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RSS FeedPosted 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 ...
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
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. ...
Posted by Michael Wonder on 18 Oct 2016
Time to reassess the cancer compendia for off-label drug coverage in oncology
18 October 2016 - Use of cancer therapies for indications not approved by the US FDA, also known as “off-label” use, ...
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. ...