Novartis AG, an early and active player in bringing gene therapies to market, has agreed to pay Voyager Therapeutics Inc. $54 million up front and up to $1.7 billion in fees and milestone payments for options to license up to five next-generation adeno-associated virus (AAV) capsids to use as gene therapy vectors for neurological diseases. Read More
Rather than focus on making one drug at a time, Creyon Bio Inc. is taking its more than $40 million in seed and series A financing to build its platform to understand the genetic roots of disease and then create precision medicines. Creyon is creating datasets to engineer RNA-based and single-stranded oligonucleotide-based medicines (OBMs) in addition to DNA and RNA editing systems. Those datasets are tailored to deliver models that create OBMs that are safe and effective for treating both common diseases and rare diseases. Read More
The potholes in the U.S. FDA’s accelerated approval path could be paved over by a bill introduced in Congress this week. Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, introduced the Accelerated Approval Integrity Act March 8 to keep the path open to innovative drugs where there is unmet need while streamlining the process for taking drugs off the market when they don’t prove clinical benefit in a timely manner. Read More
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
“In 2015, when I started in this field…. people considered breast cancer a cold tumor,” Marleen Kok told the audience at the European Society of Medical Oncology’s 2022 Targeted Anticancer Therapy meeting (ESMO TAT). But the sensitivity of breast cancer to immunotherapy, or lack thereof, is “not a black and white phenomenon.” Read More
Mallinckrodt plc agreed to pay $260 million to resolve separate U.S. allegations that it violated the False Claims Act by underpaying Medicaid rebates for its H.P. Acthar Gel (corticotropin) and that it violated the anti-kickback law by using a foundation as a conduit to illegally pay Medicare patients’ copay subsidies. Read More
New hires and promotions in the biopharma industry, including: Affinia, Coda, Curie, Dermavant, Frontier, Genocea, Inozyme, Mirobio, Pluristem, Rocket, Teon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, BMS, Boehringer, Eli Lilly, Harpoon, Horizon, Sanbio, Servier. Read More
