Bora Pharmaceuticals, the Taiwan listed CDMO with a growing U.S. network, has announced an agreement to acquire Emergent BioSolutions’ sterile manufacturing facility in Baltimore-Camden, Maryland.

It wasn’t so very long ago that progress in delivering systemic treatments, via new oral technologies, inhalables and via a plethora of alternative routes of delivery suggested that the days were numbered for invasive injections, but recent reports now suggests injectables will remain a mainstay of drug delivery for some time to come.

Since breaking ground in October 2022 and fresh from its IPO in September 2023, SCHOTT Pharma, the maker of drug containment solutions and delivery systems for injectable drugs, announced the culmination of a EUR 76 million investment with the opening of its new production facility in Lukácsháza, Hungary.

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.

With plenty of panels happening at BIO 2024, one convention discussion highlighted the transformative potential of gene therapy and the challenges of funding these high-cost, one-time treatments. Experts from bluebird bio, Vertex Pharmaceuticals, and other stakeholders emphasized the need for innovative payment models that reflect the long-term value of gene therapies.

A new report suggests that the global sterile injectable CDMO market is projected to reach $33.7 bn by 2034, driven by high demand for biologics, accelerated development timelines, and the shift towards end-to-end business models offering comprehensive services from API development to drug manufacturing.

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 latest product for automated lab integration, Heracell VIOS 250i AxD CO₂ Incubators feature automated door control for robotic handling and are designed to support optimal cell growth conditions and minimal contamination risk and support large-scale and automated cell therapy production for efficiency and safety.

Simtra BioPharma Solutions, the new name for Baxter International’s BioPharma Solutions (BPS), announced last week that work had started on constructing a 150,000 square foot extension to its facility in Bloomington, Indiana.

AstraZeneca says the acquisition will enhance its oncology portfolio with Fusion’s expertise in radioconjugates (RCs), a type of drug that combines radiation with a tumor-targeting agent.

GSK has secured a non-exclusive license to Elsie Biotechnologies' oligonucleotide discovery platform following a successful research collaboration.

South Korea's Lotte Biologics and Germany's Merck KGaA have signed a partnership to enhance biopharmaceutical production and process development as part of Lotte's "Bio Venture Initiative" at their Songdo Bio campus in South Korea.

Thermo Fisher Scientific has inaugurated a GMP-certified ultra-cold facility in Bleiswijk, Netherlands, to enhance its clinical trial network in Europe. This state-of-the-art facility supports the development of advanced therapies, including cell and gene therapies, biologics, and vaccines through comprehensive services, including ambient to cryogenic storage, clinical packaging, labeling, and distribution.

Kindeva Drug Delivery, the drug and device CDMO, is to expanding its facilities at its Charnwood campus in Loughborough, U.K. The expansion will support growth in demand for so-called green propellants, providing commercial-scale supply and doubling the company’s UK laboratory footprint.

The company will move its development services site from Skokie to Des Plaines, Illinois, where a construction project was announced to add new buildings for clinical manufacturing and related services. Vetter will also expand its commercial business at its 125-acre site in Saarland, Germany, to meet increasing customer demand for high quality injectables.

Sharp Services announced a significant expansion of its Macungie, Pennsylvania site, doubling its size to 315,000 square feet and enhancing production capacity for sterile injectable secondary packaging, including vial labeling, pre-filled syringe assembly, and autoinjector packaging. The expansion - driven by increasing demand for biologics and injectable medicines - will also add new packaging suites, cold storage, and create 75-100 new jobs.

Despite its parent company facing scrutiny and potential sanctions from the U.S. government, WuXi AppTec continues to expand its contract research, development and manufacturing organization (CRDMO) services in its native China.

Japan headquartered chemicals group, Asahi Kasei, is expanding its Bionova CDMO’s services to include plasmid DNA (pDNA) production for cell and gene therapy developers by establishing a new facility in The Woodlands, Texas, where it is set to begin research-grade pDNA production in early 2025 and GMP manufacturing later that year.

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.

Ask any executive why they think there are drug shortages, and they will no doubt blame some combination of the long-lasting impact of the global pandemic, inflation, energy costs and global conflicts.