December 2016

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.

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.

Daiichi Sankyo Company, Limited  and DarwinHealth announced a strategic partnership to use quantitative systems biology-based algorithms and novel, validated approaches focused on tumour checkpoints - a new class of cancer targets - to help prioritize investigational compounds in the Daiichi Sankyo Cancer Enterprise pipeline for clinical development.

Alvogen, the next generation pharmaceuticals company, has launched the first generic equivalent to Tamiflu (oseltamivir phosphate) capsules in the United States.

CDSCO decided to abolish practice of pre-inspection by State Licensing Authority & Central Licensing Authority for issuing Form 29 License to manufacture drugs for purposes of examination, test or analysis for biological products (Vaccines & r-DNA products).