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Merck/Organon to acquire Alydia Health and with it …
WEBMerck and Alydia Health announced that they have entered into a definitive agreement pursuant to which, after the intended Merck spinoff of Organon, Organon will acquire Alydia Health. Alydia Health is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or …
Actived: Just Now
Health Canada approves Keytruda for adjuvant treatment of stage …
WEBMerck Inc. announced that Health Canada has granted approval for Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB …
Health Canada approves Arexvy to prevent respiratory syncytial …
WEBHealth Canada has granted approval for GSK’s Arexvy vaccine to prevent respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD) in people aged 60 years and above. A recombinant, AS01E-adjuvanted RSV vaccine, Arexvy is the first to obtain approval for use in older adults in the country.
Japan’s Ministry of Health, Labour and Welfare accepts Arexvy …
WEBGSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus (RSV) vaccine (recombinant adjuvanted) for the prevention of RSV disease in adults aged 50-59 at increased risk
Health Canada approves Trodelvy for locally advanced or …
WEBGilead Sciences, Inc. announced that Health Canada has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease.
Twice-yearly lenacapavir demonstrates sustained impact on health
WEBThese 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 care.
Opsynvi becomes the first and only Health Canada-approved once …
WEBThe Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada approved Opsynvi (macitentan 10mg and tadalafil 40mg) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose …
Vision for a better future: lessons from The Lancet Global Health
WEBVision impairment affects more than the individual, and its prevalence and impacts are of global concern. There are many strategies we can implement to help address the causes of vision impairment and to help improve equitable access to eye care.
FDA approves Symplicity Spyral renal denervation (RDN) system …
WEBGenentech, a member of the Roche Group announced that the FDA has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor …
GSK acquires Bellus Health and with it camlipixant , a potential
WEBGSK plc and Bellus Health Inc announced that they have entered into an agreement under which GSK will acquire Bellus, a Canada-based, late-stage biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC) for US$14.75 per share of common stock in cash representing an approximate total equity …
FDA accepts NDA for IDP 126 gel triple therapy to treat acne
WEBBausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, announced that the FDA has accepted the NDA for investigational IDP 126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) Gel with a Prescription Drug User Fee Act (PDUFA) action date of October 20, 2023. If approved, IDP-126 has the potential to be …
AstraZeneca launches Evinova a provider of digital health solutions.
WEBThe Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Baxter highlights new data indicating Sharesource Digital Health
WEBBaxter International Inc. a global innovator in renal care,announced new data showing kidney patients may experience a survival rate nearly two-times higher and a prolonged time to an adverse event (AE) and hospitalization when the Sharesource remote patient management digital health platform is used to help manage home automated peritoneal …
Amgen announces cardiovascular study to evaluate the …
WEBASCVD is defined as the buildup of cholesterol plaque in arteries and includes events such as heart attack and stroke. The African American Heart Study: is a unique collaborative study including community outreach in partnership with trusted organizations to help improve our understanding of the disproportionate higher incidence of Lp(a) and …
Novan to acquire dermatology company EPI Health
WEBNovan, Inc. announced its acquisition of EPI Health, LLC (“EPI Health”), a specialty pharmaceutical company focused on the U.S. dermatology market. “As we prepare for the planned NDA submission of our lead product candidate, SB206 (berdazimer gel 10.3%), it was imperative that we evaluate a broad spectrum of options for potential …
Top-line results from Phase III OASIS 1 and OASIS 2 studies of
WEBJohnson & Johnson announced the first data from the Phase III QUASAR Maintenance Study (Abstract #759) that showed 50.0 percent (p<0.001) of patients with moderately to severely active ulcerative colitis (uc) receiving subcutaneous (sc) tremfya (guselkumab) 200 mg every four weeks (q4w) and 45.2 percent (p><0.001) of patients receiving sc tremfya …
MHLW (Japan) approves Lyfnua (gefapixant) to treat refractory or
WEBPublished: 25th Jan 2022. The Japan Ministry of Health, Labor and Welfare (MHLW) has approved Lyfnua (gefapixant) Tablets 45 mg for adults with refractory or unexplained chronic cough. In Japan, Lyfnua is the planned trademark for gefapixant; the trademark for gefapixant in other countries has not been approved. Outside of Japan, gefapixant is
3M spins off Solventum as an independent healthcare company
WEB3M has announced Solventum will be the name of the planned, independent health care company following its spin-off. The new name and branding will go into effect when the spin-off of the independent health care company occurs, which is expected in the first half of 2024, subject to final approval by 3M's Board of Directors and other required
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