Florida-based Catalyst Pharmaceuticals is attempting to show in court that the price of a newly approved treatment for a rare autoimmune disease and pressure from U.S. Sen. Bernie Sanders lead to the approval of a rival treatment.
Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
Novartis boss Vas Narasimhan expects higher sales and profitability for 2020, lifted by the company’s broad range of medicines, and minimal disruption to the Swiss drugmaker’s supply chain from the coronavirus outbreak in China.
Ireland’s Horizon Therapeutics became the first to win regulatory approval in the United States for the treatment of Thyroid Eye Disease (TED), a progressive autoimmune disorder that can threaten the vision of those afflicted.
Takeda Pharmaceutical has been on a tear over the past few weeks, striking deals to develop new therapies for various diseases. Now the Japan-based pharma powerhouse has announced a multi-year drug discovery deal with Charles River Laboratories.
EVERSANA and Noom announced a collaboration to increase medication adherence and improve health outcomes for the millions of patients suffering from chronic conditions and rare diseases worldwide.
Solid Biosciences Inc. announced organizational structure changes to create a leaner company focused on advancing SGT-001, a gene transfer candidate for the treatment of Duchenne muscular dystrophy.
U.S. researchers who conducted the largest study yet into whether applying powder to the genitals increases a woman’s risk of ovarian cancer were unable to definitively put to rest the issue that has prompted thousands of lawsuits against Johnson & Johnson and other companies.
Alnylam Pharmaceuticals Inc. priced the company’s gene silencing drug to treat patients with a rare genetic disorder that can cause severe pain at $575,000 per year after receiving an early U.S. approval.
The FDA approved BeiGene Ltd.’s lymphoma treatment Brukinsa, validating the China-based drugmaker’s strategy of largely using data from clinical trials held outside the U.S. to file for approval.