European approval for AstraZeneca’s Trixeo Aerospace in moderate to severe COPD
December 14, 2020Sales and Marketing AstraZeneca, COPD, EMA, Europe, Trixeo Aerosphere
The European Medicines Agency (EMA) has announced the approval of AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) in the European Union …
Novartis and Incyte’s ruxolitinib fails to show benefit in COVID-19 at Phase 3
December 14, 2020Research and Development, Sales and Marketing COVID-19, Incyte, Novartis
Novartis has unveiled that its JAK 1/2 tyrosine kinase inhibitor ruxolitinib fell short of its main efficacy goal in the …
Top Ten most popular articles on Pharmafile.com this week
December 11, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, COVID-19, Pfizer, Vaccine, pharma, top 10
With just around three weeks until the end of a long year, rapidly emerging news around the leading COVID-19 vaccine …
Janssen’s esketamine nasal spray secures CHMP recommendation in Europe for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
December 11, 2020Medical Communications EMA, Europe, Spravato, depression
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has moved to recommend Janssen’s …
Sanofi/GSK COVID-19 vaccine development delayed after failing to induce strong response in over-50s
December 11, 2020Medical Communications, Research and Development COVID-19, GSK, Sanofi, Vaccine
Sanofi and GlaxoSmithKline have taken the decision to delay the development programme for their adjuvanted recombinant protein-based COVID-19 vaccine after …
FDA advisory panel recommends US approval of Pfizer/BioNTech’s COVID-19 vaccine
December 11, 2020Medical Communications, Sales and Marketing COVID-19, FDA, Vaccine
An advisory panel on behalf of the FDA has strongly recommended that Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 be approved …
NICE backs Novartis’ Aimovig for prevention of episodic and chronic migraine
December 11, 2020Medical Communications, Sales and Marketing Aimovig, NICE, Novartis, migraine
NICE has announced its decision to recommended Novartis’ Aimovig (erenumab) for the prevention of migraine, including both episodic and chronic …
Hackers breach EMA server to steal data on Pfizer/BioNTech’s COVID-19 vaccine
December 10, 2020Research and Development COVID-19, EMA, Vaccine
Pfizer and BioNTech’s jointly-developed COVID-19 vaccine, which this week began to rolled out to elderly patients in the UK after …
NICE authorises Takeda’s Alunbrig for ALK-positive advanced non-small cell lung cancer
December 10, 2020Sales and Marketing ALK-positive advanced non-small cell lung cancer, Alunbrig, NICE, Takeda
NICE has published its final appraisal of Takeda’s Alunbrig (brigatinib), recommending the therapy for the treatment of ALK-positive advanced non-small …
UAE reveals 86% effiacy for Sinopharm’s COVID-19 vaccine
December 10, 2020Research and Development COVID-19, Sinopharm, UAE, Vaccine
The Health Ministry of the United Arab Emirates has unveiled the first known efficacy data for the COVID-19 vaccine candidate …
Lilly’s tirzepatide generates significant reductions in weight and blood sugar in type 2 diabetes patients
December 10, 2020Research and Development Eli Lilly, diabetes, tirzepatide
Eli Lilly has announced new data for its glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, showing …
AbbVie unveils new Phase 3 upadacitinib data in moderate to severe ulcerative colitis
December 10, 2020Research and Development AbbVie, upadacitinib
AbbVie has announced data from the first of two Phase 3 studies investigating the efficacy of upadacitinib in treating moderate …
Pharmafile.com’s weekly COVID-19 news round-up
December 9, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Top 5, pharma
COVID-19 vaccine news continues to roll in and continues to be positive, with AstraZeneca now releasing Phase 3 data that …
Novartis’ Kisqali delays need for chemo by over 4 years in post-menopausal HR+HER2- metastatic breast cancer
December 9, 2020Research and Development Kisqali, Novartis, breast cancer
Novartis has lifted the curtain on updated Phase 3 data for Kisqali (ribociclib) in the treatment of hormone receptor positive, …
MHRA warns patients with history of significant allergic reactions not to receive Pfizer/BioNTech COVID-19 vaccine
December 9, 2020Research and Development COVID-19, MHRA, UK, Vaccine
While the rolling out of Pfizer and BioNTech’s COVID-19 in the UK this week marked a historic moment in a …
AstraZeneca and Oxford Uni vaccine is safe and effective in preventing COVID-19 infection, Phase 3 data show
December 9, 2020Research and Development AstraZeneca, COVID-19, Vaccine
The latest efficacy data on the COVID-19 vaccine developed by AstraZeneca in partnership with the University of Oxford have been …
Amryt’s Lojuxta approved in Brazil to reduce cholesterol in homozygous familial hypercholesterolaemia patients
December 9, 2020Research and Development, Sales and Marketing Amryt, Brazil, rare disease
Brazil’s National Health Surveillance Agency (ANVISA) has moved to authorise Amryt’s Lojuxta (lomitapide) in the country as a treatment for …
UK launches COVID-19 vaccination drive with first dosings of Pfizer/BioNTech’s candidate
December 8, 2020Manufacturing and Production, Sales and Marketing COVID-19, UK, Vaccine
The first doses of Pfizer and BioNTech’s approved COVID-19 vaccine have been administered in the UK in a historic occasion …
NICE recommendation for AstraZeneca’s Calquence in chronic lymphocytic leukaemia populations
December 8, 2020Manufacturing and Production, Sales and Marketing AstraZeneca, NHS, NICE, UK, leukaemia
The National Institute for Health and Care Excellence (NICE) has recommended that AstraZeneca’s Calquence (acalabrutinib) be used on the NHS in …
US pharma lobby launches legal action against the Trump administration over drug pricing proposals
December 8, 2020Manufacturing and Production, Sales and Marketing Drug pricing, PhRMA, Trump, US
US industry organisations including the Pharmaceutical Research and Manufacturers of America (PhRMA) have launched legal action against the Trump administration …
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