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RSS FeedPosted by Michael Wonder on 19 Sep 2019
Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...
Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...
Posted by Michael Wonder on 17 Sep 2019
With ominous TV spots and a senior ‘strike force,’ AARP launches an all-out attack on pharma
17 September 2019 - As beachgoers soaked up the sun on a balmy August day in Ocean City, Md., single-engine ...
Posted by Michael Wonder on 17 Sep 2019
PHARMAC may have to compete for measles vaccine
17 September 2019 - PHARMAC is looking at whether it can order more measles vaccine in case the latest batch runs ...
Posted by Michael Wonder on 17 Sep 2019
I'm not in ...some Third World place': bladder cancer patients face ongoing scarcity of life-saving drug
16 September 2019 - Canada's only supplier, Merck, is now projecting BCG shortage will last until December 2020. ...
Posted by Michael Wonder on 16 Sep 2019
FDA seeks input on product-specific guidances to facilitate generic drug development
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
Posted by Michael Wonder on 16 Sep 2019
HTA in the European Union: osteoporosis screening without proof of benefit
16 September 2019 - For the first time, an IQWiG team is in charge of assessing health technology for the ...
Posted by Michael Wonder on 16 Sep 2019
Canada decides: Leading parties plan to tackle ways to make medicine affordable
16 September 2019 - Canadian voters will be hearing a lot about a new national prescription drug program to fill a ...
Posted by Michael Wonder on 16 Sep 2019
Lenvima to get benefit as first-line treatment of hepatocellular carcinoma
16 September 2019 - Lenvima (lenvatinib), a new liver cancer drug that arrived in a decade after Nexavar (sorafenib), is to ...
Posted by Michael Wonder on 16 Sep 2019
Prescription drug price gouging must stop
16 September 2019 - How big pharma can be prevented from indiscriminately raising the prices of its drugs. ...
Posted by Michael Wonder on 16 Sep 2019
Wholesale drug prices have been falling, and so have net prices
16 September 2019 - Amid continuing political pressure on drug makers, a new analysis finds that brand-name companies increased their ...
Posted by Michael Wonder on 16 Sep 2019
Verrica Pharmaceuticals submits new drug application to U.S. FDA for VP-102 for the treatment of molluscum contagiosum
16 September 2019 - No FDA approved treatments are currently available for this highly contagious, primarily paediatric, viral skin infection affecting ...
Posted by Michael Wonder on 16 Sep 2019
EMA publishes agenda for 16-19 CHMP meeting
13 September 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Sep 2019
Wave Life Sciences announces fast track designation from U.S. FDA for suvodirsen
16 September 2019 - Suvodirsen is an investigational stereopure oligonucleotide in development for the treatment of DMD patients amenable to exon ...
Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 16 Sep 2019
FDA grants fast track designation for Farxiga in heart failure
16 September 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...