MHRA bans sodium valproate in the UK following birth defect controversy

April 24, 2018
Manufacturing and Production, Research and Development, Sales and Marketing MHRA, Sanofi, Sodium valproate, bipolar, epilepsy, pharma

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that sodium valproate, a drug used in the treatment …

Lilly’s arthritis drug hits trouble at FDA committee

April 24, 2018
Manufacturing and Production, Sales and Marketing Eli Lilly, Incyte, biotech, drugs, pharma, pharmaceutical, rheumatoid arthritis

FDA’s advisory committee were openly conflicted about deciding on the safety of Eli Lilly and Incyte’s drug, baricitinib, for the …

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AZ’s combo woes continue, with failure in lung cancer

April 24, 2018
Manufacturing and Production, Research and Development AstraZeneca, Imfinzi, biotech, drugs, pharma, pharmaceutical

AstraZeneca has been hit by a fresh blow in its search for an immunotherapy combination treatment that could differentiate it …

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Prothena collapses on double trial failure

April 23, 2018
Manufacturing and Production, Research and Development Prothena Therapeutics, biotech, drugs, pharma, pharmaceutical

Shares in Prothena have dropped by close to 70% on the news that two of its trials into its lead …

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Living with atrial fibrillation

April 23, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing KardiaMobile, Tony Green, atrial fibrillation, patient experience

Tony Green discusses the difficulty in pinning down his diagnosis of the irregular heart rhythm condition, until his use of …

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Novartis expands Pear partnership to tackle opioid and substance use disorder

April 23, 2018
Research and Development, Sales and Marketing Novartis, Pear Therapeutics, Sandoz, opioids, pharma, substance use disorder

Novartis has announced that it will expand its current partnership with Pear Therapeutics, signed in March, as it reveals that …

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Biogen boosts pipeline with $1bn Ionis deal

April 23, 2018
Sales and Marketing Biogen, Ionis, Spinraza, biotech, drugs, pharma, pharmaceutical

Somewhat unusually for an early drug development deal, Biogen has put down a serious amount of cash up-front in its …

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CHMP rejects AB Science’s ALS therapy in Europe

April 23, 2018
Sales and Marketing AB Sciences, EMA, European Medicines Agency, ab science, als, masitinib, pharma

AB Science has revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

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Fresenius attempts to back out of $4.75bn deal for Akorn

April 23, 2018
Sales and Marketing

Fresenius has announced its intention to terminate the merger agreement with Akorn, over the $4.75 billion deal that the two …

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UK Ministers call on Vertex to speed up price negotiations

April 23, 2018
Sales and Marketing NHS, NICE, Orkambi, UK government, Vertex, biotech, drugs, pharma, pharmaceutical

After a parliamentary debate in the House of Commons regarding making Orkambi available to patients with cystic fibrosis (CF), MPs …

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Top Ten most popular articles on Pharmafile.com this week

April 20, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Amgen, EMA, GW Pharma, J&J, JJ, MHRA, Mylan, Novartis, Sanofi, Shire, Takeda, biotech, drugs, epipen, keytruda, pharma, pharmaceutical

It’s the end of another week and there’s really been one story that has dominated the headlines – Takeda’s potential …

Lilly and Incyte’s resubmission of arthritis drug data fails to assuage FDA concerns

April 20, 2018
Medical Communications, Sales and Marketing Eli Lilly, FDA, Incyte, baricitinib, pharma, rheumatoid arthritis

Eli Lilly and Incyte are facing more complications in the US approval of their experimental rheumatoid arthritis (RA) drug baricitinib …

Prototype skin implant signals cancer by forming a visible mole

April 20, 2018
Medical Communications Cancer, device, implant, medtech, pharma

Researchers working with Professor Martin Fussenegger at the Department of Biosystems Science and Engineering at ETH Zurich in Basel have …

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FDA advisory committee sets GW Pharma up for approval

April 20, 2018
Medical Communications, Sales and Marketing Epidiolex, GW Pharma, biotech, drugs, pharma, pharmaceutical

After the FDA advisory committee unanimously recommended GW Pharma’s Epidiolex for approval, the chances of it not receiving the nod …

Allergan out but Takeda sticks to guns on Shire

April 20, 2018
Medical Communications, Sales and Marketing Allergan, Shire, Takeda, biotech, drugs, pharma, pharmaceutical

Allergan performed an odd about-turn after initially declaring its interest in pursuing a deal for Shire, before reneging on that …

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The UK’s Royalties withholding tax consultation: Pushing extraterritorial boundaries

April 19, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Norton Rose Fulbright, feature, pharma, tax consultation

Norton Rose Fulbright’s Dominic Stuttaford, James Baillieu and Susie Brain discuss the implications regarding the recent reforms to cross-border royalties.The …

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AZ’s Tagrisso gets FDA nod in first-line EGFR-mutated lung cancer

April 19, 2018
Sales and Marketing AstraZeneca, Cancer, EGFR-TKIs, NSCLC, Tagrisso, lung cancer, pharma

AstraZeneca has announced that its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) has received approval from …

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BenevolentAI financing round takes valuation to $2bn+

April 19, 2018
Medical Communications BenevolentAI, biotech, drugs, pharma, pharmaceutical

BenevolentAI, a London based drug discovery biotech, has revealed that a $115 million financing round now sees the company valued …

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Novartis snatches Amgen and BMS veteran for CMO and Drug Development Head

April 19, 2018
Medical Communications Amgen, BMS, Bristol-Myers Squibb, Novartis, appointment, pharma

Dr John Tsai has been welcomed to the fold as Novartis’ new Head of Global Development and Chief Medical Officer, …

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