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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

It is the company ’s most advanced manufacturing facility to date. “As part of Amgen’s global biomanufacturing network, Amgen Ohio will play an important role in helping us address serious disease around the world with our innovative biomedicines.”

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Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Legacy MEDSearch

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .

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Tariffs could threaten medicine innovation, industry bodies warn

European Pharmaceutical Review

According to the findings, nearly 90 percent of US biotechs rely on imported components for at least half of their products approved by the US Food and Drug Administration. Proposed tariffs on the EU would force half of companies to find new research and manufacturing partners.

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Inspira™ Technologies Begins Manufacturing of the ALICE™ CPB Device, ahead of planned 2023 FDA submission

Legacy MEDSearch

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

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How automation and digital technologies will unlock the full potential of advanced therapies

European Pharmaceutical Review

It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000. 1 It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000.

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NKGen and Parkinson’s Foundation partner to advance cell therapy

Pharmaceutical Technology

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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WuXi Biologics and InflaRx to jointly manufacture Covid-19 therapy Gohibic

Pharmaceutical Technology

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic.