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RSS FeedPosted 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 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
Mylan’s settlement with DOJ not tough enough, Senator says
20 October 2016 - Connecticut’s Blumenthal calling for criminal inquiry. ...
Posted by Michael Wonder on 19 Oct 2016
Medicare shouldn’t pay more for drugs when others pay less
18 October 2016 - Hillary Clinton and Donald Trump don’t see eye-to-eye on much. But they do agree that drug ...
Posted by Michael Wonder on 19 Oct 2016
Treat pharma as a utility, and 10 other ways states can lower drug prices
19 October 2016 - As prescription drug costs continue to squeeze state budgets, a group of state health policy makers ...
Posted by Michael Wonder on 19 Oct 2016
FDA approves Lilly's Lartruvo (olaratumab) in combination with doxorubicin for soft tissue sarcoma
19 October 2016 - Lartruvo received the FDA's breakthrough therapy designation and was approved under the Agency's accelerated approval program. ...
Posted by Michael Wonder on 19 Oct 2016
FDA approves Genentech’s cancer immunotherapy Tecentriq (atezolizumab) for people with a specific type of metastatic lung cancer
18 October 2016 - First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 19 Oct 2016
Where Clinton will take ObamaCare
17 October 2016 - As with HillaryCare, a single payer, national health-care system has always been the goal. ...