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.

Roche has received CE mark approval for its AI-enabled Accu-Chek SmartGuide continuous glucose monitoring (CGM) system, designed for adults with type 1 and type 2 diabetes on flexible insulin therapy. The system, which features a 14-day wear time and a one-step application process, uses predictive AI to provide real-time glucose predictions and assess hypoglycemia risk with clinical evaluations showing high accuracy, with 99.8% of glucose values within acceptable zones.

The FDA has issued a Complete Response Letter (CRL) to AbbVie for its Parkinson’s treatment ABBV-951 due to issues with a third-party manufacturer. The regulator did not highlight safety or efficacy concerns with the drug or its administration device.

Novo Nordisk has gained approval from China’s National Medical Products Administration (NMPA) for its obesity drug Wegovy, which will be marketed as NovoCare in China and consisting of the same compound, semaglutide, as that used in Ozempic.

The FDA has broadened the label for Sarepta Therapeutics’ Elevidys - a gene therapy for Duchenne muscular dystrophy (DMD). The therapy is now approved for all DMD patients aged 4 and older after the therapy showed meaningful clinical benefits in secondary measures, despite the trial missing its primary endpoint.

WuXi AppTec and WuXi Biologics saw significant stock gains (7% and 14%, respectively) after the BIOSECURE Act was unexpectedly excluded from the National Defense Authorization Act (NDAA). The Act, which targets foreign biotech companies over U.S. national security concerns, proposed cutting ties with certain Chinese firms by 2032.

The U.S. Federal Trade Commission (FTC) has proposed a rule change that will require pharmaceutical companies to file all pre-institution patent settlements with the Patent and Trademark Office (USPTO), with the ruling aimed at enhancing the FTC's ability to detect anticompetitive settlements that delay generic drug competition and keep drug prices high.

The FDA has introduced guidance for platform technology designations that is designed to streamline regulatory processes for biotech companies using ‘well-understood and reproducible technology’, such as specific nucleic acid sequences, vectors or delivery methods, to expedite subsequent drug applications.

In response to President Biden’s Executive Order 14081, the EPA, FDA, and USDA have jointly unveiled a plan to streamline the regulation of biotech innovations in plants, animals, and microorganisms.

The move comes amidst increasing geopolitical tensions and a U.S. biosecurity crackdown, in which it was alleged that the company transferred the data of a US client to Beijing ‘without consent’.

U.S.-based drugmaker Eli Lilly has settled with a medi spa that sold counterfeit versions of its diabetes drug Mounjaro and obesity treatment Zepbound.