Industry News
Life Sciences
Top stories summarized by our editors
1/14/2022

The FDA has given breakthrough status designation to WaveGate for its StimuLux optical reflectometry system, a closed-loop spinal cord stimulation system. "This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain," said WaveGate CEO Erich Wolf.

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MassDevice (Boston)
1/14/2022

European regulators have given CE mark certification to LumiraDx for its portable C-reactive protein test that is used for respiratory infection evaluation.

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FDAnews
1/14/2022

India's Central Drugs Standard Control Organization has given clearance to Co-Diagnostics' CoSara Diagnostics for its SARAGENE human papillomavirus high-risk RT-PCR test, allowing it to be sold and manufactured in the country.

1/14/2022

22nd Century Group has received the FDA's authorization to market its VLN Menthol King and VLN King low-nicotine content combustible, filtered cigarettes as modified risk tobacco products. Evidence showed that the reduced-nicotine cigarettes can help reduce nicotine exposure and consumption for smokers who plan to use the products, according to the FDA's Center for Tobacco Products.

1/14/2022

COUR Pharmaceuticals received the FDA's fast track status for its investigational therapy CNP-104 to treat primary biliary cholangitis. CNP-104 was developed in partnership with Ironwood Pharmaceuticals, and the companies are planning to conduct a midstage trial early this year to evaluate CNP-104's efficacy, safety, tolerability and pharmacodynamics in patients with PBC.

1/14/2022

BioNTech and Crescendo Biologics will work together to develop targeted T-cell enhancing therapies for cancers and other diseases. The partners will use Crescendo's transgenic platform to study targets chosen by BioNTech, with Crescendo eligible for $40 million up front in addition to research funding as well as development, regulatory and commercial milestone payments worth more than $750 million.

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BioPharmaReporter
1/14/2022

Shehnaaz Suliman, former president and chief operating officer of Alector, was named CEO of ReCode Therapeutics, whose disease-modifying therapeutics for respiratory diseases are nearing clinical trials. Suliman, who is active in Women In Bio and serves on the boards of 10x Genomics and Ultragenyx Pharmaceutical, says she's "passionate about advancing leadership opportunities for underrepresented minorities."

1/14/2022

An undergraduate degree in biochemistry, a graduate degree in biomedical sciences, a PhD in natural sciences and project management professional certification are not enough for Geeta Peverada, who manages Catalent's quality control program manager, and is now pursuing an MBA. "Pursuing additional certifications and degrees beyond my regular duties not only makes me highly proficient in my job, it also opens avenues for opportunities that I might not otherwise be aware of," says Peverada, who serves as vice-chair of the Women In Bio Capital Region chapter.

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BioBuzz
1/14/2022

As executive director, Michelle Lewis wants to develop the biopharmaceutical education and training center at Albany College of Pharmacy and Health Sciences into a national fee-for-service biopharmaceutical manufacturing training institute. Lewis managed science staff at the University of Georgia's bioexpression and fermentation facility, and guided business development as well as employee and student training opportunities.

1/14/2022

COVID-19 poses a significant health risk to pregnant people and fetuses, but until now little was known about the safety of COVID-19 vaccines because pregnant people were excluded from the first clinical trials. An array of recent scientific studies show COVID-19 vaccines are far less likely than the disease itself to be associated with maternal death, stillbirth and premature delivery, but maternal vaccination rates remain below 50% in the US and are even lower elsewhere.

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Nature