The Pharma Data

JULY 23, 2021

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. Roche’s Chief Medical Officer and Head of Global Product Development.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer. This deadly cancer has a 5-year survival rate of just 7%.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer. This deadly cancer has a 5-year survival rate of just 7%.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). Indeed, flavopiridol, a non-selective pan-CDK inhibitor that targets CTD kinases, has demonstrated efficacy for the treatment of chronic lymphocytic leukemia (CLL), but suffers from a poor toxicity profile (Lin et al.,). Inhibitors of CDK7 are currently being developed for the treatment of cancer.

Production 62

Production DNA RNA Regulations 62

The Pharma Data

MARCH 5, 2021

The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP scientific opinion under Article 5.3

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

MAY 7, 2021

The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

Treatment 52

Treatment Vaccine Virus Trials 52

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40