Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse

Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024

USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab

Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor

Wipro to implement Independent Health’s Medicare prescription payment plan platform

Wipro's MPPP360 platform will assist Independent Health in streamlining the payment process to seamlessly integrate these new provisions

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met