FDA committee votes to pull US approval for AMAG’s preterm birth drug Makena
October 31, 2019Sales and Marketing FDA, Makena, pharma
An FDA committee has passed a contentious vote recommending by a slim majority for the withdrawal of existing approval of …
The November 2019 issue of Pharmafocus is available to read for free online now!
October 30, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
The latest monthly edition of Pharmafocus, the November issue, is available to read for free online now!
FDA approves Biogen and Alkermes’ Vumerity for relapsing multiple sclerosis
October 30, 2019Research and Development, Sales and Marketing Alkermes, Biogen, FDA, Vumerity, multiple sclerosis, pharma
The FDA has given the green light to Vumerity (diroximel fumarate), a novel oral fumarate developed by Biogen and Alkermes, …
FDA slams brakes on trial for world’s most expensive drug following safety concerns in children
October 30, 2019Research and Development FDA, Novartis, Zolgensma, pharma
The FDA has temporarily shut down a clinical trial evaluating Zolgensma – the world’s most expensive drug at $3.1 million …
Expanded EU label for Benlyta now covers paediatric lupus patients
October 30, 2019Research and Development, Sales and Marketing Benlyta, Europe, GSK, Lupus, pharma
GlaxoSmithKline is celebrating the news that the European Commission has chosen to approve an expansion to the label of its …
European Commission approves Sanofi’s Dupixent in chronic rhinosinusitis with nasal polyposis
October 30, 2019Research and Development, Sales and Marketing Dupixent, EU, Sanofi, pharma
Sanofi’s Dupixent (dupilumab) has secured European approval for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), it has emerged. …
Bavencio+Inlyta combo OK’d in Europe for first-line advanced kidney cancer
October 29, 2019Manufacturing and Production, Sales and Marketing Bavencio, Cancer, Kidney cancer, Merck KGaA, Pfizer, inlyta, pharma
Merck KGaA and Pfizer’s joint drug Bavencio (avelumab) has received European approval in combination with Inlyta (axitinib) in the first-line …
GSK’s tuberculosis vaccine shows efficacy over three years in HIV negative patients
October 29, 2019Manufacturing and Production, Research and Development GSK, IAVI, Vaccine, pharma, tuberculosis
Promising results have been revealed from a GlaxoSmithKline study, conducted in partnership with non-profit scientific research organisation IAVI, investigating the …
Mylan issues recall for anxiety drug Xanax over contamination fears
October 29, 2019Manufacturing and Production Mylan, anxiety, pharma, xanax
Mylan has announced it has issued a recall of its anxiety therapy Xanax (alprazolam) over suspicions the drug could be …
AstraZeneca’s Imfinzi triple combo beats chemo in treatment-naive metastatic lung cancer
October 29, 2019Manufacturing and Production, Research and Development AstraZeneca, Cancer, Imfinzi, NSCLC, lung cancer, pharma
AstraZeneca has unveiled positive new Phase 3 data for the combination of Imfinzi (durvalumab) and anti-CTLA4 antibody tremelimumab with chemotherapy …
Deeper patient insights for stronger patient outcomes
October 28, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing eyeforpharma, pharma
Patient insights are crucial. As you already know, they are the key to the creation of successful, targeted programmes and …
Gilead’s filgotinib combos fall short in lupus and Sjögren’s syndrome
October 28, 2019Research and Development, Sales and Marketing Gilead, Lupus, filgotinib, pharma
Gilead’s impending regulatory submission of its JAK inhibitor filgotinib to the FDA for the treatment of rheumatoid arthritis has been …
UKRI and BBSRC award £170m to 3 UK universities for biotech and biology PhD studentships
October 28, 2019Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing UK, pharma, research
The Biotechnology and Biological Sciences Research Council (BBSRC) and UK Research and Innovation (UKRI) have awarded a funding injection of …
Ovarian cancer market set to smash $6.7 billion by 2025
October 28, 2019Sales and Marketing Cancer, GlobalData, ovarian cancer, pharma
New research from GlobalData has forecast that the worldwide market for ovarian cancer is set to expand at a compound …
Almost 400 Nigerian medical dispensaries shut down for sub-standard practice
October 28, 2019Manufacturing and Production, Medical Communications, Sales and Marketing Nigeria, pharma
Nigeria has seen almost 400 of its medicine dispensaries shut down over “unethical practices and lack of compliance, it has …
European approval announced for Astellas’ Xospata in FLT3+ treatment-resistant acute myeloid leukaemia
October 28, 2019Sales and Marketing Astellas, Xospata, leukaemia, pharma
Astellas has revealed that the European Commission has awarded marketing approval for Xospata (gilteritinib) as an oral, once-daily monotherapy for …
Seattle Genetics reports topline phase 3 HER2-Positive Breast Cancer Data
October 25, 2019Medical Communications
Seattle Genetics, a strong competitor in the breast cancer space, has reported topline results in its phase 3 study evaluating …
Top Ten most popular articles on Pharmafile.com this week
October 25, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
It’s another end of the week here at Pharmafile and here we run down our top 10 articles and features …
South West Biosciences to receive £18.5m boost
October 25, 2019BioSciences in the UK has received a massive boost of £18.5 million awarded from the Biotechnology and Biological Sciences Research …
Biogen plans Alzheimer’s drug approval after initial research failure
October 25, 2019Medical Communications
Biogen is planning to seek approval for its experimental drug aducanumab, that could potentially be first to treat Alzheimer’s and …
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