All articles by Vidya Sagar Maddela

Vidya Sagar Maddela

Sarepta secures expanded FDA approval for its DMD drug Elevidys

The FDA approval expands Elevidys indication to include both ambulatory and non-ambulatory DMD patients aged at least 4 years, with a confirmed mutation in the DMD gene, and the approval is based on the totality of the evidence

J&J seeks FDA approval for Tremfya to treat active Crohn’s disease

The latest sBLA submission is based on results from the Phase 3 GALAXI program, which includes GALAXI 2 and GALAXI 3 studies, and is also based on results from the Phase 3 GRAVITI investigational study

Sobi granted EC authorisation for Altuvoct to treat haemophilia A

The EC authorisation was based on results from the Phase 3 XTEND-1 study in adults and adolescents and XTEND-Kids in children, which evaluated the efficacy and safety of Altuvoct in treating severe haemophilia A

Woolsey’s Bravyl shows positive outcomes in ALS clinical study

In the Phase 2a REAL study, an open-label, single-arm study, Woolsey’s investigational drug Bravyl showed a statistically significant reduction in neurofilament light (NfL), a key biomarker, and directionally improved clinical outcomes

Roche, Ascidian partner to develop RNA therapies for neurological diseases

The collaboration will combine Ascidian’s RNA Exon Editing platform with Roche’s next-generation CNS delivery capabilities to develop novel RNA therapeutics targeting difficult-to-treat neurological diseases

Marea Therapeutics Launches with $190m to Accelerate a New Generation of Medicines for Cardiometabolic Diseases

Leveraging large-scale human genetics to advance clinical-stage pipeline of first-in-class treatments that target critical, unaddressed and genetically validated causes of cardiometabolic diseases

AbbVie gets FDA approval for SKYRIZI to treat ulcerative colitis

The FDA approval is based on results from two Phase 3 clinical trials, INSPIRE and COMMAND, in which Skyrizi achieved clinical remission, the primary endpoint, along with endoscopic improvement, a key secondary endpoint

Merck secures FDA approval for 21-valent pneumococcal vaccine Capvaxive

Capvaxive is a 21-valent pneumococcal conjugate vaccine indicated for active immunisation of adults 18 years of age and above, to protect them from invasive disease and pneumonia caused by Streptococcus pneumoniae

Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer

Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab

Pyros secures FDA approval of Vigafyde to treat infantile spasms

Vigafyde (vigabatrin), designed to inhibit the enzyme GABA transaminase to increase the levels of gamma-aminobutyric acid (GABA) in the brain, is indicated for the treatment of paediatric patients with infantile spasms