PharmaFocus Today – Page 260 – media

Cannabis and derivatives show promise in reducing weight and waist circumference, with nuanced effects on body fat

In a recent study published in the International Journal of Obesity, researchers examined the effects of cannabis on anthropometric measures. Obesity remains a significant global public health concern, with about 650 million adults affected, per the World Health Organization (WHO). Obesity results in metaphysical changes and chronic conditions that reduce life expectancy. Obesity-related complications are linked to excess body fat, an inflammatory condition that disrupts body functioning, resulting in cardiac, vascular, hemodynamic, skeletal, and cerebral malfunctions. Various strategies have been described to reduce fat mass and, thereby, obesity. These include improvements in physical activity standards, adoption of healthy eating guidelines, drug interventions, and surgical interventions. In recent years, Cannabis sativa has been used to treat/relieve symptoms of some diseases. Although it is well tolerated in some conditions, adverse effects have been frequently reported for psychiatric disorders with long-term use. Various diseases have been linked to the therapeutic or recreational use ...
- Source: drugdu
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EU HTA harmonisation may land off key for pharma

Heading towards 2025, pharmaceutical companies have begun preparing for the harmonisation of health technology assessment (HTA) processes in the EU, but the looming change has led to mixed sentiments. “I hope that this will broaden and speed up access…, but realistically, as the process stands now, I am a bit sceptical that it will reach that goal quickly,” said Kevin Rieger, the director of corporate affairs at Beigene. Rieger discussed the upcoming HTA process with Fabian Berkemeier, the managing director at the IGES Institute, at the Bio-Europe conference. In a 7 November panel, Rieger expressed concerns about the logistics of the joint-EU HTA. He highlighted that the new process would rather duplicate the data submissions needed as all requirements for member states would be added into one HTA process, alongside the European Commission’s (EC) own rules. Furthermore, he said that thus far, receiving direct advice meetings with the EC had ...
- Source: drugdu
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- November 10, 2023
Alfasigma opens new doors in the US with Intercept acquisition

Alfasigma has expanded its drug portfolio for treating rare and serious liver diseases after completing its acquisition of US-based Intercept Pharmaceuticals. The completed acquisition comes just over a month after Intercept agreed to a $794m (€751.76m) buyout by Alfasigma. Any remaining common shares of Intercept were bought at $19.00 per share. Now being owned by the leading Italian pharmaceutical company, Intercept will no longer be traded on the Nasdaq exchange. In acquiring Intercept, Alfasigma has gained access to Ocaliva, the only US Food and Drug Administration (FDA)-approved second-line therapy for primary biliary cholangitis (PBC). Ocaliva, in combination with bezafibrate, also has orphan drug designation for PBC that was granted by the FDA in May. As per Alfasigma CEO Francesco Balestrieri, the company seeks to expand its gastroenterology and hepatology market presence and will benefit from Intercept’s innovation and R&D pipeline. Though Intercept’s Ocaliva has had its victories, the drug has ...
- Source: drugdu
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With FDA approval, Eli Lilly’s weight-loss drug Zepbound arrives to challenge Novo Nordisk

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday, the Indianapolis-based company scored FDA approval for its GIP/GLP-1 compound tirzepatide to treat obesity, which will allow broader access to the treatment in the U.S. Dubbed Zepbound, Lilly’s new product is the same formula as blockbuster Type 2 diabetes drug Mounjaro. Since it was endorsed by the FDA in May 2022, Mounjaro has gained widespread, off-label use to treat obesity. Now, Zepbound has been indicated for adults with a BMI of 30 or higher as well as those with a BMI of 27 or higher with weight-related problems such as hypertension, Type 2 diabetes, sleep apnea or cardiovascular disease. With the FDA nod, Lilly now has its answer to Novo’s blockbuster duo of Ozempic for diabetes and Wegovy for obesity. The Danish company gained FDA green lights ...
- Source: drugdu
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- November 10, 2023
BioNTech acquires right to Biotheus’ bispecific antibody candidate in deal worth over $1bn

BioNTech has entered into an exclusive licensing and collaboration agreement with Biotheus to develop and commercialise its bispecific antibody candidate outside of China, with the deal potentially worth over $1bn. PM8002, which simultaneously targets PD-L1 and VEGF, is currently being evaluated in mid-stage studies in China as both a monotherapy and in combination with chemotherapy in patients with advanced solid tumours. The asset has already demonstrated a positive safety profile and encouraging anti-tumour activity “presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumour microenvironment,” the Chinese biotech said. Under the terms of the agreement, Biotheus will receive an upfront payment of $55m and will be eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1bn, as well as tiered royalties on potential future product sales. The transaction is expected to close in the fourth-quarter of this year subject to customary closing conditions. Xiaolin ...
- Source: drugdu
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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
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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
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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
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- 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
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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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