rejection
FDA knocks back Alkermes’ opioid-based depression therapy over lack of evidence
February 4, 2019Sales and Marketing Alkermes, FDA, major depressive disorder, pharma, rejection
Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment …
FDA rejects Insys Therapeutics sublingual opioid spray
July 31, 2018Manufacturing and Production Crisis, FDA, insys, opioid, rejection, spray
The FDA has rejected Insys Therapeutics buprenorphine sublingual spray due to concerns about the safety of the Arizona-based company’s opioid …
NICE rejects expanded treatment indication for Roche’s Esbriet
September 19, 2016Sales and Marketing Esbriet, NICE, Roche, rejection
NICE has published a final appraisal rejecting the expanded use of Roche’s Esbriet (pirfenidone) for the treatment of early idiopathic …
Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug
June 1, 2016Research and Development, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, EMA, FDA, Kyndrisa, failure, rejection
Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …
Board at Medivation unanimously reject Sanofi bid
April 29, 2016Medical Communications, Sales and Marketing Medivation, Sanofi, board, hostile, rejection, takeover
The board at Medivation has unanimously rejected the $9.8 billion takeover bid from Sanofi. They declare that Sanofi’s bid of …
Teva suffers EpiPen generic setback after FDA rejection
March 4, 2016Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection
The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after …
Storm brewing over Roche cancer drug price
August 8, 2014Medical Communications, Research and Development, Sales and Marketing Cancer, Haslam, Kadcyla, NICE, Roche, Yervoy, rejection
The Breakthrough Breast Cancer charity and England’s drug pricing watchdog NICE have both attacked Roche for not lowering the price …
Another NICE no for Avastin in breast cancer
August 22, 2012Sales and Marketing NICE, avastin, breast cancer, rejection
Roche’s Avastin has been rejected once again for use in breast cancer patients. NICE has now issued final guidance saying …
NICE no for Avastin in breast cancer
July 6, 2012Sales and Marketing NICE, Roche, avastin, breast cancer, rejection
NICE has decided once again not to recommend Roche’s Avastin on the NHS for the first line treatment of metastatic …
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FibroFind appoints Lee Borthwick as CEO
