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Drug Firms' Proprietary Data Significantly Boost AI Protein Model Performance

Drug Firms' Proprietary Data Significantly Boost AI Protein Model Performance

Drug Firms' Proprietary Data Significantly Boost AI Protein Model Performance
ReutersReuters
Experts urge FDA to set clear safety and access standards for psychedelic drugs

Experts urge FDA to set clear safety and access standards for psychedelic drugs

By Puyaan Singh and Kamal Choudhury Sept 14 (Reuters) - Doctors, veterans, pharmacists and therapists on Monday urged the U.S.
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Representatives Introduce Bipartisan Bill to Permanently Authorize Rare Pediatric Disease Priority Review Voucher Program

Representatives Introduce Bipartisan Bill to Permanently Authorize Rare Pediatric Disease Priority Review Voucher Program

U.S. Representatives Gus Bilirakis (R-FL), Nanette Barragán (D-CA), Kat Cammack (R-FL), Jake Auchincloss (D-MA), Tom Kean, Jr. (R-NJ), and Kevin Mullin (D-CA) have introduced bipartisan legislation to permanently authorize the U.S. Food and Drug Administration’s (FDA) Rare Pediatric Disease Priority Review Voucher (PRV) Program. This program, established in 2012, incentivizes the development of treatments for children suffering from rare and devastating diseases. The PRV program awards a transferable priority review voucher to companies that successfully develop and receive FDA approval for qualifying treatments. Since its inception, the program has facilitated the market entry of treatments for 47 rare pediatric diseases, a significant increase from the four FDA-approved treatments that existed before the program. The current authorization for the program is set to expire in 2029. The proposed permanent authorization aims to provide long-term certainty for researchers and investors, encouraging continued ...
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FDA holds public hearing on psychedelic drugs as Trump-driven push gathers pace

FDA holds public hearing on psychedelic drugs as Trump-driven push gathers pace

By Puyaan Singh and Kamal Choudhury Sept 14 (Reuters) - The U.S.
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Tenaya Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for TN-401

Tenaya Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for TN-401

Tenaya Therapeutics, a clinical-stage biotechnology company, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for its gene therapy candidate, TN-401. This designation is for the treatment of PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), a serious heart disease. The RMAT designation is an expedited program designed to facilitate the development and review of regenerative medicine therapies for severe conditions where preliminary clinical evidence suggests the potential to address unmet medical needs. Tenaya's RMAT application included data from the RIDGE-1 clinical trial, which showed improvements in electrical stability measures, such as reduced rates of premature ventricular contractions (PVCs) and non-sustained ventricular tachycardias (NSVTs), common forms of ventricular arrhythmias in ARVC. The company's CEO, Faraz Ali, highlighted that this designation underscores the recognition of the seriousness of PK...
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Medicare Part D Plans Face Increased Financial Risk and Declining Options for Beneficiaries

Medicare Part D Plans Face Increased Financial Risk and Declining Options for Beneficiaries

Medicare's stand-alone prescription drug plans (PDPs) are experiencing significant challenges, including higher premiums and a substantial reduction in available options for beneficiaries. Between 2023 and 2026, the number of PDPs decreased by 55%, from 804 to 360 plans. This decline is partly attributed to the Inflation Reduction Act of 2022 (IRA), which restructured Part D benefits. The IRA increased the generosity of standard benefits, improving affordability for many but also leading to higher drug spending. Additionally, the IRA shifted greater financial liability to Part D plan sponsors, making their benefit costs less predictable. In 2025, Medicare significantly reduced its reinsurance payments to plans while increasing direct-subsidy payments, forcing plans to bear risk on 60% of brand-name drug spending above the out-of-pocket (OOP) cap, compared to 15% previously. This change, coupled with a lowered OOP cap, has created uncertainty for plans regarding future prescription fills and overall costs. ...
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Viva Biotech Advances Cyclic Peptide Drug Development with AI and Hybrid Synthesis Methods

Viva Biotech Advances Cyclic Peptide Drug Development with AI and Hybrid Synthesis Methods

Viva Biotech Advances Cyclic Peptide Drug Development with AI and Hybrid Synthesis Methods
ReutersReuters
Electra Therapeutics targets $977.6 million valuation in US IPO

Electra Therapeutics targets $977.6 million valuation in US IPO

Sept 14 (Reuters) - Drug developer Electra Therapeutics is targeting a valuation of up to $977.6 million in its U.S. initial public offering, according to a filing on Monday, extending a comeback in biotech listings this year.
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Viva Biotech Discusses Challenges and Opportunities in Cyclic Peptide Drug Development and Manufacturing

Viva Biotech Discusses Challenges and Opportunities in Cyclic Peptide Drug Development and Manufacturing

Viva Biotech Discusses Challenges and Opportunities in Cyclic Peptide Drug Development and Manufacturing
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FDA Approves Simtriyo, a New ADHD Medication for Adults and Children Aged 6 and Older

FDA Approves Simtriyo, a New ADHD Medication for Adults and Children Aged 6 and Older

The U.S. Food and Drug Administration (FDA) has approved Simtriyo (centanafadine), a new once-daily extended-release capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children aged 6 and older. Simtriyo is classified as a central nervous system stimulant but operates differently from traditional ADHD stimulants by acting on three neurotransmitters: dopamine, norepinephrine, and serotonin. Traditional stimulants primarily target dopamine and norepinephrine, while serotonin is involved in mood and emotional processing. Clinical trials demonstrated that Simtriyo improved core ADHD symptoms, though it has not been directly compared to other ADHD medications. The drug's manufacturer, Otsuka, suggests Simtriyo may help with emotional dysregulation and executive function, benefits that were observed in exploratory post hoc analyses of trial data. Simtriyo is not yet commercially available as it awaits controlled substance scheduling by the U.S. Drug Enforcement Administrat...
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Cancer Treatments Induce Genetic Mutations in Healthy Cells, Impacting Efficacy and Side Effects

Cancer Treatments Induce Genetic Mutations in Healthy Cells, Impacting Efficacy and Side Effects

Recent studies have revealed that various cancer treatments, including chemoradiotherapy and combination chemotherapy, can significantly alter the genetic landscape of normal, healthy tissue. Researchers at the Wellcome Sanger Institute, University of Cambridge, and University College London found that chemoradiotherapy increases mutations in vital tumor suppressor genes like TP53 and PPM1D in human patients. Similarly, combination chemotherapy leads to an increase in normal cells carrying mutations associated with resistance to drugs such as 5-fluorouracil (5-FU). These findings, published in Nature Genetics, indicate that cancer treatments can dramatically change the mutational landscape of normal epithelium within weeks, a process that typically takes decades. The study analyzed normal esophagus tissue from esophageal cancer patients who received different treatments, highlighting how drugs can create a selective pressure that favors the expansion of certain mutant cell clones. This research suggests th...
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Retro Biosciences Adjusts Alzheimer's Drug Dosing in Clinical Trial

Retro Biosciences Adjusts Alzheimer's Drug Dosing in Clinical Trial

Retro Biosciences, a longevity startup backed by Sam Altman, is expanding its Phase 1 safety trial for the Alzheimer's drug RTR-242. The company is adding two new cohorts, increasing total enrollment by over 42% from 76 to 108 participants. This decision comes after initial doses of RTR-242 showed no significant side effects or safety signals. According to Retro CEO Joe Betts-LaCroix, the absence of any signal, even minor side effects, makes it difficult to assess the drug's efficacy at the current dosage. The drug is designed to target lysosomes, which are cellular recycling centers responsible for breaking down old proteins. This process, known as autophagy, tends to slow with age and is linked to neurodegenerative diseases like Alzheimer's and Parkinson's. RTR-242 aims to restore the acidity of aging lysosomes, thereby improving their function. The trial is currently testing the drug in healthy volunteers aged 18 to 65.