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Clinical courses

  • Allergan plc. , a leading global pharmaceutical company  announced that its Phase III ready investigational medication rapastinel (GLYX-13) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for adjunctive treatment of Major Depressive Disorder (MDD). This follows the Fast Track Designation for rapastinel granted by the FDA in 2014.

  • MabVax Therapeutics Holdings, Inc., announces receipt of notice from the U.S. Food and Drug Administration (FDA) authorizing initiation of a Phase I clinical trial with 89Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer.  The Company filed an Investigational New Drug (IND) application for this trial with the FDA on December 29, 2015.  MabVax previously announced receipt of FDA authorization for a Phase I trial with HuMab-5B1 as a therapeutic treatment for patients with pancreatic cancer, and patient enrollment in both Phase I trials is expected to commence in the first quarter of 2016.

  • Matinas BioPharma Holdings, Inc., announced that its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) is now open and the Company is authorized to initiate a Phase 1 clinical study for investigational drug, MAT2501 (encochleated amikacin), for the treatment of  non-tuberculous mycobacterium (NTM) infections, its lead chronic indication.

  • Dr. Reddy's Laboratories, announced  that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously.

  • The U.S. Food and Drug Administration  approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. Halaven is marketed by Eisai based in Woodcliff Lake, New Jersey.

  • Drug development company SCYNEXIS, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track and Qualified Infectious Disease Product (QIDP) designations for the intravenous (IV) formulation of SCY-078, SCYNEXIS' novel antifungal product, for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. SCYNEXIS is currently conducting a Phase 1 study of the IV formulation of SCY-078 to evaluate the safety, tolerability and pharmacokinetics of single-rising doses. The FDA granted QIDP and Fast Track designations for the oral formulation of SCY-078 for both the treatment of invasive candidiasis and invasive aspergillosis in 2014. The oral formulation is currently in Phase 2 development for both invasive candidiasis and vulvovaginal candidiasis.

  • AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).

  • AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

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