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Experimental Hepatitis B Drug Shows Promise for Functional Cure

Experimental Hepatitis B Drug Shows Promise for Functional Cure

A new experimental drug for hepatitis B, developed by GSK and Ionis Pharmaceuticals, has shown promising results in achieving a 'functional cure' for some patients. In two international studies, approximately 20% of patients treated with the drug, bepirovirsen, experienced a reduction in the virus to levels manageable by the immune system, allowing them to stop treatment without the virus rebounding. This development marks a significant advancement in hepatitis B treatment, as current therapies require lifelong adherence and do not offer a cure. The drug works by binding to the virus's genetic components, suppressing replication and stimulating the immune system. The findings were presented at a scientific meeting in Barcelona and published in the New England Journal of Medicine.
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FDA Initiates Priority Review for Sanofi's Gaucher Disease Drug Venglustat

FDA Initiates Priority Review for Sanofi's Gaucher Disease Drug Venglustat

FDA Initiates Priority Review for Sanofi's Gaucher Disease Drug Venglustat
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BeOne Medicines Reveals Phase 3 HERIZON-GEA Trial Results with Significant Survival Benefits

BeOne Medicines Reveals Phase 3 HERIZON-GEA Trial Results with Significant Survival Benefits

BeOne Medicines Reveals Phase 3 HERIZON-GEA Trial Results with Significant Survival Benefits
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PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization for BESREMi Launch

PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization for BESREMi Launch

PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization for BESREMi Launch
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FDA Approves AbbVie's Decnupaz for Ultra-Rare Blood Cancer Treatment

FDA Approves AbbVie's Decnupaz for Ultra-Rare Blood Cancer Treatment

FDA Approves AbbVie's Decnupaz for Ultra-Rare Blood Cancer Treatment
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PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization for BESREMi Expansion

PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization for BESREMi Expansion

PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization for BESREMi Expansion
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Experts Warn Against Creatine Use in Children Due to Lack of Long-Term Data

Experts Warn Against Creatine Use in Children Due to Lack of Long-Term Data

Recent discussions have emerged regarding the use of creatine supplements in children, particularly among young athletes. Influencers and some parents have been advocating for creatine use, citing potential benefits in physical and cognitive development. However, experts caution against this practice due to insufficient long-term data on safety and efficacy. A 2021 review highlighted the need for more comprehensive studies, as existing research is limited and often involves small sample sizes. Concerns also arise from the potential normalization of performance-enhancing supplements among adolescents, which could lead to future use of more potent substances.
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American Cancer Society Recommends Blood Test for Colorectal Cancer Screening

American Cancer Society Recommends Blood Test for Colorectal Cancer Screening

The American Cancer Society has updated its guidelines to include a blood test as a screening option for colorectal cancer. This new recommendation aims to provide an alternative for adults aged 45 and older who are at average risk and have declined traditional visual or stool-based tests. The Shield test, developed by Guardant Health and approved by the FDA in 2024, detects tumor DNA in the blood with 83% sensitivity for colorectal cancer. However, it is less effective at identifying precancerous polyps. The inclusion of blood testing is intended to increase screening rates, as colorectal cancer has become the leading cancer killer among U.S. adults under 50.
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Amazon Recalls Beverage Mixes and Supplements Due to Salmonella Risk

Amazon Recalls Beverage Mixes and Supplements Due to Salmonella Risk

Amazon has issued recalls for two separate product lines due to potential salmonella contamination. The recalls involve cafe-style drink mixes by SKS Copack and Mogo Moringa dietary supplements. The U.S. Food and Drug Administration (FDA) announced these recalls after concerns over salmonella contamination were raised. The affected drink mixes, distributed across 25 states, include various powdered products such as matcha green tea and milk tea mixes. The contamination was traced back to a nonfat dry milk ingredient. Meanwhile, Mogo Moringa has recalled specific lots of its Moringa Oleifera Capsules sold online, including through Amazon. Although third-party tests did not detect salmonella, the recall was initiated as a precaution. Consumers are advised to check product lot numbers and expiration dates and to stop using any affected products immediately.
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Corcept Therapeutics to Resubmit NDA for Relacorilant to FDA for Cushing’s Syndrome Treatment

Corcept Therapeutics to Resubmit NDA for Relacorilant to FDA for Cushing’s Syndrome Treatment

Corcept Therapeutics to Resubmit NDA for Relacorilant to FDA for Cushing’s Syndrome Treatment
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SkinnyDipped Chocolate Bites Recalled Nationwide Due to Undeclared Peanut Risk

SkinnyDipped Chocolate Bites Recalled Nationwide Due to Undeclared Peanut Risk

SkinnyDipped Dark Chocolate Coconut Almond Bites have been recalled across the United States due to the potential presence of undeclared peanuts, posing a significant risk to individuals with peanut allergies. The recall was initiated by Bazzini, a co-manufacturer for SkinnyDipped, after a consumer reported finding peanut butter in the product. The recall affects various package sizes and lot codes with best-by dates through December 2026. The Food and Drug Administration (FDA) published the recall notice, emphasizing the potential for serious or life-threatening allergic reactions. Consumers are advised to return the products for a full refund and contact SkinnyDipped for further information.
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Emalex Biosciences Seeks FDA Approval for Ecopipam to Treat Tourette Syndrome in Children

Emalex Biosciences Seeks FDA Approval for Ecopipam to Treat Tourette Syndrome in Children

Emalex Biosciences is preparing to seek approval from the U.S. Food and Drug Administration (FDA) for ecopipam, a drug designed to treat children with motor and vocal tics caused by Tourette syndrome (TS). This follows a successful phase III clinical trial led by Dr. Donald Gilbert at Cincinnati Children's Hospital, which demonstrated that ecopipam can significantly reduce the risk of tic relapse in children. Unlike existing FDA-approved treatments for TS, which are antipsychotics initially approved for schizophrenia, ecopipam targets the dopamine D1 receptor, potentially offering fewer side effects. The trial involved 216 participants, with results showing a 50% reduction in relapse risk for those continuing ecopipam compared to a placebo.