Vifor Pharma and Cara Therapeutics, Inc. | October 20, 2020
Vifor Pharma and Cara Therapeutics, Inc. today announced that both companies have signed a license agreement for commercialization of Korsuva (difelikefalin) Injection (“IV Korsuva”) for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in the US dialysis market for non-Fresenius Medical Care clinics under a Cara 60%, Vifor Pharma 40% profit-sharing arrangement. “With an established fully dedicated nephrology sales force in the US, Vifor Pharma is an ideal commercialization partner to bring IV Korsuva to dialysis patients across the country,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “In addition, we believe Vifor Pharma’s existing relationships with US dialysis providers will provide significant momentum for the launch and adoption of IV Korsuva, if approved. As a result of this agreement, we expect to focus Cara’s internal resources on our clinical programs for Oral Korsuva in atopic dermatitis, pre-dialysis CKD and additional pruritic conditions.”
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PHARMACY MARKET
Alcami Corporation | March 02, 2022
Alcami, a U.S.-based pharmaceutical contract development and manufacturing organization announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The dedicated Non-GMP formulation development space, which is co-located within the same facility as Alcami's parenteral manufacturing operation that offers four isolator filling lines for liquid and lyophilized products, is ready to support customers with Preclinical and Clinical development programs.
"This is a truly a unique offering that will provide our clients' current and future development programs with flexibility, speed, and a streamlined progression throughout the drug development lifecycle,"
Louise Hall, Vice President of Formulation Development & Technology Transfer at Alcami Corporation
Alcami's Non-GMP Formulation Development Laboratory is outfitted with a high potency suite, lyophilization cycle development center, stability chambers to facilitate lead candidate selection, and the equipment to support a wide variety of research and early-phase development activities, including bench-scale manufacturing of drug product to support Preclinical studies. Furthermore, it is fully integrated within Alcami's RTP campus, encompassing over 100,000 ft².
"We are pleased to provide our clients with a seamless transition from characterization to formulation and analytical development through GMP manufacturing and analytical release," added Louise Hall.
About Alcami
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging 675,000 ft² across the United States, Alcami serves pharmaceutical and biotech companies of all sizes providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami's private equity ownership includes Madison Dearborn Partners and Ampersand Capital Partners.
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BUSINESS INSIGHTS
Applied BioMath | October 18, 2021
Applied BioMath, the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, today announced a collaboration with BYOMass, Inc. for systems pharmacology modeling in chronic diseases. BYOMass is a preclinical stage pharmaceutical company focused on the TGF-ß superfamily.
"We chose Applied BioMath given their proven track record of helping companies identify ideal therapeutic properties and platforms, We hope that this collaboration will help us identify the properties of a lead candidate as efficiently as possible and aid in the design of future studies."
- Margaret Jackson, D.Phil., Founder and CEO of BYOMass
Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis.
"We often work with early-stage companies to help them understand what their therapeutic needs to look like in order to be best in class, We look forward to collaborating with BYOMass and helping them decide next steps for this project."
- John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath.
About Applied BioMath
Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic.
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