Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
Adalta Ltd. is outlicensing all of its internal products and focusing instead on inlicensing early stage T-cell assets from Asia, mostly from China, Adalta CEO Tim Oldham told BioWorld. Dubbed its “East to West” strategy, Adalta is integrating Asia's prowess in T-cell therapy development with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway connecting Eastern innovation in cellular immunotherapies with Western regulated markets and patients.
It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices.
News from Tectonic Therapeutic Inc. in January took away some of Wall Street’s jitters about the relaxin pathway brought about by Eli Lilly and Co.’s recent moves, but another big pharma player – Astrazeneca plc – is still providing suspense in pulmonary hypertension in heart failure with preserved ejection fraction.
Imunon Inc. soared by 179% on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the drug plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone. Increased activity was seen among patients treated with poly ADP-ribose polymerase inhibitors, with the median OS not yet reached after more than five years vs. 37 months in the control arm.
Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abli, Belite, Cel-Sci, Genentech, Innocare, Johnson & Johnson, Moderna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelyrin, Alumis, Evofem, Genfit, Ipsen, Multispan, Optinose, Paratek, Pfizer, Pharma 1, SK Bioscience, Synfini.
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