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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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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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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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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.