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Sarah Faulkner

Orexo touts PK data for intranasal opioid overdose reversal drug

January 7, 2019 By Sarah Faulkner

Orexo updated logo

Orexo (STO:ORX) touted results today from a 20-person pharmacokinetic study of its OX124-001 naloxone nasal spray. The company’s product is designed to reverse opioid overdoses. In the PK study, Orexo compared its drug to Narcan – the market-leading naloxone rescue medication. Sweden-based Orexo reported that all formulations of OX124 were well-tolerated by study participants and showed […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: orexo

Vital Therapies pulls the trigger on Immunic share swap

January 7, 2019 By Sarah Faulkner

Vital Therapies logo - updated

Vital Therapies (NSDQ:VTL) said today that it inked a deal to swap shares with Germany-based Immunic, transitioning its efforts to focus on Immunic’s pipeline of drugs for chronic inflammatory and autoimmune diseases. Once the deal is closed, Vital Therapies plans to operate under the name Immunic and trade on the Nasdaq market. A group of investors, […]

Filed Under: Business/Financial News, Featured, Pharmaceuticals, Wall Street Beat Tagged With: immunic, vitaltherapies

Bigfoot Biomedical inks insulin deal with Eli Lilly

January 7, 2019 By Sarah Faulkner

Bigfoot Biomedical updated logo

Bigfoot Biomedical said today that it inked a non-exclusive deal with Eli Lilly (NYSE:LLY) to integrate Eli Lilly’s insulin products into Bigfoot’s investigational insulin delivery devices. The California-based company expects to launch its first two insulin delivery systems – Bigfoot Inject and Bigfoot Loop – in 2020, contingent upon finishing a pivotal trial and landing regulatory […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: abbott, Bigfoot Biomedical, Eli Lilly & Co.

Dexcom Q4 prelims top consensus | Wall Street Beat

January 7, 2019 By Sarah Faulkner

Wall Street beat for prelims, financial results

Dexcom (NSDQ:DXCM)  topped estimates on Wall Street today with preliminary results for its fourth-quarter financial results. The San Diego, Calif.-based company said it expects to report $331 million in sales for the quarter ended Dec. 31 – up at least 50% from the same period last year. For the full year of 2018, Dexcom is slated […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Pharmaceuticals, Wall Street Beat Tagged With: DexCom Inc., Intersect ENT Inc.

Frequency Therapeutics raises $42m for hearing regeneration drug

January 7, 2019 By Sarah Faulkner

Frequency Therapeutics updated logo

Frequency Therapeutics said today that it closed a $42 million Series B round to support the clinical development of its hearing regeneration drug, FX-322. The company is slated to publish top-line data from an ongoing Phase I/II study of FX-322 in the first half of the year. The Series B round was led by Taiwania […]

Filed Under: Clinical Trials, Featured, Funding Roundup, Otolaryngology Ear, Nose & Throat, Pharmaceuticals, Regenerative Medicine Tagged With: Frequency Therapeutics

Pops! Diabetes Care raises funds for newly-approved glucose monitoring system

January 4, 2019 By Sarah Faulkner

Pops Diabetes Care logo updated

Pops! Diabetes Care said yesterday that it closed a new equity financing round to support the launch of its newly-approved Pops! One blood glucose monitoring system. The Park Heights, Minn.-based company did not disclose how much money it raised but it did report that 30Ventures led the round. “We are honored by the support and […]

Filed Under: Business/Financial News, Diabetes, Featured, Funding Roundup Tagged With: popsdiabetescare

Senseonics touts first U.S. trial implant of 180-day CGM

January 4, 2019 By Sarah Faulkner

Senseonics - updated logo

Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA. The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days. Senseonics also […]

Filed Under: Clinical Trials, Diabetes, Featured, Food & Drug Administration (FDA), Implants, Regulatory/Compliance, Wall Street Beat Tagged With: Senseonics

Medtronic, IBM Watson debut hypoglycemia prediction feature for diabetes app

January 3, 2019 By Sarah Faulkner

Medtronic, IBM Watson's hypoglycemia prediction feature

Medtronic (NYSE:MDT) and IBM Watson Health today launched a new feature for its Sugar.IQ personal diabetes assistant app that can predict the likelihood of a user experiencing a low glucose event within a four-hour window. The feature, called IQcast, uses AI tech from IBM and becomes more accurate as the low blood sugar event draws nearer, […]

Filed Under: Diabetes, Featured, mHealth (Mobile Health), Patient Monitoring, Wall Street Beat Tagged With: IBM Watson Health, Medtronic

Results RNA recalls eye drops over undeclared colloidal silver

January 3, 2019 By Sarah Faulkner

Results RNA recalled eye drops

Results RNA said this week that it voluntarily recalled its Lubrisine eye drops following an FDA inspection that found the product was not manufactured with sterile practices. The company also said that the eye drops, which are designed to lubricate dry eyes, were found to contain undeclared colloidal silver. Exposure to colloidal silver over an […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Recalls Tagged With: resultsrna

Valeritas’ V-Go wins preferred status on Humana’s Medicare formularies

January 3, 2019 By Sarah Faulkner

Valeritas V-Go device - updated

Valeritas (NSDQ:VLRX) said today that its V-Go insulin delivery device won preferred status on Humana’s Part D formularies. The Bridgewater, N.J.-based company’s device is designed for people with Type 2 diabetes. Worn like a patch, the V-Go product delivers a continuous preset basal rate of insulin over 24 hours and can also provide on-demand bolus dosing […]

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

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