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Top Stories
The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.
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While the US public and law makers push for price controls, pharma’s venture capitalists have other ideas for balancing innovation and affordability.
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Industry News
By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.
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The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.
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Supplier News
Karen Flynn rejoins Catalent as president of biologics operations; regional presidents named for US and Europe.
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The renaming comes after the sale of Bosch Packaging Technology to CVC Capital Partners was completed on Jan. 2, 2020.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Bio/Pharma News
A development and manufacturing partnership with Thermo will allow Civica to expand its internal pipeline of medications for use in emergency and critical care in the United States, further preventing the risk of drug shortages.
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The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.
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Regulatory News
FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.
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FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
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Featured Topics |
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QUALITY
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
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DEVELOPMENT
FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
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February 5–6, 2020
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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