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Showing 15 posts of 1442 posts found.

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Clovis cuts staff by 35% after FDA knock back on lung cancer drug

May 6, 2016
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Q1 results, clovis, failure, job cuts, job losses, rociletinib, workforce

Clovis Oncology (NASDAQ: CLVS) is set to cut up to 35% of its workforce following the US Food and Drug …

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FDA grants priority review for Amgen leukaemia drug

May 4, 2016
Research and Development, Sales and Marketing Amgen, FDA, blincyto, leukaemia, lymphoblastic leukaemia, paediatric

Amgen has announced that the US Food and Drug Administration (FDA) has granted priority review status for the supplemental Biologics …

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Allergan launches Crestor generic in the US

May 3, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Allergan, AstraZeneca, Crestor, FDA, FDA Approval, cholesterol, generic, patent, patent expiry, sales

Allergan has received FDA approval on the generic version of AstraZeneca’s high cholesterol drug, Crestor (rosuvastatin), and has become the …

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FDA, WHO criticise integrity of data at contract research firm Semler

April 25, 2016
Research and Development, Sales and Marketing FDA, India, WHO, World Health Organisation, semler, semler research

The US Food and Drug Administration and the World Health Organisation have raised serious concerns related to violations of good …

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Novartis muscular drug fails in Phase III trials

April 22, 2016
Medical Communications, Research and Development FDA, Novartis, bimagrumab, breakthrough, morphosys, muscular, phase III

A muscular drug developed by Novartis (NYSE: NVS), in partnership with MorphoSys (ETR: MOR), failed to meet its primary endpoint …

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Shares plunge at Sarepta after negative FDA review on muscle disorder drug

April 21, 2016
Research and Development, Sales and Marketing FDA, Sarepta Therapeutics, Shares, dive, fall, negative, plunge, sarepta

Sarepta Therapeutics (NASDAQ: SPRT) is counting the cost as shares plunge following a negative review given by staff at the …

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MSD receives fourth Breakthrough Therapy Designation for Keytruda

April 19, 2016
Manufacturing and Production, Research and Development Breakthrough Therapy Designation, FDA, Hodgkin lymphoma, MSD, Merck, breakthrough designation, breakthrough therapy, keytruda

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) …

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Sun Pharma receives FDA approval for ocular pain treatment

April 11, 2016
Research and Development, Sales and Marketing FDA, Sun Pharma, bromsite, ocular treatment

Sun Pharma (BSE: 524715) has announced that their ocular pain prevention treatment, BromSite (bromfenac ophthalmic solution), has been approved by …

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FTC launches tool to help mobile health app developers determine applicable regulations

April 8, 2016
Medical Communications, Sales and Marketing FDA, FTC, apps, health, health apps, regulation

The US Federal Trade Commission has created a new web-based tool for developers of health-related mobile apps to help them …

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FDA releases biosimilars labelling guidance

April 1, 2016
Manufacturing and Production, Medical Communications, Research and Development FDA, biosimilars

The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs. The guidance states …

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Jazz Pharmaceuticals receives FDA approval for rare veno-occlusive disease treatment

March 31, 2016
Research and Development, Sales and Marketing FDA, jazz pharmaceuticals

Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Defitelio …

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acadia

FDA says positives outweigh risks on Acadia’s Parkinson’s psychosis drug

March 30, 2016
Research and Development, Sales and Marketing FDA, Parkinson's, Parkinsons, acadia, nuplazid, pimavanserin, psychosis

Acadia Pharmaceuticals (NASDAQ: ACAD) has announced a positive result from the US Food and Drug Administration (FDA) concerning Nuplazid (pimavanserin) …

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Mylan launches generic of Valeant’s Ultram in the US

March 29, 2016
Manufacturing and Production, Sales and Marketing FDA, Mylan, Valeant, abbreviate new drug application, generic, pain, tramadol, ultram

Mylan (NASDAQ, TASE: MYL) has announced the launch of its generic version of Valeant’s Ultram tablets in the US. The …

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Teva announces FDA approval for asthma injection, Cinqair

March 24, 2016
Research and Development, Sales and Marketing FDA, Teva, approval, asthma, cinqair

The US Food and Drug Administration has approved Cinqair (reslizumab), an injection for patients with severe asthma developed by Teva …

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FDA announces strongest warnings for opioid pain medications

March 23, 2016
Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings

The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …

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