FDA
Amgen submits next gen cholesterol drug
August 29, 2014Sales and Marketing Amgen, FDA, PCSK9, Regeneron, Sanofi, statins
Amgen has put itself in pole position in the race to market the next generation of injectable statins known as …
FDA approves Biogen’s long-acting MS drug
August 18, 2014Sales and Marketing Avonex, Biogen, FDA, MS, Rebif, plegridy, tecfidera
Biogen Idec has racked up another approval over the weekend after its latest multiple sclerosis treatment Plegridy gained FDA backing. …
InterMune stock jumps on suitor claims
August 14, 2014Sales and Marketing Boehringer, Esbriet, FDA, GSK, IPF, InterMune
Riding high of the success of its new lung drug Esbriet, InterMune has become the focus of some serious takeover …
FDA approves Gilead’s blood cancer drug
July 24, 2014Research and Development, Sales and Marketing Cancer, FDA, Gilead, blood, follicular lymphoma and small lymphocytic lymphoma, lymphocytic leukaemia, sovaldi, zydelig
The Food and Drug Administration has approved Gilead Sciences new treatment Zydelig (idelalisib) to treat three types of blood cancer. …
Sun Pharma recalls 40,000 bottles
July 14, 2014Manufacturing and Production Caraco Pharmaceutical Laboratories, FDA, Pfizer/Wyeth’s Effexor XR, Sun Pharma, antidepressant, recall
India-based manufacturer Sun Pharmaceutical Industries is recalling more than 40,000 bottles of its antidepressant venlafaxine hydrochloride, the US regulator has …
BMS to make Opdivo submission
July 11, 2014Sales and Marketing BMS, Cancer, EMA, FDA, ono, opdivo, pd-1
Bristol-Myers Squibb is to submit cancer treatment Opdivo to the US authorities after the drug received its first approval in …
GSK manufacturing woes continue
July 8, 2014Manufacturing and Production Canada, FDA, GSK, Paxil, Vaccine, manufacturing
Health Canada has told GlaxoSmithKline that it wants to see the firm fix major problems at the country’s only flu …
Spectrum wins FDA approval for rare cancer drug
July 4, 2014Research and Development, Sales and Marketing Beleodaq, Cancer, FDA, Spectrum, non-Hodgkin lymphoma
In an expedited review the FDA has approved a new cancer drug from Spectrum Pharmaceuticals to treat a rare cancer …
FDA clears St. Jude Medical
July 4, 2014Manufacturing and Production, Sales and Marketing CardioMEMS, FDA, california, st jude medical
US medical device manufacturer St. Jude Medical has been given a clean bill of health by the Food and Drug …
FDA breakthrough for Amgen
July 2, 2014Research and Development, Sales and Marketing Amgen, BiTE antibody blinatumomab, FDA, all, leukaemia
Amgen has taken a major step down the road to getting its investigational cancer drug blinatumomab onto the market after …
FDA ‘yes’ to inhaled insulin
June 30, 2014Manufacturing and Production, Sales and Marketing Afrezza, FDA, Mannkind, diabetes, insulin human
The FDA has approved the first ‘ultra-rapid-acting’ mealtime insulin therapy available in the US, to improve glycemic control in both …
FDA rejects olaparib
June 27, 2014Sales and Marketing AstraZeneca, Cancer, FDA, PARP, adp, olaparib
AstraZeneca has been dealt a blow by a key advisory committee to the US Food and Drug Administration, which has …
Ranbaxy’s Diovan copycat approved in US
June 27, 2014Manufacturing and Production, Sales and Marketing Diovan, FDA, Novartis, Ranbaxy, blood pressure, sun pharmaceuticals, valsartan
Ranbaxy has won approval for its copycat form of Novartis’ blockbuster blood pressure drug Diovan, as the Swiss firm finally …
FDA warns GSK plant
June 26, 2014Manufacturing and Production, Sales and Marketing FDA, GSK, Quebec, flu, flulaval, vaccines
GlaxoSmithKline’s Canadian operation has incurred the displeasure of the US Food and Drug Administration for irregularities in its production of …
India ‘likely’ to increase price caps
June 25, 2014Manufacturing and Production, Sales and Marketing China, FDA, India, UK, pricing
India’s government is ‘likely’ to increase the number of drugs which are subject to price caps, according to a report …
