Two phase III studies of Xiaflex show efficacy in Peyronie’s disease – Endo International

Endo International announced that new post-hoc data from two Phase III studies of Xiaflex (collagenase clostridium histolyticum, or CCH) in treating men with Peyronie’s disease (PD) will be presented in an oral presentation during the Sexual Medicine Society of North America (SMSNA) annual meeting. A post-hoc analysis of pooled data from two randomized, double-blind, placebo-controlled studies Phase III trials was […]

Cibinqo recommended for approval by CHMP for atopic dermatitis – Pfizer

Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The […]

Booster of COVID-19 vaccine administered six months after two-dose regimen of BNT162b2, shows substantial increase in antibody and T-cell responses – Johnson & Johnson

Johnson & Johnson announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, […]

Nucala is the first and only anti-IL-5 add-on treatment approved in Canada that targets eosinophilic inflammation in adults with chronic rhinosinusitis with nasal polyps – GSK

Nucala (mepolizumab) is now approved in Canada as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone. This is the fourth approved indication for Nucala for Canadian patients with eosinophilic driven diseases and is the first and only anti-IL-5 add-on treatment that targets eosinophilic inflammation […]

COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States – Roche

Roche has announced that the FDA has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old. The test is able to produce accurate, reliable and quick […]

FDA approves Tecartus for B-cell precursor acute lymphoblastic leukemia – Kite

Kite announced the FDA has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with […]

European Commission approves Ronapreve to treat of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union (EU) and other countries. The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who […]

Opdivo + Yervoy demonstrates durable overall survival at three years compared to chemotherapy in first-line unresectable malignant pleural mesothelioma – BMS

– Bristol Myers Squibb announced three-year data from the CheckMate -743 trial that demonstrated a durable survival benefit with first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to platinum-based standard-of-care chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM), regardless of histology. With a minimum follow-up of three years (35.5 months): i Among patients treated with Opdivo plus Yervoy, […]

Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity – Novo Nordisk

Results from the STEP 5 phase IIIb trial, presented by Novo Nordisk at the Obesity Week 2021 interactive congress, showed that adults treated with Wegovy (semaglutide 2.4 mg injection) achieved significant and sustained weight loss over the two-year study period . The STEP 5 trial investigated Wegovy vs. placebo, both used with a reduced calorie meal plan and increased physical […]

EU approves Qinlock for advanced gastrointestinal stromal tumor – Deciphera Pharma

Deciphera Pharmaceuticals announced that the European Commission (EC) has approved Qinlock (ripretinib) in the European Union (EU) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. The Qinlock approval was supported by efficacy results from the primary analysis of the pivotal Phase III INVICTUS […]