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Drug-Device Combinations

Struggling GlaxoSmithKline bets big on neural implants to fuel turnaround

June 10, 2016 By drugdelivery

GlaxoSmithKline‘s (NYSE:GSK) interest in tiny neural implants is stronger than ever, even amid declining earnings and flopped drug candidates that have turned CEO Andrew Witty into a lame duck who will step aside in 2017. Despite the turmoil, the British pharma giant is investing $50 million in so-called bioelectronics via Action Potential Ventures, aiming to fund companies […]

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: GlaxoSmithKline plc

Fresenius, Smiths in the hunt for Pfizer’s $1.5B infusion pump biz

June 7, 2016 By drugdelivery

Germany’s Fresenius (NYSE:FMS) and Britain’s Smiths Group (LON:SMIN) have emerged as the final bidders for Pfizer‘s (NYSE:PFE) infusion pump business, inherited via the Big Pharma’s September 2015 purchase of Hospira for $15 billion. The winning bid is expected to be around $1.5 billion, according to Reuters. Private equity firm Pamplona Capital Management was also interested and reportedly made a […]

Filed Under: Drug-Device Combinations Tagged With: Fresenius Medical Care, Hospira Inc., Pfizer Inc., Smiths Group plc

Intarcia launches Medici drug delivery platform

June 7, 2016 By Fink Densford

Intarcia Therapeutics said today it launched its subcutaneous Medici drug delivery system designed for the continuous delivery of medication. The Medici system is comprised of a matchstick-sized osmotic minipump placed just under the skin to deliver medication, a placement system for implantation and stabilization technology designed for proteins, peptides, antibody fragments and other high-potency small […]

Filed Under: Business/Financial News, Drug-Device Combinations Tagged With: Intarcia Therapeutics

Delcath raises $35m in private placement

June 7, 2016 By Fink Densford

Delcath (NSDQ:DCTH) said today it inked a securities purchase agreement with an investor for $35 million in senior convertible notes and stock purchase warrants, expecting to bring in $32.2 million to support operations and ongoing clinical trials. Of the $32.2 million in proceeds, Delcath said $3 million will be immediately available, with the remaining $29.2 million […]

Filed Under: Business/Financial News, Drug-Device Combinations Tagged With: Delcath Systems Inc.

Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint

June 6, 2016 By Fink Densford

Ocular Therapeutix (NSDQ:OCUL) today saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint. Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear […]

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: Ocular Therapeutix

Intarcia, Numab log milestones for autoimmune drug-device combo

June 2, 2016 By Brad Perriello

Intarcia Therapeutics and pharmaceuticals maker Numab said today that they’ve logged several milestones in their joint project to develop a drug-device combination for treating inflammatory and autoimmune diseases. Wädenswil, Switzerland-based Numab identified a pair of antibody-based compounds for the program, which aims to use the delivery and formulation technology developed by Cambridge, Mass.-based Intarcia. The companies said […]

Filed Under: Discovery, Drug-Device Combinations Tagged With: Intarcia Therapeutics, Numab

Clearside Biomedical floats $50m IPO

June 2, 2016 By Brad Perriello

Clearside Biomedical raised $50 million with its initial public offering, floating 7.2 million shares at $7 apiece. That’s below the range Clearside earlier set for the IPO, when it planned to put up 4.0 million shares at a range of $14 to $16, for a midpoint value of $60 million. Alpharetta, Ga.-based Clearside is developing a drug-device combination to treat […]

Filed Under: Drug-Device Combinations Tagged With: Clearside Biomedical

Fighting opioid addiction with medical devices: FDA approves new implant

May 27, 2016 By Fink Densford

The FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog. The matchstick-sized Probuphine implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies. […]

Filed Under: Drug-Device Combinations Tagged With: Braeburn Pharmaceuticals

iVascular wins CE Mark for Luminor 18 DCB

May 20, 2016 By Fink Densford

Spanish vascular device company iVascular S.L.U. said today it won CE Mark approval in the European Union for its Luminor 18 drug eluting balloon designed for lower limb angioplasty. The Luminor 18 is 0.018 guidewire compatible and has an extra low profile, and joins the company’s Luminor 14 and Luminor 35 portfolio of drug-eluting balloons […]

Filed Under: Drug-Device Combinations Tagged With: iVascular S.L.U.

Otsuka gets in on ReCor Medical's Paradise renal denervation device

May 16, 2016 By drugdelivery

ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea […]

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: Otsuka Pharmaceutical, ReCor Medical

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