The EMA’s 2025 annual report highlights the pressure it is under to streamline and simplify assessment processes, and the expanded – and explicit – role the agency now has in boosting the competitive position of the EU in the development and manufacturing of drugs.
Moderna Inc. will soon find out if the tumult-ridden U.S. FDA’s switcheroo in mid-February will stick regarding mRNA-1010, a prospective new seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee on June 17 takes up the matter of the shot, which trails a curious history.
Technophage SA has obtained clinical trial clearances in Europe to initiate a phase I/IIa study of the bacteriophage cocktail TP-122 (component TP-122A) in Portugal and the Netherlands.
Immunomic Therapeutics Inc. has obtained clinical trial notification (CTN) clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for ITI-9001, an investigational immunotherapy for Japanese red cedar allergy. The first-in-human phase I trial will begin in Japan in the second quarter.
The Centers for Medicare & Medicaid Services (CMS) proposed a rule June 12 that would codify the Inflation Reduction Act of 2022’s Medicare Drug Price Negotiation Program, establish new negotiation and drug benefit policies, and modify the fixed combination drug policy – the latter of which would negatively impact biopharmas attempting to extend lifecycles of blockbuster products.
Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D).
In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The drug, which expects to be branded Oclaiz in the U.S. upon approval, is called Oczyesa in the EU and the U.K., where it received marketing authorization in 2025.
Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions.
T-Curx GmbH has obtained clinical trial approval from the Swiss agency Swissmedic for the company’s nonviral lead CAR T program, TCX-001. The first-in-human phase I study will open in Switzerland, and a submission to the EMA will seek to expand the trial to sites in Germany. The study will enroll adults with relapsed or refractory acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), including patients not eligible for stem cell transplantation.
Antengene Corp. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for ATG-201 for the treatment of B-cell related autoimmune diseases.
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