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Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.

The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

The new excipients manufacturing facility is expected to be completed in 2025.

The merger agreement states that Novartis will acquire all the shares of Chinook through a subsidiary for a price of $40 per share in cash at closing.

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.

This will allow industry leaders to make and sell the product, in addition to providing more choice to pharma and biotech companies.

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

Sartorius and Waters will collaborate to develop integrated analytical solutions for downstream biomanufacturing.

The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

Domino Data Lab's expanded platform includes a new project hub, additional cloud offerings, and the Model Sentry solution suite.

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

Lonza will gain access to R&D capabilities, including payload and site-specific linker technology, through its acquisition of ADC company, Synaffix.

Adamis Pharmaceuticals announced the closing of its merger with DMK Pharmaceuticals on May 25, 2023.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

Hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.

Through the acquisition, Avacta gains Coris’ product portfolio consisting of diagnostic tests for respiratory, gastroenteric, and blood-borne pathogens as well as for the detection of antibiotic resistance markers.

WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.

Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.

A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.

The start of production of US engineering batches of NXC-201, a CAR-T cell therapy candidate in early clinical development, is the first step in transferring Nexcella’s existing manufacturing process to the United States.

API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

Under the new MTA and Option License Agreement, Adcendo can nominate ADCs against two novel ADC targets, according to the press release.

The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.

The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.

The $87.5 million purchase grants Novartis rights to an investigational gene therapy program intended for treatment of cystinosis.