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Cochrane Review Questions Efficacy of Anti-Amyloid Alzheimer's Drugs

Cochrane Review Questions Efficacy of Anti-Amyloid Alzheimer's Drugs

A recent analysis by the Cochrane health research organization has cast doubt on the efficacy of anti-amyloid drugs used in treating Alzheimer's disease. The review assessed 17 studies involving over 20,000 participants and concluded that these drugs, including Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, likely have no clinically meaningful positive effects on cognitive function or dementia severity. The analysis also noted a small increase in the risk of brain swelling associated with these medications. Despite some drugs like Leqembi and Kisunla receiving FDA approval based on statistically significant reductions in clinical decline, the review suggests that the overall impact of amyloid-targeting therapies is minimal.
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FDA Considers Easing Restrictions on Peptides Amid Safety Concerns

FDA Considers Easing Restrictions on Peptides Amid Safety Concerns

The U.S. Food and Drug Administration (FDA) is contemplating easing restrictions on the compounding of certain peptides, which have previously been flagged for safety risks. This development comes as the FDA plans a two-day meeting in July to gather independent expert advice on seven peptides, six of which were previously identified as having significant safety concerns in 2023. The peptides in question include BPC-157, KPV, and MOTs-C, which are being considered for various medical applications such as ulcerative colitis, wound healing, and obesity. Health Secretary Robert F. Kennedy Jr. has been a vocal advocate for loosening these restrictions, arguing that the FDA's previous categorization of these peptides as high-risk was done without sufficient safety signals. Kennedy has expressed concerns about a burgeoning black market for these peptides, which are currently being produced under the guise of animal use or research purposes.
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LEO Pharma's FDA Acceptance for ANZUPGO Cream for Pediatric Eczema

LEO Pharma's FDA Acceptance for ANZUPGO Cream for Pediatric Eczema

LEO Pharma has announced the FDA's acceptance of its supplemental New Drug Application for ANZUPGO cream, aimed at treating chronic hand eczema in children aged 12-17. The cream, a non-steroidal pan-Janus kinase inhibitor, is already approved for adults with moderate to severe chronic hand eczema. If approved for pediatric use, ANZUPGO would be the first treatment specifically indicated for this age group, addressing a significant unmet medical need. The application is supported by positive data from the Phase 3 DELTA TEEN trial.
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FDA Considers Lifting Restrictions on Peptides Amid Wellness Trend

FDA Considers Lifting Restrictions on Peptides Amid Wellness Trend

The Food and Drug Administration (FDA) is evaluating the possibility of allowing compounding pharmacies to produce seven peptides that are currently restricted due to safety concerns. This move comes as peptides gain popularity for their purported wellness and anti-aging benefits. Health and Human Services Secretary Robert F. Kennedy Jr. has expressed support for making these peptides more accessible, citing their potential benefits for conditions such as ulcerative colitis, wound healing, and obesity. The FDA's advisory panel on pharmacy compounding is set to discuss these peptides in a meeting scheduled for late July. The agency's previous classification of certain peptides as 'Bulk Drug Substances that Raise Significant Safety Risks' has led to a black market for these substances.
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PolyPid Presents Phase 3 Data on D-PLEX100's Sustained Antibiotic Release for Surgical Site Infections

PolyPid Presents Phase 3 Data on D-PLEX100's Sustained Antibiotic Release for Surgical Site Infections

PolyPid Presents Phase 3 Data on D-PLEX100's Sustained Antibiotic Release for Surgical Site Infections
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Unapproved Weight-Loss Drug Retatrutide Gains Attention Despite FDA Status

Unapproved Weight-Loss Drug Retatrutide Gains Attention Despite FDA Status

Unapproved Weight-Loss Drug Retatrutide Gains Attention Despite FDA Status
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FDA Urges Over 2,200 Sponsors and Researchers to Disclose Clinical Trial Results

FDA Urges Over 2,200 Sponsors and Researchers to Disclose Clinical Trial Results

The U.S. Food and Drug Administration (FDA) has issued reminders to more than 2,200 medical product companies and researchers about their obligation to submit clinical trial results to ClinicalTrials.gov. This action addresses the issue of non-disclosure of trial results, which can lead to publication bias and a skewed perception of drug efficacy and safety. According to the FDA, nearly 30% of studies that should report results have not done so, particularly those involving FDA-regulated products. The agency's reminders aim to encourage voluntary compliance before considering further regulatory actions.
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FDA Criticizes Clinical Trial Sponsors for Lack of Transparency, Threatens Non-Compliance Notices

FDA Criticizes Clinical Trial Sponsors for Lack of Transparency, Threatens Non-Compliance Notices

The FDA has initiated a campaign to ensure clinical trial sponsors disclose the results of their studies, highlighting that approximately one-third of trials remain unreported. The agency has sent reminders to around 2,200 product manufacturers and researchers about their obligation to report study results to the clinicaltrials.gov database. According to the FDA, 29.6% of clinical trials that are likely subject to mandatory reporting have not uploaded their results. This lack of transparency has been a contentious issue in the pharmaceutical industry, with the FDA previously issuing warning notices to companies and researchers who failed to comply with federal law. Current U.S. regulations require that results from phase 2 to 4 trials of FDA-regulated drugs, biologics, and devices be reported within 12 months of the study's primary completion date. The FDA has warned that failure to meet these standards could result in notices of non-compliance, potentially leading to fines.
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FDA Grants Full Approval to Travere Therapeutics' Filspari for Rare Kidney Disease FSGS

FDA Grants Full Approval to Travere Therapeutics' Filspari for Rare Kidney Disease FSGS

FDA Grants Full Approval to Travere Therapeutics' Filspari for Rare Kidney Disease FSGS
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PolyPid to Present Phase 3 SHIELD II Data on D-PLEX100 at ESCMID Global 2026

PolyPid to Present Phase 3 SHIELD II Data on D-PLEX100 at ESCMID Global 2026

PolyPid to Present Phase 3 SHIELD II Data on D-PLEX100 at ESCMID Global 2026
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FDA Urges Over 2,200 Sponsors to Disclose Clinical Trial Results, Addresses Publication Bias

FDA Urges Over 2,200 Sponsors to Disclose Clinical Trial Results, Addresses Publication Bias

The U.S. Food and Drug Administration (FDA) has reminded more than 2,200 medical product companies and researchers to submit clinical trial results to ClinicalTrials.gov. The agency highlights the issue of publication bias, where negative trial results are often not disclosed, leading to a skewed perception of drug efficacy and safety. The FDA's initiative aims to ensure transparency and improve public access to clinical data. The agency has sent messages to companies and researchers to encourage voluntary compliance with reporting requirements, emphasizing the ethical obligation to disclose all trial outcomes.
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FDA Approves Travere Therapeutics' FILSPARI for Rare Kidney Disease FSGS

FDA Approves Travere Therapeutics' FILSPARI for Rare Kidney Disease FSGS

FDA Approves Travere Therapeutics' FILSPARI for Rare Kidney Disease FSGS