FDA
GSK hit by recall of 600,000 inhalers
April 5, 2017Manufacturing and Production, Research and Development FDA, GSK, Ventolin
The FDA has released that GSK would be voluntarily recalling close to 600,000 of its Ventolin asthma inhalers across the …
Teva’s Huntington’s treatment becomes first FDA-approved deuterated drug
April 4, 2017Manufacturing and Production, Sales and Marketing Austedo, FDA, Teva
Israel’s Teva Pharmaceuticals has announced that the FDA has given its approval for Austedo (deutetrabenazine) in the treatment of chorea …
FDA issues US-wide recall of Mylan’s EpiPen
April 3, 2017Medical Communications, Sales and Marketing FDA, Mylan, epipen
After recent reports of around 80,000 defective EpiPen’s across Australia, New Zealand, Japan, Norway, Denmark, Finland and Ireland, the FDA …
Trump’s FDA pick vows to sever past pharma ties to avoid partisanship
March 30, 2017Medical Communications, Sales and Marketing FDA, Scott Gottlieb, Trump
After much speculation, Donald Trump recently announced his top pick for Commissioner of the FDA as Dr Scott Gottlieb. Gottlieb …
Novartis investigational CAR-T therapy gets FDA priority review
March 30, 2017Sales and Marketing CTL019, FDA, Novartis, leukaemia
Novartis’ investigational chimeric antigen receptor T cell (CAR-T) therapy CTL019 (tisagenlecleucel-T) has been awarded has been awarded priority review by …
FDA approves first Parkinson’s treatment in a decade
March 22, 2017Research and Development, Sales and Marketing FDA, Parkinson's, Xadago
The FDA has approved Xadago (safinamide) as a supplementary treatment for Parkinson’s in patients currently taking levodopa/carbidopa and who are …
FDA warns API manufacturer about river water as ingredient
March 17, 2017Manufacturing and Production, Medical Communications Badrivishal Chemicals & Pharmaceuticals, FDA, India
The FDA has issued Badrivishal Chemicals & Pharmaceuticals a warning letter regarding numerous violations of manufacturing codes. The most worrying …
AstraZeneca hit with second blow on $2.7 billion drug
March 17, 2017Medical Communications AstraZeneca, FDA, hyperkalaemia
AstraZeneca paid $2.7 billion for ZS Pharma, back in 2015, with the desire to get its hands on the company’s …
FDA warns China’s Lumis over misbranded APIs
March 16, 2017Manufacturing and Production FDA, Lumis
Chinese firm Lumis Global Pharmaceuticals became the latest to face the FDA’s ire as it was hit by a warning …
Trump’s proposed budget doubles FDA regulatory fees
March 16, 2017Sales and Marketing FDA, Trump
Trump’s presidency could cost the industry more than twice as much in regulatory review fees next year, as his administration …
FDA-approved preterm birth drug has no benefit and may cause harm, study suggests
March 15, 2017Research and Development FDA, Makena
A study by the UT Southwestern Medical Center has found that the synthetic progestogen hormone 17-alpha hydroxyprogesterone caproate (17-OHPC), a …
FDA lifts block on Sun Pharma facility
March 14, 2017Manufacturing and Production FDA, Sun Pharma
Sun Pharma has announced that the FDA informed it that the Import Alert in place upon its Mohali manufacturing facility …
Trump makes choice on new FDA head
March 13, 2017Medical Communications, Sales and Marketing FDA, Gottlieb, Trump
Dr. Scott Gottlieb is Trump’s chosen nominee for the role of commissioner of the FDA. The nomination appeases fears within …
13 FDA observations on Dr Reddy’s plant send shares to 3 year low
March 9, 2017Manufacturing and Production Dr Reddy's, FDA
Indian pharmaceutical firm Dr Reddy’s has seen its shares drop on the Bombay Stock Exchange to their lowest point in …
FDA and NICE approve of first new hyperparathyroidism drug in 12 years
March 8, 2017Research and Development, Sales and Marketing FDA, NICE, Parsabiv, hyperparathyroidism
The FDA has given the go-ahead for Amgen’s hyperparathyroidism (HPT) therapy Parsabiv (etelcalcetide), marking the first new treatment for patients …
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Five Facts about cardiovascular disease
