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RSS FeedPosted by Michael Wonder on 24 Jun 2019
Trump Administration pushes to make health care pricing more transparent
24 June 2019 - President Trump signed an executive order Monday on price transparency in health care that aims to ...
Posted by Michael Wonder on 25 Jun 2019
Petition for national cancer agency gathers steam
25 June 2019 - A petition launched in support of a national cancer agency has so far gathered more than ...
Posted by Michael Wonder on 25 Jun 2019
U.S. FDA accepts GSK’s application for Zejula (niraparib) in late stage ovarian cancer with priority review
24 June 2019 - GlaxoSmithKline plc today announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental new ...
Posted by Michael Wonder on 25 Jun 2019
UK's MHRA renews EAMS scientific opinion for Santhera's idebenone in Duchenne muscular dystrophy
24 June 2019 - Santhera Pharmaceuticals announces that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for ...
Posted by Michael Wonder on 25 Jun 2019
Krystal Biotech receives regenerative medicine advanced therapy designation from FDA for KB103
24 June 2019 - RMAT designation granted to KB103 based on positive interim data from GEM-1 and GEM-2 study. ...
Posted by Michael Wonder on 25 Jun 2019
Ipsen announces U.S. FDA approval for newly designed pre-filled syringe for Somatuline Depot (lanreotide)
24 June 2019 - New syringe designed to help enhance injection experience. ...
Posted by Michael Wonder on 25 Jun 2019
Nabriva Therapeutics announces EMA validation of marketing authorisation application for lefamulin
24 June 2019 - Nabriva Therapeutics today announced that the EMA has determined that the company’s marketing authorisation application for the ...
Posted by Michael Wonder on 25 Jun 2019
Lung cancer advocates feel disease is being ignored by Government
25 June 2019 - Advocates for lung cancer patients say the country's deadliest cancer is being ignored by health authorities. ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 24 Jun 2019
The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies
24 June 2019 - The FDA made a mistake Friday by approving a new drug called Vyleesi for women with ...
Posted by Michael Wonder on 24 Jun 2019
It’s Pioneer Institute vs. ICER: drug-pricing watchdog comes under fire for a ‘one-size-fits-all’ approach
24 June 2019 - An influential Boston-based watchdog group uses a “one-size-fits-all” approach to judge a fair price for prescription ...
Posted by Michael Wonder on 24 Jun 2019
Forcing patients to switch to biosimilars puts them in uncharted waters
23 June 2019 - On May 27, the B.C. government announced a policy that will forcibly switch thousands of patients, ...
Posted by Michael Wonder on 24 Jun 2019
England to fast-track tumour agnostic drugs like Vitrakvi – if the price is right
21 June 2019 - NHS England’s chief executive Simon Stevens was in Manchester this week at the NHS Confederation conference, ...
Posted by Michael Wonder on 24 Jun 2019
Correvio resubmits Brinavess (vernakalant) new drug application to U.S. FDA for the treatment of patients with recent onset atrial fibrillation
24 June 2019 - Correvio Pharma today announced it has resubmitted a new drug application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 24 Jun 2019
Veterans Agency to offer new depression drug, despite cost and safety concerns
21 June 2019 - Confronted by a rising rate of suicides in some groups of veterans., the Department of Veterans ...