Press Releases

KemPharm, Inc., a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, today announced the submission of an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder. KemPharm successfully completed the p

Jazz Pharmaceuticals plc and Sumitomo Pharma Co., Ltd. announced that the companies have entered into an exclusive licensing agreement under which Jazz has acquired development and commercialization rights in the United States, Europe and other territories for Sumitomo Pharma's investigational DSP-0187, a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, idiopathic hypersomnia and other sleep disorders. Jazz has designated

Vizient Inc. and RISCS, Inc. today announced a joint pilot program aimed at enhancing assurance of pharmaceutical supply. Once implemented, the program would use a rating system to enable the evaluation of critical aspects of a resilient supply chain and provide increased transparency. During the pilot, pharmacy suppliers will be asked to provide key information on their supply chains through the request-for-proposal process. The information provided will enable visibility into supp

AstaLynx Global today announced the agreement with a midsize biopharmaceutical company to centralize their mission critical Pharmacovigilance activities. The biopharmaceutical will adopt and implement the full suite of AstaLynx's proprietary Drug Safety system, ADRiumTM, into their core business processes. The system will operate compliance intensive activities including case intake, case processing, reporting, and signal detection. The full suite includes ADRium, ADRium-Intake

Alcami, a leading United States-based contract development and manufacturing organization (CDMO), announced today that it is partnering with Civica Inc. (Civica Rx), a nonprofit pharmaceutical company focused on ensuring quality generic medicines are accessible and affordable to everyone. With the execution of this agreement, Alcami will provide analytical support for products to be manufactured at Civica's 140,000 square-foot sterile injectable manufacturing facility in Petersburg, Virgi

Supernus Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for the treatment of ADHD in children (

Fresenius Kabi announced today it has introduced Bortezomib for Injection, a new generic equivalent to Velcade® in the U.S. and the newest addition to the most comprehensive injectable oncology portfolio in the industry. Fresenius Kabi Bortezomib for Injection is available in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use. Fresenius Kabi Bortezomib for Injection is an affordable treatment option for adult patients with mu

The Muscular Dystrophy Association celebrates yesterday's approval by the US Food and Drug Administration (FDA) to ravulizumab (Ultomiris) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody. To date, Ultomiris is the third disease modifying drug approved to treat gMG. Ultomiris will be made available in the United States (US) and marketed by Alexion, the group within AstraZeneca focused on rare diseases.

Incyte and Maruho Co., Ltd. today announced that the companies have entered into a Strategic Alliance Agreement for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan. Under the terms of the agreement, Maruho will make an upfront payment to Incyte and Incyte is eligible to receive additional

FACIT announced two recent strategic investments from its Prospects Oncology Fund in innovations arising from renowned cancer experts at the Ontario Institute for Cancer Research (OICR): Dr. Rima Al-awar, Head of Therapeutic Innovation and Drug Discovery, and Dr. Lincoln Stein, Head of Adaptive Oncology. FACIT's Prospects Oncology Fund is a unique source of Ontario seed-stage capital for local oncology innovations, derived in part from the Government of Ontario. FACIT's investment dil