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.
U.S. FDA Expands Regulatory Approvals for LEO Pharma’s Enstilar Foam and Taclonex Topical Suspension in Treatment of Plaque Psoriasis
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.
There was a flurry of activity during the first few days of the American Society of Clinical Oncology, with multiple presentations made showing the benefits of various oncology treatments.
AbbVie halted the Phase III INTELLANCE-1 trial of depatuxizumab mafodotin in patients with newly diagnosed glioblastoma whose tumors have epidermal growth factor receptor amplification.
Cambridge, Mass.-based Agios Pharmaceuticals announced that Tibsovo (ivosidenib) hit the primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 mutation.
Teva Pharmaceutical Industries Ltd. will stop developing the migraine drug Ajovy for treating cluster headaches after finding the treatment was unlikely to meet the main goal of a late-stage trial.