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Sarah Faulkner

Inovio prices $65m senior notes offering

February 14, 2019 By Sarah Faulkner

Inovio device and logo - updated

Inovio Pharmaceuticals (NSDQ:INO) said today that it priced an offering of $65 million of 6.5% convertible senior notes due 2024. The Plymouth Meeting, Penn.-based company also gave initial purchasers a 13-day option to buy up to an additional $20 million in notes. Inovio expects to reel in roughly $62.7 million in net proceeds from the offering […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: Inovio Pharmaceuticals

FDA committee backs J&J’s nasal spray for depression

February 13, 2019 By Sarah Faulkner

Updated Janssen logo

An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Wall Street Beat Tagged With: janssen, Johnson & Johnson

Touting pricetag, Mylan launches Advair generic

February 12, 2019 By Sarah Faulkner

Mylan logo - updated

Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease. The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. The wholesale acquisition costs for Mylan’s Wixela Inhub devices […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Mylan

Insulet president & CEO Shacey Petrovic to participate in keynote interview at DeviceTalks Boston 2019

February 12, 2019 By Sarah Faulkner

DeviceTalks Boston 2019 - Shacey Petrovic

[Press Release] – WTWH Media and MassDevice.com announced today that Shacey Petrovic, president and CEO of Insulet (NSDQ:PODD), will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019, at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices […]

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

Delcath wins approval for Chemosat in Brazil

February 11, 2019 By Sarah Faulkner

Delcath Systems - updated logo

Delcath Systems (OTC:DCTH) said today that it won medical device approval for its Chemosat hepatic delivery system from the national health authority in Brazil. The New York-based company plans to market and sell Chemosat in Brazil for the percutaneous intra-arterial administration of melphalan hydrochloride to the liver with subsequent extracorporeal filtration of blood. Delcath will work with […]

Filed Under: Drug-Device Combinations, Featured, Oncology, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Delcath Systems Inc.

Propeller, Orion to develop digital asthma, COPD therapy

February 11, 2019 By Sarah Faulkner

Propeller Health updated logo

Propeller Health said today that it inked a deal to connect Orion’s Easyhaler line of inhalers for asthma and COPD with Propeller’s digital medicine platform. The two companies plan to co-develop a sensor that will attach to Orion’s inhalers and pair with a mobile app. Propeller touted that its existing digital medicine portfolio includes more […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: orion, Propeller Health, ResMed

Study: Researchers develop ingestible capsule for insulin delivery

February 11, 2019 By Sarah Faulkner

A team of researchers from MIT developed an ingestible, blueberry-sized capsule that can deliver insulin orally. In animal models, the capsule lowered blood sugar levels and performed comparably with the traditional route of insulin delivery – injections. The capsule features a small needle made of freeze-dried, compressed insulin. The needle is attached to a compressed […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Research & Development Tagged With: Brigham & Women's Hospital, Massachusetts Institute of Technology, National Institutes of Health, Novo Nordisk

Regeneron touts one-year diabetic retinopathy data for Eylea

February 11, 2019 By Sarah Faulkner

Regeneron - updated

Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Of the 133 people […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Regeneron

Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy

February 7, 2019 By Sarah Faulkner

Pulmatrix

Pulmatrix (NSDQ:PULM) said today that the FDA approved a Phase II trial of the company’s inhaled formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in people with asthma. The Lexington, Mass.-based company plans to kick off the trial in the first half of 2019, with top-line data expected in the second […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Pulmatrix Inc.

Bigfoot Biomedical, Owen Mumford ink deal for pen needles

February 7, 2019 By Sarah Faulkner

Bigfoot Biomedical updated logo

Bigfoot Biomedical said today that it inked a commercial supply deal to include Owen Mumford‘s Pentips line of pen needles with Bigfoot’s injection system subscription bundles. Milpitas, Calif.-based Bigfoot is working on monthly subscription packages for people with insulin-requiring diabetes. The company said it selected Owen Mumford’s pen needle because of the needle’s compatibility with […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Bigfoot Biomedical, owenmumford

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