Policy

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An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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The Information Technology & Innovation Foundation recently published a report diving into the U.S.’s trade deficits in the life sciences industry worldwide and steps that can be made to keep the biopharma and medical device industries competitive globally.
On May 1, the U.S. Food and Drug Administration (FDA) granted Scynexi’s oral formulation of SCY-078 to treat vulvovaginal candidiasis (VVC) and recurrent VVC both Qualified Infectious Diseases Product (QIDP) and Fast Track Designation.
Shares of Sarepta Therapeutics slipped Thursday after the company announced a European Medicines Agency committee rejected Exondys 51 (eteplirsen), the company’s treatment for Duchenne Muscular dystrophy.
Scandals are nothing new in any industry. The pharmaceutical and biotech industry are certainly no strangers to scandals – just ask convicted scandal-magnet Martin Shkreli.
Sam Isaly has finally stepped down from his position as a managing member OrbiMed more than four months after he was accused of sexual harassment. Sexual harassment allegations have been in the forefront of the news cycles for months as the #MeToo movement gained traction.
Patent fights are nothing new in the pharmaceutical industry but a new report shows that during 2017 the number of legal battles of pharmaceutical patents increased by 30 percent.
Shares of Achaogen are down more than 30 percent in premarket trading following the results of split support from a U.S. Food and Drug Administration panel for its lead antibiotic treatment, plazomicin, which is being developed for the treatment of adults with complicated urinary tract infections and bloodstream infections.
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz, a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.
All that is lacking from the likely drama surrounding patent battles over CRISPR technology in the U.S. Court of Appeals today is Michael Buffer’s cry of “Let’s get ready to rumble.”
During the 2016 U.S. presidential election, the push for lower drug prices became one of the hot-button topics. Now there appears to be some efforts by advocacy groups and government entities to tackle the subject in several different ways.