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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. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label.

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Manufacturing foul-up hits Novartis’ radioligand business

pharmaphorum

For Pluvicto that includes a pair of phase 3 trials in metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer, while for Lutathera it will affect studies for brain cancer glioblastoma, extensive-stage small cell lung cancer, and new NET indications.

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

Pharmaceutical Technology

Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer. Furthermore, Orion will oversee the manufacturing of ODM-208 for clinical and commercial supply. An oral, non-steroidal and selective CYP11A1 inhibitor, ODM-208 is currently being analysed in a Phase II trial in mCRPC patients.

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(LAI-287 + semaglutide) by Novo Nordisk for Type 2 Diabetes: Likelihood of Approval

Pharmaceutical Technology

Novo Nordisk overview Novo Nordisk, a subsidiary of Novo Holdings AS, is a healthcare company focused on discovering, developing, and manufacturing of innovative biological medicines. The company markets its products through subsidiaries in North America, Europe, Asia, Latin America, Africa, the Middle East and Australia.

Insulin 182
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Thyroid Awareness Month 2024: Increasing Awareness and Exploring New Treatments for Thyroid Diseases

XTalks

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues.

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