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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.

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.

This agreement is intended to be executed and see the impact of any financial transfers by the fiscal year ending March 31, 2024.

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

The new CGMP facility is expected to contribute to the development of mRNA therapeutics, with a building designed for the CGMP manufacture of mRNA-based in-vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.

The facility is based on a state-of-the-art design concept that allows maximum flexibility for a multi-product, multi-platform offering.

The current lack of standardization within the industry can be attributed to the recent rapid growth of the cell therapy market and the associated drive to improve the efficiency and cost-effectiveness of production.

uBriGene Biosciences will acquire Mustang Bio’s Worcester, Mass., CGT manufacturing facility in a deal worth up to $11 million, expanding its operations into the US market.

With $73 million in financing from investment firms, Myeloid Therapeutics plans to accelerate its lead clinical candidate into Phase I/II development for treating solid tumors.

The pin-point system is completely modular, allowing for different components to be selected for optimal performance specific to the gene targets.

ProBioGen’s Lenti.RiGHT is a lentivirus production platform for use in gene transfer applications.

Sania Therapeutics has emerged from stealth mode and launched its technology platforms for enabling the development of novel therapeutics to treat neural circuit dysfunction.

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

The new partnership hopes to increase funding and awareness of global health security challenges and highlight the role of the pharmaceutical industry in increasing access to medicines and improving health worldwide.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.