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GSK’s Arexvy gets Japan’s MHLW nod for Arexvy to prevent RSV in older adults
The approval was given based on the results from the AReSVi-006 Phase 3 vaccine efficacy trial that enrolled around 25,000 participants from 17 countries
Regeneron completes acquisition Of Decibel Therapeutics, adding Promising Gene Therapy Programs For Hearing Loss
The acquisition of Decibel builds on prior collaboration between the companies and includes three ongoing gene therapy programs targeting different forms of congenital, monogenic hearing loss
Lilly, Boehringer’s Jardiance secures FDA approval for CKD treatment
The approval was based on the data from the EMPA-KIDNEY trial in which Jardiance showed a 28% relative risk reduction compared with placebo, both on top of standard care
Jazz Pharmaceuticals gets EC approval for Enrylaze to treat ALL and LBL
The EC approval was based on findings from the Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group (COG) in a group of 228 paediatric and adult patients
Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial
First Phase III results in breast cancer for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan
Glenmark to divest majority stake in Glenmark Life Sciences for $680m
The deal will enable Glenmark Pharma to concentrate on its line of branded drugs for the treatment of skin and respiratory conditions and help the pharmaceutical firm to make investments in product development for the expansion of its market presence in Latin America, some regions of Europe, and India
Novo, Gurnet Point wrap up $462m acquisition of Paratek Pharmaceuticals
The flagship product of Paratek Pharmaceuticals is Nuzyra (omadacycline), an oral and intravenous antibiotic approved for use in the US, in adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, particularly for patients with comorbidities or suspected resistant pathogens
Cyclo Therapeutics to merge with Applied Molecular Transport
The merged entity will initially focus to advance Cyclo’s Phase 3 global TransportNPC study that is evaluating investigational Trappsol Cyclo for Niemann-Pick Disease Type C1
U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
FDA Orphan Drug Designation (“ODD”) qualifies one-time treatment NXC-201 for 7 years of U.S. market exclusivity after approval
Menarini Group’s Orserdu gets EC approval for breast cancer treatment
The approval was supported by data from the Phase 3 EMERALD trial in which Orserdu showed statistically significant progression-free survival (PFS) versus standard-of-care