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RSS FeedPosted by Michael Wonder on 20 Dec 2016
Dynavax receives complete response letter from U.S. FDA for biologics license application for Heplisav-B
14 November 2016 - Dynavax Technologies today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Dec 2016
ProMetic initiates rolling submission of its biologics license application for plasminogen with U.S. FDA
19 December 2016 - ProMetic Life Sciences announced today that it has initiated the rolling submission of its biologics license ...
Posted by Michael Wonder on 20 Dec 2016
Tonix Pharmaceuticals’ PTSD Phase 3 ready drug candidate, TNX-102 SL, granted breakthrough therapy designation by the FDA
19 December 2016 - Responding to AtEase study results in military-related PTSD population, FDA agrees to work closely with Tonix ...
Posted by Michael Wonder on 19 Dec 2016
Why drug costs will keep rising in 2017
19 December 2016 - And nine more healthcare predictions for next year. ...
Posted by Michael Wonder on 19 Dec 2016
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C
19 December 2016 - AbbVie's investigational regimen was granted breakthrough therapy designation by the FDA for genotype 1 patients not ...
Posted by Michael Wonder on 19 Dec 2016
FDA grants accelerated approval to new treatment for advanced ovarian cancer
19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain ...
Posted by Michael Wonder on 19 Dec 2016
Boehringer Ingelheim and Lilly welcome new recommendation for Jardiance (empagliflozin) tablets in updated American Diabetes Association's 2017 standards
16 December 2016 - Guidelines include new recommendation to consider the use of Jardiance in people with type 2 diabetes ...
Posted by Michael Wonder on 19 Dec 2016
20 states accuse generic drug companies of price fixing
15 December 2016 - A wide-ranging investigation into generic drug prices took its most significant turn yet on Thursday, as ...
Posted by Michael Wonder on 19 Dec 2016
G.O.P. plans to replace health care law with ‘universal access’
15 December 2016 - House Republicans, responding to criticism that repealing the Affordable Care Act would leave millions without health ...
Posted by Michael Wonder on 19 Dec 2016
The most expensive drugs of 2016
16 December 2016 - Prescription drug prices have gotten out of control for many Americans and many insurers. ...
Posted by Michael Wonder on 18 Dec 2016
Obama administration scraps controversial drug pricing proposal
15 December 2016 - The Obama administration announced Thursday night that it is calling off a controversial initiative to fight ...
Posted by Michael Wonder on 17 Dec 2016
Grünenthal receives breakthrough therapy designation from U.S. FDA for neridronic acid for the treatment of complex regional pain syndrome, a debilitating orphan disease with high medical need
16 December 2016 - Neridronic acid is the first investigational medicine to receive breakthrough therapy designation for the treatment of ...
Posted by Michael Wonder on 16 Dec 2016
Why did new drug approvals in the U.S. plunge this year?
15 December 2016 - New drug approvals dropped more than 50% this year. ...
Posted by Michael Wonder on 16 Dec 2016
Trump's FDA chief may implement progressive approval for drugs
15 December 2016 - The first potential FDA chief appointee leaked by the Trump transition team is Jim O’Neill. ...
Posted by Michael Wonder on 15 Dec 2016
US states sue Mylan, Teva, others for allegedly fixing drug prices
15 December 2016 - One day after federal prosecutors unsealed a criminal information against the former CEO of Heritage Pharmaceuticals, ...