Policy
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.
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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In addition to patent cases, partnerships and pledging money to global tropical disease efforts, Novartis scored a win on a combo-treatment for solid tumors.
According to a recent report, the New York City Metro area is home to 7% of the U.S. population but contains 10% of all U.S. biochemists and biophysicists and 12% of U.S. chemists.
Enanta filed a patent infringement lawsuit against Pfizer for the latter’s alleged use of its proprietary antiviral component in producing the COVID-19 antiviral Paxlovid.
Krystal Biotech announced that it submitted a Biologics License Application to the FDA for its candidate B-VEC, intended for the treatment of dystrophic epidermolysis bullosa.
U.S. President Joe Biden nominated Arati Prabhakar, Ph.D., to be his science advisor. If confirmed by the Senate, Prabhakar will become the first woman, first person of color and the first immigrant to hold the position.
The bill would curb the pricing of insulin by capping monthly co-pays for diabetics who use both commercial insurance plans, as well as the government-backed Medicare.
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Novartis’ win in the patent dispute over its drug, Gilenya, was short-lived after a U.S. appeals court reversed its 2020 ruling vs. HEC Pharm’s attempt to create a generic version.
Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.
Despite the refutation of research articles by Piero Anversa, they continue to serve as a basis for funding requests from scientists who hope to prove that the heart can regenerate cardiac muscle.