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.

Danish biotech, Zealand Pharma, has faced its second FDA rejection for its hypoglycemia drug - dasiglucagon - which is tied to manufacturing issues uncovered during a CDMO inspection. Despite the setback, Zealand said it remains committed to resolving the issues and pursuing approval for the drug, which is designed to treat severe low blood sugar in diabetic patients.

Several U.S. consumer groups and labor unions have asked the FTC to block Novo Holdings planned $16.5 bn acquisition of Catalent, amidst concerns that the potential deal could stifle competition in the market for GLP-1 receptor agonist drugs.

The groups argue that the acquisition would further solidify Novo Nordisk's leading position - dominated by Ozempic and Wegovy – and that this could potentially lead to higher prices and reduced access to these critical medications. They also contend that the deal could give Novo Nordisk control over Catalent's production facilities, and thus limit its rivals' ability to manufacture competing drugs. The move comes amid growing scrutiny from lawmakers - including the U.S. Senator Elizabeth Warren - who has also raised concerns about the merger’s potential to reduce competition. Senator Warren has asked the FTC to closely investigate the deal.

Ahead of CPHI Milan, a recently published survey shows positive growth predictions for CDMOs in 2025, despite concerns about the BIOSECURE Act. While 49% of respondents said they are highly optimistic about CDMO expansion, there are mixed views on the Act itself, with 38% of respondents suggesting it was politically motivated, 19% saying they perceive Chinese CDMOs as a threat, and 43% supporting the diversification of supply chains.

The Biosecure Act, recently passed by the U.S. House of Representatives, may force U.S. biotech and pharma companies to sever ties with major Chinese CROs and CDMOs, such as WuXi AppTec and Complete Genomics.

A significant FDA inspection backlog is delaying new drug approvals, particularly for drugs manufactured overseas. Exacerbated by the pandemic, the delay in regulatory approval impacts the availability of new treatments in the U.S. and could hinder the introduction of innovative therapies. Although the FDA is working on reducing the backlog, the delays are causing concerns across the pharmaceutical industry.

The Danish pharma giant’s latest obesity product, a cannabinoid CB1 receptor blocker, was linked to mild to moderate neuropsychiatric side effects in a Phase 2 clinical trial. While its prospect showed promise in addressing obesity, some trial participants experienced unwanted side-effects such as mood swings and mild cognitive changes. The company is closely monitoring these symptoms as it prepares for further trials. Despite these concerns, the company says its CB1 receptor blocker continues to offer hope for patients struggling with obesity.

The UK government has introduced legislation to ban xylazine and 21 other dangerous substances, including six highly potent synthetic opioids. Xylazine, a veterinary sedative also known as "tranq," is used illicitly to extend opioid doses and has caused severe health issues and overdose deaths. The new law categorizes xylazine as a Class C drug and other potent opioids as Class A, imposing strict penalties for production and distribution.

Immpact Bio announced that the FDA has cleared its IND application for a CD19/CD20, a bispecific CAR-T cell therapy for treating multiple sclerosis (MS). The therapy is designed to target and eliminate the B cells implicated in MS and offers a potential new treatment option for patients with this autoimmune disease.

Plasmid DNA (pDNA) manufacturer, VGXI, has been accepted as a member of the Biopharmaceutical Manufacturing and Advanced Preparedness BioMAP Consortium, allowing it to collaborate with industry leaders to enhance the preparedness and resilience of biopharmaceutical manufacturing.

India has waived the requirement for local clinical trials to fast-track the approval of new medicines, particularly those already approved in other major markets. This decision is aimed at accelerating availability to innovative treatments and therapies to benefit patients, whilst maintaining regulatory standards.

The U.S. FDA has approved the first-ever nasal spray designed to treat severe allergic reactions, including anaphylaxis. ARS Pharmaceuticals received the approval for their product - Neffy - the first epinephrine nasal spray that provides a needle-free alternative to traditional epinephrine injections, making it easier and quicker for patients to manage severe allergic reactions.

The FDA has opened a public docket seeking input on their new guidance for biosimilar product development, with the agency having invited stakeholders to provide feedback on scientific and regulatory considerations for biosimilar and interchangeable biologics. The initiative aims to refine and enhance the development process for these emerging products and encourages the scientific public to submit comments and suggestions to help shape future policies and regulatory frameworks.

The BIOSECURE Act's momentum may significantly raise drug development costs as U.S. companies reduce reliance on Chinese CDMOs like WuXi AppTec. The Act will restrict federal funding for biotech equipment and services from certain Chinese firms, pushing U.S. pharma companies to explore more expensive alternatives outside of the region, which could result in more complicated supply chains and increased expenses, particularly for small-to-mid-sized biotech's.

GLP-1 drugs - Ozempic, Wegovy, Mounjaro and others - first attracted attention for their ability to manage and aid weight loss in diabetes patients. With such profound results, the drugs soon found Hollywood notoriety, before becoming popular with everyday users looking to fast track their weight loss efforts. Unsurprisingly, expenditure of semaglutide - the active ingredient in these medications - reached $38.6bn in 2023.