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A new viral surveillance system in West Africa is showing the world how to prevent the next pandemic

Broad Institute

Christian Happi and Pardis Sabeti on the campus of Redeemer's University in 2013. Christian Happi and Pardis Sabeti on the campus of Redeemer's University in 2013. In 2013, Happi and Sabeti applied to the World Bank for support to establish a genomic center of excellence in Nigeria. Scientists train at ACEGID in October 2013.

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Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

The Pharma Data

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

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The Feverish Pricing of MS Treatments

The Pharma Data

Towards the end of March, the FDA approved two new treatments for multiple sclerosis (MS): Mayzent (siponimod) and Mavenclad (cladribine). Take the first disease-modifying agent approved, interferonB (Betaseron) as an example. By 2013 this had risen to $61,529, and today’s estimate is close to $66,000. Consumer News.

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Where's the Synthetic Blood?

Codon

Biotechnology Journal (2013). Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. A cost analysis to make one unit of red blood cells from stem cells. Data from Rousseau G.F. Each particle includes a lipid shell and a liquid core containing biomolecules.

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Federal Marijuana Rescheduling: States Get Ready

FDA Law Blog: Biosimilars

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. Department of Justice (“DOJ”) and DEA respond?

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Brain organoids: a fascinating and powerful tool for drug discovery

Drug Target Review

Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 502:327-332 (2013). Induction of myelinating oligodendrocytes in human cortical spheroids. Nat Methods. link] Shaker MR, et al.

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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog: Biosimilars

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. Section II at 2.

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