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Janssen Sends Data for Phase III Children’s Pulmonary Tuberculosis Treatment to FDA and EMA

Don Tracy, Associate Editor Company aims to receive approval on a Type II Variation application for Sirturo for patients with pulmonary tuberculosis. The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for bedaquiline (Sirturo), indicated as part of a combination therapy for adults and pediatric patients over the age of five with pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis. Back in August, a supplemental New Drug Application (sNDA) was also submitted to the FDA for the medication. According to data from the CDC, there was a report of approximately 8,300 cases of TB in 2022, up from 7,874 cases reported in 2021. The center also reports that TB cases in the United States are beginning to return to pre-pandemic levels, following a substantial decline in 2020, likely due to factors associated with ...
- Source: drugdu
- 131
- November 10, 2023
FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less. By FRANK VINLUAN A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right. Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year. The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision ...
- Source: drugdu
- 101
- November 10, 2023
HHS Considers Removing J&J’s Stelara from Medicare Drug Price Negotiations

By Tristan Manalac Pictured: Entrance to the Department of Health and Human Services in Washington, DC/iStock The Department of Health and Human Services in a supplemental court filing posted late last week has suggested that Johnson & Johnson’s blockbuster psoriasis therapy Stelara (ustekinumab) might soon be “deselected” from the Inflation Reduction Act’s Drug Price Negotiation Program. The development comes after the FDA last week approved Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara. In May 2023, Amgen and J&J settled their patent dispute over the biosimilar challenge to Stelara, allowing the entry of Wezlana “no later than January 1, 2025.” Under the current negotiation guidelines, the Centers for Medicare and Medicaid Services can reconsider a drug product for price negotiations when it is “subject to meaningful competition.” HHS referred to this provision in a separate October 2023 court filing, supporting its prior motion to dismiss a lawsuit filed by various ...
- Source: drugdu
- 112
- November 9, 2023
Novartis Inks Potential $1.3B Contract with Korean Biotech for Small Molecule

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Monday inked a technology export contract with Korean biotech company Chong Kun Dang Pharmaceutical for an early-stage HDAC6 Inhibitor, according to Korea Biomedical Review. Under the agreement, Novartis will make an upfront payment of $80 million and pledge up to nearly $1.23 billion more in development and regulatory milestones. The Korean biotech will also remain eligible to future sales-based royalties, as well as an ongoing technology fee depending on net sales. In return, Novartis will gain the exclusive global rights—except in Korea—to develop and commercialize the investigational small-molecule HDAC inhibitor CKD-510. The candidate in 2021 cleared a Phase I first-in-human study in 87 healthy volunteers and the Korean company appears to be positioning the drug candidate as a potential treatment for Charcot-Marie-Tooth disease, a rare and heritable disease that afflicts the nerves in the limbs. However, a Chong ...
- Source: drugdu
- 106
- November 9, 2023
J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

Dive Brief Johnson & Johnson has linked its Qdot Micro radiofrequency (RF) catheter to improved quality of life in patients with paroxysmal atrial fibrillation (AFib). The single-arm study found that, compared to baseline, scores on an AFib quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device. Qdot Micro, which received approval in the U.S. in 2022, is set to face competition from pulsed field ablation (PFA) devices. A Boston Scientific study suggests PFA and thermal ablation result in similar levels of improvement in quality of life. Dive Insight Qdot Micro is temperature-controlled, contact force-sensing, RF catheter. The temperature control feature supports the use of higher radiofrequency power in short bursts, an approach that J&J sees as a way to improve efficacy without compromising safety. J&J published 12-month data on the effectiveness of the device in its Q-FFICIENCY study earlier this year. The latest ...
- Source: drugdu
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- November 9, 2023
Novel and emerging therapies offer new hope for patients with inflammatory bowel disease

Ulcerative colitis (UC) and Crohn’s disease (CD) are chronic inflammatory bowel diseases (IBD) that affect the gastrointestinal tract. In recent decades, there have been significant advances in the understanding of IBD pathophysiology and the development of new treatments. The International Organisation for the Study of Inflammatory Bowel Diseases (IOIBD) developed the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) programs, which recommend specific treatment goals for UC and CD in children and adults. These goals include clinical response and remission, endoscopic healing, normalization of C-reactive protein/erythrocyte sedimentation rate and fecal calprotectin, prevention of disability, restoration of quality of life, and normal growth in children. The current mainstay treatments for IBD include immunomodulators, biologics (anti-tumor necrosis factor alpha (TNF-α) agents being the most commonly used), and other monoclonal antibodies such as anti-integrins and anti-interleukins (IL-12/23). However, primary and secondary loss of response to these therapies is a major recurring issue, with ...
- Source: drugdu
- 89
- November 9, 2023
Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

Pharmaceutical Executive Editorial Staff Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus. Sanofi has announced that a higher than expected demand for nirsevimab-alip (Beyfortus) 50 mg and 100 mg injection to protect infants against respiratory syncytial virus (RSV) has caused a change in the company’s distribution plan. Sanofi said it developed an aggressive supply plan to outperform prior launches of pediatric vaccines, but the demand exceeded the supply. Image credit: MargJohnsonVA | stock.adobe.com “We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season,” Sanofi said in a statement.1 “Currently, due to demand, we are carefully managing distribution of the ...
- Source: drugdu
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- November 9, 2023
Covera Health Acquires CoRead, Secures up to $50M To Improve Radiology

Covera Health has finalized its acquisition of CoRead, the companies announced last week but did not disclose the terms of the deal. Covera also announced that it raised up to $50 million in additional Series C funding led by Insight Partners. By MARISSA PLESCIA Covera Health, an AI-enabled diagnostic technology company focused on radiology, has finalized its acquisition of CoRead, an AI quality assurance company, the organizations announced last week. In addition, Covera Health has secured up to $50 million in additional Series C funding. New York City-based Covera Health works with providers to help them improve the quality of their radiology care and works with payers and employers to ensure that members and employees are directed to the best radiology provider for their needs. Its customers include Walmart, Premera Blue Cross and Nuance. CoRead, based in Cary, North Carolina, offers a solution that helps radiologists identify blindspots and misdiagnoses. ...
- Source: drugdu
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- November 9, 2023
FDA warns of hidden drug ingredients in Dr Ergin’s SugarMD

The US Food and Drug Administration (FDA) has issued a warning against the use of the glucose management product, Dr Ergin’s SugarMD Advanced Glucose Support. The regulator asked consumers not to buy and to immediately stop using the product, promoted and sold for blood glucose management due to hidden drug ingredients. Several SugarMD products are sold online on Amazon as supplements for those with type 1 and type 2 diabetes. One of the supplements, GlucoDefense to maintain glucose metabolism is advertised to produce “truly remarkable [results] within just 6 weeks”. In laboratory tests carried out by the FDA, active ingredients glyburide and metformin were confirmed to be present in the drug. Glyburide and metformin are in several FDA drugs used to treat type-2 diabetes that can only be obtained with a prescription. Both of these ingredients can pose a serious risk to consumers. Glyburide can result in unsafe drops in ...
- Source: drugdu
- 92
- November 9, 2023
EU pharma legislation may bring ‘more harm than good’ to the region

Debates across Europe are needed to ensure that other global markets do not overtake it following the infamous EU Pharmaceutical Legislation, says Ricardo Marek, president of the Europe and Canada business unit at Takeda. Speaking at the opening day of the FT Global Pharma and Biotech Summit in London, Marek noted how the reformed legislation, which was released by the European Commission (EC) in April, will establish the next few decades of the European market. While the new legislation shifts focus to garnering equal access to new medicines across the EU, certain policies may stifle innovation in the region. For example, there will be a shorter regulatory data protection period, meaning generic drug makers will not be able to refer to innovator drug’s data to obtain marketing authorisation. Also, approved drugs must be launched in all EU countries within two years. In the panel “Macro Focus – How is Pharma ...
- Source: drugdu
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- November 9, 2023

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