News

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

Eli Lilly & Company will pay Verve Therapeutics up to $525 million to advance a lipoprotein gene editing research program.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

Advanco’s acquisition of Vantage Consulting Group boosts its position as a provider of independent pharmaceutical serialization solutions.

The collaboration between the Pistoia Alliance and Matador Japan will work to accelerate research and promote access to a global pharmaceutical ecosystem.

Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.

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

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.

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.

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

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

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

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.

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.

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.