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Man in Hong Kong reinfected with COVID-19 four months after initially contracting the virus

August 25, 2020
Manufacturing and Production COVID-19, coronavirus, infection

A man in Hong Kong has been reinfected with the coronavirus, stoking fears that immunity to the virus may be …

News
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US approves new generic to treat people suffering from respiratory conditions

August 25, 2020
Manufacturing and Production asthma, inhaler

The FDA has granted Lupin Ltd approval for their generic version of ProAir, which is used to prevent asthma symptoms …

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AstraZeneca begins antibody COVID-19 treatment trial in the UK

August 25, 2020
Manufacturing and Production Vaccine, coronavirus

AstraZeneca has started a clinical trial of its antibody treatment designed to prevent and also treat symptoms of coronavirus. The …

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AstraZeneca reaches deal with RenalytixAI to develop medicine strategies for a variety of diseases

August 24, 2020
Sales and Marketing AI, chronic disease

AstraZeneca and RenalytixAI have agreed a deal to develop joint precision medicine strategies for cardiovascular, renal and metabolic diseases. The …

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China’s ‘insect’ vaccine for COVID-19 approved for human testing

August 24, 2020
Sales and Marketing COVID, Vaccine, coronavirus

China is set to move ahead with human testing of a potential coronavirus vaccine that has been created using insect …

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Gilead says FDA could expand eligibility of coronavirus patients for remdesivir

August 24, 2020
Sales and Marketing FDA, Gilead

The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead.

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FDA approves Phase 1 trial for HIV gene therapy

August 24, 2020
Sales 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. …

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FDA grants emergency authorisation for coronavirus plasma treatment

August 24, 2020
Sales 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 …

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Janssen granted US approval for multiple myeloma drug combination

August 21, 2020
Medical Communications

The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined …

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FDA approves Novartis’ MS drug Kesimpta for treating relapsed forms of the disease

August 21, 2020
Medical Communications

The FDA has authorised Novartis’ Kesimpta (ofatumumab) for treating patients with relapsing forms of multiple sclerosis (MS), it has been …

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NICE recommends combination treatment from Roche for certain lymphoma patients

August 21, 2020
Medical 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 …

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AstraZeneca scores Japanese approval for Imfinzi combo in extensive-stage small cell lung cancer

August 21, 2020
Medical 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 …

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Top Ten most popular articles on Pharmafile.com this week

August 21, 2020
Medical Communications COVID-19, coronavirus

The top 10 news stories this week again focus on coronavirus vaccines and treatments, as professor Alexander Chuchalin has quit …

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FDA turns down Gilead’s JAK inhibitor filgotinib in rheumatoid arthritis, endangering 2020 approval hopes

August 20, 2020
Research 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 …

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Mylan secures first FDA approval for generic version of Biogen’s Tecfidera following patent dispute

August 20, 2020
Sales 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 …

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FDA delays BioMarin’s gene therapy for haemophilia A

August 20, 2020
Research 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, …

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Johnson & Johnson seals largest pharmaceutical merger of the year by purchasing Momenta for $6.5 billion

August 20, 2020
Business 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 …

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Former MP and Labour leadership candidate joins Bristol Myers Squibb

August 20, 2020
Business 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 …

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MSD unveils plans for $1.3bn central London research centre

August 19, 2020
Manufacturing 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 …

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Australia signs first COVID-19 vaccine deal for 25 million doses of AstraZeneca/Oxford University candidate

August 19, 2020
Research 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 …

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