The U.S. Food and Drug Administration approved Jazz Pharmaceuticals and company partner PharmaMar’s Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Eli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.
Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
On Valentine’s Day, BioSpace would be remiss not to mention, er, matters of the heart. There are reportedly 59 life sciences companies or organizations worldwide that focus on the cardiovascular system, ranging from the Aab Cardiovascular Research Institute based in West Henrietta, New York to XyloCor Therapeutics, with headquarters in Philadelphia. That number is probably low.
Two months after Pfizer and Astellas’ Xtandi won regulatory approval for a new indication in prostate cancer, the companies released positive new data in another type of prostate cancer.
A recent study published in the journal SSRN by researchers at Harvard University, the University of Texas at Dallas and the Massachusetts Institute of Technology (MIT) questions if the FDA and other regulatory agencies worldwide rush certain approvals, particularly at the end of the year in a kind of “desk-clearing” activity.
BeiGene Ltd. priced the China-based drugmaker’s Brukinsa to treat a rare form of lymphoma at $12,935 for a 30-day supply.
Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Shares of Dova Pharmaceuticals were up more than 38 percent after Sweden-based Sobi announced the intended acquisition of the North Carolina-based company for $915 million.