FDA
Companies face mixed fortunes in ultra-orphan approvals
November 26, 2015Medical Communications, Research and Development BioMarin, Duchenne Muscular Dystrophy, FDA, Genzyme, NICE, ultra-orphan drugs
UK regulator NICE has recommended Vimizin, a drug for a very rare genetic disorder, after the manufacturer and NHS England …
FDA approves Beximco to manufacture Carvedilol for US
November 24, 2015Manufacturing and Production Bangladesh, Beximco, Carvediol, FDA, exports, generics
Beximco Pharmaceuticals has become the first Bangladeshi pharma company to receive approval for a prescription drug to be manufactured in …
Obama FDA commissioner nominee Califf defends big pharma ties
November 18, 2015Sales and Marketing Bernie Sanders, FDA, FDA commissioner, Robert Califf
President Obama’s nominee to head the FDA was forced to defend his history of ties to the pharma industry as …
FDA approves Roche skin cancer combination
November 11, 2015Research and Development, Sales and Marketing Cotellic, FDA, Genentech, Roche, Zelboraf, cobimetinib, melanoma, skin cancer, vemurafenib
The FDA has approved the skin cancer drug Cotellic for certain forms of melanoma in combination with another Roche cancer …
FDA warnings create woe for Indian drugmakers
November 10, 2015Manufacturing and Production CGMP, Dr Reddy's, Dr. Reddy's, FDA, India, Sun Pharma, manufacturing, production
Recent enforcement action has taken its toll on the fortunes of several Indian pharmaceutical manufacturers, with Sun Pharmaceuticals and Dr. …
FDA alleges records cover-up at Chinese Pfizer plant
November 3, 2015Manufacturing and Production FDA, Pfizer, compliance, inspection, manufacturing, production, regulations
The FDA has discovered violations at a Pfizer plant in China, including the use of out-of-date materials and record- keeping …
FDA approves new therapy for pancreatic cancer
October 30, 2015Medical Communications, Sales and Marketing FDA, Pancreatic cancer
The FDA has approved drug a pancreatic cancer drug, Onivyde, which has produced significant overall survival rates in an international …
Shire’s dry eye treatment gets a no – for now
October 19, 2015Sales and Marketing Complete Response Letter, FDA, Flemming Ornskov, Shire, dry eye disease, lifitegrast
Shire has seen an application for its dry eye treatment lifitegrast rejected by the US regulator. The FDA says it …
FDA approves Boehringer’s Pradaxa reversal agent
October 19, 2015Sales and Marketing Boehringer Ingelheim, FDA, Pradaxa, Praxbind, anticoagulant, idarucizumab
The FDA has approved Boehringer Ingelheim’s Praxbind, a reversal agent for its anticoagulant Pradaxa. The US regulator approved Praxbind (idarucizumab) …
FDA rejects AstraZeneca diabetes combination
October 16, 2015Research and Development, Sales and Marketing AstraZeneca, FDA, NDA, dapagliflozin, saxagliptin
The FDA has declined to approve AstraZeneca’s New Drug Application (NDA) for the investigational fixed-dose combination of Onglyza and and …
Pfizer’s Xeljanz denied plaque psoriasis indication by FDA
October 16, 2015Research and Development, Sales and Marketing FDA, Pfizer, Xeljanj, tofacitinib
The FDA has rejected the indication expansion of Pfizer’s Xeljanz (tofacitinib) for treatment of moderate to severe cases of plaque psoriasis. …
Shire’s Cinryze gets FDA fast track designation
October 13, 2015Research and Development AMR, FDA, Shire
Shire has announced that the United States Food and Drug Administration (FDA) has granted fast track designation for the investigation …
Obama’s FDA nominee criticised for big pharma ties
October 12, 2015Sales and Marketing Bernie Sanders, Dr Robert Califf, FDA
Democratic presidential nomination candidate Senator Bernie Sanders has criticised President Obama’s choice for the next FDA commissioner, as a result …
Akebia passes vadadustat for anaemia phase III study with FDA & EMA
October 7, 2015Research and Development Akabia, FDA, anaemia
Akebia Therapeutics has announced the successful completion of the End-of-Phase II Meeting process with the FDA and the Scientific Advice …
FDA approves Alkermes schizophrenia treatment
October 6, 2015Research and Development Alkermes, Aristada, FDA, schizophrenia
The US Food and Drug Administration (FDA) has approved Alkermes’s Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada …
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