As a result of the capability to be used across multiple therapeutic programs, the U.S. regulatory body has granted Sarepta’s AAVrh74 platform with platform technology designation.

This approval, which was based on the results of a Phase III trial demonstrating a higher relative efficiency of the new vaccine compared with the old version, marks the third for the company from the FDA.

The recombinant protein-based, non mRNA vaccine has been granted full marketing approval to prevent COVID-19 in adults aged 65 years and older and patients aged 12–64 years who are at risk of severe infection due to underlying conditions.

The oral combination therapy has been shown to provide a significant overall response rate in LGSOC patients with disease progression despite prior systemic treatment.

The European regulatory body’s safety committee has started its review of the vaccine after receiving reports of serious adverse events in elderly patients.

After a successful AI-assisted scientific pilot review, the agency has decided to implement the use of AI across all centers in an accelerated timescale.

The bispecific monoclonal antibody has demonstrated robust and durable responses in patients with relapse/refractory multiple myeloma.

Supported by clinical trial data, this new indication for upadacitinib provides GCA sufferers with an alternative treatment option that can achieve sustained remission.

The monoclonal antibody therapy is now the first and only treatment approved for patients with IgG4-RD.

Medical technology company, Terumo, has announced that it has received Medical Device Regulation (MDR) approval for an expanded indication of its Ultimaster Nagomi™ and Ultimaster™ Tansei™ stent systems.

Johnson & Johnson (J&J) has filed a lawsuit against Samsung Bioepis, alleging a breach of their 2023 agreement concerning the launch of Pyzchiva, a biosimilar to J&J's Stelara. The dispute centers on Samsung's attempt to sublicense Pyzchiva to a private-label distributor, a move J&J contends violates their settlement terms.

Merck expects its leading cancer drug, Keytruda, to be included in government price negotiations under the IRA starting in 2026 as its U.S. patent expires at the end of 2028. In 2024, Keytruda accounted for 46% of Merck’s total sales, and Merck’s CEO has expressed that price-setting via Medicare could limit the development of new therapies.

The U.S. government has awarded Moderna USD 590 mn to advance its mRNA-based avian influenza vaccine, mRNA-1018, into late-stage clinical trials amid rising human H5N1 infections. The funding also supports clinical studies for up to five additional pandemic influenza subtypes.

Eli Lilly has requested to join a lawsuit opposing compounding pharmacies and the FDA over the agency's determination that Lilly's weight-loss and diabetes drugs are no longer in shortage.

The European Commission has granted unconditional approval for Novo Holdings A/S to acquire Catalent, Inc., with the acquisition expected to close by the end of 2024. Catalent's CEO Alessandro Maselli has welcomed the approval, while Novo Holdings' Senior Partner Jonathan Levy affirmed their commitment to supporting Catalent's future growth. The transaction remains subject to final regulatory clearances and closing conditions.

The BIOSECURE Act - intended to address national security concerns by restricting U.S. government contracts with certain Chinese biotechnology companies - has been omitted from the 2025 National Defense Authorization Act (NDAA), providing a temporary reprieve to targeted Chinese firms like WuXi AppTec, WuXi Biologics, and BGI Group.

The possible appointment of Robert F. Kennedy Jr. to a cabinet position has ignited fierce controversy in the U.S.; raising questions that could reshape the pharmaceutical industry and challenge the direction of federal scientific agencies.

With a well-publicized history of being a vaccine sceptic, Kennedy’s track record suggests a blend of reformist zeal and controversial positions that could redefine the role of agencies he is likely to oversee – the FDA, NIH and CDC.

Earlier this year, the FTC requested additional information regarding Novo Holdings’ proposed acquisition of Catalent, but now, the EU antitrust regulators have announced they are probing the deal for anti-competitiveness impacts surrounding injectables, pre-filled syringes, orally dissolved pills and soft gels.

The FDA has removed Novo Nordisk's weight-loss drug, Wegovy, from its drug shortage list, indicating that all dose strengths are now available, as Novo Nordisk's efforts to increase production meet the high demand for GLP-1 therapies like Wegovy and Ozempic.

The FDA's action comes shortly after removing Eli Lilly's tirzepatide-based drugs, Mounjaro and Zepbound, from the shortage list.

The UK government has pledged up to £520 mn through the Life Sciences Innovative Manufacturing Fund (LSIMF) to drive economic growth and enhance the National Health Service (NHS). The fund will support capital investments across the life sciences sector - providing grants for the manufacture of human medicines, including active pharmaceutical ingredients (APIs) and finished products, medical diagnostics for disease identification and monitoring, and MedTech products related to human health.

The initiative aims to strengthen the UK’s position in life sciences while simultaneously ensuring the NHS is equipped for future healthcare needs, as well as to support innovation and expand manufacturing capabilities across the UK.