India's Drug Controller General sent out a memo this week ordering that the backlog of pending clinical trial applications and drug and device approvals be cleared within three weeks. The memo to the subject expert committees at the Central Drugs Standards Control Organization provides instructions on expediting the reviews. Read More

Ionis Pharmaceuticals Inc., of Carlsbad, Calif., said it earned a milestone payment of $7.5 million from Biogen Inc., of Cambridge, Mass., for advancing nusinersen (formerly ISIS-SMNRx) in the open-label extension study, SHINE, initiated in October 2015 to provide nusinersen to infants and children with spinal muscular atrophy who completed their participation in the phase III ENDEAR and CHERISH studies and are eligible for participation. Read More

Kineta Inc., of Seattle, reported data demonstrating that KIN 1148 enhances the efficacy of existing influenza vaccines in animal models through a balanced immune response. Additionally, enhanced effectiveness with KIN 1148 was achieved while using lower vaccine doses. Data were presented at the World Vaccine Congress in Washington. Read More

Immunexcite Inc. completed an $8.6 million series A-1 financing, topping off a series of smaller rounds that sustained the immuno-oncology (I-O) company and its technology, dubbed Mabxcite, for more than five years. All told, the Lexington, Mass.-based company has raised more than $15 million since it was incorporated in 2007, mostly beginning with a $2.4 million series A at the end of 2011. Read More

TOKYO – Japanese company Fujifilm Corp., best known for its photographic equipment, is adapting its technology for use in human regenerative therapy. Read More

DUBLIN – Amryt Pharmaceuticals plc, a recently formed specialty pharma company with a focus on orphan diseases, is gaining a listing on London's AIM through a reverse takeover of the former oil and gas exploration firm Fastnet Equity plc, of Dublin, in a deal valued at £29.6 million (US$42.6 million). At the same time the Dublin-based company is raising £10 million in new funding and acquiring two European specialty pharma firms, Birken AG and Sompharmaceuticals SA, for a combination of cash, including milestone-based payments, and shares. Read More

More than a year after the FDA approved the first biosimilar in the U.S., the agency has released draft guidance on how biosimilars should be labeled. Read More

Genocea Biosciences Inc.'s latest, 12-month, dose-optimization phase II results with its GEN-003 vaccine immunotherapy for genital herpes compare well with those achieved by way of currently available, daily, oral medicine, and a phase IIb efficacy trial with the injectable alternative goes on. Read More