FDA chief tough on e-cigs steps down in surprise resignation
WASHINGTON (Reuters) – U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down…
U.S. Senator Sanders urges FDA to allow older versions of $375,000 drug
(Reuters) – U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and manufacturers to resume distributing unbranded, lower-cost…
Swiss team develop ‘microswimmer’ robot to deliver drugs through the body
LONDON (Reuters) – – A tiny sliver of elastic material swims along inside a narrow tube, coiling up and changing…
U.S. FDA approves Alexion Pharma’s blood disorder drug
(Reuters) – The U.S. Food and Drug Administration has approved Alexion Pharmaceuticals Inc’s blood disorder drug Ultomiris, the pharma regulator’s…
BrainStorm gets FDA okay for stem cell trial in MS patients
TEL AVIV (Reuters) – BrainStorm Cell Therapeutics Inc has received approval from the U.S. Food and Drug Administration to begin…
Brain implants might one day help paralyzed patients use tablets
(Reuters Health) – – Paralyzed people might one day be able to operate smartphones and tablets just by thinking about…
Two studies find probiotic therapy ineffective against stomach flu, diarrhea
(Reuters Health) – A widely-used probiotic therapy is ineffective against the diarrhea, vomiting and abdominal pain of gastroenteritis, two large…
EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics
(Reuters) – The European Medicines Agency’s risk assessment committee has recommended restrictions on the use of broad-spectrum antibiotics fluoroquinolone and…
Merck KGaA, Pfizer’s immuno-drug shown to alleviate kidney cancer
FRANKFURT (Reuters) – Merck KGaA said that its immunotherapy Bavencio, jointly developed with Pfizer, delayed the progression of kidney cancer…
U.S. health secretary says agency can eliminate drug rebates
WASHINGTON (Reuters) – U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate…
Pfizer bets on biotech flu vaccine in $425 million BioNTech alliance
FRANKFURT (Reuters) – Pfizer has agreed to pay German biotech firm BioNTech up to $425 million in an alliance to…
More drugmakers build Brexit stockpiles as EU agency faces exodus
PARIS/ZURICH/LONDON (Reuters) – Sanofi (SASY.PA) and Novartis (NOVN.S) said on Wednesday they planned to increase stockpiles of medicines in Britain…
Bayer hits back at new Netflix medical device documentary
NEW YORK (Reuters) – Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the…
FDA declines to approve Insys Therapeutic’s opioid painkiller
(Reuters) – Insys Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid painkiller,…
Mersana’s cancer drug trial put on hold by FDA; shares halted
(Reuters) – Mersana Therapeutics said on Thursday an early stage trial testing its lead cancer drug has been put on…
Pfizer-Lilly pain drug meets late-stage trial goals
(Reuters) – An experimental osteoarthritis drug developed by Pfizer Inc and Eli Lilly and Co achieved its main goal of…
CTI Biopharma’s cancer drug fails late-stage trial, shares tumble
(Reuters) – CTI Biopharma Corp said on Monday its treatment for a type of blood cancer did not meet the…
GSK’s two-drug HIV treatment meets main goal in late stage studies
(Reuters) – GlaxoSmithKline’s two-drug treatment for HIV, the virus that causes AIDS, met its main goal in late stage studies,…
Leading oncology group wary of Trump drug price proposals
CHICAGO (Reuters) – America’s leading group of cancer doctors is wary of new Trump administration proposals for lowering drug costs,…
Merck KGaA’s lung cancer drugs show promise in early-stage trials
FRANKFURT (Reuters) – Germany’s Merck KGaA said two of its experimental oncology drugs showed early signs of promise in certain…
FDA says manufacturing delays are constraining EpiPen supply
NEW YORK (Reuters) – The U.S. Food and Drug Administration added Mylan NV’s (MYL.O) EpiPen to its list of drugs…
FDA clears Pluristem radiation treatment for emergency use
HAIFA, Israel (Reuters) – Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said the U.S. Food and Drug…
FDA declines to approve Pfizer’s biosimilar to Roche’s cancer drug
(Reuters) – Pfizer Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve the company’s biosimilar…
FDA approves Ultragenyx’s drug for rare form of rickets
(Reuters) – The U.S. Food and Drug Administration has approved Ultragenyx Pharmaceutical Inc’s treatment for a rare and inherited form…
Medical studies in humans often launched on faulty evidence base
(Reuters Health) – New research reveals serious flaws in the animal studies that regulators and ethicists use to decide if…
Pfizer signs deal with Allogene to develop cancer cell therapy
(Reuters) – Pfizer Inc said on Tuesday it signed an agreement with Allogene Therapeutics, a company formed by a consortium…
FDA refuses to review Alkermes’ depression treatment, seeks more trials
(Reuters) – Alkermes Plc has been told to conduct more clinical trials of its experimental depression treatment after the U.S.…
Biohaven plunges as investors pit migraine data against Allergan’s drug
(Reuters) – Biohaven Pharmaceutical Holding said its treatment for acute migraine cleared two late-stage studies, but investors worried about its…