Category Archives: Regulatory

Europe: More Direct-Acting Antivirals, More Controversy

The storms raging across Europe—and beyond—over the pricing of new hepatitis C treatments have been intensified by the European Union’s approval last week of the latest directly-acting antiviral, Bristol-Myers Squibb’s Daklinza (daclatasvir). Just two months after the European Medicines Agency gave a positive opinion on the drug, the formal authorization was delivered for use in […]
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From the Generic to the Supergeneric Era

By Adeline Siew, Pharmaceutical Technology. Generic drugs save patients and European healthcare systems approximately EUR 35 billion (US$46bn) each year, according to the European Generics Association (EGA). Of the 16 health-related recommendations made by the European Commission for 2014–2015 to EU member states, 11 concerned cost efficiency in the healthcare sector. But, speaking at the EGA […]
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More Finger Pointing Over Sunshine System Snafus

Further delays in implementing the Open Payments program for disclosing industry financial relationships with prescribers has ignited a blame-game over who is at fault. The Centers for Medicare and Medicaid Services (CMS) is citing inaccurate data from pharma and medical device companies for the latest problems involving erroneous payment attributions. Manufacturers maintain they fully validate […]
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Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs […]
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Ebola Outbreak Raises Ethical Issues

The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened […]
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