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RSS FeedPosted 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 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
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 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
Trouble on the exchanges - does the United States owe billions to health insurers?
19 October 2016 - Yet another bruising fight has erupted over health care reform. ...
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
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 18 Oct 2016
FDA accepts for review new drug application for sodium zirconium cyclosilicate for the treatment of hyperkalaemia
18 October 2016 - AstraZeneca today announced that the US FDA has accepted a complete re-submission of a new drug ...
Posted by Michael Wonder on 18 Oct 2016
The biggest pharma election risk is in California
16 October 2016 - Political risks surrounding high drug prices aren’t limited to the presidential campaign. ...
Posted by Michael Wonder on 17 Oct 2016
FDA, EMA officials: regulators must adapt to effectively regulate precision medicine
14 October 2016 - In order to effectively regulate precision medicine, regulators must adapt to alternative methods of evidence generation, ...