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Nancy Crotti

AbbVie gains U.S. nod for $63B Allergan takeover

May 6, 2020 By Nancy Crotti

Pharmaceutical giant  AbbVie (NYSE:ABBV) has won U.S. antitrust approval for its  purchase of Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. North Chicago-based AbbVie announced the deal in June 2019, but ran up against U.S. Federal Trade Commission […]

Filed Under: Business/Financial News, Featured, Immunotherapy, Pharmaceuticals, Wall Street Beat Tagged With: AbbVie, Allergan, AstraZeneca plc, Federal Trade Commission (FTC), Johnson & Johnson

Fauci: Hundreds of millions of COVID-19 vaccine doses could be ready in January

April 30, 2020 By Nancy Crotti

coronavirus COVID-19

Dr. Anthony Fauci said this morning that hundreds of millions of doses of a vaccine for COVID-19 could be ready by January. In an interview on the Today Show, the director of the National Institute of Allergy and Infectious Diseases said that a vaccine candidate is in the first phase of a clinical trial. If the second […]

Filed Under: Business/Financial News, Clinical Trials, Hospital Care Tagged With: coronavirus, COVID-19, Gilead Sciences, National Institutes of Health

Qosina touts single-use bioprocessing components for coronavirus response

April 8, 2020 By Nancy Crotti

With the bioprocess industry mobilizing to support the development of tests, vaccines and treatments for COVID-19, medtech distributor Qosina said that its supply of single-use bioprocessing components can offer significantly reduced time to clinic and market over multi-use systems during situations like the coronavirus pandemic. Ronkokoma, N.Y.-based Qosina said it also provides 3D CAD models and […]

Filed Under: Business/Financial News, Diagnostics, Featured, Hospital Care Tagged With: coronavirus, COVID-19, Qosina

Study: High- and low-dose drug-coated balloons equally effective in PAD

January 30, 2020 By Nancy Crotti

Medtronic, Boston Scientific

A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week. The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: Boston Scientific, Medtronic

Indiana man may proceed with pain pump lawsuit against Medtronic

January 6, 2020 By Nancy Crotti

An Indiana federal judge on Friday dismissed two parts of a lawsuit against Medtronic (NYSE:MDT), but said that the plaintiff can continue to pursue the third count. Kirk Bledsoe sued Medtronic in Indiana state court in 2017 after the company’s Synchromed II pain pump, which Bledsoe had implanted in 2011, failed on two occasions and […]

Filed Under: Featured, Implants, Legal News, Pain Management Tagged With: Medtronic

FDA wants feedback on combination products guidance

December 27, 2019 By Nancy Crotti

FDA-logo-new

The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency. The FDA defines a combination product as one composed of any combination of a drug, device and/or a […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: FDA

Medtronic adds AI-fueled Klue to its diabetes management lineup

December 17, 2019 By Nancy Crotti

Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development Tagged With: klue, Medtronic, Nutrino

Dexcom CEO apologizes for remote monitoring outage

December 16, 2019 By Nancy Crotti

Dexcom (NSDQ:DXCM) CEO Kevin Sayer publicly apologized on Friday for an outage over Thanksgiving weekend that cut off users’ ability to share glucose monitoring data with caregivers and loved ones. The Dexcom Follow app normally allows users of the company’s G6 continuous glucose monitor to share that data with up to 10 people, according to the […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Dexcom

FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller

December 13, 2019 By Nancy Crotti

The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM)  t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: artificialpancreas, DexCom Inc., FDA, Tandem Diabetes Care

Senate confirms Dr. Stephen Hahn to lead FDA

December 12, 2019 By Nancy Crotti

The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s […]

Filed Under: Food & Drug Administration (FDA) Tagged With: AdvaMed, Dr. Stephen Hahn, FDA

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