New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. This suggests that the CDK7 enzyme complexes are involved in multiple functions in the cell: cell cycle control, transcription regulation and DNA repair. Oct 1 5;24(20):2303-16, 2010; Blazek et al., Konig et al.,

Production 62

Production DNA RNA Regulations 62

The Pharma Data

JULY 23, 2021

Outside Japan, the antibody combination has been authorised for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. The CHMP scientific opinion under Article 5.3 Lilly Antibody Therapies Around the World.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. Review will support a formal Marketing Authorisation Application.

Treatment 52

Treatment Vaccine Virus Trials 52