Policy
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
FEATURED STORIES
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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The approval is based on the Phase III UNIFI study that showed that after eight weeks of taking a single intravenous dose of Stelara, patients saw “clinical remission in a significantly greater proportion of UC patients.”
Thanks to a new regulatory win, AstraZeneca’s Farxiga can now be used to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with cardiovascular disease and with certain risk factors.
We round out the month of October and start the month of November with four PDUFA dates on the U.S. Food and Drug Administration’s calendar. Here’s a look.
Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
Two teams and an individual have been awarded this year’s President’s Science and Technology Awards[1][1], the highest honours bestowed upon research scientists and engineers in Singapore whose work have resulted in significant scientific, technological or economic benefits for the country.
ADC Therapeutics SA announced that the first patients have been dosed in a 100-patient pivotal Phase 2 clinical trial evaluating the efficacy and safety of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma The trial is intended to support the submission of a Biologics License Application to the U.S. Food and Drug Administration.
Minoryx Therapeutics announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation in Friedreich’s Ataxia by the US Food and Drug Administration (FDA).
For fiscal year 2019, the agency reported 1,171 generic drug approvals, 935 of them full approvals and 236 tentative approvals. This is up from last year’s all-time record of 971 generic drug approvals.
Netherlands-based Pharming Group NV has denied any involvement in a potential theft of intellectual property belonging to CSL Behring from Joseph Chiao, who recently joined Pharming as medical director.
Citing “sources familiar with the matter,” The Wall Street Journal reported that the agreement, should it be reached, would ultimately settle the matter for the company related to sales of Duragesic and Nucynta.