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Novartis halts recruitment of Kisqali trials as it adjusts production methods

Fierce Pharma

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients (..)

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Solution to Clinical Trial Enrollment Lies Hidden in FDA Guidance

MedCity News

The FDA is apparently open to new technologies that enable patients to easily participate in clinical research, whether it be from their homes, a nearby clinic, or a provider’s office.

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Clinical trial DTC? It may not be right for your drug candidate

World of DTC Marketing

More than 18,000 clinical trials are actively recruiting patients in the U.S. The FDA approved 309 new drugs between 2011 and 2018, 38 per year on average. In 2018, the FDA approved 59 new drugs – an all-time high. We’ve been asked, a lot of times, to give our opinion on using DTC for clinical trial recruitment.

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What Pear Therapeutics’ Bankruptcy Has Left the DTX Industry to Ponder

MedCity News

Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations. This strategy eliminates the per-unit sticker price, but at the cost of losing the FDA credibility. The result was more diverse and inclusive data.

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FDA rejects Spectrum’s lung cancer drug poziotinib

pharmaphorum

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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Potrero Medical Receives FDA Breakthrough Device Designation for Accuryn AKI Predict Algorithm

Legacy MEDSearch

Potrero Medical announced that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients. For more information, visit potreromed.com .

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Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.

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