ABBVIE

IGM Biosciences shifts to autoimmune research, cutting oncology jobs. Metsera partners with Amneal for obesity drug production. Gritstone Bio explores strategic options. UCB plans a trial comparing Bimzelx to Skyrizi for arthritis treatment.

The BIOSECURE Act aims to reduce US dependence on Chinese biopharma manufacturing, impacting supply chains and partnerships. The bill, passed by the House, restricts government contracts with Chinese 'biotechnology companies of concern,' affecting ~80% of US biopharma firms reliant on Chinese CDMOs. Industry responses include investment in biomanufacturing capacity and strategic partnerships, with new contracts with Chinese partners declining since the Act's introduction.

AbbVie submitted a Biologics License Application for Teliso-V, an investigational ADC targeting c-Met overexpressing NSCLC, to the FDA. Supported by Phase 2 LUMINOSITY trial data, Teliso-V aims to address unmet needs in NSCLC treatment, potentially becoming the first therapy for this specific patient population.

Tavapadon, a dopamine agonist, significantly improved motor function in early-stage Parkinson’s patients in the Phase 3 TEMPO-1 trial. Both 5 mg and 15 mg doses showed significant decreases in MDS-UPDRS scores compared to placebo, indicating improved motor function. The therapy's safety profile was consistent with previous trials, with most adverse events being mild to moderate. Data from TEMPO-2 and TEMPO-3 trials further support tavapadon's potential as a new treatment option for Parkinson’s disease.

AbbVie filed a BLA with the FDA for Teliso-V in NSCLC patients with EGFR wild type, nonsquamous, c-Met overexpression. The application is based on the Phase II LUMINOSITY trial results, showing 35% ORR in c-Met High and 23% in c-Met Intermediate patients, with median DoR of 9 and 7.2 months, and median OS of 14.6 and 14.2 months, respectively.

AbbVie seeks FDA accelerated approval for Teliso-V, targeting c-Met overexpressing NSCLC patients with limited treatment options. Supported by Phase 2 LUMINOSITY trial data, Teliso-V aims to address unmet medical needs in NSCLC, a leading cause of cancer deaths. Phase 3 TeliMET NSCLC-01 study further evaluates its efficacy.

AbbVie submitted a BLA to the FDA for accelerated approval of Teliso-V, targeting c-Met overexpressing NSCLC, based on phase II LUMINOSITY study data showing ORRs of 35% and 23% in c-Met high and intermediate patients, respectively. If approved, Teliso-V would be the first therapy for this indication. AbbVie's shares have risen 25.7% YTD.

Stay updated on biopharmaceutical advancements with the Synapse database, offering daily or weekly insights on drugs, targets, indications, and organizations.

AbbVie submitted a Biologics License Application for Teliso-V, a first-in-class ADC targeting c-Met overexpressing NSCLC, based on Phase 2 LUMINOSITY trial data. If approved, it would address unmet needs in NSCLC treatment, offering hope for patients with poor prognosis.

AbbVie submits BLA to FDA for Teliso-V, an ADC targeting c-Met overexpressing NSCLC, supported by Phase 2 LUMINOSITY trial data. If approved, Teliso-V would be the first-in-class therapy for this patient population.