Industry News

GlenmarK Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has announced the discovery and initiation of IND-enabling studies for a novel clinical development candidate, GBR 1342. GBR 1342 is a CD38xCD3 bi-specific antibody based on Glenmark’s proprietary BEAT® platform. GBR 1342 is the second clinical development candidate (following GBR 1302 a HER2xCD3 bi-specific antibody) based on the BEAT® technology. It is also Glenmark’s second clinical candidate targeting oncology indications.

Gavi, a global vaccine alliance, has announced a partnership with the government here to accelerate access to modern, highly-efficacious vaccines to support India's immunisation programme, it was announced on Thursday.

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MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with HuMab-5B1 as a therapeutic treatment for pancreatic cancer.  The Company filed an Investigational New Drug (IND) application for its lead fully human antibody product on November 30, 2015.  Patient enrollment in the Phase I clinical trial is expected to begin at multiple investigational sites in early 2016.

MannKind Corporation announced the termination of its license and collaboration agreement with sanofi-aventis U.S. LLC for the development and commercialization of Afrezza® (insulin human) Inhalation Powder.

Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, announced that on December 31, 2015, the Company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its lead antibacterial development candidate, MAT2501.

Vericel Corporation, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, announced that it has submitted a

Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.

BioQ Pharma and Cipla the signed of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's  Ropivacaine infusion  pharmaceutical in India.

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Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF)