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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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Ovid’s Angelman syndrome therapy falls short at Phase 3

December 2, 2020
Research 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 …

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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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Optimise your clinical trials with Avantor Clinical Services

December 1, 2020
Business 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 …

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Cabometyx scores Japanese approval for unresectable hepatocellular carcinoma patients following systemic therapy

November 30, 2020
Sales 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 …

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Analysis confirms Moderna’s COVID-19 vaccine efficacy to be 94.1%

November 30, 2020
Research 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 …

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Dupixent becomes first systemic medicine approved in Europe for children with severe atopic dermatitis

November 30, 2020
Sales 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 …

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UK secures another two million COVID-19 vaccine doses from Moderna

November 30, 2020
Sales 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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Japan approves AstraZeneca’s Forxiga for chronic heart failure

November 30, 2020
Sales and Marketing AstraZeneca, Forxiga

Japan’s Ministry of Health, Labour and Welfare (MHLW) has announced the authorisation of AstraZeneca’s Forxiga as a treatment for chronic …

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AstraZeneca targeted by suspected North Korean hackers

November 27, 2020
Medical Communications

Hackers suspected to be operating from North Korea have tried to break into the systems of AstraZeneca, two people with …

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Japan approves Astellas and FibroGen’s Evrenzo for chronic kidney disease patients currently not receiving dialysis

November 27, 2020
Medical Communications, Sales and Marketing Astellas, Japan, fibrogen

Japan’s Ministry of Health, Labour and Welfare (MHLW) has passed approval for Astellas and FibroGen’s Evrenzo (roxadustat) in the treatment …

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New trial expected for AstraZeneca’s COVID-19 vaccine

November 27, 2020
Medical Communications

AstraZeneca is expected to launch new global trials to assess the efficacy of its COVID-19 vaccine using a lower dosage.  …

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EU fines Teva and Cephalon for keeping cheap sleep disorder medicine off the market

November 27, 2020
Medical Communications

The European Union has fined Teva and Cephalon for colluding to keep a cheap alternative sleep disorder medicine off the …

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Top Ten most popular articles on Pharmafile.com this week

November 27, 2020
Medical Communications

The top ten news stories this week once again focus on COVID-19 treatments, with the Canadian Government securing 26,000 doses …

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Y-mAbs announces FDA approval of Danyelza for the treatment of Neuroblastoma

November 26, 2020
Business Services

Y-mAbs Therapeutics has announced that the FDA has approved Danyelza in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment …

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