FDA

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fdaoutsideweb_18

FDA fuelled opioid crisis by failing to police pharmaceutical companies, new study shows

January 2, 2020
Business 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 …

lda1_last_capsule_sm

LSD treatment for Alzheimer’s patients proves safe in recent trial

December 19, 2019
Business 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 …

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Trump administration takes steps to allow cheaper drug imports from Canada

December 18, 2019
Business 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 …

merck__co

FDA advisory panel back Merck & Co.’s Keytruda treatment for bladder cancer

December 18, 2019
Research 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, 2019
Manufacturing 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, 2019
Medical 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 …

fdaoutsideweb

Correvio’s atrial fibrillation drug voted down by FDA committee over safety concerns

December 11, 2019
Research 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 …

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FDA investigating if carcinogen NDMA is in diabetes drug

December 6, 2019
Medical 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 …

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Top Ten most popular articles on Pharmafile.com this week

December 6, 2019
Business 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

Allergan’s ubrogepant doses smash primary endpoints in acute treatment of migraine

December 5, 2019
Research 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 …

fdaoutsideweb_18

Trump’s new FDA nominee advances in the Senate

December 4, 2019
Research 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 …

tecentriq

Roche’s Tecentriq combo scores FDA approval in non-small cell lung cancer

December 4, 2019
Research 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 …

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Reagan-era FDA Commissioner Frank Young dies

December 3, 2019
Manufacturing 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 …

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FDA urged to investigate use of unapproved drug on prisoners

December 2, 2019
Sales 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 …

FDA gives priority review for AstraZeneca’s Imfinzi

November 29, 2019
Medical Communications AstraZeneca, Cancer, FDA, Imfinzi, lung cancer

The FDA has granted a priority review of AstraZeneca’s cancer treatment drug Imfinzi (durvalumab) for treatment of patients with untreated …

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