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Mira’s New Menopause Transitions Kit Allows for At-Home Hormone Monitoring

XTalks

Mira, a California-based women’s health technology company, has introduced its Menopause Transitions Kit, a new hormone monitoring kit designed for menopausal women. The at-home device enables women to track key hormone levels, offering real-time insights into the complex hormonal fluctuations associated with perimenopause and menopause.

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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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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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(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.

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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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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

We’re using a combination of gut hormones to mimic the effectiveness of bariatric surgery. Mounjaro is a combination of the two gut hormones GLP-1 and GIP. Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices.

Drugs 264
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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

We’re using a combination of gut hormones to mimic the effectiveness of bariatric surgery. Mounjaro is a combination of the two gut hormones GLP-1 and GIP. Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices.

Drugs 246