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Donald Trump nominates Dr Stephen Hahn as next FDA Commissioner

November 4, 2019
Medical Communications, Sales and Marketing Donald Trump, FDA, Ned Sharpless, President trump, Scott Gottlieb, Trump, US

The US FDA could be set to receive its next long-term Commissioner after the White House revealed President Donald Trump’s …

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China green lights first novel Alzheimer’s therapy since 2003

November 4, 2019
Sales and Marketing Alzheimer's, China, Green Valley, Oligomannate, pharma

Shanghai Green Valley Pharmaceuticals has announced that its therapy Oligomannate (GV-971) has secured marketing approval from China’s National Medical Products Administration (NMPA) …

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Promising Phase 3 data for Sanofi’s Toujeo secures CHMP recommendation of label expansion in type 1 diabetes

November 4, 2019
Research and Development, Sales and Marketing EU, Sanofi, Type 1 diabetes, diabetes, pharma, toujeo

Sanofi took the opportunity at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts to …

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Top Ten most popular articles on Pharmafile.com this week

November 1, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharma, top ten

Happy Friday!

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Current drugs are “poisoning” elderly patients due to insufficient trial data, House of Lords committee hears

November 1, 2019
Medical Communications, Research and Development elderly patients, pharma, trial diversity

Elderly patients are being put at risk by prescriptions for drugs which have not been properly tested in their age …

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England’s antibiotic use is down, but antibiotic-resistant infections still spreading, report warns

November 1, 2019
Medical Communications, Research and Development Antibiotics, England, Review on antimicrobial resistance

A new report has revealed that GPs in England are writing fewer prescriptions for antibiotics, but this has done little …

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Amgen drops $2.7bn to acquire stake in Chinese biotech in bid to expand in the region

November 1, 2019
Medical Communications, Research and Development, Sales and Marketing Amgen, BeiGene, Cancer, China, deal, oncology, pharma

Amgen has signed an agreement with Chinese biotech BeiGene to acquire a 20.5% stake in the latter, in a bid …

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Despite some advantages, Novartis’ Cosentyx fails to outclass Humira in active psoriatic arthritis

November 1, 2019
Medical Communications, Research and Development Cosentyx, Humira, Novartis, active psoriatic arthritis, pharma

Novartis has announced new data drawn from a trial pitting Cosentyx (secukinumab) in head-to-head competition with AbbVie’s Humira (adalimumab) – …

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Transactions in the pharma sector: Through the EU merger review looking-glass

October 31, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing mergers, mergers and acquisitions, pharma

With mergers and acquisitions back in full swing after a period of drought, Alec Burnside (Partner) and Delphine Strohl (Associate) …

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AbbVie’s Rinvoq impresses at Phase 3 in active psoriatic arthritis sub-population

October 31, 2019
Research and Development AbbVie, Rinvoq, pharma

AbbVie has unveiled new Phase 3 data on two doses of its JAK inhibitor Rinvoq (upadacitinib), showing that the therapy …

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Catalyst’s lead candidate Firdapse falls short in Congenital Myasthenic Syndromes

October 31, 2019
Research and Development Catalyst Pharmaceuticals, FDA, firdapse, pharma, trial failure

Catalyst Pharmaceuticals has made it known that its lead product Firdapse (Amifampridine Phosphate) fell short of its primary endpoint in …

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Morphosys, Novartis and Galaagos shut down development of atopic dermatitis candidate

October 31, 2019
Research and Development Galapagos, Novartis, atopic dermatitis, morphosys, pharma

The trio of Galapagos, MorphoSys and Novartis Pharma has revealed that all further development of its MOR106 drug candidate for …

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Genmab’s Executive VP and CFO to retire in 2020

October 31, 2019
Research and Development Genmab, appointment, pharma

David Eatwell, Executive Vice President and Chief Financial Officer at Genmab, has announced his intention to step down from the …

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FDA committee votes to pull US approval for AMAG’s preterm birth drug Makena

October 31, 2019
Sales 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 …

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The November 2019 issue of Pharmafocus is available to read for free online now!

October 30, 2019
Business 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!

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FDA approves Biogen and Alkermes’ Vumerity for relapsing multiple sclerosis

October 30, 2019
Research 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, …

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FDA slams brakes on trial for world’s most expensive drug following safety concerns in children

October 30, 2019
Research 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 …

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Expanded EU label for Benlyta now covers paediatric lupus patients

October 30, 2019
Research 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 …

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European Commission approves Sanofi’s Dupixent in chronic rhinosinusitis with nasal polyposis

October 30, 2019
Research 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. …

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Bavencio+Inlyta combo OK’d in Europe for first-line advanced kidney cancer

October 29, 2019
Manufacturing 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 …

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