The U.S. FDA has cleared Biocity Biopharma Co. Ltd.’s IND application for a phase I study of BC-2027. This is the company’s second first-in-class antibody-drug conjugate (ADC) to be approved for clinical trials, following BC-3195, which is directed against placental-cadherin (CDH3).
Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years.
With two respiratory syncytial virus (RSV) vaccines approved by the U.S. FDA in 2023 and a third nearing its May PDUFA date, decades of research has finally provided infants and older adults protection from the disruptive and sometimes deadly virus. But what about people in the middle, particularly those with certain chronic medical conditions? New York-based Pfizer Inc. rolled out phase III data April 9 showing that its approved RSV vaccine, Abrysvo (RSVpreF), met primary endpoints in adults ages 18 to 59 who were at high risk of RSV.
The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases.
While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices.
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
A quick jury verdict that a biopharma official was guilty of insider trading validated the U.S. SEC’s broader view of what constitutes such trading and could ignite more SEC “shadow trading” investigations and allegations. Following an eight-day trial before the U.S. District Court for the Northern District of California and a little more than two hours of deliberation, a jury found April 5 that Matthew Panuwat violated national securities laws when he purchased short-term, out-of-the-money stock options in Incyte Corp. in 2016.
Following the U.S. FDA’s expansion of competing BCMA-targeting CAR T therapy Abecma (idecabtagene vicleucel) to include third-line and later treatment in multiple myeloma (MM) patients, the agency cleared Carvykti (ciltacabtagene autoleucel) from Legend Biotech Corp. and Johnson & Johnson’s Janssen unit for use in MM patients as early as second-line treatment. The label, which RBC Capital Markets analyst Leonid Timashev called a “best-case scenario,” includes no notable updates to the black box warning and should help accelerate and expand Carvykti’s update in the U.S., with 2024 revenues expected to top $950 million.
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