Pharma News

Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha (evolocumab). The new automated mini doser (AMD) with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.

Amgen and UCB announced that an application seeking marketing approval of romosozumab for the treatment of osteoporosis for those at high risk of fracture has been submitted for review to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Amgen and UCB are co-developing romosozumab worldwide, with development in Japan being led by Amgen Astellas BioPharma (AABP) K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.

Amedica Corporation, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company's porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation. "We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future.

AMTZ (Andhra MedTech Zone) aims to make India a self-sufficient and in fact an exporter of good quality and cost-effective medical technology.

The objective of the Seminar was to familiarize the Industry on this opportunity which exists in fulfilling this gap which is likely to only widen as the healthcare services reach out to semi-urban and rural areas. The seminar also threw up opportunities for foreign collaborations for technology transfers and financing for setting up units.

68^th Indian Pharmaceutical Congress (IPC) is organised and started at city of happening, Visakhapatnam under the premises of Andhra University. More than 9000 delegates and students from various part of India participated in this event. This event is organised in Andhra University for three days, 16^th to 18^th December 2016. The main theme of the event is Quality pharmaceuticals & patients welfare.

Trovagene, Inc., a developer of circulating tumour DNA (ctDNA) molecular diagnostics, announced that it will increase its focus on the global distribution of kits and systems to clinical research laboratories for the liquid biopsy oncology testing market.

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CytomX Therapeutics, Inc.  announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer.  The company plans to immediately initiate the study and open clinical sites to support patient enrollment.

CytomX Therapeutics, Inc. announced that Bristol-Myers Squibb Company has selected a clinical candidate for its CTLA-4 Probody program under the strategic oncology collaboration established in May 2014.  Achieving this milestone results in a $2 million payment to CytomX.

BioDelivery Sciences International, Inc. (BDSI) announced that its phase 2b clinical study assessing the efficacy and safety of Clonidine topical gel for the management of painful diabetic neuropathy failed to show a statistically significant difference in pain relief between Clonidine topical gel and placebo.  As a result, BDSI is discontinuing further development of the product at this time.

The U.S. Food and Drug Administration  approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. Maci is manufactured by Vericel Corporation, headquartered in Cambridge, Massachusetts.