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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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CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology

Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. The EMA had provided a positive opinion for this marketing authorization back in July. Regulatory decisions come in. NICE decisions.

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Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Cost of collaboration and contract manufacturing (COCM). $. Regeneron Pharmaceuticals, Inc. Business Highlights. 30%. *. *.

Sales 52
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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.

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CMO Moves: Regulatory catalysts for therapy manufacturing -January

Pharmaceutical Technology

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API.