The NHS will launch the world’s largest trial of a revolutionary new blood test that can detect more than 50 types of cancer before symptoms appear. The first people to take part will have blood samples taken at mobile testing clinics in retail parks and other convenient community locations. The NHS launches world first trial for new cancer test from […]
MacroGenics announced the final overall survival (OS) results of the SOPHIA Phase III study of Margenza (margetuximab-cmkb) in adult patients with metastatic HER2-positive breast cancer. The final OS analysis of the SOPHIA study was performed after 385 OS events occurred in the intent-to-treat (ITT) population. As per the study protocol, OS was defined as the number of days from randomization […]
The Bristol-Myers Squibb-Pfizer Alliance issued the following statement: We welcome the decision by the Court of Appeals for the Federal Circuit’s to affirm the U.S. District Court’s August 2020 decision finding the composition of matter (COM) patent (US 6,967,208) and formulation patent (US 9.326,945) covering Eliquis valid and infringed. Given today’s decision, the earliest that generic manufacturers are permitted to […]
Impel NeuroPharma, Inc. announced that the FDA approved Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa was previously known as INP 104. Using Impel’s proprietary Precision Olfactory Delivery (POD ) technology, Trudhesa gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich […]
Moderna announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The Phase II study of mRNA 1273 was amended to offer a booster dose of mRNA 1273 at the 50 µg dose level to […]
Moderna, Inc., announced it has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The Company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days. </p. The Phase II study of mRNA-1273 […]
Abbott has announced that the FDA approved the company’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The device offers immediate closure of the left atrial appendage (LAA) – an area where blood clots can form in people suffering from AFib – reducing their risk of stroke and […]
Pfizer Inc. announced that the FDA has approved Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. Ticovac is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas. Following today’s FDA approval, the U.S. Centers for […]
Astellas Pharma Inc.and FibroGen, Inc. announced that the European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney diseases (CKD). CKD impacts one in 10 people globally, of whom one in five are affected by anemia. Anemia of CKD is often untreated or not treated to target, and is associated […]
Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase III KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an […]
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