News

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.

The updated vaccine will be ready to ship following a positive European Commission review.

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

Royalty Pharma agreed to spend up to $500 million for a 5.1 to 8% royalty on net sales of Ferring’s gene therapy adstiladrin (nadofaragene firadenovec-vcng).

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.

Sartorius’ Biostat STR now incorporates Repligen’s XCell ATF hardware.

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

With this agreement, Chiesi Global Rare Diseases will co-develop drug delivery systems with Aliada Therapeutics for large molecule therapeutics that can cross the blood-brain barrier.

A major grant from the Bill & Melinda Gates Foundation will bolster efforts to fight the global HIV/AIDS epidemic.

The collaboration between Parexel and Partex is designed to leverage artificial intelligence-powered solutions to accelerate drug discovery and development.

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

Gilead and Tentarix established three multi-year collaborations to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases.

CPHI 2024 will return to the Fiera Milano in Milan, Italy.

The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

A report from the UK Bioindustry Association report indicated that biotech venture and public financing rose from £295 million in the first quarter to £382 million in the second quarter.

Cytomos will use the £4 million in funding to develop its dielectric spectroscopy technology.

Novartis has completed its acquisition of biopharma company Chinook Therapeutics.

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.