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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 ...
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- 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 ...
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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 ...
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- 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 ...
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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. ...
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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
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- 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 ...
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- November 9, 2023
AbbVie, AstraZeneca, Boehringer and more face FTC’s ire for ‘improper’ patent listings

Only two months after the Federal Trade Commission (FTC) said it was eyeing a crackdown on “improper” patents listed at the FDA, the agency has filed a challenge against more than 100 patents in the agency’s Orange Book. The patents cover drugs marketed by the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva, among other companies, the FTC said in a Tuesday release. In all, the commission has sent letters to 10 companies notifying them of the patent disputes. The FTC argues “improper” listings in the FDA’s Orange Book—the registry of patents on approved medicines—can throw up hurdles to competition in the drug industry. Specifically, improper patents can trigger regulatory delays for would-be generics challengers and throw up legal hurdles for generics players, the commission says. Some of the medicines targeted in this crackdown include AbbVie’s Restasis and Viatris’ EpiPen autoinjectors. As the antitrust agency points out, FDA regulations ...
- Source: drugdu
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- November 9, 2023
New UK research institute launched for motor neurone disease

A new research institute in London has been launched aimed at discovering a cure and new treatments for motor neurone disease (MND). The UK Motor Neuron Disease Research Institute (UK MND RI) will bring together a virtual network of MND labs, clinical centres and researchers to carry out MND research across the UK. Affecting one in every 300 people in the UK, MND is a neurodegenerative disease which affects the nerve cells in the brain and spinal cord. Around one-third of patients with MND die within one year of diagnosis, and more than half within two years. Currently, Sanofi’s Rilutek (riluzole) is the only licenced drug for MND in the UK. Collaboratively, doctors, clinicians, scientists and people living with MND, along with funders and charities, will work to speed up drug discovery and drug development and aim to test potential treatments in clinical trials. LifeArc, the MND Association, MND Scotland, ...
- Source: drugdu
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- November 9, 2023
Siemens Healthineers to lay off 300 workers, move some manufacturing to Ireland

Dive Brief Siemens Healthineers plans to lay off 300 workers amid a restructuring of the company’s diagnostics business, according to a filing last week with the New Jersey Department of Labor & Workforce Development. The filing represented 180 new layoffs and 120 layoffs announced in June, a Siemens spokesperson said in an emailed statement. The company also plans to consolidate some of its instrument manufacturing operations conducted in Flanders, New Jersey, to Dublin by September 2024. The spokesperson did not comment on whether the company expects to save money with the moves, writing that if Siemens makes any figures public, it will happen on its fourth-quarter earnings call on Wednesday. Dive Insight Siemens has been restructuring its diagnostics segment after telling investors last year that the business has been burdened by inflation, logistical and supply challenges and revenue hits due to the COVID-19 pandemic. The company announced it would cut ...
- Source: drugdu
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- November 8, 2023

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