News

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.

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.

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.

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.

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 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.

Gilead Sciences and Arcus Biosciences have expanded their research collaboration to include inflammatory diseases in addition to oncology.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

Astellas and Sony will collaborate to discover a novel ADC platform for use in oncology.

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

Avirmax’s new gene therapy facility in Hayward, Calif., will specialize in AAV gene therapy research and development.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.