Policy
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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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 US 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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Representatives from Cigna, CVS, OptumRx, Prime Therapeutics and Humana will meet with Congress regarding prescription drug prices.
Celgene and its developmental partner Acceleron Pharma are eying a potential U.S. Food and Drug Administration approval of a blood-disease treatment.
It is with deep regret that the Agency for Science, Technology and Research announces the passing of Dr Sydney Brenner, Honorary Singapore Citizen, and A*STAR Senior Fellow, early this morning.
The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda
A review of top officials at Memorial Sloan Kettering Cancer Center found that there were repeated violations on financial conflicts of interest. The review was conducted by law firm Debevoise & Plimpton and jointly reported by The New York Times and ProPublica.
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
Sino-American relations continue to show signs of strain after the administration of President Donald Trump ordered the Chinese majority owner of healthcare company PatientsLikeMe to sell his stake.
The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.
In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases.
Amgen is suing Novartis, alleging a breach of the partnership and seeking to terminate the 2015 contract. Novartis, in response, filed a lawsuit accusing Amgen of inappropriately attempting to end the alliance.