The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio. Read More
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer. Read More
A new horizon may be opening up in low-grade serious ovarian cancer (LGSOC) with the advent of Verastem Oncology Inc.’s therapy pairing two small molecules: avutometinib (VS-6766), a kinase inhibitor that binds to and inhibits the kinase activities of RAF and MEK to block the signal transduction pathways they mediate; and defactinib (VS-6063), an inhibitor of FAK. Read More
In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020. Read More
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview. Read More
A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren’t attractive enough for Fibrobiologics’ management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O’Heeron said was worth the effort. “We couldn’t be more happy with the outcome,” he said. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: A2, Apogee, Arvinas, Avenue, Biogen, Carisma, Eli Lilly, Flamingo, Genentech, Innocare, Ionis, Kira, Moonlake, Oragenics, Tourmaline, Voyager. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelerated Biosciences, Biogen, Eli Lilly, Entero, Erasca, First Wave, GSK, Ionis, Joyo, Medshine, Morphosys, Novartis, Totus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, BMS, HLB. Read More
