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.

Top 20 Life Sciences Deals of 2020 by Total Deal Value

  • Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020
  • Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal value of $6.9B. The second-highest deal valued at $6B was Daiichi Sankyo’s development and commercialization deal with AstraZeneca for DS-1062
  • This article is based on the 2020 biotech and pharma deals data as provided by Chris Dokomajilar of DealForma. Our team at PharmaShots curated the top 20 deals in healthcare and life sciences by disclosed total deal value in R&D partnerships

20. insitro’s Development and Commercialization Deal with Bristol Myers Squibb

Deal Date: Oct 28, 2020

Deal Value: $2.07B

insitro granted Bristol Myers Squibb rights to develop and commercialize therapies for the treatment of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). insitro will apply its platform, the insitro Human (ISH) platform, to generate induced pluripotent stem cell (iPSC) derived disease models for ALS and FTD to provide insights into disease progression after which BMS has the option to select a few targets for further clinical development and commercialization. Insitro received $50M up front and is eligible for up to $20M in operational and up to $2B in discovery, development, regulatory, and commercial milestones, plus royalties.

19. Silence Therapeutics’ Development and Commercialization Deal with AstraZeneca

Deal Date: Mar 25, 2020

Deal Value: $2.08B

Silence Therapeutics granted AstraZeneca rights to develop and commercialize 5 liver-based small interfering RNA (siRNA) therapies for cardiovascular, renal, metabolic, and respiratory diseases using Silence’s established GalNAc-siRNA platform. AstraZeneca and Silence will conduct discovery research on the 5 targets during a 3-year research period. Silence is responsible for designing siRNA molecules against gene targets selected by AstraZeneca, and for manufacturing of material to support GLP toxicology studies and Phase I clinical studies. AstraZeneca will lead clinical development and commercialization. AstraZeneca has the option to extend the partnership for a further 5 targets. Silence has the option to co-develop 2 programs of their choice starting from Phase II. Silence received $60M up front, a $20M upfront equity investment, a potential $10M option fee for each selected target, and is eligible for up to $140M in development milestones and up to $250M in commercial milestones for each target, plus high single-digit to low double-digit tiered royalties.

18. UCB’s Research Partnership with Roche and Genentech with an Option to License for UCB0107

Deal Date: July 29, 2020

Deal Value: $2.12B     

UCB granted Roche and Genentech an exclusive, worldwide option to license the development and commercialization of UCB0107 for the treatment of progressive supranuclear palsy (PSP) and Alzheimer’s Disease. UCB will fund and conduct a proof-of-concept study in Alzheimer’s Disease after which Genentech has the option to either progress with the development or return full rights to UCB. UCB received $120M up front. If Genentech exercises its option, UCB is eligible to receive up to $2B in cost reimbursement, development, and sales-based milestones, plus royalties.

17. Denali’s Development and Commercialization Deal with Biogen for DNL151

Deal Date: Aug 6, 2020

Deal Value: $2.15B

Denali granted Biogen rights to co-develop and co-commercialize Denali’s small molecule leucine-rich repeat kinase 2 (LRRK2) inhibitor program, DNL151, for the treatment of Parkinson’s disease. Additionally, Biogen has an exclusive option to license up to 2 preclinical programs including its Antibody Transport Vehicle (ATV), Abeta program (ATV enabled anti-amyloid beta program), and a second program utilizing its TV technology. Biogen also has the right of first negotiation on 2 additional TV-enabled therapeutics. Both companies will co-commercialize DNL151 in the US and China. Denali received $560M up front, $465M as an equity investment, and is eligible for up to $1.125B in development and commercial milestones for DNL151, plus royalties. Biogen and Denali will share responsibility and development costs on a 60:40 basis globally, share costs, profits, and losses 50:50 in the US, and 60:40 in China for the LRRK2 program.

16. Skyhawk’s Research Partnership with Vertex with an Option to License Small Molecules

Deal Date: December 22, 2020

Deal Value: $2.24B

Skyhawk signed a research partnership with Vertex to develop small molecule therapies that modulate RNA splicing using Skyhawk’s SkySTAR platform for the treatment of neurodegenerative diseases and cancer. Vertex has a worldwide option to license intellectual property rights to compounds developed under the collaboration. Skyhawk will receive $40M up front and is eligible for up to $2.2B in milestones, plus royalties if Vertex exercises the option.

15. Kymera Therapeutics’ Development and Commercialization Deal with Sanofi for Inflammatory Diseases

Deal Date: July 9, 2020

Deal Value: $2.33B

Kymera granted Sanofi exclusive, worldwide rights to develop and commercialize 2 programs outside of oncology/immuno-oncology: a preclinical IRAK4 lead compound for immune-inflammatory diseases and an earlier stage program for an undisclosed use. Kymera is responsible for discovery and preclinical research and conducting a Phase 1 trial for at least 1 protein degrader directed against IRAK4, plus up to 3 backup degraders. Sanofi will be responsible for further clinical development and commercialization and will also be responsible for all clinical development activities for the second program. Kymera has the option to co-develop and co-commercialize both programs in the US and share all the costs and profits equally. Kymera will receive $150M up front and is eligible for up to $1.48B in the development milestones (more than $1B of the $1.48B relates to IRAK4 dev. and reg. events), up to $700M in sales milestones ($400M of the $700M relates to IRAK4), plus tiered royalties from the high single digits to high teens, subject to low-single digits upward adjustments in certain circumstances.

14. Taiho and Astex’s Development and Commercialization Deal with Merck

Deal Date: Jan 6, 2020

Deal Value: $2.55B

Taiho and Astex granted Merck exclusive, worldwide rights to develop and commercialize Taiho and Astex’s combined small molecule and data for the treatment of cancer. Taiho and Astex received $50M up front, undisclosed R&D funding, and are eligible for up to $2.5B in milestones, plus royalties. Also, Taiho has co-commercialization rights in Japan and an option to promote in specific areas of South East Asia.

13. Nurix’s Development and Commercialization Deal with Sanofi for Cancer

Deal Date: Jan 9, 2020

Deal Value: $2.58B

Nurix granted Sanofi exclusive, worldwide rights to develop and commercialize immuno-oncology therapeutics discovered by Nurix using its DELigase platform. Nurix’s drug discovery platform integrates DNA-encoded libraries and a portfolio of E3 ligases to create small molecules designed to induce protein degradation of drug targets. Nurix granted Sanofi 3 specific targets and Sanofi has the option to expand to 5 targets. Sanofi is responsible for clinical development and commercialization. Nurix has the option to co-develop and co-promote up to 2 products in the US under certain conditions. The partnership excludes Nurix’s lead degradation programs for which Nurix retains all rights. Nurix received $55M up front, undisclosed option payments for additional targets, and is eligible for up to $2.5B in total payments including undisclosed research, preclinical, clinical, regulatory, and sales milestones. If Nurix exercises its option to co-develop and co-promote certain products, the partners will split US profits and losses for those products 50/50. Nurix to receive undisclosed royalties on ex-U.S. net sales on all optioned products. In January 2021, Nurix received $22M following Sanofi exercising its option for a total of five targets.

12. Precision BioSciences’ Development and Commercialization Deal with Eli Lilly

Deal Date: Nov 20, 2020

Deal Value: $2.66B

Precision BioSciences granted Eli Lilly exclusive rights to develop and commercialize in vivo therapies for genetic disorders with the initial focus on Duchenne muscular dystrophy and 2 undisclosed gene targets by applying Precision’s ARCUS genome editing platform. Eli Lilly will have an option to expand the partnership to 3 additional targets. Precision BioSciences received $100M up front, $35M in an upfront equity purchase of its common stock, and is eligible for up to $420M per product in development, regulatory, and sales milestones (up to $2.52B for 6 targets), plus tiered royalties ranging from the mid-single digits to low-teens.

11. Sangamo’s Development and Commercialization Deal with Biogen

Deal Date: Feb 27, 2020

Deal Value: $2.72B

Sangamo granted Biogen exclusive, worldwide rights to develop and commercialize gene regulation therapies, including ST-501, for the treatment of tauopathies, including Alzheimer’s disease, ST-502 for the treatment of synucleinopathies, including Parkinson’s disease, a third undisclosed neuromuscular disease target, and up to nine additional undisclosed neurological disease targets using Sangamo’s zinc finger protein (ZFP) technology. Sangamo received $125M up front, $225M in upfront equity for approximately 24M shares at $9.21 per share, and is eligible for up to $2.37B in milestones, plus royalties.

10. Schrodinger’s Development and Commercialization Deal with BMS

Deal Date: Nov 23, 2020

Deal Value: $2.76B

Schrodinger granted BMS exclusive, worldwide rights to develop and commercialize small molecule therapeutics for the treatment of cancer, autoimmune, and neurologic diseases using Schrodinger’s physics-based computational platform. Schrodinger received $55M up front and is eligible for up to $2.7B in preclinical, development, regulatory, and sales milestones, plus royalties.

09. Repare’s Development and Commercialization Deal with BMS for Oncology

Deal Date: May 26, 2020

Deal Value: $3.06B     

Repare granted BMS exclusive, worldwide rights to develop and commercialize multiple oncology products using Repare’s SNIPRx synthetic lethal discovery platform for the treatment of cancer. Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from therapies based on the genetic profile of their tumors. Repare received $65M up front comprised of $50M in cash and $15M in an upfront equity investment and is eligible for up to $3B in license fees and milestone payment, plus royalties.

08. Fate Therapeutics’ License Option Deal with Janssen Biotech for Cancer

Deal Date: Apr 2, 2020

Deal Value: $3.1B

Fate Therapeutics granted Janssen exclusive, worldwide option to develop and commercialize up to four iPSC-derived chimeric antigen receptor (CAR) NK and CAR T-cell therapies using Fate’s iPSC product platform for the treatment of hematologic malignancies and solid tumors. Janssen will reimburse development cost until IND after which Janssen has the right to exercise its option. Fate received $50M up front, a $50M upfront equity investment at $31.00 per share, and is eligible for up to $1.8B in development and regulatory milestones and up to $1.2B in commercial milestone, plus double-digit royalties. Additionally, Fate has the option to co-commercialize and share equally in profits and losses in the US in place of certain clinical development costs and adjustments in milestone and royalty payments.

07. Sage Therapeutics’ Development and Commercialization Deal with Biogen

Deal Date: Nov 27, 2020

Deal Value: $3.12B

Sage Therapeutics granted Biogen exclusive rights to develop and commercialize zuranolone for the treatment of the major depressive disorder (MDD), postpartum depression (PPD), and other psychiatric disorders, and SAGE-324 for the treatment of tremor and other neurological disorders outside the US excluding rights to zuranolone in Japan, Taiwan, and South Korea. Sage received $875M in upfront cash and $650M in upfront equity in exchange for approximately 6.2M newly issued shares of Sage common stock at $104.14 per share and is eligible for up to $1.6B in development and commercial milestones. Both companies will equally share the responsibility and development costs and profits for commercialization in the US, whereas Biogen will be responsible for development and commercialization outside the US excluding Japan, Taiwan, and South Korea for which Sage will receive royalties.

06. Alteogen’s Development and Commercialization Deal with an Undisclosed Company

Deal Date: June 24, 2020

Deal Value: $3.88B

Alteogen granted an undisclosed company non-exclusive, worldwide rights to ALT-B4, Alteogen’s Hybrozyme technology, a hyaluronidase-derived technology used for subcutaneous administration of biologic products which are otherwise administered as an IV injection. The undisclosed company has the right to elect to develop additional products in combination with ALT-B4 upon achievement of a pre-specified milestone. Alteogen will be responsible for regulatory development and commercial supply of ALT-B4. Alteogen received $16M up front and is eligible for up to $3.865B in development, regulatory, and sales-based milestones.

05. Genmab’s Development and Commercialization Deal with AbbVie for Cancer

Deal Date: June 10, 2020

Deal Value: $3.9B

Genmab granted AbbVie worldwide rights to co-develop and co-commercialize three bispecific antibody programs: epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37, and DuoBody-CD3x5T4 using AbbVie’s antibody-drug conjugate (ADC) platform for the treatment of hematological cancers. Additionally, AbbVie has the option to develop four additional antibody-based therapeutics using Genmab’s DuoBody technology and AbbVie’s ADC technology for solid tumors and hematological malignancies. Both companies will be responsible for the co-commercialization of epcoritamab in the US and Japan and will be responsible for the worldwide development and commercialization of DuoHexaBody-CD37, DuoBody-CD3x5T4, and any product candidates developed under the agreement in the US and Japan. Genmab has the right to co-commercialize these products outside of the US and Japan and AbbVie has the right to opt-in to program development. Genmab received $750M up front and is eligible for up to $1.15B in development and commercial milestones for epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37, and DuoBody-CD3x5T4 and up to $2B in success-based milestones for additional antibody product candidates developed under the collaboration, plus 26% royalties for epcoritamab outside the US and Japan. Both companies will share profits on a 50:50 basis.

04. Seagen’s Development and Commercialization Deal with Merck

Deal Date: Sep 14, 2020

Deal Value: $4.2B

Seagen (formerly Seattle Genetics) granted Merck exclusive, worldwide rights to develop and commercialize ladiratuzumab vedotin, a Phase II antibody-drug conjugate targeting LIV-1 for the treatment of cancer. The partners will develop ladiratuzumab as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) in triple-negative breast cancer (TNBC), hormone receptor-positive breast cancer, and other LIV-1-expressing solid tumors. Seagen will be responsible for the marketing applications in the US and Canada and will book sales in the US, Europe, and Canada. Merck will be responsible for the marketing applications in Europe and other territories and will book sales worldwide excluding the US, Europe, and Canada. The partners will share development costs and profit equally. Seagen received $600M in cash and Merck invested $1B in Seagen common stock by purchasing 5M shares at $200.00 per share. Also, Seagen is eligible to receive up to $850M in development milestones and up to $1.75B based on sales performance. The partners will share costs and profits equally.

03. Myovant’s Development and Commercialization Deal with Pfizer for Orgovyx

Deal Date: December 28, 2020

Deal Value: $4.25B

Myovant Sciences granted Pfizer rights to develop and commercialize Orgovyx (relugolix) for prostate cancer and relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women’s health in the US and Canada. Pfizer has an exclusive option to commercialize relugolix in oncology outside the US and Canada, excluding certain Asian countries. Both companies will equally share profits and expenses for Orgovyx and relugolix combination tablets. Myovant will receive $650M up front and is eligible for up to $200M in regulatory milestones for FDA approvals for the relugolix combination tablet in women’s health and up to $3.35B in sales-based milestones upon reaching certain thresholds up to $2.5B. If Pfizer exercises its option, Myovant will receive $50M and will be eligible for double-digit royalties.

02. Daiichi Sankyo’s Development and Commercialization Deal with AstraZeneca for DS-1062

Deal Date: July 27, 2020

Deal Value: $6B

Daiichi Sankyo granted AstraZeneca worldwide rights to develop and commercialize DS-1062, a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) for the treatment of multiple tumors. Both companies will equally share development and commercialization costs and profits worldwide whereas Daiichi Sankyo will be responsible for all costs and will pay mid-single-digit royalties to AstraZeneca for Japan. Daiichi Sankyo received $1B up front and is eligible for up to $1B in regulatory milestones and up to $4B in sales-based milestones.

01. Artios’ Research Partnership with Merck with an Option to License up to 8 Oncology Targets

Deal Date: Dec 3, 2020

Deal Value: $6.9B

Artios signed a research partnership with Merck to discover and develop therapies using Artios’ nuclease targeting discovery platform for the treatment of cancer. Merck has an exclusive, worldwide option to license the development and commercialization of up to 8 cancer targets. Additionally, Artios has opt-in rights for joint development and commercialization with Merck. Artios received $30M in upfront and near-term payments. If Merck chooses to exercise the option, Artios will receive undisclosed option fees and is eligible for up to $860M in milestones for each target, plus royalties.


The post Top 20 Life Sciences Deals of 2020 by Total Deal Value first appeared on PharmaShots.

One in 11 over-65s unwilling to take COVID-19 shot

One in 11 adults aged over 65 have reported a lack of willingness to receive a COVID-19 vaccine, according to a US-based survey.

The findings are concerning given that adults in this group are at highest risk for complications from the disease.

Findings from part of the Heartline clinical study, sponsored by Johnson & Johnson and Apple, have been published online on a preprint server and have yet to be peer-reviewed.

Recruitment to the study began in February last year and it was initially set up to test whether wearable and custom-built mobile apps could enable earlier detection and better treatment of atrial fibrillation in patients aged 65 and older.

Willingness to vaccinate against COVID-19 was assessed through an optional survey through the Johnson & Johnson app between 6th and 20th November last year,

The assessment included questions on beliefs about vaccines in general, beliefs about COVID-19 and the COVID-19 vaccine, and opinions on vaccine dosing and potential side effects.

Shortly after the survey was offered, Pfizer announced first interim analysis results showing the vaccine it developed with BioNTech had an efficacy of around 90% and authors compared answers before and after this event to gauge its impact on opinions.

Of the 7,402 people who responded, 63.6% of participants reported they were very willing to receive a COVID-19 vaccine, 27.8% were somewhat willing, 6.0% were not very willing, and 2.6% were not at all willing.

Overall, authors said that 91.3% were “willing” to be immunised and 8.7% were “unwilling”.

Analysing different demographic groups, the study found participants identifying as Black or African American were least likely to want to take COVID-19 vaccines.

A total of 26.8% of Black or African American participants noted they were not very willing or not at all willing to vaccinate, compared with 8.0% of white participants.

Study author Janeta Nikolovski, director of the World Without Disease Accelerator at Johnson & Johnson’s Janssen pharma unit, told pharmaphorum in an emailed interview that she not surprised about vaccine hesitancy in older age groups.

“Several prior published studies have shown those trends as well,” said Nikolovski, who said further work is being done to understand why older people are more likely to be sceptical about vaccines.

She added: “Among those who said they were unwilling to get vaccinated, the majority stated that they would discuss their decision with their healthcare provider, providing an important opportunity for education.”

Further work is also needed to identify why different demographic groups have differing attitudes to the vaccine.

She added: “We agree that further study is needed and a one-size-fits all approach in communication will not be ideal to address specific concerns.”

Nikolovski is hopeful that as vaccine campaigns are rolled out, attitudes to vaccines could change for the better.

“Given that we found vaccine safety and efficacy to be a strong predictor of willingness to vaccinate, I think as people get vaccinated and share their experience with others, trust will grow.

“We saw an increased vaccine willingness after the trial results were released, suggesting that public willingness to vaccinate may continue to rise as additional positive data are released.”

Conversely, negative news stories about vaccines, including reports about adverse events, may have a negative impact.

“In general however, I believe transparency with research results is important, whatever the results, as it is important to realistically manage expectations, “ she concluded.

Janssen is working on a single shot COVID-19 vaccine, which has shown promise in early trials with phase 3 data possibly due by the end of the month.

The post One in 11 over-65s unwilling to take COVID-19 shot appeared first on .

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England.

Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

ROS1 is a rare mutation found in fewer than 2% of NSCLC cases, and patients have few treatment options, especially when the disease has spread to the brain. NICE has previously estimated that roughly 412 patients across the UK are have NSCLC eligible for treatment with Rozlytrek.

The SMC cleared Rozlytrek via its Patient and Clinician Engagement (PACE) programme, a mechanism that brings agency reviewers, clinicians and patient group representatives together in order to discuss benefits of a medicine that may not be fully captured in the conventional appraisal process.

In the meeting, patients and clinicians said ROS1-positive NSCLC is often diagnosed at an advanced stage, so is associated with a short life expectancy, and there are limited treatment options available.

“This type of advanced NSCLC is a very rare and incurable lung cancer that often occurs in non-smokers and affects many under 60 years old,” commented Gemma Boni, head of lung cancer at Roche Products Ltd.

“Our commitment is to ensure that people in Scotland with lung cancer live longer and healthier lives, and today’s news shows how we are advancing science to achieve this,” she added.

In 2018, Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) was cleared by NICE in England – via the Cancer Drugs Fund (CDF) – as well as in Scotland by the SMC as a first-line option for treating ROS1-positive advanced NSCLC in adults.

Second-line treatment options include pemetrexed with carboplatin or other platinum doublet chemotherapy, with pemetrexed as a maintenance therapy.

Rozlytrek is also approved to treat people aged 12 years of age and older with solid tumours that have an NTRK gene fusion – regardless of where they appear in the body – and the SMC should decide whether that use is cost effective in the next couple of months. NICE has already approved Rozlytrek for that use in England via the CDF.

Other decisions

The SMC also backed NHS use for four other medicines in its January update, including Janssen’s Darzalex (daratumumab) for adults with newly-diagnosed multiple myeloma who are eligible for autologous stem cell transplant. NICE is due to deliver a verdict on this use for the drug in April.

Meanwhile, Rigel Pharmaceuticals’ Tavlesse (fostamatinib) – sold by Spain’s Grifols in Europe – can now be used in Scotland to treat chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. NICE is also conducting an appraisal of Tavlesse, but hasn’t yet set a timeframe for review.

Also backed were Takeda’s Adcetris (brentuximab vedotin) for systemic anaplastic large cell lymphoma (sALCL) – a use already approved by NICE in England – and Novartis’ Cosentyx (secukinumab) for non-radiographic axial spondyloarthritis which NICE expects to decide on in May.

The SMC rejected RAD Neurim Pharma’s Slenyto (melatonin) for the treatment of insomnia in children with autism spectrum disorder and rare neurogenetic disorder Smith-Magenis syndrome, ruling the company had not provided strong enough evidence to show it was cost-effective.

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

Shots:

  • The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis
  • Genmab to receive $30M as milestones with the first commercial sale of Darzales faspro in this indication. The US FDA reviewed the submission of data for approval in this indication under RTOR pilot program and Project Orbis
  • Darzalex faspro is the SC formulation of daratumumab and is the only therapy for newly diagnosed Light-chain (AL) amyloidosis in the US

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

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J&J’s Darzalex Faspro is first US therapy for rare blood disorder

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder.

The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its own and as part of multiple combination therapies.

J&J’s Janssen pharma unit got approval for Darzalex Faspro as a multiple myeloma treatment in the US last May and in Europe the following month, lending further momentum to a franchise that looks set to make more than $4 billion in sales in calendar 2020.

AL amyloidosis is a much smaller indication for the drug, but a crucial one medically as patients with the disease currently have limited treatment options and a poor prognosis.

It is caused by a defect in bone marrow cells called plasma cells, causing them to produce abnormal forms of light chain proteins, which enter the bloodstream and form amyloid deposits. Amyloid plaques can then form in multiple organs such as the heart, kidneys and liver, damaging them and in some cases leading to organ failure.

Until now people with AL amyloidosis have had to rely on chemotherapy, with its accompanying side effects, and other drugs to tackle organ failure once damage gets severe.

A stem cell transplant or organ transplant can be an option for some patients and other drugs – notably Takeda’s Ninlaro (ixazomib), which failed a phase 3 trial in 2019 – have struggled to show an impact on the disease.

Darzalex Faspro looks set to transform the prospects for the 30,000 to 45,000 people in the US and Europe AL amyloidosis patients. It has already been submitted for approval in the EU.

In the phase 3 ANDROMEGA trial, adding Darzalex Faspro to a standard chemotherapy regimen of bortezomib, cyclophosphamide and dexamethasone (VCd) and comparing it to VCd alone.

Patients treated with Darzalex Faspro saw a haematologic response rate that was nearly triple that of those treated with VCd alone, at 53% compared to 18%, respectively.

Moreover, J&J’s drug seemed to limit the organ damage, improving measures of heart and kidney function after six months’ treatment and prolonging the time to major organ deterioration.

Isabelle Lousada, founder and chief executive of the Amyloidosis Research Consortium (ARC), hailed the approval as a major step forward for AL amyloidosis patients, but noted that much more has to be done.

“Sadly, most patients with AL amyloidosis are diagnosed more than one year after their initial symptoms present, at a time when they may already be experiencing organ deterioration or failure,” she pointed out.

“I believe this approval will increase awareness of and education around this life-threatening disease and offer new hope for people with AL amyloidosis and their caregivers.”

It’s an added benefit that Darzalex Faspro can be delivered in three to five minutes, while the original IV formulation requires a four- to six-hour infusion, meaning it will be easier to administer.

J&J licensed the daratumumab antibody used in both Darzalex products from Danish biotech Genmab in 2012, while US company Halozyme supplied the subcutaneous delivery technology that underpins Darzalex Faspro.

The AL amyloidosis filing was reviewed under the FDA Real-Time Oncology Review (RTOR) programme, which allows data for certain applications to be reviewed before the applicant formally submits the complete application.

There are some other drugs coming through the development pipeline for AL amyloidosis, notably Alexion and Caelum Biosciences’ CAEL-101, a first-in-class amyloid fibril targeted therapy which started phase 3 testing last September.

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PharmaShots’ Key Highlights of Fourth Quarter 2020

  • The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
  • Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated the review for AZ’s COVID-19 vaccine. Meanwhile, AZ’s AZD1222 met its primary endpoint in preventing COVID-19
  • Our team at PharmaShots has summarized and complied with the insights of Q4’20

Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Date – Oct 01, 2020

Product – Tetraxim

  • Sanofi’s Tetraxim combines four vaccines into one and provides protection against four diseases – Diphtheria, Pertussis, Tetanus and Polio. The launch reduces the number of injections, increases comfort, and improves vaccination compliance for children
  • Booster vaccines are designed to boost the immunity acquired during prior vaccination. With the launch, Sanofi currently protects school children in 100+ countries, with 63M doses distributed globally
  • Tetraxim (DTaP-IPV) is a 4-in-1 booster vaccine and the only inactivated poliomyelitis containing combination vaccine in India that has full-dose antigenic strength of Diphtheria, Tetanus and acellular Pertussis (whooping cough) for preschoolers

BioMarin Receives the US FDA’s Approval Allowing Maximum Dose of 60mg with Palynziq (pegvaliase-pqpz) for PKU

Date – Oct 08, 2020

Product – Palynziq (pegvaliase-pqpz)

  • The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg
  • The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level ≤360 μmol/L consistent with the Phe target ACMG recommended guidelines @2yrs. of treatment and 50% had blood Phe levels ≤120 μmol/L @2yrs. 75%, 66% & 48% had a blood Phe ≤600, 360, and 120 μmol /L, respectively @3yrs. of treatment
  • Additional, safety data with over 6yrs. of follow up remains consistent with the previous safety profile of Palynziq irrespective of dose. Moreover, BioMarin has dosed the first participant in the global Phearless P-I/II study of BMN 307 for PKU

AbbVie Reports Results of Skyrizi (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Date – Oct 08, 2020

Product – Skyrizi (risankizumab)

  • The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
  • Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
  • Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

 Date – Oct 09, 2020

 Product – REGN-COV2

  • Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
  • The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
  • REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen

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

 Date – Oct 29, 2020

 Product – BI 764198

  • 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

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

Date – Oct 30, 2020

Product – Tecentriq + Avastin

  • 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

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

 Date – Oct 30, 2020

 Product – Keytruda

  • 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

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

 Date – Oct 30, 2020

  Product – Tremfya

  • The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
  • @12wks. (Tremfya vs PBO), reductions in CDAI (154.1, -144.3, -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%, 56.0%, 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy, (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
  • @12wks, Tremfya induced greater improvement across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 receptor

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Date – Nov 02, 2020

Product- BNT162b2

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Date – Nov 02, 2020

Product- Crestor

  • Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1’21
  • The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
  • Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Date – Nov 02, 2020

Product- Xolair

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Date – Nov 03, 2020

Product – CT-P17(biosimilar,adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre- filled syringe (PFS)

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

Date – Nov 03, 2020

Product – FPI-1434

  • 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

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

Date – Nov 03, 2020

Product- HMR59

  • 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

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasi

Date – Nov 04, 2020

Product- Deucravacitinib

  • The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
  • Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Date – Nov 04, 2020

Product- amivantamab

  • The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
  • The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
  • Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020

Merck to Acquire VelosBio for $2.75B

Date – Nov 05, 2020

Product- VLS-101

  • Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020
  • The acquisition will bolster Merck’s oncology pipeline with the addition of VelosBio’s VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors
  • In Oct’2020, VelosBio has initiated P-II study to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with TNBC, HR+/HER2+ BC, and NSCLC. Additionally, VelosBio is developing a preclinical pipeline of ADCs and bispecific Abs targeting ROR1 to complement VLS-101 by offering alternative methods of tumor cell killing

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Date – Nov 05, 2020

Product- N/A

  • Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program
  • The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO
  • Iktos’ AI technology is based on deep generative models that help bring speed & efficiency to the drug discovery process by automatically designing virtual novel molecules having desired activities for treating a disease

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Date – Nov 05, 2020

Product- NVX-CoV2373

  • Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
  • The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
  • NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India

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

Date – Nov 07, 2020

Product- Hemlibra

  • The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
  • Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
  • Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab

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

Date – Nov 09, 2020

Product – CT-P59

  • The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
  • Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
  • Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients

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

Date – Nov 10, 2020

Product- Calquence (obinutuzumab)

  • The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
  • ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
  • Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020

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

Date – Nov 12, 2020

Product- Abrocitinib

  • The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
  • Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
  • Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

Date – Nov 13, 2020

Product – Handl Therapeutics

  • 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

Henlius report the NMPA’s Acceptance of HLX15(biosimilar, Daratumumab) to treat multiple myeloma

Date – Nov 16, 2020

Product- HLX15  

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Date – Nov 20, 2020

Product- BNT162b2

  • collaborate to focus at developing & commercializing transformative therapies in Greater China. Both the companies will leverage their clinical development, regulatory and commercial expertise
  • Pfizer will contribute ~$70M of non-dilutive capital toward in-licensing & co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development
  • Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets & each company will carry separate financial considerations. Additionally, Pfizer may provide in-kind support for marketing, development & regulatory activities

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Date – Nov 23, 2020

 Product – AZD1222

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.

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

Date – Dec 15, 2020

Product- Cobas PIK3CA Mutation Test

  • Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
  • The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
  • This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy

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

Date – Dec 16, 2020

Product- SARS-CoV-2 IgG II Quant test

  • Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
  • The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
  • The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Date – Dec 15, 2020

Product- COVID-19 vaccine

  • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
  • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
  • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

Related Post: PharmaShots’ Key Highlights of Third Quarter 2020

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

ViewPoints Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for Metastatic EGFR Exon 20+ NSCLC

In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

Shots:

  • Janssen reported the BLA submission to the US FDA seeking approval of Amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
  • The filing is the first regulatory submission for patients with exon 20 insertion mutations and it also marks Janssen’s first filing for the treatment of patients with lung cancer
  • Amivantamab is an investigational bispecific antibody that targets both a driver mutation as well as a resistance mechanism and has received BTD in March, is being studied as a monothx. & combination therapy in NSCLC with EGFR mutations, including in earlier lines of therapy

Tuba: A quick highlight of clinical data submitted for the BLA submission of Amivantamab to the US FDA?

Kiran: On December 3, 2020, Janssen submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)  seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The BLA is supported by data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-center, open-label, multi-cohort study. The study evaluated the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), in adult patients with advanced NSCLC.

The submission of this BLA is an important step as we hope to advance a new therapeutic option for patients with NSCLC and exon 20 insertion mutations for whom there are currently no approved targeted therapies. The current standard of care for EGFR Exon 20 insertion mutation-positive NSCLC is chemotherapy.

Tuba: What is the mechanism of action of Amivantamab and how does it work?

Kiran: Amivantamab is an investigational, fully-human, EGFR, and mesenchymal-epithelial transition factor (MET) bispecific duo-body with immune-cell directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications. As a monotherapy, amivantamab has shown activity in patients with diverse EGFR mutant disease.

Tuba: Why is Janssen focused on metastatic NSCLC with EGFR exon 20 insertion mutations?

Kiran: Lung cancer is the leading cause of cancer deaths worldwide. In the U.S., lung cancer is the second most common cancer in both men and women, after skin cancer and NSCLC makes up 80 to 85 percent of all lung cancers. EGFR genetic alterations are among the most common driver mutations for NSCLC and are present in 10 to 15 percent of patients with NSCLC. Additionally, EGFR exon 20 insertion mutations identify a distinct subset of lung adenocarcinomas, accounting for at least nine percent of all EGFR mutations.

Currently, there are currently no FDA-approved targeted therapies for patients with NSCLC who have EGFR exon 20 insertion mutations. Given this significant unmet need, we are committed to improving outcomes for patients diagnosed with this complex, deadly disease. Janssen is committed to advancing targeted therapies for patients living with genetically defined lung cancer where there remains a high unmet need for new treatment options.

Tuba: When can we expect approval and launch of amivantamab in the US?

Kiran: The BLA submission was completed on December 3, 2020. In March 2020, amivantamab received FDA Breakthrough Therapy Designation, which is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. We do not speculate on potential approval timelines.

Tuba: When can we expect results from the CHRYSALIS combination arm?

Kiran: We presented interim data from the CHRYSALIS combination arm at the ESMO 2020 Virtual Congress in September. Data showed the combination of amivantamab and lazertinib achieved a 100 percent overall response rate in the cohort of patients with treatment-naïve EGFR-mutated NSCLC. We look forward to the continued evaluation of amivantamab in combination with lazertinib in EGFR mutation-positive NSCLC patients.

Tuba: How many patients have been part of the expanded access program (EAP) in the US?

Kiran: Jansen established an expanded access program (EAP) for EGFR Exon 20 insertion patients in the U.S. who may be eligible to obtain access to amivantamab during review of the BLA. For information about Janssen’s pre-approval access program, visit https://www.janssen.com/compassionate-use-pre-approval-access. We cannot disclose patient enrollment numbers for the EAP.

Tuba: Has Janssen started any HCP awareness, HCP education, and patient support and awareness programs?

Kiran: We recently launched a website, Hidden EGFR Threats, intended to inform physicians and patients about the multiple threats of EGFR-mutated advanced NSCLC.

Tuba: Is Janssen planning to assess amivantamab in other indications?

Kiran: The results from the CHRYSALIS study have led to new studies to further evaluate the potential of amivantamab and lazertinib combination therapy. The Phase 3 MARIPOSA study will compare amivantamab in combination with lazertinib with osimertinib in untreated advanced EGFR-mutated NSCLC, and a Phase 2 trial, CHRYSALIS-2 is ongoing and enrolling patients who have progressed after treatment with osimertinib and chemotherapy.

Tuba: Any near-future plans to file for EU or any other geographies?

Kiran: We have plans to pursue approval of amivantamab in other markets with the goal of bringing this novel therapy to patients around the world who may benefit, but it is premature to speculate about timing.

Image Source: Medical Forum

About Author:

Kiran Patel is a Vice President of Clinical Development, Solid Tumor Franchise at Janssen and is serving Janssen since 2015.

Related Post: ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

The post ViewPoints Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for Metastatic EGFR Exon 20+ NSCLC first appeared on PharmaShots.

ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

In a recent interview with PharmaShots, Andrew Greenspan, MD, VP Medical Affairs of Janssen Immunology shared his views on Janssen’s commitment to advance research in rheumatic disease.

Shots:

  • Janssen presented clinical trial results in 35 abstracts featuring findings across PsA, RA, and SLE at ACR Convergence 2020 Virtual Scientific Program
  • Sixteen abstracts focus on Tremfya in adults with active PsA, including 52-week safety and efficacy data, axial disease-related endpoints, and more.
  • Other presentations feature new research across Janssen’s portfolio of medications including Simponi Aria (golimumab), Stelara (ustekinumab), and Remicade (infliximab)

Tuba: How was your virtual experience at ACR2020? Can we have an insight on data presented at ACR 2020?

Andrew: Speaking on behalf of those who represented Janssen at the conference – we are so proud of the breadth of data presented at ACR this year. Even though the conference looked a little different than it has in years past, we were still thrilled to share our findings – including 35 abstracts highlighting our research across psoriatic arthritis, rheumatoid arthritis and system lupus erythematosus. Specifically, we presented 16 abstracts focused on TREMFYA in adults with active psoriatic arthritis, including 52-week safety and efficacy data, spinal disease-related endpoints, as well as analyses that highlight patient-reported outcome measures including fatigue. Other presentations featured new research across our portfolio of medications.

Tuba: As the focus of the presentation is Tremfya, give a quick review about the clinical data supporting the therapy?

Janssen’s Tremfya (guselkumab) Receives the US FDA's Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis
Source: MPR

Andrew: As a company, we’re constantly striving to keep our foot on the gas to create new clinical evidence and innovation. As a testament to this, we were proud to expand our rheumatology portfolio this year with the U.S. FDA approval of TREMFYA for adult patients with active psoriatic arthritis, which was first approved to treat adults with plaque psoriasis in 2017. Let me share some additional information on the compelling data we shared at ACR:

  • Data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, showed that TREMFYA improved fatigue in adult patients with active psoriatic arthritis and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale. TREMFYA is the first and only treatment approved for active psoriatic arthritis to have an improvement in fatigue as measured by FACIT-F in the product label.
  • The positive outcomes in fatigue assessment add to the body of data for TREMFYA, which has shown improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, and physical function.
  • Fatigue is considered one of the three most important symptoms by patients with active psoriatic arthritis, and moderate to severe fatigue occurs in up to 50 percent of these patients.

Tuba: Can we have a glance at Janssen’s immunology portfolio as it is working in immunology over the past two decades?

Source: Janssen

Andrew: At Janssen, we have an unmatched track record of translating science into effective therapeutics. In the past two decades, my colleagues at Janssen have developed five advanced treatments for 31 indications resulting in the treatment of more than 5 million patients living with autoimmune disease. Treatments in our immunology portfolio treat a variety of conditions for various patient populations, such as plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and Crohn’s disease. These treatments include TREMFYA (guselkumab), SIMPONIARIA (golimumab), STELARA (ustekinumab), SIMPONI (guselkumab) and REMICADE (infliximab). Looking ahead to potential future treatments, we have a robust pipeline, with 21 first-in-class Phase 2 or 3 trials underway. We’re eager to explore treatment options for less common diseases like hidradenitis suppurativa and Sjogren’s syndrome, where there are fewer or no advanced treatment options currently available.

Tuba: What are Janssens’s efforts in developing biomarkers and co-diagnostics to personalize medicine in the field of rheumatic diseases?

Andrew: We are exploring the development of tools that will better allow us to measure disease activity in patients, including sensors (digital health, actigraphy), novel biomarkers, new endpoints and new patient-reported outcomes to better identify patients appropriate for our medicines and to evaluate the efficacy and safety of them.

 Tuba:  Apart from Tremfya, Simponi, Simponi Aria, and Stelara, what next can we expect from Janssen to transform the lives of patients with autoimmune diseases? What will be your next move (in terms of the combination of internal research and development, external collaborations, and industry consortia) to complement Janssen’s existing portfolio of immunology? Who are Janssen’s potential competitors in the field of autoimmune diseases?

Andrew: I’m very proud of where our research in immunology stands and where it is leading us. While treatments today have made a big difference in the lives of many patients, there certainly remains a significant need for medicines that work better, faster, and longer. Instead of focusing on the competition, we prefer to focus on unmet needs. By unlocking new pathways, mechanisms, and regimens in our treatment options, we strive to provide innovative treatment options to patients. Looking further ahead at our mid-to-late stage pipeline, we have 21 first-in-class Phase 2 or 3 trials underway and we’re eager to explore treatment options for less common diseases like hidradenitis suppurativa and Sjogren’s syndrome, where there are fewer or no advanced treatment options currently available.

Tuba: Can we have a glimpse of Janssen’s work in other therapeutics areas? Can you list out some key advancements for our readers?

Andrew: In addition to immunology, we focus on areas of medicine where we can make the most impact, including Cardiovascular & Metabolism, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension, where we have delivered 18 new medicines in less than nine years. For more information about these specific therapeutic areas, I would be happy to put you in touch with a specialist on our team to learn more about the innovative work being done in these fields.

Tuba: Does the global pandemic affect Janssen’s ongoing as well as future clinical trials?

Andrew: As the world continues to navigate the new normal brought on by COVID-19, there has been an undeniable effort to ensure continuity of care and advance research by a wide range of experts, from healthcare professionals and clinical trial site teams to research partners and regulatory bodies. We at Janssen recognize and remain committed to supporting everyone involved in clinical research. To learn more about Janssen’s commitment to clinical trial research, visit: https://www.janssen.com/clinical-trials/janssen-global-development-leadership-commitment-clinical-research.

Image Source: MIMS Malaysia

About Author:

Andrew Greenspan, MD is a vice president of Immunology Medical Affairs at Janssen and has joined J&J in 2003.

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

The post ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020 first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm

Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, Vertex

The US FDA Grants EUA for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

Published: Dec 29, 2020 | Tags: Emergency Use Authorization, Grants, Quanterix’s Simoa, Semi-Quantitative SARS-CoV-2 IgG Antibody Test, Us FDA

Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

Published: Dec 30, 2020 | Tags: COFEPRIS, Marketing Authorization Application, reports, Sorrento, Submission

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, COVID-19, Health Canada, reports, Statement, UK, vaccine

Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

Published: Dec 30, 2020 | Tags: Cellenkos, CK0804, Development, Global, Incyte, License Agreement, Myelofibrosis, Signs

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Published: Dec 24, 2020 | Tags: Clinical, Data, Nod, P-I/II, P-III, Seeks, Start, Submits, Trial, Trials, ZyCoV-D, Zydus Cadila

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Published: Dec 29, 2020 | Tags: antibody, Cocktail, COVID-19, Data, Encouraging, flow, Hospitalized, Initial, Low, Oxygen, patients, Regeneron, reports, Trial

AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, AZD1222, Emergency, MHRA, receives, Supply, UK

Skyhawk Collaborates with Vertex to Discover and Develop Novel Small Molecules Modulating RNA Splicing for Serious Diseases

Published: Dec 22, 2020 | Tags: Develop, Discover, License Agreement, Novel Small Molecules for Serious Diseases, Sign, Skyhawk, Strategic Research, Vertex

Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

Published: Dec 29, 2020 | Tags: EMA, Label Extension, Novo Nordisk, reports, Semaglutide, Submission, T2D

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Published: Dec 28, 2020 | Tags: Advanced, Chi-Med, Initiates, NDA, Neuroendocrine, Rolling, Submission, Surufatinib, Treat, Tumors, Us FDA

Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

Published: Dec 28, 2020 | Tags: Alligator Bioscience, CTA, Mitazalimab, OPTIMIZE-1, P-II, study, Submits

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Published: Dec 28, 2020 | Tags: Acceptance, Lorbrena (lorlatinib), Pfizer, Priority Review, Report, sNDA, treat (ALK)-Positive (NSCLC), US FDA’s

Biocon has Launched Tacrolimus Capsules in the US

Published: Dec 28, 2020 | Tags: Biocon, Launches, Tacrolimus Capsules, US

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Published: Dec 28, 2020 | Tags: Agreement, Commercialize, Develop, health, Myovant, Oncology, Pfizer, Relugolix, Signs, Women

Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Published: Dec 28, 2020 | Tags: Amivantamab, EGFR Exon 20 Insertion Mutations, EMA, Janssen, MAA, Metastatic Non-Small Cell Lung Cancer, Report, Submission

Zai Lab Signs an Exclusive License Agreement with Cullinan Oncology for the Development and Commercialization of CLN-081 in Greater China

Published: Dec 28, 2020 | Tags: CLN-081, Commercialization, Cullinan Oncology, Development, Exclusive License Agreement, Greater China, Signs, Zai Lab

Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

Published: Dec 24, 2020 | Tags: Algernon, COVID-19, Ifenprodil, Last Patient Out, Multinational, P-IIb, P-IIb/III, reports

Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China NMPA’s BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Published: Dec 24, 2020 | Tags: (CD19 CAR-T), Breakthrough Therapy Designation, BT Designation, Casi, CNCT19, NMPA, receives, Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

Published: Dec 23, 2020 | Tags: Amyrt’s, AP103, Dystrophic Epidermolysis Bullosa (DEB), receives, Treatment, US FDA’s

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Published: Dec 24, 2020 | Tags: Agreement, Aurobindo, Commercialize, COVAXX, COVID-19, Develop, India, Pharma, Sign, UB-612, UNICEF, vaccine

Innovent’s Byvasda (Bevacizumab Biosimilar) Receive NMPA’s Approval for Adult Recurrent Glioblastoma

Published: Dec 28, 2020 | Tags: Adult Recurrent Glioblastoma, approval, BYVASDA (Bevacizumab Biosimilar) Treatment, Innovent, NMPA

Innovent’s Sulinno (Adalimumab biosimilar) Receives China’s NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

Published: Dec 23, 2020 | Tags: Adalimumab Biosimilar, Innovent, NMPA’s Approval, Non-infectious Uveitis, panuveitis in adults, Pediatric Plaque Psoriasis, posterior uveitis, Receive, Sulinno

Related Post: PharmaShots Weekly Snapshots (Dec 21-23, 2020)

The post PharmaShots Weekly Snapshots (Dec 28- 31, 2020) 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.

Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Shots:

  • The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with Lazertinib in adult patients for the treatment of advanced NSCLC
  • Result of CHRYSALIS Study assessed efficacy using overall response rate per Response Evaluation Criteria, CBR, DOR and PFS as well as the safety profile of amivantamab
  • Amivantamab is an investigational, fully – human EGFR-MET bispecific antibody with immune cell – directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications

Click here ­to­ read full press release/ article | Ref: Janssen | Image: Law.com

The post Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations 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.

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

Shots:

  • Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma
  • The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to be submitted and reviewed on an ongoing basis and the data were presented at the 62nd (ASH) Annual Meeting
  • Cilta-cel is a unique, structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and 2 BCMA-targeting single-domain antibodies with a preferential CD8+ T-cell expansion

Click here ­to­ read full press release/ article | Ref: Janssen  | Image: Apotheke Adhoc

The post Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma first appeared on PharmaShots.

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

Shots:

  • The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT)
  • Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in the risk of disease progression or death (53%)
  • Darzalex is the first CD38-directed mAb approved to treat multiple myeloma. The subcutaneous formulation was approved by Health Canada to treat patients with multiple myeloma in 2020

Click here ­to­ read full press release/ article | Ref: Newswire.CA  | Image: Philadelphia Inquirer

The post Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma first appeared on PharmaShots.

Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA

Johnson & Johnson’s Janssen unit has filed a rolling submission for its multiple myeloma CAR-T ciltacabtagene autoleucel (cilta-cel) to the FDA, in hot pursuit of Bristol-Myers Squibb’s delayed rival therapy.

Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment for patients with relapsed or refractory myeloma, an incurable form of blood cancer, specifically in heavily treated adults who currently have few therapeutic options.

BMS’ CAR-T idecabtagene vicleucel (ide-cel) is going after the same indication and is due for a verdict from the US regulator on 27 March 2021.

The rolling application allows portions of the dossier to be filed as they become available, shortening the review time, although BMS is still in pole position to bring a multiple myeloma cell therapy to the US market, despite a setback earlier this year when the FDA rejected the filing for the CAR-T, asking for more data.

Cilta-cel’s filing triggers a $75 million payment from J&J to its development partner Legend Biotech under the terms of a deal signed in December 2017. It is J&J’s first application for a cell therapy.

The submission is based on results from phase 1b/2 CARTITUDE-1 study, which showed an overall response rate of 97% with cilta-cel, with 67% of patients achieving a stringent complete response despite having received a median of five prior therapies.

The median duration of response and progression-free survival still have not been reached in the study, suggesting the effect is long-lasting, according to Janssen.

Like other CAR-Ts the therapy isn’t without risk however, and there were 14 deaths reported during the study, including six due to complications related to treatment itself.

With all the caveats about comparing different trials, cilta-cel’s results look a little better than those of ide-cel’s KarMMa study, which had an overall response rate of 73%, including 33% complete responses, among patients who had a median of six prior treatments.

BMS is also developing another BCMA directed CAR-T – orvacabtagene autoleucel (orva-cel) – which generated positive results in the EVOLVE trial this year.

Ide-cel and cilta-cel aren’t the first BCMA-targeted drugs for myeloma, however. GlaxoSmithKline’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) has already been approved in the US and Europe, making almost $11 million in third-quarter sales in its first few weeks on the market.

There are other BCMA drugs coming through the pipeline as well, including a string of bispecific antibody therapies from Regeneron, Amgen, J&J and others that could sidestep the cumbersome and risky treatment and manufacturing process for CAR-T therapies.

The post Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA appeared first on .

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

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

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

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

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

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

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

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

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

Gilead to Acquire MYR for ~$1.4B

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

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

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

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

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

Google Launches Health Research App Focusing on Respiratory Illnesses

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

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

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

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

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

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

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

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

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

Elsevier Acquires Shadow Health

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

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

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

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

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

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

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

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

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

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

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

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

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

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Shots:

  • Janssen reported pooled analyses of long-term follow-up from multiple clinical trials evaluating the use of Imbruvica monothx. and in combination as a 1L treatment for patients with CLL with high-risk features
  • Results from an integrated analysis of two clinical trials with ~79mos. of follow-up demonstrated PFS rates (63%-82%) @42mos.; median duration of treatment across high-risk subgroups (35.7-43.8 mos.)
  • Additionally, data with a median follow-up of >4yrs. were presented from a pooled analysis of 89 patients with high-risk CLL bearing TP53 aberrations from 4 trials. Further, data from the RWE studies highlight the benefit of ibrutinib-based therapies in a 1L setting

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: LBC

The post Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia first appeared on PharmaShots.

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

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M

Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, Jazz Pharma, P-III, patients, PharmaMar, results, SCLC, study, Zepzelca

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Published: Dec 3, 2020 | Tags: Alzheimer, Commencement, First-in-Human, P-l, reMYND, RES19-T, Treatment, Trial

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Published: Dec 2, 2020 | Tags: Abbott, Adults, approval, canada, Children, Diabetes, FreeStyle Libre 2, health, receives

Exactech Acquires Muvr and its Digital Health Tech for Orthopedic Practices

Published: Dec 2, 2020 | Tags: Acquires, Exactech, Muvr Labs, Orthopedic

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Published: Dec 3, 2020 | Tags: Janssen, Reports, BLA Submission, Amivantamab, US FDA, Metastatic NSCLC, EGFR Exon 20 Insertion Mutations

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Published: Dec 3, 2020 | Tags: Agreement, Artios Pharma, Damage, DNA, Merck KGaA, Novel, Oncology, Response, Signs, Targets

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

Published: Dec 2, 2020 | Tags: Acquires, Age Related Macular Degeneration, Biosciences, Gene, Hemera, Janssen, Late, Novel, Pioneering, Rights, Solutions, Stage, therapy, Treatment

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Published: Dec 3, 2020 | Tags: AstraZenca, DESTINY-Breast01, Enhertu, HER2 -Positive Metastatic Breast Cancer, HR, P-l, P-ll, reports, results, SERD AZD9833, SERENA-1 Study

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Published: Dec 2, 2020 | Tags: AbbVie, Agreement, Develop, Discover, E3 Degraders, Frontier Medicines, Novel Therapies, Sign

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Published: Dec 2, 2020 | Tags: (Anti-SARS-CoV-2 S), COVID-19, Elecsys, EUA, Receive, Roche’s, US FDA’s

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Published: Dec 2, 2020 | Tags: Against, BioNTech, BNT162b2, COVID-19 COVID-19, EUA, MHRA, Pfizer, receives, Regulatory, UK

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Published: Dec 2, 2020 | Tags: (pralsetinib), Advanced or Metastatic RET-Mutant, Gavreto, receives, RET Fusion-Positive Thyroid Cancers, Roche’s, US FDA’s Approval

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Published: Dec 1, 2020 | Tags: $350M, Acquire, Agreement, AstraZeneca, CRESTOR, European, Grünenthal, Rights, rosuvastatin, Signs

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Published: Dec 1, 2020 | Tags: Casirivimab, Collaborates, COVID-19 Antibody Cocktail, Delivery, Gene Therapy Platform, Imdevimab, Investigate, Penn, Regeneron

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Published: Dec 1, 2020 | Tags: Agreement, Boston, BTG, business, International, Pharmaceuticals, Scientific, Sell, Signs, Specialty, Stark

BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Published: Dec 1, 2020 | Tags: application, BioNTech, BNT162b2, CMA, Covid-19 Vaccine, EMA, Pfizer, Submitted

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Published: Dec 1, 2020 | Tags: Adults, approval, Genentech Xolair, Nasal Polyps, Novartis, omalizumab, receives, US FDA

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Published: Nov 30, 2020 | Tags: Discover, Eisai, Novel Small Molecule, Research Agreement, Sign, Synucleinopathies, Wren Therapeutics

 AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Published: Nov 30, 2020 | Tags: Antisense, AstraZeneca, Initiates, ION449, Ionis, LDL-C, Lower, Medicine, P-IIb, PCSK9, reports, study, Targeting

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Published: Nov 30, 2020 | Tags: Agreement, Chiesi Group, Europe, Kaia Health, Sign

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Published: Dec 1, 2020 | Tags: Amgen, COMMUNITY, COVID-19, enrolled, First, Patient, patients, reports, Takeda, Trial, UCB

Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Published: Nov 30, 2020 | Tags: (dupilumab), Atopic Dermatitis, Dupixent, European Commission Approval, receives, Sanofi’s

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Published: Nov 30, 2020 | Tags: 100%, 94.1%, COVID-19, Effective, EUA, Filing, Moderna, mRNA, Severe, Shows, Today, Us FDA, vaccine

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Published: Nov 30, 2020 | Tags: approval, AstraZeneca, Chronic Heart Failure, dapagliflozin, Forxiga, Japan, MHLW, receives, Treatment

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Published: Nov 27, 2020 | Tags: (adalimumab), AbbVie, Additional, Eisai, Humira, Indication, MHLW Approval, Pyoderma Gangrenosum, receives

Shionogi and Nagasaki University Collaborate with the Kitasato Institute for Antimalarial Drugs

Published: Nov 25, 2020 | Tags: Agreement, Antimalarial, drugs, Kitasato Institute, Nagasaki, Shionogi, Signs, University

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Published: Nov 27, 2020 | Tags: (baloxavir marboxil), approval, Infection, Influenza Virus, MHLW, Post-Exposure Prophylaxis, receives, Shionogi, sNDA, Treat, Xofluza

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Published: Nov 29, 2020 | Tags: 2M, Additional, Against, Agreement, Amends, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, vaccine

Dr. Reddy’s to Divest Select Anti-Allergy brands to Dr. Reddy’s in Russia and Other CIS Countries

Published: Nov 28, 2020 | Tags:  Acquire, Dr. Reddy, Glenmark, Kazakhstan, Russia, Ukraine, Uzbekistan

Related Post: PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

The post PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) first appeared on PharmaShots.

J&J files lung cancer bispecific amivantamab for FDA approval

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC).

J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy.

Janssen has ambitions to expand the use of the drug into the larger EGFR inhibitor market, which at the moment, is led by AstraZeneca’s fast-growing EGFR tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib).

Amivantamab (formerly JNJ-6372) is a bispecific or double-headed antibody, combining an EGFR-binding domain at one end with one targeting mesenchymal epithelial transition (MET) factor, which is a common resistance mechanism that can reduce the activity of EGFR drugs.

That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).

Amivantamab is also the first drug to be filed specifically for patients with exon 20 mutations, who don’t tend to respond well to current therapies including EGFR inhibitors, and as a result picked up a breakthrough designation from the FDA for this use.

EGFR mutations are some of the most common mutations in NSCLC, and that has driven sales of Tagrisso – the standard of care for previously-untreated EGFR-positive NSCLC – to more than $3 billion last year.

The Exon 20-mutated population is fairly large in its own right, as these mutations are the third most prevalent primary EGFR mutation. That said, they often go undetected, so J&J will have to develop ways to identify suitable patients if amivantamab is to make headway in the market.

In the summer, the drugmaker signed partnered with Guardant Health to seek regulatory approval of a companion diagnostic for amivantamab that will be used to identify suitable patients.

Along with the marketing approval submission, J&J has also set up an expanded access programme, which would allow patients at need to use the drug while the FDA review is underway.

Patients with exon 20 insertion mutations have a median survival of less than 17 months, around half that of patients with other EGFR mutations.

Amivantamab has been filed for approval based on the phase 1 CHRYSALIS study which showed that the drug shrank tumours in 36% of all patients in the study, and 41% of those previously treated with chemo. The median durations of response were 10 months and seven months, respectively.

CHRYSALIS also included an arm that combined amivantamab with lazertinib, an experimental EGFR TKI that J&J licensed from South Korea’s Yuhan in 2018, which showed a 100% ORR with the combination in previously-untreated EGFR-mutant NSCLC.

That result prompted J&J to start a phase 3 trial comparing the duo to Tagrisso directly in treatment-naïve patients. Called MARIPOSA, it will compare Tagrisso to lazertinib alone as well as the combination.

Meanwhile, J&J is also exploring the use of amivantamab in patients who have failed TKI therapy and only have chemo as an option.

Both lazertinib and amivantamab – which was developed using technology from Danish biotech Genmab –  have blockbuster sales potential, according to the company.

The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on .

Janssen adds Hemera’s AMD gene therapy to pipeline

Johnson & Johnson’s pharma unit Janssen has bought rights to an investigational gene therapy for a severe form age-related macular degeneration from specialist biotech Hemera Biosciences.

Financial details of the deal have not been disclosed and will add Hemera’s gene therapy HMR59 to Janssen’s pipeline of ophthalmology drugs.

The privately-held biotech has developed the gene therapy as a single shot to treat dry age-related macular degeneration, or dry AMD.

In the form of dry AMD known as geographic atrophy, dysregulation of the complement system can lead to the formation of a “membrane attack complex” that causes cells in the retina to die, leading to progressive loss of vision.

HMR59 is designed as a potential one-time treatment administered in an office setting that increases the ability of retina cells to produce a soluble form of CD59, called sCD59, that blocks the formation of the membrane attack complex and limits further damage to the retina.

It uses a modified adeno-associated virus to deliver the genetic material to the back of the eye.

Geographic atrophy affects five million people globally, and is a leading cause of blindness in people over 50 years of age.

The prevalence of geographic atrophy increases as the global population ages, with roughly one in 29 people over age 75 affected, and nearly one in four people over age 90. There are currently no available therapies other than vitamins and low vision aids.

The phase 1 study of HMR59 for patients with geographic atrophy is complete. A second phase 1 study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate long-term safety.

Janssen established its eye disease portfolio in 2018 and is developing expertise and assets across a range of rare and common eye diseases, including achromatopsia and X-linked retinitis pigmentosa, age-related macular degeneration, diabetic retinopathy, and diabetic macular oedema.

Spark Therapeutics, which is now part of Roche, has shown that gene therapies can be converted into marketable ophthalmology drugs, after approval of Luxturna in 2017 for retinal degeneration caused by mutations in the gene RPE65.

 

The post Janssen adds Hemera’s AMD gene therapy to pipeline appeared first on .

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

Shots:

  • 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

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

The post Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production

Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Published: Nov 25, 2020 | Tags: Agreement, Alzheimer Disease, Collaborative, Develop, NeuroLucent, Novel, PostEra, Sign, Treatment

BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

Published: Nov 26, 2020 | Tags: BASE10, Collaborates, DNA, Link, Support, Authorization, COVID-19, IgG Antibody, Test, Point, Care

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Published: Nov 26, 2020 | Tags: Agreement, Alliance, Egle, First, Identifies, Novel, Regulatory, Research, T-cell, Takeda, Targets, therapeutics

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Published: Nov 26, 2020 | Tags: Advanced NSCLCs, EMA’s Validation, MAA, Merck, reports, Tepotinib, Treat

Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA’s, Y-mAbs Therapeutics

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Published: Nov 24, 2020 | Tags: 510(k), Brain, Clearance, CorticoMetrics, MRI, receives, Reporting, THINQ, Us FDA, Volumetric

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Published: Nov 25, 2020 | Tags: BioNTech, BNT162b2, China, Clinical Trial, Covid-19 Vaccine, Fosun Pharma, Lead mRNA, P-ll, Resumes

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Published: Nov 24, 2020 | Tags: Irritable Bowel Syndrome, P-IIa, reports, results, Sciences, study, Treatment, Urovant, Vibegron

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Published: Nov 25, 2020 | Tags: Avastin, BAT1706 Proposed Biosimilar, Bio-Thera Solutions, Cancer, EMA, Marketing Authorization Application, Submits

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Published: Nov 25, 2020 | Tags: Active Psoriatic Arthritis (PsA), EC’s Approval, First in Class, guselkumab, Janssen’s, receives, Treatment, Tremfya

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Published: Nov 24, 2020 | Tags: Associated, Bausch Health, Disease, Dry Eye, Initiates, Investigational, MGD, NOV03, P-III, Second, study, Treatment

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Published: Nov 24, 2020 | Tags: Agreement, Development, Discovery, Evotec, Focused, Oncology, Rappta, Signs, Target, therapeutics

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Published: Nov 24, 2020 | Tags: COVID-19, Gamaleya Center, P-lll Study, RDIF, reports, results, Second Interim Analysis, Sputnik V

Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Published: Nov 24, 2020 | Tags: Alvotech, CCHT, China, Eight Biosimilar Medicines, Exclusive Commercialization Agreement, Sign, Yangtze River

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 24, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, Us FDA

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Published: Nov 24, 2020 | Tags: 2L Treatment, Bristol Myers Squibb, EC’s Approval, Metastatic Esophageal Squamous Cell Carcinoma (ESCC), Nivolumab, Opdivo, receives, Unresectable Advanced

Selvita to Acquire Fidelta from Galapagos for ~$37M

Published: Nov 23, 2020 | Tags: $37.08M, Acquire, Fidelta, Galapagos, Selvita

Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Published: Nov 24, 2020 | Tags: (SoC), 1L and 2L Treatment, Malignant Pleural Mesothelioma (MPM), ONCOS-102, P-l/ll Study, reports, results, SITC Annual Meeting, Standard of Care, Targovax

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

 Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected,  Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Published: Nov 23, 2020 | Tags: Baxter’s, Claria Automated Peritoneal Dialysis (APD) System, Clearance, Homechoice, Kidney Failure, receives, US, US FDA’s 510 (k)

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Published: Nov 23, 2020 | Tags: Agreement, Areas, BMS, Commercialize, Develop, Discover, Disease, Multiple, Schrödinger, Signs, therapeutics

Merck to Acquire OncoImmune for $425M

Published: Nov 23, 2020 | Tags: Acquire, CD24Fc program, Merck, OncoImmune

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Published: Nov 23, 2020 | Tags: AstraZeneca, AZD1222, COV002, COV003, COVID-19, P-II/III, P-III, Positive, Preventing, reports, results, Trial, vaccine

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Published: Nov 20, 2020 | Tags: Develop of Potential, Genetic Disorders, License Agreement, Lilly, Precision, Research, Research Collaboration, Signs, Vivo Therapies

Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment, Us FDA, Zokinvy

Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Published: Nov 22, 2020 | Tags: 1L treatment, Advanced Hepatocellular Carcinoma (HCC), Byvasda, ESMO ASIA Virtual Congress 2020, Innovent, ORIENT-32 Study, P-lll, reports, results, Tyvyt

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Published: Nov 20, 2020 | Tags: Authorization, Bamlanivimab, canada, COVID-19, health, Interim, Lilly, LY-CoV555, receives, Treatment

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Published: Nov 21, 2020 | Tags: Casirivimab, COVID-19, EUA, Imdevimab, patients, receives, Regeneron, US FDA’s

Related Post: PharmaShots Weekly Snapshot (Nov 16-20, 2020)

The post PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) first appeared on PharmaShots.

3 steps for comprehensive patient collaboration

Janssen’s Daniel de Schryver tells us why it’s time to give patients a permanent seat at the table and improve health outcomes through patient-pharma dialogue.

I’m struck by just how much we thrive when we share a common purpose; when – as a society, a group or a family unit – we work together to achieve the same goal. It’s no different in healthcare. Pharma companies, healthcare providers and governments share a well-established common purpose: the desire to make disease a thing of the past. But healthcare is often a system of silos, and what can get lost in the gaps is the input of patients themselves. Which rather begs the question: how well are we caring for patients, if we can’t always hear their voices?

I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies. Patient-centricity has, I fear, turned into a buzzword. We must remind ourselves to focus on systematic changes – from the early R&D phases, all the way through to reimbursement discussions – that enable us to develop optimal solutions together with patients. In short, to ensure they have a seat at the table at every stage of the process.

To get back on track and embed a comprehensive collaboration between patients and industry, I believe we need to consider the following three areas:

“To ensure we are making a difference, we need robust KPIs, both short and long-term, to measure patient-industry collaborations. We must understand the value over time of these solutions”

1. Open conversations lead to better patient-industry collaborations

Pharma needs to convey a clear picture of who we are and what we’re trying to achieve. When the public sees patients working directly with us, it can still arouse suspicions, as if there’s some form of collusion going on. Transparency is crucial, therefore, so that any outcomes from our collaborations with patients are shared and accepted.

We have been adapting our processes at Janssen to put patients at the heart of everything we do. It’s a work-in-progress, because this means streamlining the way we work to include the patient voice within acceptable timelines, while still meeting compliance requirements. But the aim is for every function in our value chain to demonstrate how they have involved the patient in their decision-making.

A good example of a productive, open collaboration we’ve experienced with patients, clinicians and regulators is the one that resulted in the Psoriasis Symptoms and Signs Diary (PSSD). Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most.

A major insight revealed once the tool was in use was to not just focus on the percentage of the body covered by psoriasis – a patient with smaller areas of their face or hands affected, for example, may find it more difficult to cope compared to patients with larger areas affected on their backs.

Projects like these are time intensive, of course; this collaboration with psoriasis patients took five years to co-develop. But the important thing was that it worked, and that it has provided a great model of patient interaction for us to replicate.

2. Pharma must support patient empowerment

Patient empowerment is not a catchphrase; it is a genuine drive to enable patients to take ownership of their health. We need more people to see themselves as experts in their own treatment, so they feel able to provide input into key debates and initiatives. It should be our duty, as pharma, to help more people achieve this.

The European Patients’ Academy on Therapeutic Innovation (EUPATI) is a good example of this in action. EUPATI is a public-private partnership run by a multi-stakeholder consortium. It brings together patients, pharma, academia, regulators, non-profit organisations, and health technology assessment bodies, and it allows trained patient experts to input into the R&D process, regulatory deliberations, and other initiatives.

In the UK, my colleagues have created a Patient Advisory Committee, two of whom mentor several members of the UK management committee, helping them to further embed the patient voice in their decisions. A more empowered patient helps improve solutions that are beneficial to their own health and the health of many other patients besides, thereby contributing to a healthier future for all.

3. Measure the success of patient-industry collaborations

To ensure we are making a difference, we need robust KPIs, both short and long-term, to measure patient-industry collaborations. It is rewarding to see the immediate impact these projects can have, but we must also understand the value over time of the solutions we are co-developing with patients.

Patients Active in Research and Dialogues for an Improved Generation of Medicines (PARADIGM) is a public-private partnership paid for by the European Commission and the pharma industry, and co-led by the European Patients’ Forum and The European Federation of Pharmaceutical Industries and Associations (EFPIA).

PARADIGM provides a framework for innovative patient engagement approaches and is able to demonstrate the benefits of these approaches to all stakeholders. Through this partnership, we have been able to support the development of solutions designed to not only improve an individual patient’s experience of care, but also the overall health of populations, and which, ultimately, should reduce the per capita costs of care.

Putting patients at the heart of the process

It’s essential to listen to what patients have to say, to identify solutions that are beneficial individually and collectively, and to provide feedback on how patients’ insights have helped shape better outcomes for all. If we can listen and listen well, and if we can show we genuinely care about patients’ views, then their contributions can make a real difference.

As I said at the start, we thrive when we are united behind one common purpose. We must be united with patients, and that common purpose must be their purpose.

So, to any patients reading this, I urge you to join a patient advisory group and multiply your impact, to study with EUPATI and become an expert, and – put simply – to get involved and be heard. And to everyone with whom we work across the industry, let’s follow the process: ask the patient, include them from the onset, and ensure their insights are at the core of everything we do. Let their voice be the driving force in our shared goal of making disease a thing of the past.

About the author

Daniel De Schryver is patient engagement & advocacy lead, Europe, Middle-East and Africa, at Janssen. He joined Johnson & Johnson in 2001 as Director Corporate Communications. In that function, he initially worked in the field of oncology. In 2006 he joined the Janssen teams working in Infectious Diseases where he helped to maintain and enhance the company’s relationships with the HIV Patient Community. Later, he built the external relationships in the field of Hepatitis C, before becoming the Global Therapeutic Area Communications Leader Infectious Diseases and Vaccines.

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J&J begins trial of two-dose COVID-19 vaccine regimen

Johnson & Johnson has begun a second phase 3 trial of its potential COVID-19 vaccine, including sites in the UK, testing whether it works as a two-dose regimen.

The company’s Janssen pharmaceuticals and vaccines unit has already begun the ENSEMBLE study testing the single-dose vaccine and plans to enrol up to 60,000 participants worldwide.

It has now begun the two-dose regimen trial ENSEMBLE 2 trial, which will run in parallel with the first ENSEMBLE and will recruit up to 30,000 people worldwide.

The company acknowledged that a single-dose vaccine with a good safety profile would have significant benefit but is assessing other dosing regimens as well to see if they work better in the long term.

ENSEMBLE 2 study is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older.

Patients may or may not have stable comorbidities associated with an increased risk for severe COVID-19.

The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose.

Janssen is testing the vaccine in countries with high infection rates, such as Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States.

In the UK, ENSEMBLE 2 is being conducted in collaboration with the UK National Institute for Health Research (NIHR).

There are 11 vaccines in late stage-development, according to the World Health Organization, including the Pfizer/BioNTech shot, which is more than 90% effective according to top-line clinical trial results announced last week.

BioNTech’s co-founder professor Ugur Sahin told the BBC’s Andrew Marr show that if it is approved by regulators, the vaccine’s impact will significantly kick in over summer, leading to resumption of normal life by next winter.

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Janssen combines Darzalex with COVID drug in new multiple myeloma submission

Janssen has submitted a new combination regimen for its blockbuster multiple myeloma drug Darzalex for approval with the FDA and EMA, hoping to give the treatment another edge over emerging competitors.

Specifically, the combination utilises the subcutaneous formulation of the drug, Darzalex Faspro (daratumumab/hyaluronidase) with Celgene’s multiple myeloma drug Imnovid (pomalidomide) and dexamethasone – which has gained new fame this year as one of the few treatments available for COVID-19.

Darzalex Faspro was approved earlier this year and cuts the drug’s dosing time to just a few minutes from hours.

Janssen is seeking approval for use in the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 

The submission is supported by data from the phase 3 APOLLO study, which showed significantly longer progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma who received the combination compared with pomalidomide and dexamethasone alone. 

Analysts think the shorter treatment of Darzalex Faspro time could become a particularly important advantage over the established formulation during the coronavirus pandemic, when getting access to healthcare has become more difficult under lockdown, and this combination could further boost the drug’s profile.

In September Janssen also submitted the formulation for approval in the rare and potentially fatal disease light chain amyloidosis.

The original IV version of Darzalex has been a big earner for J&J ever since it was first approved in 2015 as a fourth-line myeloma therapy, growing rapidly on the back of successive approvals in earlier lines of therapy – including most recently in newly-diagnosed patients.

The product brought in almost $3 billion in sales last year, and shows no signs of slowing down, growing another 49% to reach $937 million in the first three months of 2020. J&J licensed the drug from Danish biotech Genmab in 2012 in a deal valued at $1.1 billion.

Last month however saw the approval of its first direct competitor – Sanofi’s anti-CD38 antibody Sarclisa (isatuximab) – which was given the nod by the FDA as a third-line therapy for myeloma.

Sanofi’s drug is delivered intravenously and – according to Sanofi – has simpler, two-hour dosing that improves on the current Darzalex formulation, although analysts think the availability of J&J’s new subcutaneous version will likely cancel out that advantage.

Last year, J&J licensed a follow-up to Darzalex from Genmab, HexaBody-CD38, that it says could be used in Darzalex-resistant patients as well as in other cancer indications beyond myeloma, in the hope of extending its anti-CD38 franchise.

 

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PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke

Novo Nordisk to Acquire Emisphere Technologies for $1.8B

Published: Nov 6, 2020 | Tags: Novo Nordisk, Acquire, Emisphere Technologies, $1.8B

AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for Heart Failure

Published: Nov 5, 2020 | Tags: AstraZeneca’s, Forxiga, (dapagliflozin), Receives, EU, Approval, Heart Failure

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Nov 5, 2020 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, Receives, EU, Approved, HRD, Positive, Advanced, Ovarian, Cancer

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Published: Nov 5, 2020 | Tags: Iktos, Signs, Agreement, Merck, KGaA, AI, New, Drug, Design

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 5, 2020 | Tags: Formycon, Reports, BLA, Resubmission, Strategy, Lucentis, Biosimilar, FYB201

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Published: Nov 5, 2020 | Tags: Cosentyx, Novartis, P-IIIb, patients, Psoriatic Arthritis, reports, results, secukinumab, study, ULTIMATE

Merck to Acquire VelosBio for $2.75B

Published: Nov 5, 2020 | Tags: $2.75B, Acquire, Merck, Oncology Pipeline, VelosBio

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Published: Nov 5, 2020 | Tags: 2020, 7, Asia, Clinical, Congress, ESMO, Injection, Innovent, Lilly, Presents, results, Sintilimab, Studies, Tyvyt

Coloplast Acquires Nine Continents Medical

Published: Nov 4, 2020 | Tags: Coloplast, Acquires, Nine Continents Medical

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Published: Nov 4, 2020 | Tags: Novavax, Collaborates, Commonwealth, Australia, Supply, 40M, Doses, NVX-coV2373, COVID-19

BioInvent Presents New Clinical and Preclinical Data of BI-1206 at ASH Annual Meeting

Published: Nov 5, 2020 | Tags: ASH Annual Meeting, BI-1206, BioInvent, Follicular Lymphoma Mantle Cell Lymphoma, Marginal Zone Lymphoma, P-l/lla Study, reports, results

Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Published: Nov 4,2020 | Tags: Jounce Therapeutics, P-II EMERGE trial, Program, reports, Update, Vopratelimab

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Published: Nov 4, 2020 | Tags: Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, reports, US, Vosoritide

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Published: Nov 3, 2020 | Tags: CEPI, Clover Biopharmaceuticals, Covid-19 Vaccine, Expand, Fund, Partnership

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Published: Nov 2,2020 | Tags: Abbott, approval, CE Mark, EnSite X EP System, receives, TGA

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Published: Nov 4,2020 | Tags: BMS, BMS-986165, Deucravacitinib, Moderate, P-III, patients, Plaque, POETYK PSO-1, Positive, Psoriasis, reports, results, Severe, study

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA 

Published: Nov 4,2020 | Tags: approval, Boston Scientific, DCB, patients, Peripheral Artery Disease, PPA, Range, receives, SFA, Treatment, Us FDA

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Published: Nov 3,2020 | Tags: Advanced, breast, Cancer, HR+/HER2, Kisqali, MONALEESA-7, Novartis, P-III, reports, results, ribociclib, study, Women

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Published: Nov 3, 2020 | Tags: BPN14770, FXS, P-II, patients, Positive, reports, results, study, Tetra Therapeutics

Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Published: Nov 3, 2020 | Tags: (atezolizumab), (bevacizumab), Aavastin, EU Approval Unresectable Hepatocellular Carcinoma (HCC), receives, Roche’s, Tecentriq

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 3, 2020 | Tags: 2020, ACR, Celltrion Healthcare, Convergence, CT-P17, P-III, Positive, Presents, RA, results, study, Treatment

Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Published: Nov 3, 2020 | Tags: (PP6M), Invega Sustenna, Invega Trinza, Janssen, NDA submission, reports, Us FDA

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

Published: Nov 3, 2020 | Tags: AstraZeneca, Cancer, Collaborate, Combination Therapies, Commercialize, Develop, Fusion, Next-Generation Radiopharmaceuticals

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Published: Nov 2, 2020 | Tags: Aimovig, Episodic and Chronic Migraine (HER-MES), erenumab, Novartis, P-lV Study, positive results, Report

Sun Pharma Reports Five Year Results of Ilumya (tildrakizumab-asmn) in P-III Studies for Moderate-to-Severe Plaque Psoriasis

Published: Nov 2, 2020 | Tags: 5-year, Ilumya, Moderate, P-III, patients, reports, results, reSURFACE 1, reSURFACE 2, Severe, Studies, Sun Pharma, tildrakizumab-asmn

 Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Published: Nov 2, 2020 | Tags: Fibrodysplasia Ossificans Progressiva, Garetosmab, LUMINA-1 Trial, P-ll, patients, Regeneron, REGN2477, Report, results

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Published: Nov 2, 2020 | Tags: BE SURE, Bimekizumab, Moderate, P-III, patients, Psoriasis, reports, results, Severe, study, UCB

Sanofi to Acquire Kiadis for ~$358M

Published: Nov 2, 2020 | Tags: $358.76M, Acquire, Kiadis, Offers, Sanofi

Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Published: Nov 2, 2020 | Tags: Acquires, Ai Biomed Corp., ENT Portfolio, Medtronic’s, NIM Vital, Parathyroid Detection System, receives, US FDA’s Approval

Related Post: PharmaShots Weekly Snapshot (Oct 26 – 30, 2020)

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Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Shots:

  • The sNDA submission is based on P-lll Route-6 study assessing PP6M vs PP3M in 702 patients with schizophrenia previously stabilized on corresponding doses of PP1M or PP3M across 20 countries
  • Results demonstrated non-inferior efficacy of PP6M to PP3M on the 1EPs of time to relapse at the end of the 12mos. period in both intent-to-treat and per-protocol analysis sets, the safety profile is consistent with no new safety signals
  • If approved, PP6M will be the first and only long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen. Additionally, Janssen plans to submit an MAA extension to the EMA for PP6M in the coming months

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Canal Ideal

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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.

How real human experiences can power a healthier future

As part of our series of opinion pieces from leaders at Janssen, the company’s Maria Raad looks at how we can embrace tech and data science to overcome increasing pressures on healthcare systems.

For the next generation born in the western world, living to be the age of 100 will be the norm. While this seems like a desirable aspiration for our grandchildren, it adds new pressures on our healthcare systems. The number of people living with chronic illnesses will rise year-on-year, and the ongoing management of  illnesses like diabetes and cardiovascular disease will require ever increasing resources.

This is nothing new. Healthcare expenditure is growing faster than GDP the world over, a trend that has been amplified by the COVID-19 pandemic. Together, these forces have accelerated technological transformation, acceptance, and adoption across our industry, reinforcing my belief in the ‘triple aim’.

The triple aim considers how we balance the needs of the individual with pressures on our health systems and, in a phrase coined by Berwick, Nola and Whittington in 2008, it is defined as:

  1. Improving an individual’s experience of care
  2. Improving the health of populations
  3. Reducing the per capita costs of care

Changes to any one of these goals can affect the other two, negatively or positively. In order to succeed, we must shift the paradigm of healthcare and drive towards more objective measurements of value and improved experiences for everyone, to create a truly patient-centric system of care. ​

In the past, our collective adoption of, and trust in, digital technology has been incremental and often reluctant. All too often approached with a narrow mindset, such technologies have been regarded as simply tools to reduce costs or lessen the need for human interaction, when they have the potential to do so much more.

As the scientific evidence behind digital solutions has grown alongside our accelerated need for changes, we’re starting to see the full potential that data science might offer – a potential to create more efficient disease management solutions, reduce the economic burden of healthcare and, most importantly, empower patients to be integral decision-makers in their own care.

Real-time digital solutions for real-world evidence

Two billion people have access to mobile health data, but simply having access is not enough. It is how we use health data that will drive us forward. The emergence of big data, smartphone adoption and cloud storage technologies means that information can be captured in real-time, and then aggregated and analysed to develop new insights.

Collaborations such as HONEUR (Haematology Outcomes Network in Europe), which brings together a partnership of universities, hospitals and institutions across Europe, can help with this by bringing together multiple stakeholders to analyse real-world data (RWD), quickly and at scale, from as many sources as possible. By answering research questions in real time, partners can extract real-world evidence (RWE) that informs their conclusions and accelerates their work.

While acceptance varies between countries, we believe RWE is a key component in moving towards a more value-based healthcare model, as it is one of the few under-utilised resources left in our field.

Healthcare companies are now working with tech companies to put innovative, data-capturing tools directly in the hands of the individual. Wearable tech and mobile health apps can provide patients with information, allow them to manage medication, and help them to become experts in their own condition. This personal depth of knowledge can complement the quantitative data on which we currently rely, so we must ensure it’s integrated into treatment pathways going forward.

Combining digital therapeutics with pharmaceutical innovations

The pandemic has prompted a significant uptake in the use of data technologies. Clinicians, patients and payers are utilising the potential of these platforms, and many are doing so for the first time. We will, however, need to embed such changes across all parts of our healthcare systems, and I believe there are four foundational elements to this:

  • Evolving from sick-care to well-care: healthcare systems are struggling to provide care via traditional models, which are largely based on treating illness rather than preventing it. This means moving on from just products and treatments, to platforms and solutions focused on prevention and real-time, outcomes-based care. Digital technology will be a major contributor to this transformational shift from diagnosis and treatment to prediction and prevention.
  • Data science: harnessing data networks, artificial intelligence and real-world evidence, and the interdependence between all three, can help move us towards agreeing an objective measure of value for any given therapy. That’s essential if we are to build a new healthcare ecosystem, and if we get it right, everyone will benefit.
  • Long life care: ageing populations are growing in size and increasing the pressure on healthcare systems. Without digital technology, the amount of resources required to manage long-term, non-communicable diseases will be unsustainable.
  • Personalised care: digital therapeutics, when certified as medical devices, can enable clinicians to prescribe a treatment system that goes beyond the pill. They can also engage patients more effectively in their own care, through real-time symptom monitoring, for example, or by providing physiological support for those dealing with the burden of disease.

These are not short-term solutions. The ultimate goal is healthcare that’s thriving, sustainable and accessible to all. And we can drive towards that goal by harnessing and sharing the benefits of the ever-evolving technologies within our reach. But it’s a team sport – the days of any individual, organisation, government or industry attempting to change the world on their own are gone.

Data science actually has the potential to make healthcare more human. And, as we look to the next 100 years, with all this technology available to us, perhaps there’s reason to hope that we will yet see a world where fewer people get sick and more people live longer, healthier, happier lives.

About the author

Maria RaadMaria Raad is vice president, customer & digital strategy, EMEA at Janssen. In this capacity, Maria is responsible for the functions of business intelligence, advanced analytics, digital acceleration, and patient healthcare solutions. She has held various positions, since joining Janssen in 2006 – prior to her current role, Maria was Global VP & Chief Information Officer of Actelion, and a member of the Actelion leadership team based in Basel, Switzerland.

The post How real human experiences can power a healthier future appeared first on .

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

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

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

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

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

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

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

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

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

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

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

Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

  1. Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi

2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Published: Oct 1, 2020 | Tags: COVID-19, Moderna, mRNA-1273, P-l study

3. Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

Published: Oct 1, 2020 | Tags:  Alnylam, ILLUMINATE-B, Lumasiran, P-III study, Primary Hyperoxaluria Type 1, reports, results

4. Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Published: Oct 1, 2020 | Tags: Janssen, NDA, Pulmonary Arterial Hypertension, reports, selexipag, Submission, Treat, UPTRAVI, USFDA

5. Henlius Signs an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 1, 2020 | Tags: Accord Healthcare Inc., Develop and Commercialize, Exclusive License Agreement, Henlius, HLX02

6.  Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Published: Oct 1, 2020 | Tags: (DTaP-IPV), India, Launches, Preschoolers, Sanofi, Tetraxim

7. Abbott’s FreeStyle Libre 3 System Receives CE Mark in Europe

Published: Sept 30, 2020 | Tags: Abbott, CE Mark, Europe, FreeStyle Libre 3 System, receives

8. Medtronic to Acquire Avenu Medical

Published: Sept 30, 2020 | Tags: Acquire, Avenu Medical, Ellipsys Vascular Access system, endovascular solutions, Medtronic

9. BMS’s Reblozyl (luspatercept) Receives Health Canada Approval for Beta Thalassemia

Published: Sept 30, 2020 | Tags: Beta Thalassemia, BMS, Health Canada Approval, Luspatercept, Reblozyl

10. Junshi Reports Results of Dual Regimen in P-III Jupiter-02 Study as 1L Therapy for Nasopharyngeal Carcinoma

Published: Sept 30, 2020 | Tags: 1L Therapy, Dual Regimen, Junshi Biosciences, Jupiter-02 Study, Nasopharyngeal Carcinoma (NPC), P-lll

11. Galapagos Reports First Patients Dosing with GLPG3970 (Toledo Compound) for Psoriasis

Published: Sept 30, 2020 | Tags: First Patients Dosing, Galapagos, GLPG3970, LADYBUG study, ll CALOSOMA study, P-l/ll, Psoriasis, SEA TURTLE study

12. Regeneron’s REGN-COV2 Demonstrate Reduction in Viral Load and Improve Symptoms in Non-Hospitalized Patients with COVID-19

Published: Sept 30, 2020 | Tags: COVID-19, Demonstrate, Improve Symptoms, Non-Hospitalized, patients, Reduction, Regeneron, REGN-COV2, Viral Load

13. Boston Scientific Launches ACURATE neo2 Aortic Valve System in Europe

Published: Sept 29, 2020 | Tags: ACURATE neo2 Aortic Valve System, Boston Scientific Corporation, Europe, Launches

14. Inovio Reports FDA’s Partial Clinical Hold on P-II/III Trial of INO-4800 Against COVID-19

Published: Sept 29, 2020 | Tags: COVID-19, FDA’s, INO-4800, Inovio, P-ll/lll Study

15. CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

Published: Sept 29, 2020 | Tags: CSL behring, HAE, Haegarda, Hereditary Angioedema, Pediatric Patients, US FDA’s Approval

16. Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Published: Sept 29, 2020 | Tags: Active Polyarticular Course Juvenile Idiopathic Arthritis, approval, FDA, receives, tofacitinib, US, XELJANZ

17. AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and Fast Track Designation for Spinal Cord Injury

Published: Sept 29, 2020 | Tags: AbbVie, Elezanumab, FDA, FT, ODD, Spinal Cord Injury, US

18. Sarepta Reports Two-Year Follow Up Results of SRP-9001 for Duchenne Muscular Dystrophy

Published: Sept 29, 2020 | Tags: Duchenne Muscular Dystrophy, reports, results, Sarepta, SRP-9001, Two-Year Follow Up

19. Innovent Report Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020 | Tags: 1L Therapy, Byvasda, Hepatocellular Carcinoma (HCC), Innovent Biologics, Tyvyt

20. Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the Collaboration with Sosei Heptares

Published: Sept 28, 2020 | Tags: Candidate, Clinical Study, Collaboration, Emerges, Initiates, Pfizer, Sosei Heptares, Under

21. Roche Reports Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA

Published: Sept 28, 2020 | Tags: (risdiplam), Data, Evrysdi, Infants, reports, Roche, Two-Year, Type 1 SMA

22. GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as the First Treatment for Hypereosinophilic Syndrome

Published: Sept 28, 2020 | Tags: (mepolizumab), approval, FDA, GSK, Hypereosinophilic Syndrome, Nucala, receives, US

23. Chugai’s Tecentriq (atezolizumab) and Avastin (bevacizumab) Receive MHLW’s Approval as 1L Treatment for Unresectable Hepatocellular Carcinoma

Published: Sept 28, 2020 | Tags: (atezolizumab), (bevacizumab), 1L, approval, Avastin, Chugai, MHLW, Receive, Tecentriq, Treatment, Unresectable Hepatocellular Carcinoma

24. Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis in Japan

Published: Sept 28, 2020 | Tags: Filgotinib, Gilead, JAK1 Inhibitor, Jyseleca, MHLW Approval, Rheumatoid Arthritis, Structural Joint Damage

The post PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) first appeared on PharmaShots.

Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Shots:  

  • The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose
  • Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the oral formulation is not feasible. Both the formulation was well tolerated with no unexpected safety findings
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved in IV formulation for PAH, WHO Group I in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Penn Today

The post Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension first appeared on PharmaShots.

Time for a health innovation pact: rethinking the design and delivery of healthcare

Janssen’s Anouk De Vroey on why we need to extend the public/private partnerships resulting from COVID-19 into more high-level dialogue on health innovation with governments.

Friday 13th March 2020 – I am not a superstitious person in general, but I will never forget that particular Friday the 13th, as it marked the start of the COVID-19 lockdown in Belgium.

Wishing someone good health is a common custom with a long history, but being and staying healthy has never been more important. Nor, indeed, collaboration. In 20 years of working in the pharmaceutical sector, I’ve seen a steadily increasing willingness to partner with others to optimise healthcare and accelerate scientific research – a willingness that has only been amplified by this new context in which we find ourselves.

COVID-19 continues to have a devastating impact on peoples’ lives and businesses, and it has brought into the sharpest focus the need for everyone to work together to find both immediate and long-term solutions.

Partnering on the road to European recovery

Industries and sectors have already joined forces to develop diagnostics, therapies and vaccines that could help tackle the disease. At Janssen Belgium, for example, we quickly set up a dedicated lab for COVID-19 diagnostic testing at our Beerse campus, in collaboration with the federal government, universities and other pharmaceutical companies.

We have also seen regulators and policymakers working at an incredible speed to streamline regulatory processes and put in place new emergency measures to support the search for potential treatments and vaccines.

No single person, company, or even industry can succeed alone in making COVID-19, or any other disease, a thing of the past. It’s going to take a tremendous joint effort. This pandemic has catalysed a spirit of collaboration and demonstrated what can be achieved when society comes together with one common goal. We must continue to make progress on some of the most pressing issues facing healthcare systems, and put in place a robust, long-term policy framework that supports and enables innovation.

We need to ask ourselves how this model of partnership and trust can improve future policy, as we still face many other global public health challenges. While some threats are unpredictable, others – such as the urgent need to tackle anti-microbial resistance (AMR) – are known, and we will be better prepared for future challenges if we can operate in a framework where public policy priorities and industry incentives are aligned.

Johnson & Johnson is one of the participants in the AMR Action Fund, recently set up by a group of leading biopharmaceutical companies in collaboration with the World Health Organization, The European Investment Bank, and the Wellcome Trust. The Fund has pledged to invest nearly $1 billion, with the aim of bringing two to four new antibiotics to market by 2030. If successful, I believe that we will see many more of these types of collaborations.

“This pandemic has catalysed a spirit of collaboration and demonstrated what can be achieved when society comes together with one common goal.. We need to ask ourselves how this model of partnership and trust can improve future policy”

Building a health innovation pact for the future

As the COVID-19 pandemic has continued to evolve, European citizens have been experiencing a dual-pronged crisis; firstly, as a result of the major strain placed on healthcare and, subsequently, due to the impact on the European economy.

However, these challenges are coupled with an opportunity to build on the crisis-born willingness to create healthcare systems that are better equipped to deliver value on both a local and global scale. We need to extend the public/private partnerships that have resulted from the crisis into a high-level, strategic dialogue with local governments and the European Union institutions.

  • In the short term, joint efforts to upscale screening, tracking, tracing and data capture should be prioritised until an effective vaccine is available.
  • During the crisis, there has been a transition to telemedicine solutions at a speed previously unheard of, so we should leverage these learnings to accelerate healthcare digitisation. Remote consultations and monitoring have provided an alternative to hospital visits, showing that digital options have the potential to free up resources in health systems, and enable patient-centric solutions where people can receive care in their own homes.
  • In the longer term, we need to work together with all stakeholders to co-create a blueprint for European healthcare systems that addresses tomorrow’s needs, including – but not limited to – establishing new payment models and a greater use of big data and real-world evidence.

At Janssen, we are more committed than ever to collaborating with healthcare authorities and the research and healthcare communities (both public and private), to achieve the common goal of improving the care patients receive. We want to enable people, resources and world-leading science to contribute to the EU recovery plan. But we are just one company. Reinforcing the importance of healthcare across Europe in the long run will only be possible with a strong and innovative contribution from the entire pharmaceutical industry.

What does policy progress look like?

We all have a responsibility to work together and create innovation pacts with society that foster progress and enable lasting change. These pacts would include:

  • Improving readiness for future challenges and disease prevention. We need a globally coordinated approach to the development, testing, approval and production of vaccines and treatments. Policymakers and the industry will need to work more closely to ensure appropriate mechanisms are in place to accelerate the rapid deployment of effective interventions across the globe. We also need to ensure that the healthcare of patients suffering from other diseases is not compromised during times of worldwide crisis.
  • Supporting value-based healthcare. Sophisticated methods are needed to define Key Performance Indicators (KPIs). The use of real-world data (RWD) on a vast scale can help improve patient outcomes, drive more comprehensive measurements of value, and support decision-makers as they assess different forms of treatment in the context of limited healthcare budgets. Regulatory and HTA processes must adapt and embrace a systematic use of RWD, and efforts to iron out the significant variability across European HTA systems should continue.
  • Developing healthcare solutions that are more patient-centric and can generate better outcomes. We must integrate the perspective of the patient into all levels of decision-making, using digital apps and devices where possible to involve patients in their entire treatment pathway.
  • Improving and maintaining a world-class system for the approval of medicines. The current focus on strengthening EU health agencies is encouraging, and the European Medicines Agency (EMA) has done well so far. But it is essential to keep pace with scientific progress. The European Centre for Disease Prevention and Control (ECDC) should play a pivotal role in coordinating surveillance, preparedness and response – leaving each European country to do this independently could jeopardise the EU’s ability to lead on healthcare and science policy.

I hope, in time, that we will look back on Friday 13th March 2020 as not only the start of the Belgian lockdown, but also as the beginning of a healthy European future; one that brings together science and robust policymaking, and sees more trust and greater transparency between partners. An innovation health pact between industry and health authorities could make this vision a reality. A unilateral focus on short-term austerity measures will not.

If we can strengthen a framework that incentivises innovation, we can help provide society with opportunities to access essential vaccines and transformational therapies in areas where optimal solutions do not currently exist.

 

About the author

Anouk De Vroey is senior director, government affairs & policy EMEA at Johnson & Johnson. She is a member of the Janssen EMEA Leadership Team and also leads the Janssen External Affairs Council, driving the way the company responds to the external environment. Anouk advocates for policies across EMEA that can ensure optimal access to care for patients, and is also involved in several platforms that support a climate of biopharmaceutical innovation. Prior to joining Johnson & Johnson, Anouk was European Lead of the Global Policy, Advocacy & Government Affairs department at Bristol-Myers Squibb.

The post Time for a health innovation pact: rethinking the design and delivery of healthcare appeared first on .

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

Shots:

  • The companies will use BioSymetrics Contingent-AI engine to characterize high-risk populations, measure and predict disease progression based on biological risk factors and treatment course and identify markers for clinical phenotype and severity of the disease
  • The focus of the collaboration to predict the onset and severity of COVID-19 among different populations using machine learning
  • The collaboration will operate across several projects with a goal of enabling a vaccine and course of treatment against COVID-19

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Northeast Now

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

Shots:

  • The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients
  • The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile compared with Darzalex IV in patients with RRMS, 2/3rd reduction in systemic ARRs (13% vs 34%)
  • In P-II PLEIADES study evaluates Darzalex SC + D-VMP in newly diagnosed transplant-ineligible patients & Darzalex SC + (D-Rd) in R/R patients prior treated with 1L therapy. In general, Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Explore