Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

EMPA-KIDNEY trial showed significant benefit of Jardiance in reducing kidney disease progression

Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses

Quinten Health closes its financing round to advance disease modeling platforms

Quinten Health will announce in the coming months strategic partnerships with big pharma companies and data owners to launch the first disease modeling platforms.

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares

Lupin and I'rom signs licensing agreement for Denosumab biosimilar for Japan

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union

Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate

This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.

Ascentage Pharma and Tanner Pharma Group initiate a global innovative named Patient Program

Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.