Expanded approval of Wegovy was based on results from the Phase III ESSENCE trial (NCT04822181), which demonstrated significant improvements in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis compared to placebo at 72 weeks.
Papzimeos is the first-and-only approved therapy for adults with recurrent respiratory papillomatosis.
Rob Abbott, CEO, ISPOR, highlights how emerging data strategies, advanced technology, and a renewed focus on patient needs are setting the direction for the next era of healthcare worldwide.
Rob Abbott, CEO, ISPOR, explains how health economics and outcomes research is helping healthcare systems measure the true value of treatments, improve patient outcomes, and address rising drug costs globally.
The milestone payment is partially funded through Sarepta’s Arrowhead stock sale as both companies push forward with promising RNA interference programs.
Fate Therapeutics, Generation Bio, and ORIC Pharmaceuticals join a growing list of companies implementing workforce reductions as they restructure operations, extend cash runways, and focus resources on advancing lead clinical programs amid challenging market conditions.
The collaboration will fund early-stage clinical development of SB-4826, CIT’s first-in-class SUMO E1 inhibitor, for patients with relapsed or refractory follicular lymphoma.
The project aims to enhance AbbVie’s chemical synthesis capacity to support next-generation neuroscience, immunology, and oncology medicines, with construction beginning in 2025 and operations slated for 2027.
Results from the Phase III NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214) trials demonstrated that ianalumab significantly reduces disease activity and shows a favorable safety profile in adults with active Sjögren’s disease.
Accelerated approval was based on results from the Phase Ib Beamion-LUNG 1 trial (NCT04886804), which showed a 75% objective response rate in patients with unresectable or metastatic non-squamous non-small cell lung cancer treated with Hernexeos.
Gene Mack, CEO of Gain Therapeutics, outlines the company’s strategic approach to advancing GT-02287 through potential collaborations and financing options as they await critical Parkinson’s disease trial data.
Results from the Phase III CONVOKE trial (NCT05838625) showed that CT-155 demonstrated a favorable safety profile consistent with previous studies in patients with schizophrenia.
The settlement ends US mRNA patent disputes involving COVID-19 and influenza vaccines, while positioning GSK for additional payments and global royalty benefits if BioNTech’s acquisition of CureVac closes.
Eli Lilly’s investigational, once-daily oral GLP-1 receptor agonist orforglipron produced a 12% body weight reduction in a Phase III trial, slightly lower than Novo Nordisk’s Wegovy.
The company is streamlining its global workforce as part of a multi-year cost-cutting strategy, while raising its 2025 outlook on the strength of key pharmaceutical products.
Modeyso is the first and only approved treatment for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one year and older.
Gene Mack, CEO, Gain Therapeutics, explains how the company’s Magellan AI platform analyzes novel protein binding sites to identify and design drug candidates beyond what’s currently available in the public domain.
Ajovy becomes the first-and-only calcitonin gene-related peptide agonist approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs.
The deal brings the FDA-approved neuroblastoma therapy Danyelza (naxitamab-gqgk) to SERB Pharmaceuticals and advances its expansion in rare and pediatric oncology.
Gene Mack, CEO, GAIN Therapeutics, highlights early Phase Ib data showing GT-02287 may enhance neuroprotection across a wider spectrum of Parkinson’s patients regardless of genetic status.
The AI-driven collaboration will use Syntekabio’s DeepMatcher platform to identify new therapeutic targets for MetaVia’s DA-1241 following promising Phase IIa trial (NCT06054815) results in patients with presumed metabolic dysfunction-associated steatohepatitis.
Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.
The supplemental New Drug Application is supported by data from the Phase II TRANSCEND FL trial (NCT04245839), which showed that patients treated with Breyanzi for relapsed or refractory marginal zone lymphoma demonstrated strong and lasting responses.
Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial (NCT05516992), reinforcing its potential as a non-surgical treatment for chronic low back pain associated with degenerative disc disease.
Following the discontinuation of ALLO-647 due to a treatment-related death, Allogene will move forward with a streamlined outpatient regimen aimed at accelerating enrollment and regulatory review in the Phase II ALPHA3 trial (NCT06500273).
Gene Mack, CEO, GAIN Therapeutics, outlines how early trial results for GT-02287 are shaping the company’s strategy for advancing a potential new treatment for Parkinson’s disease.
Gene Mack, CEO, GAIN Therapeutics, shares how growing clinician confidence and strong early experiences helped accelerate enrollment in the company’s Phase Ib Parkinson’s disease trial.
Facing patent expiration for its blockbuster Keytruda, Merck aims to streamline operations with significant job cuts and continued R&D investments.
The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.
Biotech firm aims to streamline operations and reinvest in high-growth areas such as oncology and rare diseases as it targets $1.5 billion in savings by 2027.
