Core Insights - The CENTERSTONE study demonstrates that a single-dose of Xofluza significantly reduces the transmission of influenza from infected individuals to household members, marking a first in antiviral treatment for respiratory viral illnesses [1][2][3] - The study's results indicate that reducing household transmission could alleviate the overall burden of seasonal and pandemic influenza on healthcare systems [1][3] Company Overview - Roche announced positive topline results from the phase III CENTERSTONE study, which involved over 4,000 participants across 272 global sites [4] - Xofluza is a first-in-class antiviral approved in over 80 countries for treating uncomplicated influenza types A and B, representing a significant innovation in influenza treatment [5][6] Study Details - The CENTERSTONE study was a randomized, placebo-controlled trial that assessed the efficacy of Xofluza taken within 48 hours of symptom onset to reduce onward transmission of influenza [4] - The primary endpoint was the proportion of household contacts who tested positive for influenza within five days after treatment, with secondary endpoints focusing on symptom development [4] Public Health Impact - Seasonal influenza affects approximately one billion people annually, leading to millions of hospitalizations and up to 650,000 deaths worldwide [3][7] - The new evidence from the CENTERSTONE study could enhance public health strategies for influenza pandemic preparedness [3][2]

A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest healthcare news straight to your inbox. Subscribe here to receive future editions. Good afternoon! Roche is one of several drugmakers hoping to join the booming weight loss drug market, which Novo Nordisk and Eli Lilly are currently dominating. But can the Swiss company develop drugs that can compete with that duopoly? The answer isn't clear yet. We need to see more data from longer and larger clinical tri ...

Core Viewpoint - The article compares Roche Holding AG (RHHBY) and AbbVie (ABBV) to determine which stock is more attractive to value investors [1] Group 1: Zacks Rank and Earnings Outlook - Roche Holding AG has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while AbbVie has a Zacks Rank of 3 (Hold) [3] - The Zacks Rank emphasizes companies with positive earnings estimate revisions, suggesting RHHBY is likely experiencing a more favorable earnings outlook [3] Group 2: Valuation Metrics - RHHBY has a forward P/E ratio of 14.51, compared to ABBV's forward P/E of 18.01, indicating RHHBY may be undervalued [5] - The PEG ratio for RHHBY is 2.26, while ABBV's PEG ratio is 2.67, suggesting RHHBY has a better expected EPS growth relative to its valuation [5] - RHHBY's P/B ratio is 7.93, significantly lower than ABBV's P/B of 50.69, further indicating RHHBY's relative undervaluation [6] Group 3: Value Grades - Based on various valuation metrics, RHHBY holds a Value grade of B, while ABBV has a Value grade of C, making RHHBY a more attractive option for value investors [6]

Core Viewpoint - Roche's OCREVUS ZUNOVO™ has received FDA approval for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), providing a new subcutaneous administration option that enhances treatment accessibility for patients [1][2][10]. Group 1: Product Details - OCREVUS ZUNOVO is the first and only twice-a-year, healthcare professional-administered subcutaneous injection for RMS and PPMS, taking approximately 10 minutes for administration [1]. - The approval is supported by a decade of safety and efficacy data from Ocrevus® IV, with over 350,000 patients treated globally [1]. - The Phase III OCARINA II trial demonstrated that OCREVUS ZUNOVO has a safety and efficacy profile consistent with the intravenous formulation, showing a 97% suppression of relapse activity and MRI lesions through 48 weeks [3][12]. Group 2: Clinical Trial Insights - The OCARINA II trial involved 236 patients and confirmed that the subcutaneous formulation is non-inferior to the intravenous version in terms of pharmacokinetics and disease activity control [11][12]. - Injection reactions were the most common adverse events, with 49% of participants experiencing reactions after the first injection, all classified as mild or moderate [4]. Group 3: Market and Patient Impact - The introduction of OCREVUS ZUNOVO aims to provide greater flexibility for healthcare providers and patients, addressing individual treatment needs and preferences [2]. - The new delivery method is expected to improve access to treatment for patients who may face challenges with intravenous administration [2][5]. Group 4: Company Commitment - Roche is committed to advancing innovative clinical research in multiple sclerosis, with over 30 ongoing clinical trials aimed at understanding the disease and improving treatment experiences [5][16]. - The company emphasizes the importance of developing new formulations to enhance patient experience and meet diverse administration preferences [6].

Core Viewpoint - Roche has received FDA approval for the subcutaneous formulation of its immunotherapy drug Tecentriq, branded as Tecentriq Hybreza, making it the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy in the United States [1][4]. Roche's Tecentriq SC Approval - The subcutaneous formulation combines Tecentriq with Halozyme Therapeutics' Enhanze drug delivery technology [4]. - Approval was based on data from the phase IB/III IMscin001 study, showing comparable blood levels of Tecentriq and a safety and efficacy profile consistent with the intravenous formulation [4]. - A mid-stage study (IMscin002) indicated that 71% of patients preferred the subcutaneous option over intravenous infusion [4]. - The new formulation reduces treatment time to approximately seven minutes compared to 30-60 minutes for intravenous infusion [5]. - The SC formulation will be available for all adult indications of Tecentriq in the U.S., including various cancers [5]. Tecentriq's Market Position - Tecentriq is a leading drug for Roche, with sales totaling CHF 1.8 billion in the first half of 2024 [7]. - It is approved for multiple cancer types globally, either alone or in combination with other therapies [6][7]. Competitive Landscape - The phase II/III SKYSCRAPER-06 study did not meet its primary endpoints when comparing tiragolumab plus Tecentriq to Merck's Keytruda [8]. - Keytruda is a leading immuno-oncology treatment, generating over $14 billion in sales in the first half of 2024 [9]. Roche's Current Standing - Roche holds a Zacks Rank 2 (Buy) [10]. - Comparatively, Eli Lilly has a Zacks Rank 1 (Strong Buy) and Novartis has a Zacks Rank 2 [10].

OCREVUS ZUNOVO™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) with Halozyme's ENHANZE® drug delivery technology for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PP ...

Core Viewpoint - Roche is entering the competitive continuous glucose monitor (CGM) market in Europe with the launch of its Accu-Chek Smartguide, targeting adults with Type 1 or Type 2 diabetes following CE mark approval [1][10]. Product Features - The Accu-Chek Smartguide offers a 14-day wearability period and utilizes predictive algorithms to differentiate itself from competitors like Abbott and Dexcom [2][8]. - The device can assess the risk of low blood glucose within 30 minutes, forecast glucose levels for the next two hours, and predict the likelihood of night-time hypoglycemia, providing timely alerts for preventative actions [3][5]. - In trials, the Smartguide demonstrated 95% sensitivity and 99% specificity in predicting low glucose levels within 30 minutes, and 77% accuracy for detecting night-time hypoglycemia [5]. Market Competition - Roche will face strong competition from established players such as Abbott and Dexcom, whose devices are known for ease of use and factory-calibrated sensors [8][9]. - The requirement for initial calibration via a finger stick for the Smartguide may be a drawback compared to competitors' factory-calibrated models [9]. Industry Outlook - The CGM device market was valued at $4.6 billion in 2023 and is expected to grow at a CAGR of 7.2% from 2024 to 2030, indicating significant market potential for Roche's entry [11].

Recently revealed trial results for Roche's experimental weight-management drug suggest Viking Therapeutics is on the right track. Weight-management treatments are all the rage lately. According to Morgan Stanley, combined sales of injections that curb appetites and promote weight loss could reach an estimated $105 billion by 2030. Viking Therapeutics (VKTX 3.25%) is still a clinical-stage drugmaker that's developing an anti-obesity candidate called VK2735 that appears competitive with a similar drug the U. ...

FDA approval marks first and only subcutaneous anti-PD-(L)1 cancer immunotherapy SAN DIEGO, Sept. 12, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) inf ...

Roche (RHHBY) presented results of an early-stage study on its experimental obesity drug, CT-996, at the European Association for the Study of Diabetes annual meeting. CT-996 is an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity. However, shares of the company were down 6% on Sept. 11, post the presentation on concerns of side-effects from the investigational obesity drug. Image Source: Zacks Investment Research Ye ...