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Sarah Faulkner

Controversial “right to try” bill fails in the House

March 14, 2018 By Sarah Faulkner

capitol hill

A controversial bill that would grant terminal patients access to experimental therapies failed yesterday in the House. Although the “right to try” effort didn’t muster up enough votes to send it to the Senate, majority leader Rep. Kevin McCarthy (R-CA) said in a statement that the fight wasn’t over. “We will try again, pass legislation, […]

Filed Under: Featured, Food & Drug Administration (FDA), Legal News, Pharmaceuticals, Policy

Senseonics tops Q4 EPS estimates, misses sales expectations

March 14, 2018 By Sarah Faulkner

Senseonics

Shares in Senseonics (NYSE:SENS) closed down -3% yesterday after the medical device maker met earnings expectations on Wall Street with its fourth quarter and full-year financial results, but narrowly missed sales estimates. The Germantown, Md.-based company posted a net loss of -$16.3 million, or -12¢ per share, on sales of $2.9 million for the 3 months ended […]

Filed Under: Diabetes, Featured, MassDevice Earnings Roundup, Patient Monitoring, Wall Street Beat Tagged With: Senseonics

Judge rips into Abbott’s diabetes test strip supplier over discovery fraud

March 13, 2018 By Sarah Faulkner

gavel

A supplier that sells an international version of  Abbott‘s (NYSE:ABT) FreeStyle Diabetes test strips committed discovery fraud when it forked over only a select group of relevant documents last year, according to a U.S. magistrate judge. Lois Bloom ruled that the supplier, H&H, lost the right to invoke attorney-client privilege when it is deposed about […]

Filed Under: Diabetes, Featured, Legal News, Wall Street Beat Tagged With: abbott

The company behind Narcan looks toward a treatment for fentanyl overdoses

March 13, 2018 By Sarah Faulkner

Opiant Pharmaceuticals

Despite growing attention from lawmakers and doctors, the opioid crisis is not slowing up in the U.S. A new report published last week by the Centers for Disease Control and Prevention showed that emergency room visits for opioid overdoses jumped 30% in 45 states from 2016 to 2017. The problem has morphed over the years […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Adapt Pharma, Centers for Disease Control & Prevention, opiantpharmaceuticals

Intec Pharma partners for manufacture of ‘accordion pill’ for Parkinson’s disease

March 13, 2018 By Sarah Faulkner

Intec Pharma

Intec Pharma (NSDQ:NTEC) plans to partner with LTS to manufacture the company’s lead product candidate – an oral pill for Parkinson’s disease formulated with Intec’s “Accordion Pill” drug delivery tech. According to the terms of the deal, LTS will manufacture the carbidopa/levodopa capsules using Intec’s production technology in LTS’ manufacturing facility in Germany. Intec is working […]

Filed Under: Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: Intec Pharma

Anika CEO retires after two decades; president assumes corner office | Personnel Moves – March 13, 2018

March 13, 2018 By Sarah Faulkner

Anika Therapeutics

Anika Therapeutics (NSDQ:ANIK) announced this month that CEO Charles Sherwood plans to retire after working for Anika for nearly twenty years. Joseph Darling, who has been Anika’s president since July 2017, will take his place in the corner office. Darling has previously served in executive leadership roles across an array of medtech companies like Abbott (NYSE:ABT), Baxter (NYSE:BAX) […]

Filed Under: Drug-Device Combinations, Featured, Personnel, Pharmaceuticals, Wall Street Beat Tagged With: abbott, alucentmedical, Anika Therapeutics Inc., Baxter, BioTime, Brainstorm Cell Therapeutics, Kala Pharmaceuticals, medherant, milestonescientific, pertinaxpharma, smith&nephew, West Pharmaceutical Services

ACC ’18 Roundup: OrbusNeich Combo drug-eluting stent succeeds in registries

March 12, 2018 By Sarah Faulkner

ACC '18

OrbusNeich touted pooled data from two registries evaluating its dual-therapy stent this week at the annual meeting of the American College of Cardiology. The Combo stent was implanted in more than 3,600 all-comer patients and followed by researchers for one year. The registries found that the device was safe and effective after one year, featuring a […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: OrbusNeich

Medtronic wins FDA nod for connected, predictive CGM system

March 12, 2018 By Sarah Faulkner

Medtronic

Medtronic (NYSE:MDT) said today that its Guardian Connect continuous glucose monitoring system won FDA approval for people with diabetes ages 14 to 75. The medtech titan touted its system as the first connected standalone CGM designed to help people with diabetes avoid high and low glucose events. Using Medtronic’s Guardian Sensor 3, the system alerts its […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Wall Street Beat Tagged With: Medtronic

MiMedx wins FDA regenerative med status for AmnioFix

March 12, 2018 By Sarah Faulkner

MiMedx

MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week. The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee. “The FDA’s RMAT designation for AmnioFix Injectable is […]

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

Insulet nabs spot as in-network provider with UnitedHealthcare

March 12, 2018 By Sarah Faulkner

Insulet Omnipod

Insulet (NSDQ:PODD) and UnitedHealthcare (NYSE:UNH) inked a new network relationship last week, giving people enrolled in UnitedHealthcare’s commercial and Medicaid plans in-network coverage for Insulet’s Omnipod insulin delivery device. “Through this new relationship, we are working together to help people access the insulin management technology they need to effectively manage their diabetes,” the companies wrote in a […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Insulet, unitedhealth

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