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After manufacturing setback at FDA, Ascendis strikes $150M royalty deal on its first commercial drug

Fierce Pharma

Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.

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FDA rejects Lilly’s BLA for UC drug over manufacturing concerns

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. Mirikizumab also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

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Merck and Orion enter partnership to develop ODM-208 for prostate cancer

Pharmaceutical Technology

Under the deal, the companies will also develop various other drugs that act on cytochrome P450 11A1 (CYP11A1), an enzyme vital for steroid production. Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer. The latest deal complements and bolsters the oncology pipeline of Merck.

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Bayer to strengthen global Pharmaceuticals production network

The Pharma Data

Bayer announced today that it is strengthening the production network of its pharmaceutical division to ensure sustainable competitiveness and support the transformation of its pharmaceutical business based on breakthrough innovation delivering long-term, sustainable business growth.

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Leading freeze-drying systems suppliers for the pharmaceutical industry

Pharmaceutical Technology

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Manufacturing foul-up hits Novartis’ radioligand business

pharmaphorum

Novartis has shut down production of its radioligand therapies – one of its key growth areas – at facilities in Europe and the US after discovering potential quality issues at the plants. The post Manufacturing foul-up hits Novartis’ radioligand business appeared first on.