Pharma News

Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to FPA144 for the treatment of gastric cancer, including cancer of the gastroesophageal junction in patients whose tumors overexpress FGFR2b. FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy.

Insys Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").  Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.  Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration.

Onxeo S.A., an innovative company specialized in the development of orphan oncology therapies, announced it received a Notice of Allowance from the US Patent and Trademark Office (USPTO) relating to a key patent for its signal interfering DNA product candidate, AsiDNA.

Citius Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to acquiring, developing and commercializing adjunctive cancer care and critical care drug products, announced it was discontinuing Suprenza, its FDA-approved phentermine-based product for weight loss.

Merck Animal Health (known as MSD Animal Health outside the United States and Canada) announced it has executed an agreement to acquire a controlling interest in Vallée S.A., a leading privately-held producer of animal health products in Brazil.

Takeda Pharmaceutical Company Limited announced that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for ixazomib, the first oral proteasome inhibitor for the treatment of relapsed or refractory multiple myeloma.

Takeda Pharmaceutical Company Limited and Altos Therapeutics LLC jointly announced the companies have entered into a definitive agreement to further the development of Altos’s proprietary compound ATC-1906. Additionally, the agreement includes an exclusive option for Takeda to acquire Altos beginning on the date of the agreement and continuing for a period of time following the completion of ongoing phase 1 studies of ATC-1906. The parties envision future development of ATC-1906 for the treatment of gastroparesis (GP) and its symptoms.

Array BioPharma announced the submission of a New Drug Application (NDA) for binimetinib in patients with advanced NRAS-mutant melanoma to the US Food and Drug Administration (FDA). The submission is based on results of the pivotal phase 3 NEMO (NRAS MELANOMA AND MEK INHBITOR) study, which found binimetinib significantly extended median progression-free survival (PFS), the study's primary endpoint, as compared with dacarbazine.

AstraZeneca announced that it has entered into agreements that support its strategic focus on three main therapy areas; Respiratory, Inflammation and Autoimmunity, Cardiovascular and Metabolic disease and Oncology. The agreements include two of AstraZeneca’s potential new medicines for dermatitis and psoriasis, allowing the Company to further simplify and sharpen focus on innovative new medicines in the main therapy areas. 

Kiadis Pharma N.V., a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, announced that its lead product, ATIR101, has been granted an expansion to its existing Orphan Drug designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).

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