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.
The U.S. Food and Drug Administration approved Roche/Genentech’s Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in pediatric patients 2 years of age and older.
Danish drugmaker Novo Nordisk is aiming for a big slice of the multibillion-dollar diabetes market with a new pill approved by U.S. authorities that caters for patients with an aversion to needles.
LEO Pharma Inc announced the U.S. Food and Drug Administration expanded the approved indication for Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. Additionally, the FDA approved Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.