August 1, 2023

Vyalev a continuous subcutaneousinfusion for Parkinson’s disease is now launched in Japan – AbbVie

AbbVie has launched Vyalev (foslevodopa + foscarbidopa), a continuous subcutaneous infusion for Parkinson’s disease, in Japan on July 26. This is the first Parkinson’s drug in the country that can be continuously infused for 24 hours without requiring surgery. In Japan, Vyalev was approved in December 2022 for the improvement of wearing-off symptoms in Parkinson’s inadequately controlled with existing pharmacotherapies […]

admin Health 0 45 sec read
July 31, 2023

CHMP recommends Abrysvo the first RSV vaccine to protect infants up to 6 months of age and older adults – Pfizer

The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy. It is also indicated for […]

admin Health 0 1 min read
July 30, 2023

Twice-yearly lenacapavir demonstrates sustained impact on health-related quality of life in people with HIV – Gilead Sciences

Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical […]

admin Health 0 3 min read
July 25, 2023

CHMP recommends Lyfnua as a treatment for refractory or unexplained chronic cough – Merck Inc

Merck Inc., known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The CHMP’s recommendation will now be […]

admin Health 0 1 min read
July 24, 2023

First-line Opdivo plus chemotherapy provides survival benefit in metastatic urothelial carcinoma (bladder cancer) – BMS

Frontline treatment with the combination of nivolumab (Opdivo) and cisplatin-based chemotherapy, followed by nivolumab monotherapy, led to a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared with standard cisplatin-based chemotherapy regimens alone in previously untreated, cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma, according to data from the phase III CheckMate-901 trial (NCT03036098). The study met […]

admin Health 0 1 min read
July 23, 2023

FDA grants De Novo Marketing Authorization for KidneyIntelX.dkd to assess risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease – Renalytix plc

Renalytix plc announces that the FDA has granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance […]

admin Health 0 57 sec read
July 22, 2023

Biotronik receives FDA approval for next-generation family of pacemakers

Biotronik announced FDA approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management. Amvia Edge, the market’s smallest single-chamber MR conditional pacemaker, introduces a unique set of patient-centric clinical solutions coupled with automated workflow efficiency. Amvia Edge pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology, which uses always-on, dedicated […]

admin Health 0 1 min read
July 21, 2023

European Commission grants conditional approval for Lytgobi to treat cholangiocarcinoma – Taiho Oncology Europe

Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for Lytgobi (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA). The authorisation is based on the data from the global, open label FOENIX-CCA2 trial. It enrolled a total of 103 adult patients from the Netherlands, UK, Spain, Italy, France, and Germany. Patients with […]

admin Health 0 32 sec read
July 20, 2023

Phase III TRuE-AD3 study of Opzelura meets primary endpoint in atopic dermatitis – Incyte

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least 2 to <12 years) with atopic dermatitis (AD). The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success […]

admin Health 0 36 sec read
July 19, 2023

MHRA (UK) approves Arexvy for prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older – GSK

GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised […]

admin Health 0 30 sec read

Recent Posts

Meta

Categories

Archives

Recent Comments