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 FDA’s latest approval for Darzalex is based on results from the Phase III CASSIOPEIA trial that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses in patients with the blood cancer.
AbbVie’s Mayvret won expanded approval from the U.S. Food and Drug Administration to shorten the one-daily treatment duration from 12 to eight weeks in treatment-naïve hepatitis C patients without cirrhosis and with compensated cirrhosis.
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration has approved JYNNEOS™ for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes 1-3
Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the successful completion of three global regulatory GMP inspections across three facilities in the space of just two weeks.
Ergomed plc, a company focused on providing specialised services to the global pharmaceutical industry, announces its unaudited interim results for the six months ended 30 June 2019.
Biogen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), part of the of the European Medicines Agency (EMA), recommended an update to marketing authorizations of approved interferon beta treatments, including PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a), to remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS).
Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC regardless of extent of disease
Faron announces its unaudited interim results for the six months ended 30 June 2019.
The U.S. Food and Drug Administration cleared Abbott’s blood test to help aid in the diagnosis of heart attacks for men and women hours earlier than standard tests and marks significant progress for detecting heart attacks in women.