Industry News

- Read more about Clovis Oncology receive FDA accelerated approval of RUBRACA™
Clovis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca™ (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
- Read more about Amgen and UCB submit application for Romosozumab In Japan
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.
- Read more about Amedica present Positive Scientific Data and Re-files FDA Submission
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.
- Read more about 68th IPC inaugurated at Andhra University with positive pharma environment
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.
- Read more about Trovagene focus on increase global distribution of liquid biopsy technology
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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- Read more about CytomX declare U.S. FDA Clear IND application for Phase 1/2 Clinical Study of Anti-PD-L1 Probody Therapeutic, CX-072
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.
- Read more about CytomX declare Selection by BMS of First Clinical Candidate Probody From Collaboration
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.
- Read more about BioDelivery Sciences phase 2b trial of Clonidine topical gel fails to meet primary endpoint
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.
- Read more about FDA approves Vericel Corporation’s Maci for the repair of cartilage defects of the knee
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.
- Read more about Aurinia Announce receipt of EOP 2 Meeting Minutes from FDA
Aurinia Pharmaceuticals Inc. , a clinical stage biopharmaceutical company focused on the global immunology market, announced that it has received the final End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug Administration Division of Pulmonary, Allergy and Rheumatology Products. The minutes are consistent with the preliminary responses that were issued to the Company prior to the meeting which took place on October 25, 2016.