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Sarah Faulkner

Medtronic kicks off study for pain pump

January 17, 2019 By Sarah Faulkner

Medtronic Synchromed II pain pump

Medtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids. The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Medtronic

Proteus debuts digital cancer drug

January 17, 2019 By Sarah Faulkner

Proteus Digital Health updated logo

Proteus Digital Health said today that the first cancer patients were treated using its digital oncology therapy, which combines oral chemotherapy with an ingestible sensor. Patients with stage 3 and 4 colorectal cancer at the University of Minnesota Health and Fairview Health Services were treated with digital capecitabine. The Redwood City, Calif.-based company plans to […]

Filed Under: Drug-Device Combinations, Featured, mHealth (Mobile Health), Oncology, Pharmaceuticals Tagged With: Proteus Digital Health

QT Vascular expands pivotal trial of Chocolate Touch DCB

January 16, 2019 By Sarah Faulkner

QT Vascular updated logo

QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. The pivotal study of QT Vascular’s […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: C.R. Bard, QT Vascular

Rep. Cummings talks drug pricing with HHS chief

January 16, 2019 By Sarah Faulkner

Prescription drugs

Days after unveiling an investigation into the drug pricing practices of 12 pharmaceutical companies, House Oversight Committee Chairman Rep. Elijah Cummings (D-Md.) met with the Secretary of Health & Human Services, Alex Azar, to discuss ways they can work together to lower drug prices. Although the two did not discuss specific legislation, Cummings told reporters […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals

Researchers question use of antibiotic shunts in hydrocephalus patients

January 15, 2019 By Sarah Faulkner

Boston Children's Hospital - updated logo

Led by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus. Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Research & Development, Surgical Tagged With: Boston Children's Hospital

What’s ahead for the drug delivery market in 2019?

January 15, 2019 By Sarah Faulkner

West Pharmaceutical Services - updated logo

Cindy Reiss-Clark, VP & GM of West‘s (NYSE:WST) global biologics business, comments on the drug delivery trends that stood out from 2018 and what she’s keeping an eye on in the coming year.  What were the trends that drove the biopharma and drug delivery markets in 2018? Many of 2018’s key trends revolved around increasing […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: West Pharmaceutical Services

Pharma stocks fall as Rep. Cummings launches drug pricing investigation

January 14, 2019 By Sarah Faulkner

Pills

Chairman of the House Oversight Committee Rep. Elijah Cummings (D-MD) launched an investigation today into the drug pricing practices of 12 pharmaceutical companies. A number of companies named in the investigation saw their stock prices fall, including Amgen (NSDQ:AMGN), AbbVie (NYSE:ABBV), AstraZeneca (NYSE:AZN), Eli Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO). A hearing is reportedly set for Jan. 29 and will […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: AbbVie, Amgen, AstraZeneca plc, Eli Lilly & Co., Novo Nordisk, Sanofi-Aventis

Amneal wins FDA nod for generic rivastigmine transdermal patch

January 14, 2019 By Sarah Faulkner

Amneal Pharmaceuticals logo

Amneal Pharmaceuticals (NYSE:AMRX) said today that it won FDA approval for a generic rivastigmine transdermal patch. The drug, which is sold under the brand name Exelon, is an acetylcholinesterase inhibitor that is commonly used to treat mild to moderate Alzheimer’s disease and Parkinson’s disease. The Exelon patch reeled in roughly $225 million in U.S. sales […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: amnealpharmaceuticals

Valeritas’ V-Go nabs preferred status on OptumRx formularies

January 14, 2019 By Sarah Faulkner

Valeritas V-Go device - updated

Valeritas (NSDQ:VLRX) said today that its wearable insulin delivery device, V-Go, won preferred status on the OptumRx formulary. The Bridgewater, N.J.-based company’s device is designed for people with Type 2 diabetes. The V-Go product is worn like a patch and delivers a preset basal rate of insulin over the course of 24 hours. The device can […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Valeritas Inc.

Ocular Therapeutix seeks second indication for drug-delivery eye insert

January 11, 2019 By Sarah Faulkner

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) said yesterday that it submitted a supplement NDA to the FDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up to 30 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Ocular Therapeutix

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