The U.K.’s Medicines & Healthcare products Regulatory Agency’s ‘sandbox’, AI Airlock, will be used to create simulated environments to address regulatory challenges associated with AI as a Medical Device (AIaMD).

The FDA has approved Lumicell's LumiSystem, which combines the company’s FDA approved optical imaging agent with its direct visualization system. The imaging system will help surgeons identify residual cancer cells during breast cancer surgeries, and claims 84% diagnostic accuracy.

After multiple manufacturing setbacks, the strategic commercialization partnership has finally seen U.S. FDA approval for Simlandi, their biosimilar to Humira. Simlandi is a high-concentration biosimilar with interchangeability status for Humira (an antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis), allowing it to be substituted at pharmacies without a prescriber's approval.

The FDA has placed a clinical hold on Neumora Therapeutics' schizophrenia drug due to safety concerns identified in preclinical studies. The drug - a highly selective positive allosteric modulator of the M4 muscarinic receptor - was put on clinical hold to further investigate the safety signals that emerged during the preclinical phase, indicating potential risks that need to be addressed before continuing with human trials.

A study analysing 129 fast track cancer medication approvals between 2013 and 2023 has failed to demonstrate survival benefits after five years. The accelerated approval pathway, initially introduced to expedite treatments for urgent health crises like HIV/AIDS, has predominantly been applied to oncology drugs.

The U.S. FDA has approved Johnson & Johnson’s CARVYKTI as the first and only B-cell maturation antigen (BCMA)-targeted therapy for adult patients with relapsed or refractory multiple myeloma, based on the Phase 3 CARTITUDE-4 study results that demonstrated a 59% reduction in disease progression or death risk compared to standard treatments.

Novartis is set to expand the use of its radiotherapy drug Pluvicto to earlier stages of prostate cancer following positive survival data from its phase 3 PSMAfore trial. Originally delayed, this decision comes after new analyses showed a survival benefit, contradicting earlier data suggesting a risk increase.

The FDA has approved Basilea Pharmaceutica's Zevtera (ceftobiprole medocaril sodium) for the treatment of several bacterial infections.

Terumo Europe has initiated a study to evaluate the safety and efficacy of BioPearl microspheres, designed for treating unresectable hepatocellular carcinoma (HCC) with doxorubicin.

The FDA has approved two groundbreaking treatments for Pulmonary Arterial Hypertension (PAH): OPSYNVI®, a once-daily tablet combining macitentan and tadalafil from Johnson & Johnson, and Merck's Winrevair (sotatercept-csrk), a first-in-class therapy.

The FDA has rejected Regeneron's application for odronextamab, aimed at treating two forms of lymphoma, due to incomplete confirmatory trial enrolment.

Illumina's appeal against European Commission’s fine has seen a positive development after it was suggested by the Court of Justice of the European Union (ECJ) that the EC lacked jurisdiction over the Grail takeover, as Grail's revenue did not meet EU turnover thresholds.

Following on from the lead story in this newsletter, BioNTech are facing issues related to their success during the pandemic. The company has received a notice of default from the National Institutes of Health (NIH), the U.S. medical research agency, alleging unpaid royalties on its COVID-19 vaccine Comirnaty, developed in partnership with Pfizer.

As election campaigns in the US begin to ramp up, Big Pharma continues to battle Biden’s plans to introduce negotiations for drug pricing.

A lawsuit led by a cystic fibrosis patient will see Vertex accused patent abuse and of violating patients’ human rights under the country’s constitution.

The company has received approval for Trikafta, a drug that can transform the lives of people with cystic fibrosis, but costs more than $300,000 per patient, per year.

Recent FDA warning letters have highlighted data integrity issues at pharmaceutical manufacturing sites, particularly concerning microbiology and environmental monitoring.

The FDA has granted breakthrough therapy status to the LSD-like substance MM120, developed by Mind Medicine Inc., to speed up the development and review for the treatment for generalized anxiety disorder (GAD).

Initially developed for type 2 diabetes - and its effectiveness in reducing food cravings and slowing stomach emptying - Wegovy has found fame in its ability to aid weight loss.

The UK's MHRA has authorized a new formulation of XGEVA (denosumab) through the new International Recognition Procedure (IRP) in just 30 days.

The MHRA recently issued new guidance designed to streamline the assessment process for established medicines, implemented since March 1, 2024.