The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the […]

The FDA has granted approval to Sanofi-Aventis U.S. for Admelog, a short-acting insulin product. Admelog is the first short-acting insulin approved as a “follow-on” product and was submitted through the agency’s 505(b)(2) abbreviated approval pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is […]

The FDA has approved the FoundationOne CDx (or F1CDx), a breakthrough cancer diagnostic test developed by Cambridge-based biotech Foundation Medicine. F1CDx detects gene mutations that may be found in any solid tumor. This information can be used by physicians to manage cancer patients. Moreover, it can be used as a companion diagnostic to identify patients […]

The Massachusetts Life Sciences Center (MLSC) has announced the launch of the Massachusetts Next Generation Initiative (MassNextGen), a new competitive program for women entrepreneurs in early stage life sciences companies. MassNextGen will begin as a five year, $1 million commitment focused on advancing diversity and providing support for the next generation of life science entrepreneurs. […]

The FDA has granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology […]

The Broad Institute and MIT scientists who first harnessed CRISPR for mammalian genome editing have engineered a new molecular system for efficiently editing RNA in human cells. RNA editing, which can alter gene products without making changes to the genome, has profound potential as a tool for both research and disease treatment. In a paper […]

Kite Pharma, acquired by Gilead Sciences in October 2016 for $11.9 billion, has announced that the FDA has granted approval to Yescarta™ (axicabtagene ciloleucel), a CAR T (chimeric antigen receptor T cell) cancer therapy. CAR T therapy is a breakthrough in hematologic cancer treatment in which a patient’s own T cells are engineered to seek […]

Leading RNAi therapeutics company, Alnylam Pharmaceuticals, and Sanofi Genzyme have announced that the Phase 3 study of patisiran met its primary efficacy endpoint and all secondary endpoints. Patisiran is an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy. “We are very proud to report the first ever positive Phase 3 […]