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Beta Bionics’ bionic pancreas wins breakthrough status from FDA

December 11, 2019 By Nancy Crotti

Beta Bionics - updated logo

The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device  — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Beta Bionics, FDA, Zealand Pharma

Tusker Medical’s pediatric ear tubes land breakthrough device designation

November 26, 2019 By Nancy Crotti

The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Research & Development Tagged With: FDA, Tusker Medical

Medtronic warns patients of MiniMed insulin pump safety issue

November 22, 2019 By Nancy Crotti

Medtronic Minimed 630g

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Recalls Tagged With: FDA, Medtronic, minimed

Surmodics shares drop on Q3 earnings, Sundance DCB wins breakthrough FDA nod

November 1, 2019 By Sean Whooley

SurModics

Surmodics (NSDQ:SRDX) shares plummeted today despite third-quarter results that topped Wall Street projections. Eden Prairie, Minn.-based Surmodics posted profits of $3.55 million, or 26¢ per share, on sales of $30.8 million for the three months ended Sept. 30, moving from red to black on revenue growth of 33.8% compared with Q3 2018. Adjusted to exclude one-time […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Regulatory/Compliance, Wall Street Beat Tagged With: Surmodics, SurModics Inc.

FDA approves expanded indication for Liletta 6-year IUD

October 28, 2019 By Sean Whooley

Allergan, Medicines360

Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Women's Health Tagged With: Allergan, FDA, Medicines360

Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin

October 28, 2019 By Sean Whooley

Insulet

Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: FDA, Insulet, Novo Nordisk

FDA approves Flowonix’s Prometra II programmable pump

October 25, 2019 By Sean Whooley

Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday that […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: Flowonix Medical

Clearside Biomedical inks $76m licensing deal with Bausch for Xipere

October 23, 2019 By Sean Whooley

Clearside Biomedical logo - updated

Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device. Bausch agreed to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Bausch Health, Clearside Biomedical

Aptar Pharma’s two-dose nasal spray device to deliver epinephrine

October 21, 2019 By Nancy Crotti

Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar’s Bidose (BDS) nasal device to deliver Bryn’s epinephrine nasal spray (BRYN-NDS1C). Crystal Lake, Ill.-based Aptar’s Bidose tech enables two-shot nasal drug delivery and will replace the need to carry two epinephrine auto-injectors, according to the companies. Last March, Aptar won FDA approval to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: aptarpharma, Bryn Pharma, FDA

Clearside Biomedical confirms timeline for Xipere

October 21, 2019 By Sean Whooley

Clearside Biomedical logo - updated

Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]

Filed Under: Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Clearside Biomedical, FDA

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