BioDuro-Sundia, the U.S. headquartered contract research, development and manufacturing organization (CRDMO), has opened a new kilo laboratory at its R&D campus, located in the Free-Trade Zone of Shanghai, China. Kilo labs provide pilot-scale production and enable scale-up synthesis for drug substance. The company said the investment will further enhance its ability to accelerate more drug candidates from discovery through to preclinical and clinical phases to meet the growing demands of its global partners.

The opening follows closely behind that of a new compound management center at the same site, which enabled the site to store and handle clients’ compounds at the drug discovery phase.

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.

As the 2024 U.S. election between Donald Trump and Kamala Harris approaches, the biopharma industry is keenly watching how each candidate's policies could shape the future of the sector.

Although the Inflation Reduction Act (IRA) has already set the stage for significant changes in drug regulations, neither candidate is expected to completely overhaul the current regulatory framework due to the IRA and a divided Congress, but their differing approaches could lead to important shifts in the industry.

The 2024 Nobel Prize in Physiology or Medicine has been awarded to Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (miRNA) - a class of small RNA molecules that play a crucial role in gene regulation. Their research revealed a new mechanism that controls gene expression, which is essential for cellular function and development, which has significantly expanded the understanding of gene regulation and its impact on diseases like cancer and diabetes.

An AI proof-of-concept study from Dandelion Health has identified an additional 44 million lower-risk cardiovascular patients who could benefit from a GLP-1 treatment. Using inclusion criteria similar to the Novo Nordisk-sponsored trial that helped convince the FDA that Wegovy had heart benefits, Dandelion examined whether GLP-1 use might reduce the risk of major adverse cardiac events such as heart attack or stroke in overweight and obese patients in lower-risk patients that didn’t have severe pre-existing cardiovascular disease.

Clinical-stage biopharmaceutical - OnKure Therapeutics - has finalized its merger with Reneo Pharmaceuticals and raised $65 mn through a private investment as the company looks to accelerate the development of their mutant-specific PI3Kα inhibitor portfolio.

AstraZeneca has signed an exclusive license agreement with CSPC Pharmaceutical Group for a preclinical small molecule called YS2302018. The molecule, an oral Lp(a) disruptor, will be developed as a lipid-lowering therapy alone or in combination with AstraZeneca’s oral PCSK9 inhibitor, AZD0780, as the company targets dyslipidaemia - a major risk factor for cardiovascular diseases such as coronary artery disease and stroke.

Biotech startup Judo Bio has secured $100 mn in funding to pioneer oligonucleotide medicines delivered to the kidney using a novel approach to create medicines. Preclinical studies successfully demonstrated the receptor-mediated delivery of oligonucleotides with proprietary ligand-siRNA conjugates that silence multiple target genes. The financing will be used to advance the lead ligand-siRNA conjugate to the clinic and to further build the company’s proprietary STRIKE (Selectively Targeting RNA Into KidnEy) platform. Rajiv Patni, a seasoned pharmaceutical leader including roles at Pfizer, Roche, and Actelion, has been appointed as CEO to steer the company's growth.

Global CDMO, Recipharm, and integrated pharmaceutical specialists, Exela Pharma Sciences, have established a strategic alliance to enhance sterile manufacturing capabilities in the U.S. This partnership will leverage Exela’s FDA-approved facility with a focus on sterile injectables and complex biologics as both companies look to expand production capacity and offer comprehensive solutions for biopharmaceutical clients across U.S. and global markets.

CDMO, Afton Scientific, is investing $200 mn to expand its sterile injectables manufacturing facility in Charlottesville, Virginia to significantly boost production capacity of which will create 200 new jobs. The project aims to strengthen Afton’s position in the sterile manufacturing market and support both current and future clients with enhanced capabilities for high-demand sterile products.

Cell and gene therapy experts, Dark Horse Consulting, has acquired BioTechLogic, a leader in biopharmaceutical CMC and manufacturing consulting, to expand the company’s capabilities in cell and gene therapy, biologics, and vaccines. By combining expertise, Dark Horse aims to optimize development timelines and resources for CGT clients by enhancing technical operations and quality support.

South Korean vaccine developer, SK bioscience, has completed the acquisition of German CDMO IDT Biologika as the company looks to double its sales by 2028 by investing in high-growth businesses that include late-stage cell and gene therapy (CGT) and recombinant vaccines.

As part of the ambition, the company is expected to launch next-generation pneumococcal vaccines, maximize the utilization rate of IDT Biologika’s drug substance and drug product manufacturing facilities, and add additional cell line manufacturing and recombinant vaccine development technologies to pursue new CDMO contracts for mid- to large-scale products.

MRNA and lipid nanoparticle manufacturing experts, Vernal Biosciences, have announced the launch of its integrated analytical and QC services for plasmid DNA, mRNA, and lipid nanoparticles, as commercial services for customers’ complex analytical requirements in mRNA medicine development.

Vernal aims to support drug developers in evaluating CQAs and expediting timelines, whilst maintaining high safety and efficacy standards without compromise. Their state-of-the-art facility in Colchester, Vermont, offers access to advanced analytical technologies, including HPLC, UPLC-MS, digital PCR and nanopore sequencing to customers looking to streamline the development process and minimize costs.

Aptar Pharma has announced a 28,500 sq ft expansion to its manufacturing facility in Congers, New York, as it looks to support the growing demand for prescription and consumer healthcare proprietary drug delivery systems in North America. The extension to its existing facilities will enhance cleanroom, warehousing, and manufacturing capabilities, supporting Aptar’s products including Unidose Nasal Spray for opioid reversal and neffy, the first and only needle-free treatment approved by the U.S. FDA for the emergency treatment of patients with allergic reactions.

Hurricane Helene was the second major hurricane of the 2024 Atlantic hurricane season as it hit the southeastern United States just two weeks ago. Sadly, over 200 people have already lost their lives, and Initial estimates suggest it to be the eighth costliest U.S. hurricane on record.

Global medtech company, Baxter International, faced the full force of the natural disaster as its North Cove facility in North Carolina was affected by flooding due to the storm and has been forced to cease production since. Although no structural damage to the plant has been identified (so far), remediation efforts are ongoing to provide temporary transport in and out of the facility and ensure the necessary electrical and water supplies to the plant are ready for when production can resume.

Avenacy, the injectable medicines company, will use the Milan show to showcase the successful launch of 13 FDA-approved injectable medications within its first year of operations. The company is on track to reach 25+ product launches in its first two years, aiming to address critical drug shortages in the U.S. market. With a growing portfolio, Avenacy will also discuss its unique packaging solutions and plans for further expansion.

Watson-Marlow Fluid Technology Solutions will present its new WMArchitect™ single-use fluid management solutions and a range of peristaltic pumps in Milan. On show will be the the DriveSure OEM pump with advanced digital control and Flexicon PF7+ for small-batch applications, and the company will also showcase their Aflex Hose solutions designed for biopharmaceutical processes.

IFF Pharma Solutions will showcase new excipient technologies at CPHI 2024, including low nitrite microcrystalline cellulose grades and ultrapure alginate biopolymers designed for safer pharmaceutical formulations. Highlights include the NOVAMATRIX-3D™ system for 3D cell cultures and new sustainable packaging for POLYOX™ WSR resins, with the innovations aimed at addressing nitrosamine risks, supporting biotech applications, and enhancing drug product stability.

Bormioli Pharma, the designers and manufactures of pharmaceutical packaging solutions, will showcase its sustainable and high-quality primary packaging solutions in Milan next week, presenting its EcoPositive product line that features over 3,000 glass and plastic packaging solutions made from recycled and renewable materials. The products have been designed with the aim of reducing environmental impact while maintaining pharmaceutical safety. The EcoPositive product line now accounts for half of Bormioli's catalogue, supporting its “50-in-5” strategy to achieve 50% sustainable materials by 2025.

BioDuro-Sundia, the U.S. contract research, development and manufacturing organization (CRDMO) with facilities with facilities in the U.S. and China, has launched new compound management center at its Waigaoqiao site in the Shanghai Free-Trade Zone, China. The new center enables the systematic storage, handling, and management of compounds.

Dr. Armin Spura, CEO of BioDuro-Sundia commented that the center will “Offer clients faster, more reliable solutions to bring their new drug candidates to market, benefiting patients."