Research and Development

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Bioproject’s narcolepsy treatment recommended for European approval

November 20, 2015 Research and Development, Sales and Marketing

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Bioproject’s Wakix (pitolisant) for the treatment of narcolepsy …
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Biogen’s Enbrel biosimilar gets positive CHMP opinion

November 20, 2015 Research and Development, Sales and Marketing

The Committee for Medicinal Products for Human Use (CHMP) today gave a positive opinion to Benepali- the first biosimilar version …
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Turing boss Shkreli joins KaloBios as CEO; takes 70% of shares

November 20, 2015 Medical Communications, Research and Development

KaloBios Pharmaceuticals has announced the appointment of Turing CEO Martin Shkreli as its own new CEO and his election as …
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Alan Dunton appointed senior vice president at Purdue Pharma

November 20, 2015 Manufacturing and Production, Medical Communications, Research and Development

Purdue Pharma LP has announced the appointment of Alan Dunton, MD, to the role of senior vice president of Research …
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Lilly and Merck extend immuno-oncology collaboration

November 20, 2015 Medical Communications, Research and Development Eli Lilly, Merck

Eli Lilly and Merck have announced the extension of their existing collaboration to evaluate the safety and efficacy of the …
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Bayer awaits FDA decision on new contraceptive

November 20, 2015 Medical Communications, Research and Development

Bayer has submitted a new drug application (NDA) to the FDA, seeking approval for LCS-16, an investigational hormonal intrauterine device …
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NHS England and NICE announce plans for new Cancer Drugs Fund

November 19, 2015 Medical Communications, Research and Development Cancer Drugs Fund, NHS England, NICE

A 12-week consultation on draft proposals for a revamped Cancer Drugs Fund (CDF) has been launched by NHS England and NICE, …
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NICE decision restricts Bayer’s Xofigo to select prostate cancer patients

November 19, 2015 Research and Development, Sales and Marketing Bayer, NICE, prostate cancer

NICE has issued its Final Appraisal Determination (FAD) recommending Bayer’s Xofigo (radium-223 dichloride) for use on the NHS in England …
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Merck criticises NICE ‘no’ to personalised bowel cancer drugs

November 19, 2015 Research and Development

NICE has issued preliminary not recommending two specific personalised treatments used in combination with chemotherapy for previously untreated metastatic colorectal …

NICE rejects Amgen’s Repatha in draft guidance

November 18, 2015 Research and Development, Sales and Marketing Amgen, NICE, Repatha, evolocumab, high cholesterol

NICE has published draft guidance rejecting Amgen’s Repatha as a treatment for people with high cholesterol.   
Takeda oncology

Challenges in oncology R&D

November 18, 2015 Manufacturing and Production, Research and Development Dixie-Lee Esseltine, Takeda, Takeda oncology, Velcade, multiple myeloma, oncology

Pharmafile put questions on the challenges pharma companies face when working in oncology R&D to Dixie-Lee Esseltine, vice president of …
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FDA accepts regulatory submission for Novartis biosimilar

November 18, 2015 Research and Development, Sales and Marketing Neulasta, Novartis, Sandoz, biosimilar, pegfilgrastim

Novartis’ generics unit Sandoz has announced it has had its Biologics License Application (BLA) for a proposed biosimilar to Amgen’s …
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Global drug spending will rise 30% by 2020, to $1.4 trillion

November 18, 2015 Research and Development IMS Health, OTC, drug spending, emerging markets, generics, prescribing

Global spending on drugs will increase 30% to $1.4 trillion by 2020, as more patients get access to treatments and …
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Scientists make possible pancreatic cancer discovery

November 18, 2015 Research and Development Pancreatic cancer

Cancer researchers say they have discovered a potential new method of treatment for pancreatic cancer that could improve survival rates.  …
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UCB appoints Steve Turley as MD for Britain and Ireland

November 18, 2015 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing UCB

Steve Turley has joined UCB as the company’s managing director for the British and Irish isles, moving from Lundbeck. He …
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