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CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. GlobalData is the parent company of Pharmaceutical Technology. Regulatory decisions come in.

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Chinese manufacturers’ transition to innovative pharma requires more investment

Pharmaceutical Technology

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Roots Analysis

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Future trends: biopharma to outpace small molecule drug development  

Drug Discovery World

Advances in new manufacturing technology accelerate Back in 2019 I wrote a paper about transforming the drug life cycle, which included what I felt were the opportunities and the challenges that were going to affect the pharmaceutical sector over the next few years.

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Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3. government.

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions.