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Fewer New Drugs but Affordable Access for Existing Ones: The Big Elephant in the Room

Policy Prescription

Would you vote for legislation to lower drug prices that would lead to a five percent reduction in pharmaceutical innovation — yet simultaneously create a health system in which all Americans could afford the prescription drugs they need? That’s compared to the one we have now where a quarter of Americans struggle with drug prices.

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Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing

Alta Sciences

billion by 2029. Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects. So much so that the HPAPI market is estimated to reach USD 31.5 View the full library of The Altascientist publications.

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

Disease 64
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What is the largest CRO in the US?

Vial

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA 40