BioSpace News Archive

Sensorion announces that the European Medicines Agency has accepted its Pediatric Investigation Plan for both development in the treatment of severe hearing loss and for prevention of ototoxicity caused by cisplatin in the pediatric population.

Saluda Medical Pty Limited announced that it has secured $75 million in equity financing from Boston Scientific Corporation and Redmile Group LLC to fund the final stages of development through commercialization of its Evoke® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation System for the treatment of chronic intractable pain of the trunk and limbs.

Picovax® has been approved by the Danish Medicines Agency, and the WHO prequalification is expected by the end of 2019, enabling initial delivery of up to 100 million doses globally via UN agencies in 2020-2024

Experienced leader of oncology clinical trial approvals to head BioAtla’s clinical development programs

PTC Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has completed their review of a proposed indication extension of Translarna™ for the treatment of patients with nonsense mutation Duchenne muscular dystrophy who are non-ambulatory.

Growth Achieved in Revenue and Business Diversification Synergies from Each Business Segment, Steady Expansion in New Biomedical Businesses

Lannett Company, Inc. announced that it has entered into a three-year agreement with Elite Pharmaceuticals to be the exclusive U.S. distributor of a Dantrolene Capsules 25 mg, 50 mg and 100 mg.

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Dupixent®, recommending to extend its approval in the European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

10,000 children’s bandages donated at McKesson ideaShare to support those facing cancer

Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced that the company will be added to the Russell 2000® and 3000® Indexes, effective after the market close on Friday, June 28, 2019,