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UK takes measures to tackle Utrogestan hormone replacement shortage

Pharmaceutical Technology

As supplies for Besins Healthcare’s hormone replacement therapy (HRT) medication Utrogestan (progesterone) experience shortages in the UK, the Department of Health and Social Care has issued a Serious Shortage Protocol (SSP) addressing the measures being made to mitigate the issue. This SSP is one of two protocols active for HRTs in the UK.

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Five Trends in Contract Drug Manufacturing Organisations

Pharmaceutical Technology

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

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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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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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High biologics demand spurs need for greater contract manufacturing

Pharmaceutical Technology

Biologics are costly to produce and sell, and the more recent modalities, such as cell and gene therapies, can be difficult to manufacture. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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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.