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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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Prescription drug price gouging must stop

16 September 2019 - How big pharma can be prevented from indiscriminately raising the prices of its drugs. ...

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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 ...

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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 ...

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EMA publishes agenda for 16-19 CHMP meeting

13 September 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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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 ...

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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. ...

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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 ...

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