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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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The European Medicines Agency is seeking additional information from the makers of GLP-1 drugs as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class.
Lilly’s Jaypirca (pirtobrutinib) can now be used to treat chronic lymphocytic leukemia or small lymphocytic leukemia that had progressed from at least two prior lines of therapy, in addition to its previously-approved indications.
Johnson & Johnson’s AI investments include a research facility in San Francisco and a data science workforce of approximately 6,000 employees.
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze.
While Pfizer’s oral GLP-1 candidate met its primary endpoint in a Phase IIb obesity trial, twice-daily dosing of danuglipron resulted in high rates of adverse events including nausea, vomiting and diarrhea.
From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.
Citing slow enrollment and low clinical rates, the late-stage “evidence trials” are being discontinued. AstraZeneca said there are no safety concerns and no impact on Lokelma’s current approved indication.
The company’s investigational c-Met protein directed antibody-drug conjugate showed a “compelling” overall response rate in patients with previously treated non-small cell lung cancer.
This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.