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FDA approves Novo Nordisk’s Saxenda for adolescent obesity

December 7, 2020 Sales and Marketing FDA, Novo Nordisk, saxenda

The FDA has awarded US approval to Novo Nordisk’s Saxenda (liraglutide) 3mg injection to treat obesity in patients between the …
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Top Ten most popular articles on Pharmafile.com this week

December 4, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Dupixent, EMA, UK, Vaccine, top ten

As the year winds to a close, excitement is rising around the efficacy and availability of COVID-19 vaccines around the …
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FDA approves BioCryst’s Orladeyo for reducing hereditary angioedema attacks

December 4, 2020 Medical Communications, Sales and Marketing BioCryst, FDA, Orladeyo

BioCryst has scored FDA for its therapy Orladeyo (berotralstat) for reducing or preventing hereditary angioedema (HAE) attacks in patients over …
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MSD cashes in on Moderna investment as FDA mulls COVID-19 vaccine approval

December 4, 2020 Medical 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 …
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Neurogene secures EMA orphan designation for gene therapy in rare, inherited aspartylglucosaminuria

December 3, 2020 Sales 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 …
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Janssen scoops up rights to Hemera’s gene therapy for retinal geographic atrophy

December 3, 2020 Sales 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 …
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Roche secures emergency FDA approval for COVID-19 antibody test

December 3, 2020 Sales 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 …
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Pharmafile.com’s weekly COVID-19 news round-up

December 2, 2020 Business 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
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FDA greenlights Gavreto for advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer in over-12s

December 2, 2020 Research 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 …
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European approval for Janssen’s Tremfya in active psoriatic arthritis, either alone or in combo

December 2, 2020 Research 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 …
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UK becomes first nation to approve Pfizer and BioNTech’s COVID-19 vaccine

December 2, 2020 Research 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 …
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The Autumn 2020 edition of Pharmafile is available to read for free online now!

December 1, 2020 Business 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 …
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Eisai and Wren Therapeutics join forces to tackle neurodegenerative synucleinopathies

December 1, 2020 Manufacturing 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 …
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EMA receives Pfizer and BioNTech’s filing for conditional approval of COVID-19 vaccine in Europe

December 1, 2020 Manufacturing 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 …
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Grünenthal buys European rights to AstraZeneca’s Crestor for a potential $350m

December 1, 2020 Manufacturing 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 …
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