Industry News

Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.

SpringWorks Therapeutics and the Dana-Farber Cancer Institute will conduct further research into the therapeutic potential of combination therapy with nirogacestat and anti-BCMA agents for multiple myeloma.

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

The IPEC Foundation announced its 2021 award winners, who will be honored at their annual award ceremony in Philadelphia.

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).

Insilico Biotechnology has joined the Inno4vac project—an innovative European public-private partnership aimed at accelerating vaccine R&D timelines.

The University of Southern California and Amgen have teamed up to provide researchers access to two of Thermo Fisher Scientific’s cryo-EM instruments.

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

Promega will demonstrate applications of bioluminescence tools at Discover Glo 2021.

Signal Rx Pharmaceuticals, Crystec, and ADYA Consulting are collaborating on the development of an inhaled dry powder formulation of SF2523 to treat pulmonary fibrosis, lung cancer, and SARS-CoV-2 related illnesses.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

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.

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

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.

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.

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

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

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

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.