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Chinese manufacturers’ transition to innovative pharma requires more investment

Pharmaceutical Technology

Advanced biologic production involving cell and gene therapies is currently limited but concentrated in Eastern China in provinces such as Shanghai, Zhejiang and Jiangsu for US FDA-approved sites. The Chinese pharma manufacturing industry is renowned for its generic API manufacturing.

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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. Regulatory decisions by the US FDA, EMA and Swissmedic for select therapies from late September to October and the CMOs contracted to manufacture them.

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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.

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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. Cost of goods sold (COGS). $.

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

Pharmaceutical Technology

US President Joe Biden has gained approval from Congress for a new package of aid worth $40bn, and the US government announced last month that it plans to provide an additional $1bn in security assistance to Ukraine. There are no US FDA-approved pharma manufacturing facilities in Russia.