DBV Technologies SA’s pivotal phase III trial with the Viaskin Peanut allergy patch came through for the company, and officials plan a BLA filing with the U.S. FDA in the first half of next year. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Dec. 17 at $22.55, up $4.57, or 25%, on positive top-line results from the study called Vitesse with Viaskin for children, ages 4 to 7.
Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. (BMS) to develop multispecific antibodies. Harbour is getting about $90 million up front, but milestones could eventually top $1 billion. Read More
Addition Therapeutics came out of stealth mode to highlight its Precise RNA-Mediated Insertion of Transgenes (PRINT) gene therapy platform. The system is based on research of retrotransposons by Kathleen Collins’ laboratory at University of California, Berkeley, that was spun out into Addition in 2021. Read More
The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics. Read More
Gene editing can repair mutations that prematurely halt protein synthesis, resulting in incomplete peptides that cause various diseases. However, other approaches achieve the same effect without altering the genome. Startup Alltrna Inc. has developed a strategy based on transfer RNA to bypass the premature stop codons that end early protein translation. The company already has a first clinical candidate that could treat metabolic diseases such as methylmalonemia or phenylketonuria. Read More
The U.S. CDC has adopted the recommendations of its Advisory Committee for Immunization Practices (ACIP) regarding the hepatitis B virus (HBV) vaccine scheduling for infants, determining that immunization should be an individual-based decision rather than the universal birth dosing practice that has been in place for the past 30 years. Read More
The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Generation, Imcheck, Ipsen, Maplight, Nuvalent, Royalty, Sandboxaq, Tonix, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Adagene, Aldeyra, Astrazeneca, Chiesi, Daiichi, GSK, Organogenesis, Palvella, Sprout. Read More
