Following their existing lab-scale development partnership, global healthcare company Mundipharma and Vectura, the specialist inhalation CDMO, have announced they are to progress development of a more environmentally friendly reformulation of FLUTIFORM (fluticasone propionate/formoterol fumarate) pressurised metered-dose inhaler (pMDI).

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.

As the industry looks to find more effective ways to manage the rising burden of genetic, autoimmune, rare diseases, and cancers, the next 10 years could be significant for companies with an interest in biologics drug products. The sector – estimated to have been worth $460 bn in 2022 – is expected to grow significantly due to rising demand in emerging markets across Asia and Latin America.

The first and only oral CGRP receptor antagonist approved in the U.S. for preventing both episodic and chronic migraines in adults. The Phase 3 study of Qulipta (atogepant) demonstrated significantly reduced monthly migraine days compared to placebo over a 12-week period.

Regeneron Ventures has launched as a new $500 mn venture capital fund aimed at investing in early to late-stage life sciences companies. This initiative, which is part of Regeneron’s strategy to support innovative biotechnology and medical technology advancements, will target companies that are developing therapeutics, with a focus including genetic medicines, cancer treatments, and infectious diseases.

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.

Bloom Biorenewables have recently announced the successful completion of a production campaign in partnership with custom synthesis and contract manufacturer, Valsynthèse. This collaboration has led to significant advancements in scaling up aldehyde-assisted fractionation (AAF) technology to produce uncondensed lignin, a common feedstock used directly in polyurethane materials.

Another positive story for GLP-1 weight loss drugs has been announced, suggesting medications like Wegovy may have potential benefits in treating heart failure among patients with obesity and diabetes. Typically prescribed for weight management in high-risk populations, this positive news is likely to continue the high demand for these drug substances.

Nanoform and PlusVitech have partnered to repurpose the anti-nausea drug aprepitant, as a treatment for lung cancer using Nanoform’s nanomedicine technology. This collaboration aims to enhance the drug's efficacy through nanoparticle engineering, and reduce pill size and dosage complexity. Initial trials are focusing on patients with non-small cell lung cancer who are unresponsive to standard treatments.

Novo Holdings has strategically refilled its application following informal consultations with the U.S. Federal Trade Commission (FTC). The move resets a 30-day review period, with an option for a further 30-day extension, allowing the FTC to thoroughly analyse the implications of the proposed merger. 

Madrigal Pharmaceuticals' new drug, Rezdiffra, has recently been approved as the first treatment for metabolic dysfunction-associated steatohepatitis (MASH). Gastroenterologists, are highly optimistic about its potential in managing patients with moderate to advanced fibrosis and suffering from severe liver conditions such as cirrhosis.

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.

It seems that generic medicines can’t assume market dominance either. In a recent survey by GlobalData, nearly 40% of healthcare professionals said they would choose brand-name drugs over generics if cost was not a factor - particularly in countries (like Japan, Spain, and Italy) where brand loyalty is particularly strong.

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.

Head of R&D, Dr. Houman Ashrafian, announced a simplified structure aimed at reprioritizing the company’s pipeline and transforming Sanofi into an immunoscience leader by reallocating resources to accelerate high-potential programs.

Amylyx Pharmaceuticals has decided to withdraw its amyotrophic lateral sclerosis (ALS) drug, Relyvrio, from the market after it failed to meet the primary and secondary endpoints in its phase 3 trial.

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

In an all-cash payment, the deal will integrate Shockwave’s intravascular lithotripsy (IVL) technology with J&J's existing platforms like Abiomed's Impella as the company looks to build on its leadership in high-growth cardiovascular segments.

Genmab has acquired ProfoundBio for $1.8 bn as it marks its strategic entry into the antibody-drug conjugate (ADC) market. The purchase includes a pioneering ADC platform and three clinical-stage assets aimed at treating ovarian cancer and other solid tumours, with the ADC lead product demonstrating significant potential in advancing cancer ovarian cancer treatment.