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FDA Roundup: April 19, 2024
4/19/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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FDA Roundup: April 16, 2024
4/16/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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FDA Roundup: April 12, 2024
4/12/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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The U.S. Department of Justice has filed a complaint against Regeneron alleging that the pharma knowingly omitted credit card price concessions for Eylea to inflate Medicare reimbursement rates.
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While women’s clinical trial participation has increased, clinical trials still largely are not designed for women. In this episode, we discuss the many areas where trials can be improved, such as human and historical diagnosis and screening biases, accessibility, data capturing, and more
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Federal funding and legislation spotlight women’s health opportunities and challenges.
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Shorla Oncology Announces FDA Filing Acceptance of New Drug Application to Treat Certain Forms of Leukemia and Other Cancers
4/8/2024
Shorla Oncology announced that the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers.
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FDA Roundup: April 5, 2024
4/5/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Plus, another big buy points to strength of CDMO market and a new treatment for pulmonary arterial hypertension
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As the Biden administration calls for more-expansive drug pricing controls, it’s important to reflect on how we’re arriving at expected outcomes.
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FDA Roundup: April 2, 2024
4/2/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Despite strong demand for weight-loss drugs, the lack of Medicare coverage is potentially interfering with prescription and dispensing rates of anti-obesity medications for elderly adults, according to a new study.
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U.S. intelligence officials have informed senators that China-based biotech WuXi AppTec transferred an American client’s intellectual property to the Chinese government without consent, reports Reuters.
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Sanders says he wants Novo Nordisk to “do the right thing” and lower the costs of Ozempic and Wegovy. But only the Inflation Reduction Act can achieve that.
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FDA Roundup: March 29, 2024
3/29/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Citing a JAMA study that found Ozempic could be profitably produced at under $5 per month, Senator Bernie Sanders on Wednesday called on Novo Nordisk to lower prices for the diabetes treatment and the weight-loss drug Wegovy.
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Will the IRA’s Focus on the Pharmaceutical Industry Hurt the World’s Healthcare System Instead of...
3/28/2024
The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United States. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, poli... -
Global healthcare and life sciences look toward automation, AI and Quantum to protect patient data and save lives.
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The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.
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FDA Roundup: March 26, 2024
3/26/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.