ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.

3P Innovation has won a Princess Royal Training Award for its Graduate Development Programme (GDP).

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

Curia plans to expand the site’s commercial capabilities with this move.

Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.

The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).

A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.

FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.

TriRx hosts various leaders at a ribbon-cutting ceremony for their new facility.

BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.

The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.

Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.

PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.