MSD cashes in on Moderna investment as FDA mulls COVID-19 vaccine approval
December 4, 2020Medical Communications, Sales and Marketing MSD, Moderna
Moderna has wrestled its way to the forefront of the industry amidst the COVID-19 pandemic, becoming one of its most …
Jazz and PharmaMar’s Zepzelca combo misses main goal in small cell lung cancer sub-population
December 3, 2020Research and Development PharmaMar, jazz pharma, trial failure
Jazz Pharma and PharmaMar have revealed that their jointly-developed therapy Zepzelca (lurbinectedin), when combined with doxorubicin, fell short of its …
Neurogene secures EMA orphan designation for gene therapy in rare, inherited aspartylglucosaminuria
December 3, 2020Sales and Marketing EMA, Neurogene, aspartylglucosaminuria
The European Medicines Agency (EMA) has bestowed Orphan Drug Designation (ODD) to Neurogene’s adeno-associated virus vector (AAV) gene therapy in …
Janssen scoops up rights to Hemera’s gene therapy for retinal geographic atrophy
December 3, 2020Sales and Marketing Hemera Biosciences, Janssen, Retina, geographic atrophy
Janssen is set to acquire the rights to Hemera Biosciences’ intravitreal gene therapy injection HMR59, the company has announced, to …
Drug-free nasal spray could prevent COVID-19 infection, promising data show
December 3, 2020Research and Development COVID-19, Nasal Spray, auris medical
Auris Medical has revealed promising new in vitro data for AM-301, its drug-free nasal spray, showing that the product could …
Roche secures emergency FDA approval for COVID-19 antibody test
December 3, 2020Sales and Marketing COVID-19, FDA, Roche
The FDA has awarded Emergency Use Authorization to Roche’s COVID-19 test to allow users in the US to analyse the …
Pharmafile.com’s weekly COVID-19 news round-up
December 2, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Image credit: CDC, Top 5, Vaccine
EMA receives Pfizer and BioNTech’s filing for conditional approval of COVID-19 vaccine in Europe – Published on 01/12/20
FDA greenlights Gavreto for advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer in over-12s
December 2, 2020Research and Development, Sales and Marketing FDA, Gavreto, Roche
The FDA has awarded accelerated approval to Roche and Blueprint Medicines’ Gavreto (pralsetinib) for the treatment of advanced or metastatic …
European approval for Janssen’s Tremfya in active psoriatic arthritis, either alone or in combo
December 2, 2020Research and Development, Sales and Marketing Europe, Janssen, Tremfya
The European Commission has authorised Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) in the treatment of active psoriatic arthritis (PsA), either …
Ovid’s Angelman syndrome therapy falls short at Phase 3
December 2, 2020Research and Development Angelman syndrome, Ovid
Ovid Therapeutics has revealed disappointing results for its therapy OV101 (gaboxadol) in the treatment of Angelman syndrome, admitting that it failed …
UK becomes first nation to approve Pfizer and BioNTech’s COVID-19 vaccine
December 2, 2020Research and Development, Sales and Marketing COVID-19, Pfizer, UK, Vaccine
The UK has become the first country worldwide to authorise Pfizer and BioNTech’s promising COVID-19 vaccine, the UK Government has …
The Autumn 2020 edition of Pharmafile is available to read for free online now!
December 1, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing infectious diseases, pharmafile, rare disease, respiratory
The Autumn 2020 edition of Pharmafile is available to read for free online now! 2020 has seen almost unprecedented disruption …
Eisai and Wren Therapeutics join forces to tackle neurodegenerative synucleinopathies
December 1, 2020Manufacturing and Production, Research and Development, Sales and Marketing Eisai, Wren Therapeutics
Eisai has forged an exclusive research partnership with Wren Therapeutics to develop new approaches in tackling neurodegenerative diseases known as …
EMA receives Pfizer and BioNTech’s filing for conditional approval of COVID-19 vaccine in Europe
December 1, 2020Manufacturing and Production, Sales and Marketing BioNTech, COVID-19, EMA, Pfizer, Vaccine
Pfizer and BioNTech have officially submitted their application to secure conditional marketing authorisation to the European Medicines Agency (EMA) for …
Grünenthal buys European rights to AstraZeneca’s Crestor for a potential $350m
December 1, 2020Manufacturing and Production, Sales and Marketing AstraZeneca, Crestor, Grunenthal
Grünenthal has picked up AstraZeneca’s statin therapy Crestor (rosuvastatin), currently approved in dyslipidaemia and hypercholesterolaemia treatment, in a deal worth …
Optimise your clinical trials with Avantor Clinical Services
December 1, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing 2020 Campaign, Avantor, clinical trials, expertise
Serious diseases like COVID-19 put increasing pressure on researchers to find breakthrough treatments faster. Along with accelerated timelines, biopharma and …
Cabometyx scores Japanese approval for unresectable hepatocellular carcinoma patients following systemic therapy
November 30, 2020Sales and Marketing Cabometyx, Japan, Takeda
The Japanese Ministry of Health, Labor and Welfare has awarded approval to Takeda for Cabometyx (cabozantinib) as a treatment for …
Analysis confirms Moderna’s COVID-19 vaccine efficacy to be 94.1%
November 30, 2020Research and Development, Sales and Marketing COVID-19, Moderna, Vaccine
US biotech Moderna has followed up on its highly promising efficacy data for its mRNA-based COVID-19 vaccine candidate with the …
Dupixent becomes first systemic medicine approved in Europe for children with severe atopic dermatitis
November 30, 2020Sales and Marketing Dupixent, EU, Europe, Sanofi
The European Commission has moved to expand the existing authorisation of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union …
UK secures another two million COVID-19 vaccine doses from Moderna
November 30, 2020Sales and Marketing COVID-19, Moderna, UK
The UK Government has expanded upon its previous negotiations with Moderna to secure an additional two million doses of its …
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