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Novo Nordisk and Eli Lilly shares slide on new obesity drug trial from Roche
CNBC· 2024-07-17 10:19
Novo Nordisk and Eli Lilly shares slid Wednesday after Roche announced promising early-stage trial data from its latest obesity drug candidate. The Swiss pharmaceutical giant said Wednesday that a second drug candidate from its purchase of Carmot Therapeutics indicated positive results, further heating up competition in the weight loss drug market. Roche shares jumped in early deals and were trading 5.87% higher as of 11:17 a.m. London time. Shares of Wegovy-maker Novo Nordisk fell 3.77%, while Zepbound pro ...
[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase I results of its oral GLP-1 receptor agonist CT-996 for the treatment of people with obesity
GlobeNewswire News Room· 2024-07-17 05:00
After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001)1 Pharmacokinetic data supports a once-daily oral dosing regimen for CT-9961 The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed1 Obesity is one of the most urgent health challenges in the world with extensive comorbidities, such as type 2 diabetes, cardiovascular disease, liver disease, an ...
Roche Holding's (RHHBY) Accu-Chek SmartGuide Receives CE Mark
ZACKS· 2024-07-12 17:11
Company Overview - Roche Holding has received FDA clearance for its Vabysmo 6.0 mg single-dose prefilled syringe, which is used to treat neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. Vabysmo is the first bispecific antibody approved for eye treatment, showing significant vision improvements [5] - The Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution has received CE Mark approval, allowing it to be available for type 1 and type 2 diabetic patients over 18 years old on flexible insulin therapy [17] Product Details - The Accu-Chek SmartGuide CGM solution provides real-time glucose readings for 14 days, sending data to the Accu-Chek SmartGuide app every five minutes. It includes predictive algorithms to forecast glucose levels and identify potential hypoglycemia risks [3][8] - The solution consists of three components: the Accu-Chek SmartGuide CGM sensor, the Accu-Chek SmartGuide App, and the Accu-Chek SmartGuide Predict App, designed to enhance diabetes management [3] Market Insights - The global digital diabetes management market was valued at $18.9 billion in 2023 and is projected to grow to $35.8 billion by 2028, reflecting a compound annual growth rate (CAGR) of 13.6% [4] - The market is driven by advancements in diabetes care solutions, the increasing use of connected devices and apps, and the growing adoption of cloud-based solutions [21] Industry Prospects - The Accu-Chek SmartGuide CGM solution aims to address critical unmet needs in diabetes management, particularly concerning nighttime hypoglycemia and enabling proactive health management [18][19] - The integration of the Accu-Chek SmartGuide with the Accu-Chek Care platform allows healthcare professionals to access comprehensive therapy-relevant data, facilitating better patient care [20]
Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes
GlobeNewswire News Room· 2024-07-09 05:00
The Accu-Chek® SmartGuide CGM solution provides 14 days of accurate1 real-time glucose values for adults living with type 1 and type 2 diabetes on flexible insulin therapy. The built-in AI-trained algorithms will empower users to proactively intervene when their glucose levels require attention and before a complication can even occur. The solution is set to launch in selected European markets in the coming months. Clinical evaluations have demonstrated the new CGM solution's high system accuracy, with an o ...
Roche to reintroduce Susvimo in the US for people with neovascular age-related macular degeneration (nAMD)
GlobeNewswire News Room· 2024-07-08 15:45
The FDA has approved updates to Susvimo, which will be available to US retina specialists and patients with nAMD in the coming weeks Susvimo offers the first alternative to regular eye injections that are standard of care for nAMD, which impacts 20 million people worldwide and can cause blindness if left untreated By continuously delivering medicine to the eye through a refillable implant, Susvimo is the first and only approved nAMD treatment shown to maintain vision with two refills a year "We are pleased ...
Roche (RHHBY) Gets Positive CHMP Recommendation for Its Drugs
ZACKS· 2024-07-02 09:16
Roche (RHHBY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended a label expansion of ophthalmology drug Vabysmo (faricimab). The CHMP gave a positive opinion for the label extension of Vabysmo for a third indication — treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). Data from these studies showed Vabysmo demonstrated early and sustained vision improvements non-inferior to Regeneron's (REGN) Eylea ...
CHMP recommends EU approval of Roche's PiaSky for people with PNH, a rare, life-threatening blood condition
GlobeNewswire News Room· 2024-06-28 11:00
"People living with PNH face lifelong treatment, often requiring frequent intravenous infusions and timeconsuming clinic visits," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "With the option to self-administer once a month, today's recommendation may therefore offer patients and caregivers in Europe more freedom in their day-to-day lives." PiaSky is being investigated in a broad clinical development programme, including five ongoing Phase III studie ...
Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection
GlobeNewswire News Room· 2024-06-27 05:00
The WHO is focused on the elimination of cervical cancer globally with a strategy of three key goals.2 It seeks to ensure that by 2030, 70% of women are screened using a high-performance test by age 35, and again by age 45. Screening for HPV can help identify women who are at risk of developing cervical cancer, so that the disease can be treated early, before cancer has a chance to develop. In poorer countries, women are often diagnosed with cervical cancer at a more advanced stage, where the chance for a c ...
Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis
Prnewswire· 2024-06-25 05:15
Provides an additional treatment option without the need for IV facilities, expanding accessibility for patients SAN DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received European Commission (EC) marketing authorization of OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multipl ...
Roche's OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
GlobeNewswire News Room· 2024-06-25 05:00
"OCREVUS transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease. Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers." OCREVUS SC was ...