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rejection

Showing 9 posts of 9 posts found.

alk_logo_32_nodith

FDA knocks back Alkermes’ opioid-based depression therapy over lack of evidence

February 4, 2019
Sales 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 …

News
US regulators FDA building

FDA rejects Insys Therapeutics sublingual opioid spray

July 31, 2018
Manufacturing 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 …

News
roche__tree

NICE rejects expanded treatment indication for Roche’s Esbriet

September 19, 2016
Sales 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 …

News

Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug

June 1, 2016
Research 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Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …

News
sanofi_hq__boetie_hall

Board at Medivation unanimously reject Sanofi bid

April 29, 2016
Medical 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 …

News
teva_copy

Teva suffers EpiPen generic setback after FDA rejection

March 4, 2016
Medical 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 …

News
Kadcyla packshot

Storm brewing over Roche cancer drug price

August 8, 2014
Medical 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 …

News
Avastin image

Another NICE no for Avastin in breast cancer

August 22, 2012
Sales 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 …

News
Avastin pack shot

NICE no for Avastin in breast cancer

July 6, 2012
Sales 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 …

News

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