FDA ties three deaths to Edwards Lifesciences’ recalled heart devices
The U.S. Food and Drug Administration said three deaths were reported related to Edwards Lifesciences Corp.’s recall of some of the company’s heart devices.
Featured Posts
Pharma Innovators Special Feature 2018: Focus on innovation
In seeking innovative players that could change pharma and healthcare, Med Ad News found the developer of an app that helps people determine what illnesses are in their neighborhoods; the creator of a wearable injector that allows patients on biologics to receive these drugs outside the clinic; and a designer of a deep learning network aimed at giving pharma and healthcare companies a handle on their data.
2015 U.S. trends in aggregate spend, disclosure, and transparency
What are key trends in the transparency compliance landscape? And, how are life sciences manufacturers tackling growing requirements
“Dueling Numbers”: FDA Panel Trying to Determine Safety of Paclitaxel-Coated Stents and Balloons
The U.S. FDA’s Circulatory System Devices Panel is undergoing two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons and paclitaxel-eluting stents.
Abbott Launches First-ever Rapid Point-of-Care HbA1c Test to Aid in the Diagnosis of Diabetes
Abbott’s Afinion HbA1c Dx assay was launched as the only rapid point-of-care test cleared by the U.S. Food and Drug Administration to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients’ risk of developing the condition.
FDA Approves Amgen and Allergan’s Kanjinti
Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.
Many epinephrine self-injectors still potent long after expiration date
EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.
FDA Approves First-Ever Indication for Device for Patients With Functional Abdominal Pain Associated With IBS
Innovative Health Solutions Inc. announced FDA clearance for the new device IB-Stim to treat functional abdominal pain associated with irritable bowel syndrome (IBS) in patients ages 11-18 years old.
Abbott device helps in cutting blood sugar in type 2 diabetics: study
Insulin-dependent patients with T2D saw a significant drop in blood sugar levels after wearing Abbott’s continuous glucose monitoring system compared with those who use routine fingerstick testing.
Medication-free treatment for depression launches in the UK
Flow, a medical device company, launched a medication-free treatment for depression comprising a brain stimulation headset and therapy app.
FDA Approves NovoTTF-100L for Mesothelioma Therapy
The NovoTTF-100L therapy has become an FDA-approved therapy that is helping improve the lives of mesothelioma patients.
FDA Approves NovoTTF-100LTM System
The U.S. FDA approved Novocure’s NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma.
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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!