FDA
Pfizer to acquire Anacor in $5.2 billion deal
May 16, 2016Manufacturing and Production, Sales and Marketing 5.2 billion, FDA, Pfizer, acquisition, anacor, crisaborole, merger
Pfizer (NYSE: PFE) has acquired Anacor Pharmaceuticals (NASDAQ: ANAC) in a deal worth around $5.2 billion, or $99.25 per share. …
FDA issues warning about rare, but serious, side effect in Lilly antipsychotic drug
May 12, 2016Medical Communications, Sales and Marketing Eli Lilly, FDA, anti-psychotic, boxed warning, lilly, olanzapine, skin condition
The US Food and Drug Administration (FDA) has issued a new warning to all drug labels for Eli Lilly’s antipsychotic …
FDA expands Imbruvica label with new survival data
May 11, 2016Research and Development, Sales and Marketing AbbVie, FDA, Janssen, data, efficacy, expanded, imbruvica, label, late stage, phase III
The US Food and Drug Administration (FDA) has expanded the label of Imbruvica (ibrutinib) to include the data from recent …
Clovis cuts staff by 35% after FDA knock back on lung cancer drug
May 6, 2016Manufacturing 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 …
FDA grants priority review for Amgen leukaemia drug
May 4, 2016Research 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 …
Allergan launches Crestor generic in the US
May 3, 2016Manufacturing 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 …
FDA, WHO criticise integrity of data at contract research firm Semler
April 25, 2016Research 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 …
Novartis muscular drug fails in Phase III trials
April 22, 2016Medical 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 …
Shares plunge at Sarepta after negative FDA review on muscle disorder drug
April 21, 2016Research 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 …
MSD receives fourth Breakthrough Therapy Designation for Keytruda
April 19, 2016Manufacturing 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) …
Sun Pharma receives FDA approval for ocular pain treatment
April 11, 2016Research 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 …
FTC launches tool to help mobile health app developers determine applicable regulations
April 8, 2016Medical 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 …
FDA releases biosimilars labelling guidance
April 1, 2016Manufacturing 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 …
Jazz Pharmaceuticals receives FDA approval for rare veno-occlusive disease treatment
March 31, 2016Research 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 …
FDA says positives outweigh risks on Acadia’s Parkinson’s psychosis drug
March 30, 2016Research 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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Five Facts about cardiovascular disease
