The Pharma Letter10h
BioNTech throws weight behind drive for African vaccine capacity
The groups will work together to enhance Africa's vaccine infrastructure, with CEPI committing up to $145 million to ...
The Pharma Letter1d
EMA/CHMP May 2024 new medicines recommendations
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended eight novel drugs for approval at its May ...
The Pharma Letter15h
Positive top-line Phase II results for Soterios’ STS-01 in alopecia
Privately-held UK clinical-stage firm Soterios Pharma has announced positive multi-dose Phase II trial evaluating STS-01 as ...
The Pharma Letter14h
Another FDA approval for BMS’ Breyanzi
The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s (NYSE: BMY) Breyanzi (lisocabtagene maraleucel ...
The Pharma Letter9h
Moderna clocks up first approval outside COVID-19
Biotech firm Moderna (Nasdaq: MRNA) has won US Food and Drug Administration (FDA) approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 ...
The Pharma Letter11h
Novartis’ new remibrutinib Phase III data confirm value in CSU
Swiss pharma giant Novartis (NOVN: VX) today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in ...
The Pharma Letter10h
BRIEF—FDA acknowledges Astellas’ BLA resubmission for zolbetuximab
If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients. The BLA was resubmitted following a complete response letter issued by the FDA on ...
The Pharma Letter10h
Immunovant bets on IMVT-1402
Autoimmune diseases specialist Immunovant (Nasdaq: IMVT) has opted to prioritize the development of IMVT-1402 as its lead asset due to its broad potential across a number of indications.
The Pharma Letter14h
Phase III trial miss shakes faith in Gilead's Trodelvy
The study is comparing the first-in-class Trop-2-directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) with chemotherapy, in people with advanced or metastatic bladder cancer ...
The Pharma Letter13h
News - Treatment of chronic obstructive pulmonary disease
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) ...
The Pharma Letter13h
News - Soterios Pharma
The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, ...
The Pharma Letter15h
FDA delays review of Dupixent for the treatment of COPD
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab ...