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."

The Pennsylvania Department of Community and Economic Development (DCED) recently announced that Adare had relocated its global headquarters from New Jersey to Philadelphia, and has been supported by a $2.9 mn investment from the U.S. Governor Josh Shapiro Administration. Adare has committed a further $16.8 mn investment to expand its two Philadelphia manufacturing and packaging facilities. In all, at least 115 new jobs will be created and a further 200 existing Pennsylvania jobs retained. The DCED said that the move demonstrates both Pennsylvania and Philadelphia as a premier hub for life sciences.

Thermo Fisher Scientific is expanding its oral solid dose (OSD) development and manufacturing capabilities across North America with a $22 mn investment in its Cincinnati, Ohio, and Bend, Oregon sites. The expansion enhances R&D, manufacturing, and testing capabilities to support early drug development and accelerate clinical timelines, and the upgrades include new facilities for advanced drug delivery and formulation technologies, addressing challenges in solubility and bioavailability.

PCI Pharma Services is investing $365 mn to expand its facilities in the EU and US to enhance its capacity for advanced drug delivery and drug-device combination products. Key upgrades include a new center of excellence in Rockford, Illinois, and two new facilities in Dublin, Ireland, dedicated to injectable and oral solid dose drug packaging and assembly. This investment aims to support the entire lifecycle of complex therapies, from clinical development to commercialization.

Sanner Group has acquired Gilero LLC to strengthen its global medical device offerings. This acquisition enhances Sanner’s capabilities across drug delivery, diagnostics, and medtech device sectors, expanding its footprint in the US, Mexico, and Ireland. Gilero’s expertise in design, development, and contract manufacturing complements Sanner’s strategic growth plan to become a leading provider of end-to-end solutions in the medical technology field.

Nanoform and Celanese have expanded their collaboration to develop long-acting biologic drug delivery using small implants. This partnership combines Nanoform’s nanoparticle technology with the Celanese VitalDose® drug delivery platform to create controlled-release implants for biologics, and includes work on a new treatment for Multiple Sclerosis. The collaboration aims to improve patient adherence and outcomes through high-drug loading and customized release.