All articles by Manish Kumar
Manish Kumar
US FDA grants priority review to GSK’s gepotidacin for UTI treatment
The health agency has accepted GSK’s NDA based on results from Phase 3 EAGLE-2 and EAGLE-3 trials and granted a PDUFA action date of 26 March 2025
Merck’s Capvaxive shows strong immune response in at-risk adults
The STRIDE-8 trial found Capvaxive effective, demonstrating strong immunogenicity for all 21 strains included in the conjugate vaccine by Day 30
First targeted treatment to reduce the risk of ALK positive lung cancer returning after complete tumour removal recommended by NICE
For the first time, NICE has recommended a targeted treatment option for ALK-positive non-small-cell lung cancer, to be given after surgery to reduce the risk of the disease coming back
BARDA grants $119m contract to Synedgen for GI-ARS drug development
BARDA will support the development of Synedgen’s MIIST305 candidate to treat gastrointestinal injury caused by acute exposure to ionising radiation
Jazz reports positive results for Zepzelca in lung cancer trial
The combination of Zepzelca and atezolizumab showed significant improvement in OS and PFS compared to atezolizumab alone and was generally well-tolerated
Bayer submits EU marketing authorisation application for elinzanetant to treat moderate to severe vasomotor symptoms
EMA submission is based on data from Phase III OASIS development program for elinzanetant
Cycle Pharmaceuticals confirms $488m all-cash second bid for Vanda
In June this year, Cycle Pharmaceuticals made a proposal to acquire 100% of Vanda’s issued and outstanding shares for a cash consideration of $8.00 per share, representing a total cash consideration of $466m
Merck and Exelixis partner to assess new cancer combination therapies
Both companies will evaluate zanzalintinib with Keytruda in a Phase 3 trial for head and neck cancer, and with Welireg in Phase 1/2 and two Phase 3 trials for RCC
Bayer submits application for third indication of darolutamide in the EU
Submission is based on positive results from the pivotal Phase III ARANOTE trial
Roche gets FDA nod for Itovebi to treat PIK3CA-mutated breast cancer
The FDA approval is based on the Phase 3 INAVO120 study, in which the Itovebi regimen showed a statistically significant and clinically meaningful benefit, reducing the risk of death by 57%