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The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Drug Patent Watch

This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers. billion in 2022 and is expected to grow at a compound annual growth rate of 5.3% Reshaping drug development through CRO/CDMO integration.

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STAT+: FTC slams PBMs for boosting specialty drug prices at the expense of the U.S. health care system

STAT

billion in revenue by dispensing medicines to treat cancer, HIV, heart disease and other serious illnesses at prices that exceeded their estimated acquisition costs between 2017 and 2022. The FTC noted in its report that so-called specialty generic drugs represent a large and growing amount of spending by plan sponsors and patients.

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How to Develop a Sustainable Generic Drug Development Strategy

Drug Patent Watch

This article outlines key considerations and strategies for developing a sustainable generic drug development strategy. Pfizer, for example, has been applying green chemistry principles in drug development for over two decades to reduce waste, minimize resource use, and develop energy-efficient manufacturing processes.

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Drug Development In-Depth Focus 2022

European Pharmaceutical Review

Pursuing new paths in targeted protein degradation drug development. The post Drug Development In-Depth Focus 2022 appeared first on European Pharmaceutical Review. Targeted protein degradation (TPD) therapy has grown rapidly as a field, with transformational potential.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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STAT+: Biotech accelerator Curie.Bio raises $340 million for a new seed fund

STAT

Since 2022, Curie.Bio has received some 4,000 applications. Borisy and Weinberg’s firm was created to upend the biotech financing model , offering both capital and expert assistance to founders seeking on option outside of traditional VC funding. It has invested in 26 startups, giving it a less than 1% acceptance rate.

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STAT+: Drugs are still mostly tested in white men. Will the FDA change that next year?

STAT

Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials. If everything proceeds on time, drug and medical device makers will be required to submit plans for meeting diversity standards by the end of March 2025. Continue to STAT+ to read the full story…