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FDA Rejects Lilly’s Eczema Treatment Over Third-Party Manufacturing Issues

BioSpace

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

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BOEHRINGER INGELHEIM ENTERS GLOBAL LICENSING AGREEMENT TO DEVELOP AND COMMERCIALIZE INNOVATIVE ANTIBODIES FROM A*STAR FOR TARGETED CANCER THERAPIES

The Pharma Data

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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ADCs Pipeline Update: Avacta Partners with ADC Therapeutics

Roots Analysis

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline. In nature, they are made by a group of bacteria known as actinomycetes.

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Subcutaneous Medications and Drug Delivery Systems

Roots Analysis

In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017. Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.

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Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time

Pfizer

Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. A massive manufacturing undertaking. Anonymous (not verified). Mon, 12/13/2021 - 11:40.

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PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

The Pharma Data

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The challenges and trends of cell & gene therapies 

Drug Discovery World

Manufacturing . As is always the case with pharmaceuticals, the industry’s capabilities to manufacture and produce these potentially life-saving therapies will be of concern. . Because of the variation between patients, operating a consistent manufacturing process is one of the key concerns,” she explains. .