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RSS FeedPosted by Michael Wonder on 24 Oct 2016
aTyr Pharma receives FDA fast track designation for Resolaris to treat facioscapulohumeral muscular dystrophy
24 October 2016 - aTyr Pharma today announced that its product candidate Resolaris was granted fast track designation by the US ...
Posted by Michael Wonder on 24 Oct 2016
Sanders urges Californians to approve drug price ballot measure
21 October 2016 - Former Democratic presidential candidate Bernie Sanders, in an opinion editorial published in the Los Angeles Times, ...
Posted by Michael Wonder on 24 Oct 2016
Taking the initiative in healthcare: Will California voters cap drug prices?
22 October 2016 - Public anger at perceived price-gouging by drugmakers has fueled calls for lawmakers to take action. ...
Posted by Michael Wonder on 24 Oct 2016
FDA approves supplemental new drug application for Xtandi in advanced prostate cancer
24 October 2016 - Astellas and Pfizer today announced the U.S. FDA approved a supplemental new drug application to update the ...
Posted by Michael Wonder on 24 Oct 2016
FDA approves Merck’s Zinplava (bezlotoxumab) to reduce recurrence of Clostridium difficile Infection (CDI) in adult patients receiving antibacterial drug treatment for CDI who are at high risk of CDI recurrence
24 October 2016 - Merck today announced that the U.S. FDA has approved Zinplava (bezlotoxumab) 25 mg/mL solution for injection. ...
Posted by Michael Wonder on 24 Oct 2016
GSK announces US regulatory submission of candidate vaccine for prevention of shingles
24 October 2016 - Regulatory submissions in the EU and Canada remain on track for 2016. ...
Posted by Michael Wonder on 22 Oct 2016
Kite Pharma's CEO on bringing cancer-killing T-cells to the FDA
20 October 2016 - During a Q&A session with Wall Street analysts, CEO Arie Belldegrun was thrilled when an audience member ...
Posted by Michael Wonder on 22 Oct 2016
A biotech's depression drug returns from dead, setting up test for FDA
20 October 2016 - In January, Alkermes, a Waltham, Mass.-based biotechnology firm, announced that its experimental antidepressant, code-named ALKS 5461, ...
Posted by Michael Wonder on 21 Oct 2016
Bernie Sanders wants to know why this cancer drug costs nearly $200,000 a year
20 October 2016 - A tweet by Sen. Bernie Sanders of Vermont decrying the price of a cancer medicine made by ...
Posted by Michael Wonder on 21 Oct 2016
FDA official warns other drug makers not to copy Sarepta
20 October 2016 - Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval ...
Posted by Michael Wonder on 21 Oct 2016
U.S. FDA accepts for priority review the supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with advanced form of bladder cancer
21 October 2016 - Submission based on results from Phase 2 study CheckMate-275 evaluating Opdivo in patients with previously treated platinum-refractory ...
Posted by Michael Wonder on 21 Oct 2016
Teva announces FDA acceptance of resubmitted new drug application for SD-809 for treatment of chorea associated with Huntington disease
20 October 2016 - Teva Pharmaceutical Industries Ltd today announced that the U.S. FDA has accepted the resubmission of the ...
Posted by Michael Wonder on 20 Oct 2016
Pharmaceuticals and public health
20 October 2016 - The national debate over increasing costs and spending for pharmaceuticals has reached a fever pitch. Special ...
Posted by Michael Wonder on 20 Oct 2016
Binding arbitration: a flawed approach to tackling drug pricing
19 October 2016 - Addressing high drug prices has become a key priority for American health policy. Both presidential candidates ...
Posted by Michael Wonder on 20 Oct 2016
Celgene skips the placebo, fails drug development 101
19 October 2016 - Celgene is not some dinky micro-cap biotech lacking the resources or knowledge to conduct a rigorous clinical ...