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  • Female rats often respond to fear by "darting" where they start running around like crazy when they sense threat, new research has found, suggesting that the findings could lead to better treatments for post-traumatic stress disorder (PTSD) in humans.

  • Female rats often respond to fear by "darting" where they start running around like crazy when they sense threat, new research has found, suggesting that the findings could lead to better treatments for post-traumatic stress disorder (PTSD) in humans.

  • OptiNose, a privately-held specialty biopharmaceutical company, announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food & Drug Administration (FDA) approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly AVP-825, for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail is the first product developed by OptiNose to receive FDA approval and is an intranasal medication delivery system using the novel Xsail Breath Powered Delivery Device.

  • 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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