FDA
FDA approves artificial pancreas developed by the University of Virginia
January 2, 2020Business Services, Medical Communications FDA, Pancreas, Type 1 diabetes, diabetes, insulin, type 2 diabetes
The FDA has approved an artificial pancreas system based on technology from the University of Virginia’s Center for Diabetes Technology. …
FDA fuelled opioid crisis by failing to police pharmaceutical companies, new study shows
January 2, 2020Business Services FDA, Opioids Crisis, Opioids Trump, OxyContin, Trump Administration, opioids
The FDA’s Risk Evaluation and Mitigation Strategy (REMS), which began in 2012, failed to successfully police the companies creating opioids …
LSD treatment for Alzheimer’s patients proves safe in recent trial
December 19, 2019Business Services Alzheimer's, FDA, LSD, Magic mushrooms, psilocybin
The results of a Phase 1 clinical trial shows that Lysergic Acid Diethylamide (LSD) can be microdosed safely, and potentially …
Trump administration takes steps to allow cheaper drug imports from Canada
December 18, 2019Business Services Big Pharma, FDA, Trump, Trump Administraion, US Pharma
The Trump administration is close to allowing the import of some prescription Canadian drugs into the country.The FDA and the …
FDA advisory panel back Merck & Co.’s Keytruda treatment for bladder cancer
December 18, 2019Research and Development FDA, Merck, Merck and Co, NHS, NICE, keytruda
An FDA advisory committee voted 9 to 4 in favour of recommending Merk and Co’s Keytruda (pembrolizumab) for treatment in …
FDA approves Pfizer and Astellas Pharma’s prostate cancer drug
December 17, 2019Manufacturing and Production Astellas Pharma, Cancer, FDA, Pfizer, Xtandi, prostate cancer
The FDA has approved Pfizer and Astellas Pharma’s Xtandi (enzalutamide) to treat patients with a type of prostate cancer. The …
FDA U-turns to approve Sarepta’s Vyondys 53 in Duchenne muscular dystrophy
December 13, 2019Medical Communications, Sales and Marketing FDA, Vyondys 53, pharma, sarepta
The FDA has surprised industry pundits by choosing to approve Sarepta’s Vyondys 53 under an accelerated pathway for the treatment …
Correvio’s atrial fibrillation drug voted down by FDA committee over safety concerns
December 11, 2019Research and Development, Sales and Marketing Correvio Pharma, FDA, atrial fibrillation, pharma
It has emerged that Correvio Pharma’s anti-arrhythmic therapy Brinavess was shot down by the FDA’s Cardiovascular and Renal Drugs Advisory …
FDA investigating if carcinogen NDMA is in diabetes drug
December 6, 2019Medical Communications FDA, Health Canada, MDMA, NDMA, carcinogen, diabetes
The FDA is looking into if the diabetes drug metformin has unsafe levels of a cancer-causing chemical. This comes after …
Top Ten most popular articles on Pharmafile.com this week
December 6, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cancer, FDA, NHS, corruption, lung cancer, opiods crisis, opioids
Corruption and bribery feature heavily in the news this week. A recently exposed 1997 email chain shows Dr Richard Sackler, …
Allergan’s ubrogepant doses smash primary endpoints in acute treatment of migraine
December 5, 2019Research and Development Allergan, FDA, pharma, ubrogepant
New Phase 3 data has been released showing that both 50mg and 100mg doses of Allergan’s ubrogepant met their primary …
Trump’s new FDA nominee advances in the Senate
December 4, 2019Research and Development Big Pharma, FDA, FDA commissioner, Trump, US Pharma
Dr Stephen Hahn, President Donald Trump’s FDA nominee, has advanced his nomination to the full Senate chamber. The vote was …
Roche’s Tecentriq combo scores FDA approval in non-small cell lung cancer
December 4, 2019Research and Development, Sales and Marketing FDA, NSCLC, Roche, pharma, tecentriq
Roche’s immunotherapy Tecentriq (atelizumab) has chalked up another approval from the FDA, this time in combination with the chemotherapy Abraxane …
Reagan-era FDA Commissioner Frank Young dies
December 3, 2019Manufacturing and Production FDA, FDA commissioner, Frank Young
Frank Young, FDA Commissioner from 1984-1989, died on 24 November. He was 88; his son, Jonathan, said the cause was …
FDA urged to investigate use of unapproved drug on prisoners
December 2, 2019Sales and Marketing FDA, Opiods, US Opiods, opiod crisis
The Louisiana Department of Public Safety and Corrections (LDPSC) and BioCorRx Inc are alleged to have collaborated in testing an …
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