Gilead says FDA could expand eligibility of coronavirus patients for remdesivir
August 24, 2020Sales and Marketing FDA, Gilead
The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead.
FDA approves Phase 1 trial for HIV gene therapy
August 24, 2020Sales and Marketing CAR T, CAR T cancer therapies, CAR-T
The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. …
FDA grants emergency authorisation for coronavirus plasma treatment
August 24, 2020Sales and Marketing COVID-19, FDA, coronavirus
The FDA has issued an Emergency Use Authorization (EUA) for convalescent plasma to treat patients with COVID-19. The regulatory body …
Janssen granted US approval for multiple myeloma drug combination
August 21, 2020Medical Communications
The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined …
FDA approves Novartis’ MS drug Kesimpta for treating relapsed forms of the disease
August 21, 2020Medical Communications
The FDA has authorised Novartis’ Kesimpta (ofatumumab) for treating patients with relapsing forms of multiple sclerosis (MS), it has been …
NICE recommends combination treatment from Roche for certain lymphoma patients
August 21, 2020Medical Communications FDA, FDA Approval
NICE has moved to recommend Roche’s Polivy (polatuzumab vedotin), when combined with rituximab and bendamustine, for the treatment of diffuse …
AstraZeneca scores Japanese approval for Imfinzi combo in extensive-stage small cell lung cancer
August 21, 2020Medical Communications, Sales and Marketing AstraZeneca, Imfinzi, Japan
AstraZeneca’s Imfinzi (durvalumab) has secured approval in Japan for the treatment of extensive-stage small cell lung cancer when combined with etoposide and …
Top Ten most popular articles on Pharmafile.com this week
August 21, 2020Medical Communications COVID-19, coronavirus
The top 10 news stories this week again focus on coronavirus vaccines and treatments, as professor Alexander Chuchalin has quit …
FDA turns down Gilead’s JAK inhibitor filgotinib in rheumatoid arthritis, endangering 2020 approval hopes
August 20, 2020Research and Development, Sales and Marketing FDA, Gilead, filgotinib
Gilead’s JAK inhibitor filgotinib has been unexpectedly knocked back by the FDA as a therapy to treat moderately to severely …
Mylan secures first FDA approval for generic version of Biogen’s Tecfidera following patent dispute
August 20, 2020Sales and Marketing Biogen, FDA, Mylan, generic, tecfidera
The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is …
FDA delays BioMarin’s gene therapy for haemophilia A
August 20, 2020Research and Development, Sales and Marketing FDA
The FDA has delayed Roctavin, BioMarin’s gene therapy for haemophilia A, by a year to wait for more extensive results, …
Johnson & Johnson seals largest pharmaceutical merger of the year by purchasing Momenta for $6.5 billion
August 20, 2020Business Services, Sales and Marketing Johnson and Johnson, Momenta
Johnson & Johnson is set to buy the Cambridge based Momenta Pharmaceuticals for $6.5 billion, making it the largest pharmaceutical …
Former MP and Labour leadership candidate joins Bristol Myers Squibb
August 20, 2020Business Services Big Pharma, Pfizer
Owen Smith, the former Labour MP and leadership candidate, has joined Bristol Myers Squibb as its UK Government Relations Director. Smith …
MSD unveils plans for $1.3bn central London research centre
August 19, 2020Manufacturing and Production, Research and Development London, MSD, pharma
MSD has lifted the lid on plans to build a $1.3 billion research centre in central London.The London Discovery Research …
Australia signs first COVID-19 vaccine deal for 25 million doses of AstraZeneca/Oxford University candidate
August 19, 2020Research and Development AstraZeneca, Australia, COVID-19, pharma
Australia has signed its first deal to secure doses of a potential COVID-19 vaccine for its citizens, inking a partnership …
US states seek $26.4 billion from major pharmaceutical manufacturers and distributors to settle opioid litigation
August 19, 2020Research and Development opioid crisis, opioid epidemic, opioids
Multiple Attorney Generals from across the US are seeking billions of dollars in damages to settle opioid cases against major …
UK Government officially announces National Institute for Health Protection to replace Public Health England
August 19, 2020Research and Development opioid, opioid crisis, opioid epidemic
The UK Government has officially announced that Public Health England will be replaced by the National Institute for Health Protection. …
Pharmafile.com’s weekly COVID-19 news round-up
August 19, 2020Research and Development coronavirus, top 10
Potentially unsafe coronavirus treatments are in the headlines this week, as President Donald Trump reportedly wants to approve Phoenix Biotechnology’s …
Poseida suspends CAR T therapy trial in prostate cancer due to patient death
August 18, 2020Manufacturing and Production, Research and Development CAR T, CAR-T, Poseida, patient death, pharma
Poseida’s Phase 1 trial that used an investigational CAR T therapy for treating prostate cancer has been suspended due to …
Bristol Myers Squibb pays $475 million for exclusive rights to Dragonfly Therapeutics’ IL-12 immunotherapy programme
August 18, 2020Manufacturing and Production, Sales and Marketing Bristol Myers Squib, Drgonfly Therapeutics, pharma, pharma deal
Bristol Myers Squibb has scooped up the sole rights to the interleukin-12 (IL-12) immunotherapy programme of Massachusetts-based biotech Dragonfly Therapeutics, …
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