, so it is important to help people with COPD reduce their chances of experiencing a COPD exacerbation.

Source: Biophysical Society

Tuba: What were the objectives of the research conducted by CHEST?

Riju: The objectives of the survey were to:

  • Assess the frequency with which pulmonary, extrapulmonary, and behavioral traits of COPD patients are evaluated in pulmonology practices.
  • Assess which disease characteristics pulmonologists use to predict the occurrence and severity of exacerbations in patients with COPD, including those who have no history of exacerbations.
  • Identify barriers to assessing these disease characteristics in pulmonology practices.
  • Assess how often pulmonologists are actively involved sharing their knowledge of COPD treatment and management with their referring primary care physicians.

Tuba: Discuss the role of pulmonologists in improving the management of COPD.

Riju: Pulmonologists work with patients to develop a proper COPD management plan and participate in the development of treatment plans. Pulmonologists are also in a position to better educate their referral primary care physicians. According to the survey, COPD is frequently underdiagnosed, which may be partially due to primary care physicians’ (PCPs) lacking knowledge on the disease. It’s important for pulmonologists to utilize their position to educate PCPs on how to administer tests, and interpret results, and plan tailored disease management plans for their patients with COPD.

Tuba:  What were the findings of the research conducted by CHEST/GSK?

Riju: The survey uncovered a few key insights on COPD exacerbation predictors and the role of pulmonologists in better managing future COPD exacerbation risk:

  • There are 12 strong disease characteristics that pulmonologists determined to be predictors of a COPD exacerbation.
  • Pulmonologists are more likely to evaluate behavioral traits that do not require testing than pulmonary and extrapulmonary factors.
  • Most (71%) of pulmonologists surveyed use a strategy-based approach like the GOLD while 29% said their management approach is dependent on a patient’s symptoms.
  • The opportunity to educate other physicians on COPD management and exacerbation prevention is not utilized.In fact, only 16% of respondents said they make a routine practice of proactively engaging or informally educating referring physicians on how to evaluate and manage COPD.

Tuba: Can you showcase the GOLD guidelines used by the pulmonologist?

Riju: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document is used broadly by physicians to guide COPD treatment plans. It categorizes patients according to their level of airflow limitation, symptoms, and comorbidities, and disease stages. However, patients symptom burden and exacerbation history are recommended as 2 key guiding principles for determining optimal treatment. Patients grouped in the same stage of the disease often have variation in symptoms, exacerbations, and risk of mortality, so understanding how to identify and test those characteristics is important to developing a personalized treatment plan.

Tuba: What were the different traits evaluated by the pulmonologist during the research?

Riju: In the survey, pulmonologists evaluated various behavioral, pulmonary and extrapulmonary traits and determined 12 strong COPD exacerbation predictors. The behavioral characteristics include treatment adherence, tobacco use, exacerbation history (especially exacerbations leading to hospitalizations), which do not require testing. Pulmonary and extrapulmonary factors include frailty or airflow limitation, which are evaluated less frequently. This study emphasizes the importance of pulmonologists’ recognition of disease characteristics, laboratory testing, in-office assessments and physician education when developing treatment plans. 

  • When testing-based characteristics are not routinely evaluated as indicated by surveyed pulmonologists, it creates an overdependence on physician-patient communication. While this study did not specifically address communication, we know that both patients and physicians think there is room for improvement in terms of physician-patient communication during medical appointments. It is an extremely important component of the patient-physician relationship and should be considered in any disease management plan.

Tuba: What are the different predictors of future COPD exacerbations? What you consider is the best predictor for exacerbation?

Riju: The best predictor for an exacerbation is exacerbation(s) history; however, it is important for pulmonologists to evaluate other disease characteristics, especially in the absence of exacerbation history. A focus on behavioral elements like smoking cessation and adhering to their treatments especially controller medicines also ranked high from the surveyed pulmonologists. Regardless of exacerbation history, recent studies suggest triple therapy with an ICS, LAMA, and LABA showed the greatest benefit for improving both lung function and preventing exacerbations.

Tuba: What are the educational benefits of using an approach to COPD management?

Riju: As mentioned, COPD is frequently under-diagnosed, so it is important for pulmonologists to utilize all tools available to them between in-office testing, reference of GOLD and evaluation of a patient’s health history when treating people with COPD symptoms. It’s also critical pulmonologists engage PCPs in formal or informal education activities to improve patient care from the front line.

Tuba: Why do you think COPD management is necessary to improve the condition of patients?

Riju: Like any disease, proper disease management is essential to ensuring patients receive optimal care and lead a high quality of life as possible. COPD can worsen over time, especially for people who experience frequent exacerbations, but patients don’t have to settle for a life of breathlessness. Better days are possible for people living with COPD through consistent and comprehensive disease management.

Image Source: Dimerix Limited

About Author:

Dr. Riju Ray is an MD, PhD senior medical lead within the Respiratory team at GSK US medical affairs leading teams across both Asthma and COPD. He is based out of Research Triangle Park in North Carolina.

Related Post: ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

The post ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs first appeared on PharmaShots.

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

The post PharmaShots’ Most Read News of 2020 first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment

AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy

Published: Dec 22, 2020 | Tags: AMO Pharma, AMO-02, Initiation, REACH-CDM, Treatment of Congenital Myotonic Dystrophy

Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

Published: Dec 22, 2020 | Tags: (dexamethasone ophthalmic insert), Dextenza, Ocular Itching, Ocular Therapeutix, reports, sNDA Submission, Us FDA

Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

Published: Dec 21, 2020 | Tags: Autoleucel (cilta-cel), BLA, Initiates, Janssen, Multiple Myeloma, Rolling, Submission, Us FDA

Voyager Therapeutics Provides Update on NBIB-1817(VY-AADC) Program to Treat Parkinson Disease

Published: Dec 22, 2020 | Tags: (VY-AADC), NBIB-1817, Parkinson Disease, Provides, Update, Voyager Therapeutics

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

Published: Dec 22, 2020 | Tags: (daratumumab), DARZALEX, Health Canada Approval, Janssen, Multiple Myeloma, receives, Treatment

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Published: Dec 22, 2020 | Tags: Asthma, AstraZeneca, Corticosteroid, Dependent, Oral, P-III, patients, reports, results, Severe, SOURCE, Tezepelumab, Trial

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Published: Dec 21, 2020 | Tags: (BNT162b2), BioNTech, Comirnaty, Conditional Marketing Authorization, COVID-19, EC, Pfizer, receives

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Published: Dec 21, 2020 | Tags: (peginterferon beta-1a), Biogen, European Commission, Marketing Authorization, Plegridy, receives, Relapsing-Remitting MS

Servier to Acquire Agios’ Oncology Business for ~$2B

Published: Dec 21, 2020 | Tags: $2B, Agios, Agreement, business, Its, Oncology, Royalties, Sell, Servier, Signs

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Published: Dec 21, 2020 | Tags: Diabetic, Edema, Faricimab, Global, Macular, P-III, reports, results, Roche, Studies, Two

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

Published: Dec 21, 2020 | Tags: (osimertinib), approval, AstraZeneca, Early-Stage, EGFR-mutated Lung Cancer, receives, Tagrisso, US FDA’s

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Published: Dec 18, 2020 | Tags: Against, COVID-19, EUA, Moderna, mRNA-1273, receives, US, Us FDA

Ultragenyx Signs a License Agreement with Mereo for Setrusumab in Osteogenesis Imperfecta

Published: Dec 17, 2020 | Tags: Agreement, Imperfecta, Mereo BioPharma, Osteogenesis, Setrusumab, Signs, Ultragenyx

ViiV Healthcare’s First Long-Acting Injectable Receive EC’s Approval for the Treatment of HIV

Published: Dec 21, 2020 | Tags: EC Marketing Authorization, Edurant Receives, HIV-1 Infection, Rekambys, ViiV Healthcare, Vocabria (cabotegravir)

Philips to Acquire BioTelemetry for ~$2.8B

Published: Dec 18, 2020 | Tags: Acquires, BioTelemetry, Philips

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Published: Dec 18, 2020 | Tags: Agreement, Candidates, Develop, Drug, Engager, Immuno, Janux Therapeutics, Merck, Novel, Oncology, Signs, T Cell, technology, Using

GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System

Published: Dec 21, 2020 | Tags: Digestive System, Global License Agreement, GPR35, GSK, Immune Disorders, Signs, Sosei Heptares

Related News: PharmaShots Weekly Snapshots (Dec 14-18, 2020)

The post PharmaShots Weekly Snapshots (Dec 21-23, 2020) first appeared on PharmaShots.

GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System

Shots:

  • Sosei Heptares to receive $44M as upfront, near-term development milestones, and funding and is eligible to receive $437M as development, regulatory, and commercialization along with royalties on sales of products resulting from the collaboration
  • GSK gets the global rights to a Sosie Heptares’ portfolio of GPR35 agonists, developed utilizing StaR technology & SBDD platform. The licensed portfolio includes an advanced lead preclinical compound as well as multiple differentiated back-up compounds
  • The companies collaborated on research and early preclinical development while GSK will lead clinical development, manufacturing, and commercialization

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: McMaster Optimal Aging Portal

The post GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System first appeared on PharmaShots.

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.

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

Shots:

  • The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV, 10 mg/kg) + SOC vs PBO + SOC in 448 adult patients with active LN
  • The study met its 1EPs demonstrating a greater number of patients who achieved PERR @2yrs. (43% vs 32%., all 2EPs were achieved while safety results are consistent with the known safety profile of Benlysta
  • Benlysta is a mAb that binds to soluble BLyS and does not bind B cells directly. The approval extends the current indication in the US to include both SLE and LN for both the IV and SC formulations

Click here ­to­ read full press release/ article | Ref: GSK | Image: Euronews

The post GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN) first appeared on PharmaShots.

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

Shots:

  • Surface Oncology to receive ~$85 M upfront and ~$730 M as milestones along with royalties on net sales of SRF813
  • GSK to get an exclusive right to develop and commercialize Surface Oncology’s preclinical program, SRF813
  • SRF813 is an IgG1 Ab targeting PVRIG (also k/a CD112), currently in IND-enabling studies with anticipated IND submission in 2021

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Emergency Physicians Monthly

The post GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813 first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

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

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

Related Post: PharmaShots Weekly Snapshot (Nov 02-06, 2020)

The post PharmaShots Weekly Snapshots (Nov 09-13, 2020) first appeared on PharmaShots.

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Shots:

  • Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant
  • The study will evaluate the immunogenicity and safety profile of the chosen formulation and dosing regimen of CoVLP (two doses of 3.75µg combined with GSK’s adjuvant given 21 days apart) in healthy adults 18-64yrs. of age and in elderly subjects aged ≥65yrs.
  • P-II trials will be conducted in multiple locations across Canada and, upon FDA’s approval, in the US. The P-III studies will start before the end of 2020 and will evaluate CoVLP in ~30,000 volunteers globally

Click here­ to­ read full press release/ article | Ref: GSK | Image: BioPharma Reporter

The post GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine first appeared on PharmaShots.

GSK and eosinophil research: the pharmaphorum podcast

GlaxoSmithKline’s Nucala (mepolizumab) last month became the first and only biologic treatment approved in the US for Hypereosinophilic Syndrome (HES).

It’s part of the company’s focus on eosinophil-driven diseases, and ahead of that regulatory milestone I spoke with Tiffany Robinson-Smith, global medical affairs lead for biologics at GSK, about eosinophils and why they’re an important element of her company’s research programmes.

We also spoke in this episode of the podcast about some of the research challenges GSK faces with eosinophils and where they fit into the pharma company’s current product portfolio.

You can listen to episode 25 of the pharmaphorum podcast in the player below, download the episode to your computer or find it – and subscribe to the rest of the series in iTunes, Spotify, acast and Stitcher.

 

The post GSK and eosinophil research: the pharmaphorum podcast appeared first on .

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Shots:

  • The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count
  • Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally, risk of progression in those with BRCA mutation tumours showed 60% reduction
  • Zejula is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Spiegel

The post GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer first appeared on PharmaShots.

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.

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue

Immunology Segment Revenue: $0.01B

Founded Year: 1979

Market Cap: ~ $0.49B

Total Employees: ~178

Headquarter: New Jersey, United States

Stock Exchange: NASDAQ

Antares Pharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019

Immunology Segment Revenue: $0.24B

Founded Year: 2008

Market Cap: ~$15.70B

Total Employees: ~1,200

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”

Immunology Segment Revenue: $0.49B

Founded Year: 1993

Market Cap: ~$2.57B

Total Employees: ~5,047

Headquarter: Shenyang, China

Stock Exchange: HKD

3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.

Immunology Segment Revenue: $0.73B

Founded Year: 1978

Market Cap: ~$42.57B

Total Employees: ~7,400

Headquarter: Massachusetts, United States

Stock Exchange: NASDAQ

Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.

Immunology Segment Revenue: $0.81B

Founded Year: 2000

Market Cap: ~$88.14

Total Employees: ~99,000

Headquarter: Brentford, United Kingdom

Stock Exchange: LON

GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.

Immunology Segment Revenue: $1.11B

Founded Year: 2007

Market Cap: ~$34.6B

Total Employees: ~7,228

Headquarter: Osaka, Japan

Stock Exchange: TYO

Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.

Immunology Segment Revenue: $1.24B

Founded Year: 1891

Market Cap: ~$197.46B

Total Employees: ~71,000

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.

Immunology Segment Revenue: $1.68B

Founded Year: 1991

Market Cap: ~$19.38B

Total Employees: ~1,300

Headquarter: Delaware, United States

Stock Exchange: NASDAQ

Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.

Immunology Segment Revenue: $1.79B

Founded Year: 2005

Market Cap: ~ $26.49B

Total Employees: ~15,883

Headquarter: Tokyo, Japan

Stock Exchange: TYO

Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.

Immunology Segment Revenue: $1.79B

Founded Year: 1901

Market Cap: ~$135.16B

Total Employees: ~33,625

Headquarter: Indiana, United States

Stock Exchange: NYSE

Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.

Immunology Segment Revenue: $1.92B

Founded Year: 1928

Market Cap: ~$20.49

Total Employees: ~7,600

Headquarter: Brussels, Belgium

Stock Exchange: EBR

UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.

Immunology Segment Revenue: $2.53B

Founded Year: 1973

Market Cap: ~$122.35B

Total Employees: ~100,000

Headquarter: Paris, France

Stock Exchange: EPA

Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.

Immunology Segment Revenue: $2.97B

Founded Year: 1887

Market Cap: ~$135.30B

Total Employees: ~30,000

Headquarter: New York, United States

Stock Exchange: NYSE

Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.

Immunology Segment Revenue: $3.66B

Founded Year: 1925

Market Cap: ~$52.60B

Total Employees: ~49,578

Headquarter: Osaka, Japan

Stock Exchange: TYO

Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.

Immunology Segment Revenue: $4.22B

Founded Year: 1996

Market Cap: ~$205.93B

Total Employees: ~109,000

Headquarter: Basel, Switzerland

Stock Exchange: SIX Swiss Exchange, NYSE

Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.

Immunology Segment Revenue: $4.73B

Founded Year: 1849

Market Cap: ~$206.05B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.

Immunology Segment Revenue: $5.39B

Founded Year: 1980

Market Cap: ~$134.11B

Total Employees: ~23,400

Headquarter: California, United States

Stock Exchange: NASDAQ

Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.

Immunology Segment Revenue: $8.79B

Founded Year: 1896

Market Cap: ~ $281.59B

Total Employees: ~98,000

Headquarter: Basel, Switzerland

Stock Exchange: SWX

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.

Immunology Segment Revenue: $13.95B

Founded Year: 1887

Market Cap: ~$378.94B

Total Employees: ~132,100

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.

Immunology Segment Revenue: $19.57B

Founded Year: 2012

Market Cap: ~$146.29B

Total Employees: ~30,000

Headquarter: Illinois, United States

Stock Exchange: NYSE

AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.

Related Post: Top 20 Immunology Companies Based on 2018 Immunology Segment Revenue

.

The post Top 20 Immunology Companies Based 2019 Immunology Segment Revenue first appeared on PharmaShots.

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

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

The post GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020 first appeared on PharmaShots.

Pharma’s response to COVID: GSK

A few months into the pandemic, the world is now moving beyond managing the crisis, with more focus on addressing the collateral damages and shaping the future. As part of a new series looking at how pharma has responded to the pandemic, Neale Belson, SVP UK & Ireland and general manager for the UK at GSK, tells us that it is “absolutely critical” to do this with the pace and out-of-the box thinking of the past months.

Belson became GSK’s general manager in the UK in March, just before lockdown came into effect, and because of this he says he has now got to know himself and his colleagues better than he could have anticipated.

“Working remotely has given me greater appreciation and understanding of their home life, personal priorities and challenges. I have also seen how my colleagues handled the pressures of the pandemic to find solutions to brand new challenges, motivated by their passion for protecting patients and improving the way they live their lives.”

Belson says that the obvious place for GSK to start in its response to the pandemic was to leverage its experience in vaccine discovery.

“This specific vaccine effort, however, is like no other in its sense of urgency and scale of need,” he says. “With COVID, even the approach to vaccine discovery is transforming.

“The key word from the beginning has been ‘collaboration’,” he adds.“We are working in partnership with companies and research groups across the world to help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19.”

“This specific vaccine effort, however, is like no other in its sense of urgency and scale of need. With COVID, even the approach to vaccine discovery is transforming”

He highlights GSK’s “unprecedented” partnership with Sanofi, where the two companies are combining their science and technologies to develop an adjuvanted COVID-19 vaccine, which entered clinical trials in September 2020.

But he stresses again that this collaborative effort needs to extend beyond the research and discovery phase.

“We are already thinking of how we will make a potentially successful vaccine candidate available and affordable globally, and in the UK we have already agreed with the government to supply up to 60 million doses of a COVID-19 vaccine.”

Beyond the urgent need for treatments and vaccines, the pandemic has also challenged the NHS to adapt quickly to establish new ways to keep patients, especially those most vulnerable to the virus, away from hospitals and clinics and remain in the safety of their own homes.

“We’ve also had to ask ourselves how we can support the NHS to meet those demands, working as a partner to protect the public,” says Belson. “This will only become more vital as we enter the latter months of the year and support the NHS as they attend to the backlog of patients that await non-COVID related examination and treatment and as they prepare for winter, which will bring additional pressures to the system, with the flu season upon us.”

One approach GSK has taken is to leverage its experience through a series of webinars that aim to support HCPs to build their skills and confidence as they take consultations online.

“This not only protects vulnerable patients but also our vital NHS workforce, reducing their exposure to the coronavirus and maintaining their ability to remain at work,” says Belson.

GSK has also started to pool knowledge into an accessible online resource hub, with the aim of creating a “one-stop shop” of guidance and support for respiratory HCPs across the NHS.

This provides free advice and training to support HCPs as they adjust to new tools and ways of working, and to guide respiratory patients through the journey with them.

The company is also contributing to the NHS’ ‘Your Covid Recovery’ online tool as patients return home to recover from the coronavirus.

“Severe asthma, lupus and cancer patients have been able to follow government guidance to reduce their exposure to COVID-19 by receiving care and testing in their homes,” says Belson. ”We’ve brought forward formulations for self-administration by working closely with regulatory bodies, as well as doubling homecare offerings and launching a patient app.

“These initiatives share an underlying factor: the use of innovation to improve people’s lives in these new circumstances and beyond.”

Patients aren’t just vulnerable during a pandemic, and Belson says that much of the novel approaches companies have tried in the past months will continue to be present and further evolved in the future.

“The NHS has provided an incredible level of care and support during this time, demonstrating the solutions our unique healthcare system can offer patients and HCPs.

“By giving severe asthma patients the independence to access their treatment from their sofa, we are freeing up time that HCPs can spend seeing and treating new patients on waiting lists in clinics. By those with respiratory and autoimmune diseases being able to see their GP on a screen and not through a waiting room, we are protecting them from unnecessary exposure to disease and complications. These are the types of solutions we will try to explore and support as the pandemic continues, working as a trusted partner alongside the NHS and patients.”

Belson says that the pandemic has emphasised the importance of asking ‘how’ care is administered as well as ‘what’ care is administered.

“We now need to continue working with our partners to benefit patients long-term.”

This series is supported by the Association of the British Pharmaceutical Industry (ABPI)

The post Pharma’s response to COVID: GSK appeared first on .

GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses

Shots:

  • GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions including regulatory review by appropriate regulatory agencies under Hart-Scott-Rodino Act
  • The collaboration will focus on development of specific antibody candidates identified by Vir’s platforms (VIR-7831 and VIR-7832) which demonstrated high affinity for SARS-CoV-2 spike protein and highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. The companies plan to proceed directly into P-II clinical trial within next 3 to 5 mos.
  • Vir’s antibody platform has been used to identify and develop antibodies for pathogens including Ebola (mAb114, currently in use in the Democratic Republic of Congo), hepatitis B virus, influenza A, SARS-CoV-2, malaria, and others

Click here to­ read full press release/ article | Ref: GSK | Image: BGR

The post GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses first appeared on PharmaShots.

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Shots:

  • The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status
  • The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to 1L Pt.-based CT
  • Zejula (PO, qc) is a poly (ADP-ribose) polymerase (PARP) inhibitor and has received approval in 2019, in Canada for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

Click here ­to­ read full press release/ article | Ref: GSK | Image: Pharmafile

The post GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer first appeared on PharmaShots.

GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development

Shots:

  • NVIDIA reports that it is building the “Cambridge-1” supercomputer, which will be an NVIDIA DGX SuperPOD system capable of delivering 400+ petaflops of AI performance and 8 petaflops of Linpack performance and 1s expected to come online by the end of 2020
  • GSK and AstraZeneca will be the first company to harness Cambridge-1 for research. Additionally, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, and Oxford Nanopore Technologies also plan to take advantage of the system
  • Cambridge-1 will be the first NVIDIA supercomputer designed and built for external research access and will provide researchers and academics the ability to tackle challenging AI training, inference, and data science workloads at scale. NVIDIA will invest ~ $51.7M in Cambridge-1

Click here ­to­ read full press release/ article | Ref: NVIDIA | Image: Medsmart App

The post GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development first appeared on PharmaShots.

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

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: GSK | Image: StraitTimes

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Pharmaceutical Marketing

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals

As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx for its tarnished reputation?

The Pharma industry has long been at the center of a firestorm, cited consistently as one of the most disliked and distrusted industries in the Gallup poll. It’s not surprising given the media coverage of CEO and company financial disclosures, patent trials, illegal activities, and questionable practices, legal settlements, price gouging, product recalls, and, most recently, its role in the devastating opioid epidemic. While the public’s high distrust and disdain are directed at “greedy” Pharma, prescription drug spending accounts for between 10-12% of total US healthcare costs, and now, in our time of greatest need, we turn to this industry to help us confront COVID-19. This pandemic has brought the committed, community-focused side of Pharma to the forefront, with its rapid and relentless pursuit to deliver the best science to solve this crisis.

Pharmaceuticals Collaborating for COVID’s Rx

There are brilliant and talented people in dozens of companies, both established manufacturers and small start-ups, working tirelessly to find a solution. Early efforts developed and produced testing assays to help the healthcare community identify and confirm the virus. The expanded focus now pursues proven treatments and vaccines. We see unexpected partnerships and creativity abound in the race to find answers that will address the crippling impact on public health and disrupt the economy and supply chains. Thomas Cueni, who leads the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, notes, “the industry, which is traditionally fiercely competitive, has come together.”

For example, rivals like Sanofi and GSK are working to bring their innovative technologies together for a vaccine, with Astra-Zeneca and Oxford University signing a global development and distribution agreement for a CO-19 vaccine, Takeda and CoVIg-19 Alliance investing in plasma therapies, Regeneron and Sanofi conducting clinical trials for their jointly marketed Rheumatoid Arthritis drug Kevzara, and Pfizer and BioNTech are collaborating on an mRNA vaccine. There is an impressive number of ongoing trials to evaluate existing drugs for other diseases, including Gilead’s Remdesivir which now has FDA authorization for emergency use, and Gilead Sciences is applying for full authorization in the U.S., specialty biotech companies like Moderna and Novavax have also entered the race and are fast-tracked for their vaccine candidates.

Pharma’s Investments & Innovations during COVID-19

Beyond drug treatment and vaccine development, the industry has also brought new ingenuity and investment to fight COVID-19 and support the healthcare system; Johnson & Johnson is pledging $300M over ten years to help front-line workers, Astra-Zeneca donating 9M face masks to protect healthcare workers around the world, companies deploying their 3D printing capabilities to manufacture PPE and equipment, and Consumer Product companies producing hand sanitizers.

This industry, its brilliant researchers, and dedicated employees are unwavering in their mission to be a part of the solution by investing in unknowns despite the risk, diverting focus from other commercially available/development assets, and pioneering scientific innovation to confront COVID-19. With the sheer number of companies in this race, we stand the best chance of finding solutions and having the scale to keep up with the alarming projections of cases. It also helps to foster competition and encourage fair pricing. Despite Pharma‘s commitment to the cause, there continue to be critics who attribute Pharma’s efforts to capitalizing on a crisis and solely focused on profit. For those who feel Pharma should not make a profit from the deep investment, at this moment, it’s difficult to put a price on overcoming this enemy.

Pharma Marcom & PR during COVID

With the knowledge that consumers look to brands and companies that demonstrate social responsibility, philanthropic and community support, other industry leaders and I agree that there is an opportunity for Pharma to begin to evolve from some of the negative perceptions and elevate recognition of its essential role in moving us from “StayatHome” to “StayHealthy.” We are beginning to see public opinion improve throughout this pandemic, according to a recent Harris poll. From a marketing and public relations standpoint, I’m hopeful the Pharmaceutical Research and Manufacturers of America (PhRMA) will take this moment to elevate public awareness and highlight the level of corporate commitment and investment behind the scenes of this pandemic.

This is not self-serving. This is about scientific innovation, leadership during crisis, corporate responsibility, and saving lives. The industry should continue to demonstrate its thought leadership during this time through scientific publications and serving as an expert voice. As consumers increasingly search for information about the virus, vaccines, and treatment, Pharma needs to ensure the public has access to credible, scientifically-grounded content across media channels. Given the sequelae from this pandemic, there is also a tremendous need to address mental health and wellbeing. With the significant investment and access to mental health solutions and services, Pharma can also answer this call.

Pharma Marketing & Healthcare Marketing | COVID & Beyond

As advertising and communication experts, now is the time to step up and be even truer and more innovative pharmaceutical marketing agency partners. While our pharma, medical and healthcare clients are redirecting their efforts toward COVID-19, our own industry must be even more proactive and creative. Let’s bring pharmaceuticals strategically inventive marketing communication ideas and messaging programs to keep their brands and marketing more relevant during the COVID pandemic. Let’s help pharmas more effectively reach their increasingly “remote” customers and patients. Let’s drive better search rankings by developing more useful and authoritative content to educate online-engaged healthcare audiences. Let’s explore corporate campaigns and grass-roots programs to draw medical and pharmaceutical enterprises closer to their patient communities and genuinely bolster reputations. As experts in social media, let’s help Pharma be consistently compliant and proactively trustworthy participants in conversations concerning diseases & conditions. Let’s elevate the pharma industry’s core values currently on display through successfully inventive creativity and discerning innovation. As partners, let’s work tirelessly to create and focus insightful spotlights on the heroic efforts of our client-partners — healthcare and medical innovators dedicated to making “life-changing” differences within today’s life-changing public health crisis.

COVID and Healthcare Marketing — related articles: [Podcast] Hospital Crisis Management and Healthcare PR in the Age of COVID-19 | 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic | Healthcare Marketing: Pause, Pivot, or Push for Success?

 

The post Is COVID the Rx for the Pharmaceutical Industry’s Reputation? appeared first on Healthcare Success.

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)

FDA approves GSK’s Blenrep for advanced multiple myeloma

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease.

Blenrep (belantamab mafodotin) has been approved in patients who have received at least four therapies including an anti-CD38 such as Darzalex, a proteasome inhibitor and an immunomodulatory agent.

This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term.

Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly found on the surface of the malignant B-cells that cause the disease.

It is the first BCMA drug approved anywhere in the world but could face competition from bluebird bio and Bristol-Myers Squibb’s CAR-T therapy bb2121, which also works by targeting the same receptor.

However Blenrep is a very different drug, which works by latching on to the B-cells and delivering a lethal payload, while leaving most healthy tissues untouched.

GSK has not released information about its plans for pricing in the US, but antibody drugs tend to be less expensive than CAR-Ts, which are manufactured using a costly process that involves harvesting  a patient’s cells and modifying them to fight cancer.

Approval was based on six-month primary results from the pivotal DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite current standard of care.

In the study, treatment with single-agent Blenrep every three weeks demonstrated a clinically meaningful overall response rate (ORR) of 31% in patients who had received a median of seven prior lines of treatment.

The median duration of response (DoR) had not been reached at the six-month analysis, but 73% of responders had a DoR equal to or greater than six months.

There were doubts about whether Blenrep could be approved in the US after a FDA review noted problems with ocular safety associated with the drug ahead of a meeting of the regulator’s expert advisers last month.

However the Oncology Drug Advisory Committee (ODAC) unanimously voted in favour of approval, although the drug’s packaging will contain prominent warnings about changes in vision including severe vision loss, corneal ulcer and symptoms such as blurred vision and dry eyes.

Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%) and dry eye (19%).

Corneal adverse events were monitored with eye exams prior to each dose, allowing for dose reductions or interruptions as appropriate.

Patients also used preservative-free eye drops. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the cohort.

Blenrep is also set for approval in Europe in the coming months after a positive opinion from the CHMP scientific committee at the end of last month.

 

The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on .

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

Shots:

  • 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

Click here, Click here ­to­ read full press release/ article | Ref: GSK, GSK | Image: WorldPharma Today

Related News: Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine




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




Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Shots:

  • The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19
  • Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III study by the end of 2020. Additionally, the companies are expecting the approval in H1’21
  • The vaccine is deploying Sanofi’s S-protein COVID-19 antigen together with GSK’s adjuvant technology. Both the companies are scaling up manufacturing of the antigen and adjuvant to produce up to 1B doses per year

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: PharmaShots

Related News: Sanofi and GSK Collaborate to Develop Adjuvanted COVID-19 Vaccine




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




GSK’s John Fleming on rethinking oncology from the ground up

What if we could look at cancer treatment from a completely fresh perspective? This is the philosophy GSK’s UK country medical head for oncology, John Fleming, wants to bring to the company as it rethinks its approach to cancer.

Fleming joined Novartis in 2015, when GSK divested its oncology portfolio to the Swiss firm. It might seem surprising, then, that his focus on cancer would bring him back to GSK – but, as Fleming points out, the company never truly left the oncology space, and it seemed to him to be the perfect place to help transform outcomes for people living with cancer.

“When people talk about GSK re-entering oncology, that’s really a misconception,” he explains. “The divestment involved a lot of second-to-market oral therapies, which didn’t have the opportunity to be truly transformational and lead in their classes – so what was left behind was an R&D engine that was free to innovate and discover new molecular entities. It was a blank slate, if you will – an unencumbered starting point for us to look at fresh approaches and discover new modalities and classes of drugs.

“That’s why I chose to return to ‘GSK oncology 2.0’ – because we have this opportunity to build with a start-up mindset at a large pharma.”

 

• Read the full article in pharmaphorum’s Deep Dive digital magazine

The post GSK’s John Fleming on rethinking oncology from the ground up appeared first on .

GSK to Acquire 10% stake in CureVac for $163M

Shots:

  • GSK will invest $163M (€150m) in CureVac for a 10% stake to collaborate for the research, development, manufacturing, and commercialization of up to five mRNA-based vaccines and mAbs targeting infectious disease pathogens excluding CureVac’s existing COVID-19 mRNA and rabies vaccines research programs
  • CureVac to receive $137M (€120m) as upfront, $34.3 (€30m) as one-time reimbursable payment and is eligible to receive up to $366M (€320m) as development and regulatory milestones, $435M (€380m) as commercial milestones along with royalties on product sales
  • CureVac will lead pre/clinical-development till P-I trial after which GSK will develop & commercialize the therapies. Moreover, CureVAc will receive R&D funding from GSK and will be responsible for the GMP manufacturing of the candidates as well as retain the commercialization rights for all products in selected countries

Click here to read full press release/ article | Ref: GSK | Image: Twitter




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