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Home » Topics » Regulatory

Regulatory
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Digital cardiology illustration

AI-powered diagnostics repurposed for rapid assessment and triage of seriously ill COVID-19 patients

May 20, 2020
By Nuala Moran
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
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Regulatory front for May 20, 2020

May 20, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: International Trading Pharmaceuticals Laboratories Inc.
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FDA approves Lynparza for HRR gene-mutated castration-resistant prostate cancer

May 20, 2020
Health professional pointing stethoscope at Clinical Trial words, icons

Luoxin’s PIK3α inhibitor receives trial nod in China after Novartis’ alpelisib

May 19, 2020
By Elise Mak
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
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Approved stamp

Zai Lab and Novocure score the first China approval for glioblastoma in 15 years

May 19, 2020
By David Ho
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma.
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Gavel and scales

Newman dissents from Federal Circuit’s treatment of preamble in Cochlear v. Oticon

May 19, 2020
By Mark McCarty
Two judges with the U.S. Court of Appeals for the Federal Circuit sided with the Patent Trial and Appeal Board (PTAB) in a patent dispute between Oticon Medical and Cochlear, but the third judge, Pauline Newman took issue with the decision. Newman said the majority applied “an improper analytical technique” to determine that the preamble to a patent does not limit the related claims, despite that prior art cited to dispute the patent had been “disavowed by the preamble.”
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Saline enhanced radiofrequency (SERF) ablation system product image

Thermedical scores FDA breakthrough designation for ablation system to treat ventricular tachycardia

May 19, 2020
By Meg Bryant
Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.
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Patient given oral swab

Quidel assay wins EUA to detect COVID-19 without extraction step

May 19, 2020
By Liz Hollis
Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
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Regulatory front for May 19, 2020

May 19, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FBI, FDA, Glaxosmithkline, National Institute for Health and Care Excellence, NIH, U.K. National Cyber Security Agency, U.S. Department of Justice.
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Regulatory front for May 19, 2020

May 19, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Athos KT, Blue Flame Medical, Glaxosmithkline, Harsco, Lymol Medical, Pfizer, Stericycle, Vir Biotechnology.
Read More
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