Leading RNAi therapeutics company Alnylam Pharmaceuticals recently announced its corporate goals for 2018. The goals focus on clinical and regulatory progress against its five mid- to late-stage programs, including patisiran, which is advancing toward potential global regulatory approvals and commercialization. “In the year ahead, we look forward to the potential global commercial launch of patisiran, […]

The FDA has expanded the approved use of AstraZeneca’s Lynparza to include the treatment of patients with certain types of breast cancer that have spread and whose tumors have a specific inherited genetic mutation. This makes Lynparza the first PARP inhibitor to be approved for breast cancer; and the first time any drug has been […]

[The following post has been excerpted from comments by FDA Commissioner Scott Gottlieb as published by the FDA on its website on January 03, 2018.] The FDA has announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming […]

The FDA has approved Luxturna, an innovative one-time gene therapy treatment from Spark Therapeutics used to improve vision in patients with vision loss due to inherited retinal diseases (IRD). As the first adeno-associated viral (AAV) vector product approved for clinical use in the United States, Luxturna represents a historic landmark, not only in the field […]

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 […]