All articles by Swagath Bandhakavi
Swagath Bandhakavi
EC grants approval to GSK’s fully liquid Menveo vaccine for invasive meningococcal disease
GSK stated that the fully liquid presentation streamlines the vaccination process, offering greater convenience for healthcare providers
AOP Orphan’s Rapiblyk gets FDA approval for supraventricular tachycardia
The approval includes the use of Rapiblyk for managing atrial fibrillation and atrial flutter in critical care settings within hospitals
SELLAS announces positive data from preclinical studies indicating ASXL1 mutations as predictor of response to SLS009 in solid cancers
Preselection method for cancers responding to SLS009: High efficacy of SLS009 observed in 67% of ASXL1 mutated solid cancers vs 0% in non-ASXL1 mutated cancers
FDA accepts Dupixent resubmission for review in chronic spontaneous urticaria treatment
The application aims to secure approval for the treatment of adults and paediatric patients aged 12 years and above with chronic spontaneous urticaria that is not adequately managed by H1 antihistamines
Syndax secures FDA approval for Revuforj to treat R/R acute leukaemia
The FDA approved Revuforj based on Phase 1/2 AUGMENT-101 trial data, which showed a 21% combined remission rate in 104 patients with R/R acute leukaemia
Merck receives positive EU CHMP opinion for Keytruda plus chemotherapy in unresectable non-epithelioid MPM
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
J&J seeks regulatory nod for Darzalex Faspro’s new indication in US and EU
The applications are supported by data from the ongoing Phase 3 AQUILA study, which is assessing Darzalex Faspro as a monotherapy for adult patients with high-risk smoldering multiple myeloma
Alteogen partners with Daiichi Sankyo to develop subcutaneous version of Enhertu
The agreement provides Daiichi Sankyo with global rights to utilise Alteogen’s ALT-B4 for the subcutaneous delivery of Enhertu
SystImmune announces FDA clearance of IND application for BL-M17D1 in advanced solid tumours
The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development
Avid Bioservices to go private in $1.1bn deal with GHO and Ampersand
Upon completion of the transaction, the Nasdaq-listed CDMO’s shares will cease to be publicly traded, though the company will continue to operate under the same name and brand