Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

GSK immunotherapy

- PMLiVE

Merck, Eisai’s Keytruda/Lenvima regimen scores full approval in endometrial cancer

Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process

Bayer symbol

Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

In 2019, Bayer bought out its private equity partner Versant Ventures and founders in BlueRock Therapeutics for $240m

- PMLiVE

Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery

The FDA had previously rejected a supplemental biologics licence application in this indication

- PMLiVE

FDA advisory committee votes against approval of AZ, FibroGen’s roxadustat

Briefing documents published earlier this week raised questions over the safety profile of roxadustat

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

FDA rejects Provention Bio’s type 1 diabetes prevention drug

FDA said a study of healthy volunteers failed to demonstrate that the planned commercial product is comparable to an older version used in previous clinical trials

- PMLiVE

Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

- PMLiVE

Roche’s gantenerumab improves biomarkers in inherited form of Alzheimer’s disease

However, anti-amyloid antibody did not show evidence of cognitive benefit for patients

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links