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Eli Lilly's ACHIEVE-4 Study Confirms Safety and Efficacy of Foundayo for Type 2 Diabetes

Eli Lilly's ACHIEVE-4 Study Confirms Safety and Efficacy of Foundayo for Type 2 Diabetes

Eli Lilly's ACHIEVE-4 Study Confirms Safety and Efficacy of Foundayo for Type 2 Diabetes
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Eli Lilly Confirms Safety of Foundayo in ACHIEVE-4 Trial, Aiming for Diabetes Approval

Eli Lilly Confirms Safety of Foundayo in ACHIEVE-4 Trial, Aiming for Diabetes Approval

Eli Lilly Confirms Safety of Foundayo in ACHIEVE-4 Trial, Aiming for Diabetes Approval
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Eli Lilly's Foundayo Demonstrates Safety and Efficacy in ACHIEVE-4 Trial for Type 2 Diabetes

Eli Lilly's Foundayo Demonstrates Safety and Efficacy in ACHIEVE-4 Trial for Type 2 Diabetes

Eli Lilly's Foundayo Demonstrates Safety and Efficacy in ACHIEVE-4 Trial for Type 2 Diabetes
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FDA Requests Additional Safety Data for Eli Lilly’s New Obesity Drug Foundayo

FDA Requests Additional Safety Data for Eli Lilly’s New Obesity Drug Foundayo

FDA Requests Additional Safety Data for Eli Lilly’s New Obesity Drug Foundayo
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FDA Demands Safety Data for Eli Lilly's Oral GLP-1 Drug Foundayo Amidst Market Competition

FDA Demands Safety Data for Eli Lilly's Oral GLP-1 Drug Foundayo Amidst Market Competition

FDA Demands Safety Data for Eli Lilly's Oral GLP-1 Drug Foundayo Amidst Market Competition
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FDA Demands Safety Data for Lilly's Oral GLP-1 Drug Foundayo

FDA Demands Safety Data for Lilly's Oral GLP-1 Drug Foundayo

FDA Demands Safety Data for Lilly's Oral GLP-1 Drug Foundayo
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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's Accelerated Approval Pathway Criticized for Inconsistencies and Lack of Transparency

FDA's Accelerated Approval Pathway Criticized for Inconsistencies and Lack of Transparency

The FDA's accelerated approval pathway, designed to expedite the availability of new medicines for serious conditions, is under scrutiny for its inconsistencies and lack of transparency. A report by the Institute for Clinical and Economic Review (ICER) highlights frustrations among patients, manufacturers, payers, and purchasers regarding the program's shortcomings. The pathway allows for accelerated approval based on surrogate or intermediate endpoints, provided there is a strong biological rationale and developers commit to confirmatory trials. While the pathway has facilitated access to transformative treatments like Novartis' Gleevec and MSD's Keytruda, it has also faced controversy. Notable examples include Biogen/Eisai's Alzheimer's drug Aduhelm, which was removed from the market due to efficacy concerns, and Sarepta's gene therapy Elevidys, restricted over liver toxicity issues. ICER's report recommends improvements such as better selection of surrogate endpoints, increased use of randomized control...
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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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Cochrane Review Finds Limited Benefit in Alzheimer's Amyloid Drugs

Cochrane Review Finds Limited Benefit in Alzheimer's Amyloid Drugs

A Cochrane Collaboration review has concluded that amyloid beta-targeting drugs for Alzheimer's disease offer minimal clinical benefit. The analysis of 17 clinical trials involving 20,342 participants found that these drugs have negligible effects on cognitive decline and dementia severity, while increasing the risk of brain bleeding and swelling. The review included trials of approved therapies like Eisai/Biogen's Leqembi and Eli Lilly's Kisunla. Despite statistical significance in early trials, the review emphasizes the lack of meaningful clinical impact, prompting calls for research into alternative treatment mechanisms.
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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 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