News

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

The future is set to be a running theme for this year’s CPHI event, which will take place in-person at the Fira Barcelona Gran Via in Spain between 24–26 October 2023.

Here is a small selection of some of the inspiring places to visit while in Barcelona, Spain.

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.

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.

Aragen and FAR Biotech will collaborate to advance a small-molecule neurodegeneration program.

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.

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

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.

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

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.

Blueprint Medicines’ avapritinib has been approved by FDA for the treatment of indolent systemic mastocytosis.

Ironwood Pharmaceuticals’ acquisition of VectivBio grants it the rights to apraglutide, a glucagon-like peptide being evaluated for gastrointestinal diseases.

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

Alvotech and Advanz Pharma have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe.

UK government supports AMR research with significant cash injection, provided through the Global AMR Innovation Fund (GAMRIF).

ILC Therapeutics has entered into a strategic partnership with Dechra Pharmaceuticals to develop an atopic dermatitis treatment for dogs.

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 UK’s National Institute for Health and Care Excellence has recommended dapagliflozin (Forxiga) from AstraZeneca as a treatment option for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.