Michael Engsig, CEO of Oslo, Norway-based Vaccibody AS, said the company’s deal with Roche Holding AG lets his firm “fully set in motion” the plan to explore infectious diseases as well as cancer, and Chief Scientific Officer (CSO) Agnete Fredriksen pointed out that “an exceptional cross-functional team” has been put in place to get the job done. Vaccibody signed the new contract with Basel, Switzerland-based Roche’s Genentech arm to develop and sell DNA-based individualized neoantigen vaccines for cancers. The tie-up brings as much as $715 million for Vaccibody. Read More
Both Solid Biosciences Inc. and Pfizer Inc. got lifts to their Duchenne muscular dystrophy (DMD) programs from the FDA as the agency released a clinical hold and awarded a fast track designation to their respective adeno-associated viral (AAV) programs. Read More
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity. Read More
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community. Read More
Attributing recent reductions in certain U.S. prescription drug prices to intense congressional scrutiny rather than a biopharma industry commitment to affordability, Rep. John Sarbanes (D-Md.) said Congress must put more guardrails in place and restructure how the industry does business. Read More
PERTH, Australia – Antisense Therapeutics Ltd. saw its stock bounce 26% following the news that the FDA has granted rare pediatric disease designation for ATL-1102 for the treatment of Duchenne muscular dystrophy (DMD), following submission of phase II data that showed its immunomodulatory therapy met primary disease progression endpoints. Read More
An international research team has identified a bacterial/viral combination more likely to be present in children with postinfectious hydrocephalus. Read More
With phase III vaccine trials nearly enrolled and data expected soon, a half-year of expedited development efforts, plus massive government funding may soon provide the ammunition needed to effectively stop the SARS-CoV-2 scourge of 2020. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA finalizes guidance for opioid use disorder drug R&D; FDA releases draft guidance for PK models, cancer drugs. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aegle, Akari, Baylx, Ionis, Irlab, Kadmon, Pfizer, Provention, Solid, Teneobio, Zosano. Read More
