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RSS FeedPosted by Michael Wonder on 12 Oct 2016
Undermining value-based purchasing — lessons from the pharmaceutical industry
12 October 2016 - In 2015, the U.S. Department of Health and Human Services announced a goal of linking at ...
Posted by Michael Wonder on 12 Oct 2016
FDA grants QIDP and fast track designations to VT-1161 for treatment of recurrent vulvovaginal candidiasis
12 October 2016 - Viamet Pharmaceuticals today announced that the U.S. FDA has granted Qualified Infectious Disease Product and fast ...
Posted by Michael Wonder on 12 Oct 2016
What experimental drug? Most companies don’t post compassionate use policies
11 October 2016 - As patients clamour for greater access to experimental medicines, a survey released Tuesday finds that ...
Posted by Michael Wonder on 11 Oct 2016
Battling rising drug prices is like 'whac-a-mole,' says hospital executive
11 October 2016 - Inpatient hospital drug costs rose about 38% to $990 per patient admission between 2013 and 2015, ...
Posted by Michael Wonder on 11 Oct 2016
FDA grants priority review to Roche's Lucentis for mCNV
11 October 2016 - The U.S. FDA has granted priority review for Roche drug Lucentis (ranibizumab) for treating myopic choroidal ...
Posted by Michael Wonder on 11 Oct 2016
ICER releases corrected evidence report on treatments for non-small-cell lung cancer
7 October 2016 - PD-1 value-based price benchmarks are updated while the main conclusions of the analysis remain unchanged. ...
Posted by Michael Wonder on 10 Oct 2016
Elbit Imaging announces that Gamida Cell has received FDA breakthrough therapy designation for Nicord
10 October 2016 - Elbit Imaging announced today that it was informed by Gamida Cell, an indirect associate of the ...
Posted by Michael Wonder on 10 Oct 2016
Anthem says will not cover Sarepta's approved Duchenne drug
7 October 2016 - Health insurer Anthem said it will not cover Sarepta Therapeutics Inc's medicine to treat patients with ...
Posted by Michael Wonder on 10 Oct 2016
U.S. FDA approves Carnexiv (carbamazepine) injection as intravenous replacement therapy for oral carbamazepine formulations
7 October 2016 - U.S. FDA approves Carnexiv (carbamazepine) injection as intravenous replacement therapy for oral carbamazepine formulations. ...
Posted by Michael Wonder on 09 Oct 2016
Coherus Biosciences announces FDA acceptance of 351(K) biologics license application to U.S. FDA for CHS-1701 (pegfilgrastim biosimilar candidate)
6 October 2016 - Coherus BioSciences today announced that the U.S. FDA has accepted the filing of 351(k) biologics license ...
Posted by Michael Wonder on 09 Oct 2016
Muscular dystrophy drug looks set for commercial success despite clinical doubts
3 October 2016 - A newly approved drug to treat Duchenne muscular dystrophy seems likely to be used by most ...
Posted by Michael Wonder on 06 Oct 2016
FDA grants breakthrough therapy designation for Roche’s Actemra/RoActemra in giant cell arteritis, a form of vasculitis
5 October 2016 - Fourteenth breakthrough therapy designation for Roche medicines. ...
Posted by Michael Wonder on 04 Oct 2016
US FDA grants breakthrough therapy designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC
4 October 2016 - This second Alecensa breakthrough therapy designation granted is based on phase 3 J-ALEX study. ...
Posted by Michael Wonder on 03 Oct 2016
A golden ticket that fast tracks a medicine through the FDA
29 September 2016 - Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was recently approved, but the ...
Posted by Michael Wonder on 03 Oct 2016
Obama extends controversial program for rare pediatric drugs
30 September 2016 - Despite objections from his own regulators, President Barack Obama signed into law a bill on Friday ...