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10/19/2020

A pilot program has been launched by the FDA's Center for Drug Evaluation and Research to characterize quality management maturity for finished dosage forms from local over-the-counter product and prescription drug manufacturers. The CDER also launched a second pilot program that will look at QMM for active pharmaceutical ingredients including drug substance intermediates made by foreign firms and intended for use in OTC products and prescription drugs regulated by the FDA.

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Regulatory Focus
10/19/2020

The FDA is seeking information about D-tagatose, isomaltulose and similar sweeteners that are metabolized differently than traditional sugars in line with efforts to coordinate with manufacturers on the Nutrition Facts Label. The agency also stated that the Nutrition Facts Label will not categorize allulose as sugar or added sugar.

10/19/2020

Orchard Therapeutics announced it had received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use gaining its recommendation for the approval of its investigational gene therapy Libmeldy to treat a rare genetic condition known as metachromatic leukodystrophy. A final decision is expected by year's end and its approval would make Libmeldy the first gene therapy and first commercial therapy for patients with early-onset MLD who are eligible for treatment.

10/19/2020

A late-stage trial for a COVID-19 vaccine may begin next month in the Philippines if approved by regulators. China's Sinovac Biotech is one of several vaccines under evaluation by regulators there.

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Reuters
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Sinovac Biotech
10/19/2020

Bioelectronics firm iota is set to be purchased by Astellas after they entered a partnership last year for a research and development deal. Iota has developed technology using ultrasound to create miniature implantable medical devices that are battery-free and use wireless frequencies.

10/19/2020

The biomass and volume of giant redwood trees in California have been measured using laser technology, according to researchers at the University College London. The technique offers first-ever insights into the trees' 3D structure, aiding scientists in estimating carbon absorption and possible climate change response, according to a study published in Nature Scientific Reports

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University College London
10/16/2020

The FDA has issued final guidance on biotin interference testing for in vitro diagnostic devices. The agency acknowledged industry recommendations but declined to lower the recommended biotin level for interference testing from 3,500 ng/mL to 1,200 ng/mL.

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Regulatory Focus
10/16/2020

New York Gov. Andrew Cuomo and Arkansas Gov. Asa Hutchinson asked the Trump administration to provide more guidance on the logistics of mass COVID-19 vaccination, outlining questions involving funding, vaccine allocation and supply chain management. The leaders of the National Governors Association asked for a meeting with the administration to talk about the delineation between state and federal responsibilities and expectations for successful distribution of a COVID-19 vaccine.

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The Hill
10/16/2020

Stuart Simpson has been chosen to serve as executive chair of orthopedics device maker Breg. Simpson has previously served as the president of Stryker's joint replacement division.

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Becker's Spine Review
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Breg, Stryker
10/16/2020

One-year results of Royal Philips' DEFINE PCI study -- which is investigating Philips' blinded instant wave-free ratio pullback measurement guidance technology for percutaneous coronary intervention -- show less recurrent angina and improved outcomes. "The one-year data from DEFINE PCI are the latest evidence that iFR contributes to reduced costs, enhanced patient experience and improved outcomes for PCI procedures [2, 3, 4]," said Chris Landon, Philips' senior vice president and general manager of image-guided therapy devices.

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MassDevice (Boston)
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Royal Philips