Pharma News

Aeglea BioTherapeutics, Inc., announced the U.S. Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for AEB1102 for the treatment of Arginase I deficiency, a urea cycle disorder that results in elevated levels of the amino acid arginine, which can lead to a range of complications including intellectual disability and spasticity.

Celator Pharmaceuticals, Inc. announced positive results from the Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival.  Data will be submitted for presentation at the American Society of Clinical Oncology 2016 Annual Meeting.

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Genentech, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

ProNAi Therapeutics, Inc. announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL).

GW Pharmaceuticals plc, announced the positive results of the first pivotal phase 3 study of its investigational medicine Epidiolex (cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo (p=0.01). Epidiolex has both Orphan Drug Designation and Fast Track Designation from the US Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the US.

KemPharm, Inc. announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for May 5, 2016, to review KemPharm’s New Drug Application (NDA) for KP201/APAP, its lead investigational drug candidate for the short-term management of acute pain.

Suven Life Sciences Ltd (Suven) announces that the grant of one (1) product patent from China (CN103380131), one (1) product patent from Eurasia (9 Countries) (22043) and one (1) product patent from Hong Kong (HK 1180955)) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2032.

Government included more 88 drugs, surgical and consumables in Jan Aushadhi Scheme to make more covers over different portfolios. Till now Jan Aushadhi stores includes total 488 medicines including - Anti-allergy, Anti-infective, Anti-cancer, Antidiabetic agents, Central Nervous System disease, Cardio Vascular Agents, Eye Nose throat product, Eye disease, Gastro Intestinal Tract disease, Harmone, Non Opoidal Anti Inflammatory Drugs, Non-Steroidal Anti Inflammatory Drugs, Nutrient, Respiratory disease, Skin disease, Vaccine, Vitamins & Minerals, Miscellaneous etc.

The Supreme Court asked the central government as to why it was not making functional or upgrading its own vaccines manufacturing units, and instead procuring the vaccines from the market.