Industry News

- Read more about SCYNEXIS, Inc. get FDA fast track and QIDP designations for Intravenous Formulation of SCY-078
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.
- Read more about Theravance Biopharma announces commercial launch of VIBATIV(R) (telavancin) in Canada
Theravance Biopharma, Inc. announced the commercial launch of VIBATIV® (telavancin) in Canada. VIBATIV is a bactericidal, once-daily antibiotic with in vitro potency and a dual mechanism of action against Gram-positive bacteria, including difficult-to-treat pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
- Read more about Lynparza™ (olaparib) granted Breakthrough Therapy designation by US FDA
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).
- Read more about Abbvie’s Venetoclax receives 3rd Breakthrough Therapy Designation from the FDA
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.
- Read more about Exelixis announces U.S. FDA Deems NDA sufficiently complete and Grants Priority review for Cabozantinib
Exelixis, Inc. announced that the U.S. Food & Drug Administration (FDA) has determined the company’s New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016
- Read more about Merck Receive FDA approval of ZEPATIER™
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA.
- Read more about First time in globe recombinant vaccine against seasonal influenza
In October 2015, the Commission for the Protection against Sanitary Risk (COFEPRIS) gave Mexico the registry of the first recombinant vaccine against seasonal influenza in the world and designed to begin marketing in the first quarter of 2016.
30 January 2016

Global pharma industries work together to beat the rising drug resistance

More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug resistant infections so called ‘superbugs’ – with a joint declaration launched on 21st Jan at the World Economic Forum in Davos, Switzerland. The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance.
- Read more about FDA approves ZEMBRACE™ SymTouch™(sumatriptan succinate) Injection for the acute treatment of migraines in adults
Dr. Reddy’s Laboratories Ltd. Receives FDA approval for ZEMBRACE^TM SymTouch^TM (sumatriptan succinate) Injection for the acute treatment of migraines in adults.
- Read more about Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT™
Neos Therapeutics, Inc., a pharmaceutical company with a late?stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older.