Eighteen U.S. states sued President Donald Trump’s administration to stop him from scrapping a key component of Obamacare, subsidies to insurers that help millions of low-income people pay medical expenses, even as Trump invited Democratic leaders to negotiate a deal.
Swiss drugmaker Roche’s Alecensa was recommended for approval in Europe as a first-line treatment for mutated lung cancer.
CHMP Issues a Positive Opinion on Janssen’s Zytiga to Include Earlier Stage Prostate Cancer Patients
Janssen-Cilag International NV announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended broadening the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of prostate cancer than its current indications.
The U.S. FDA identified unnamed deficiencies in Antares Pharma’s NDA for Xyosted that halted discussion of labeling and postmarketing requirements.
An investor decision to renege on acquiring more than $3 million worth of stock has created a financial catastrophe for Biostage Inc. To maintain operations, the company is terminating 17 employees, about 71 percent of its workforce.
President Donald Trump urged Democrats to make a deal with him on healthcare after he scrapped billions of dollars in Obamacare subsidies to private health insurers for low-income Americans in a move that raised concerns about chaos in insurance markets and could face legal challenges.
Allergan Plc said it reached a settlement with InnoPharma Inc., one of the four generic drugmakers challenging the patents for its dry eye medication Restasis in federal court.
Spark Therapeutics Inc.’s experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded, paving the way for the first U.S. gene therapy for an inherited disease.
The National Institutes of Health said it had partnered 11 biopharma companies to help advance a new class of drugs that uses the body’s immune system to fight cancer.