FDA complete response letters – in real time
The FDA plans to begin releasing Complete Response Letters (CRLs) in real time following their issuance to sponsors. In addition, the agency has published a backlog of 89 previously unpublished CRLs issued between 2024 and 2025. The goal, according to the FDA, is to increase transparency and provide stakeholders with a clearer understanding of the issues that can delay or block product approvals. The initiative is part of a broader policy shift under Executive Order 14303, which calls for greater disclosure of regulatory data relevant to public health and industry decision-making. All CRLs will be accessible through the openFDA platform.
Novartis to acquire Tourmaline Bio
Novartis is planning to acquire Tourmaline Bio in a transaction valued at approximately $1.4 billion. The acquisition has been approved by both companies’ boards and is expected to close in the fourth quarter of 2025, subject to customary regulatory approvals. Through the deal, Novartis will gain full rights to pacibekitug, an anti–IL-6 monoclonal antibody being developed for the treatment of atherosclerotic cardiovascular disease. Pacibekitug is designed to address residual inflammatory risk, a key driver of cardiovascular events not fully managed by lipid-lowering therapies. The candidate is phase III–ready.
“With no widely adopted anti-inflammatory therapies currently available for cardiovascular risk reduction, pacibekitug represents a potential breakthrough in addressing residual inflammatory risk in ASCVD with a differentiated mechanism of action targeting IL-6,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. "Inflammation is a major driver of cardiovascular disease, and the team at Tourmaline has made significant progress with this asset.”
Sandoz and Regeneron reach settlement in patent dispute
Sandoz has reached an agreement with Regeneron Pharmaceuticals to resolve all patent disputes regarding the aflibercept biosimilar, Enzeevu. Regeneron had filed infringement proceedings in August 2024 under the Biologics Price Competition and Innovation Act, asserting up to 46 patents protecting aflibercept (Eylea) until as late as 2040.
The settlement may allow Sandoz to launch Enzeevu in the US towards the end of 2026, or earlier under certain conditions. Enzeevu was approved by the FDA in August 2024, and has the same dosage form, route of administration, and presentation as Eylea. It is subject to a provisional interchangeability designation pending exclusivity expiry for the first interchangeable biosimilar.
MD Anderson and Phoenix’s cell and gene therapy safety agreement
MD Anderson Cancer Center has signed a global licensing agreement with Phoenix SENOLYTIX to expand the use of inducible switches in cell and gene therapies that could improve safety. These switches are designed to give doctors more control over engineered cells by including a built-in “off switch” that can be activated with a small-molecule drug called rimiducid. If serious side effects occur during treatment, administering rimiducid can quickly shut down or eliminate the modified cells. As part of the deal, MD Anderson will help Phoenix develop a new injectable version of rimiducid and will gain exclusive rights to use this formulation with Phoenix’s switch platforms in its cell therapy programs. The two organizations will also set up a joint advisory board to steer research and development.
Gene therapy partnership for childhood blindness
Andelyn Biosciences has agreed a partnership with Tern Therapeutics to support late-stage manufacturing of Tern’s investigational gene therapy for CLN2 Batten disease. Andelyn will conduct process performance qualification manufacturing for TTX-381, a one-time AAV gene therapy administered via subretinal injection. The therapy is designed to deliver a functional copy of the TPP1 gene to retinal cells, addressing progressive vision loss associated with CLN2 Batten disease, an ultra-rare pediatric neurodegenerative disorder that typically manifests in early childhood and leads to blindness by around age seven.
GLP-1s added to WHO’s essential medicines lists
The World Health Organization has updated its Model Lists of Essential Medicines, adding new therapies in oncology, diabetes, among other serious conditions. Among cancer treatments, the checkpoint inhibitors pembrolizumab, atezolizumab, and cemiplimab are now included, with pembrolizumab recommended as a first-line option for metastatic cervical, colorectal, and non-small cell lung cancers. In metabolic disease, the list now features GLP-1 receptor agonists semaglutide, dulaglutide, and liraglutide, as well as the dual GLP-1/GIP agonist tirzepatide, for adults with type 2 diabetes and obesity or related complications. The revisions also incorporate therapies for cystic fibrosis, psoriasis, hemophilia, and certain blood disorders, extending the lists’ scope beyond traditional essential medicines.
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