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Drug-Device Combinations

Judge rules that Mylan can’t move EpiPen antitrust suit

July 14, 2017 By Sarah Faulkner

gavel

New Jersey federal judge Freda Wolfson rejected Mylan‘s (NSDQ:MYL) request to move an antitrust lawsuit brought against the EpiPen maker to Kansas. Mylan previously claimed that moving the case to Kansas would consolidate it with other class actions from EpiPen buyers – all of which are alleging violations of antitrust laws. Wolfson blocked the request […]

Filed Under: Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Wall Street Beat Tagged With: Mylan, Sanofi-Aventis

Sunovion divests asthma, allergy tech to Covis Pharma

July 13, 2017 By Sarah Faulkner

sunovion

Sunovion Pharmaceuticals said today that it plans to divest the U.S. market rights for its allergy and asthma products to Covis Pharma, in an effort to narrow its focus to the company’s COPD portfolio. Included in the deal is Sunovion’s Alvesco inhalation aerosol, its Omnaris nasal spray and its Zetonna nasal aerosol. All three products […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: covispharma, Sunovion Pharmaceuticals

Bigfoot Biomedical taps Abbott to collaborate on automated insulin delivery tech

July 13, 2017 By Sarah Faulkner

Bigfoot Biomedical

Abbott (NYSE:ABT) and Bigfoot Biomedical said today that the companies inked a deal to develop and commercialize diabetes management systems. The collaboration will bring together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin delivery platform, the companies reported. According to the deal, Abbott will provide Bigfoot with the next-gen version of its FreeStyle Libre continuous […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Abbott Laboratories, Bigfoot Biomedical

Milestone Scientific appoints new CEO following FDA nod | Personnel Moves – July 13, 2017

July 13, 2017 By Sarah Faulkner

Milestone Scientific

Milestone Scientific (NYSE:MLSS) said this week that it appointed Daniel Goldberger to the company’s corner office. Leonard Osser, who previously served as CEO, is slated to remain on the board and will continue to serve as director of Milestone’s China operations. The appointment comes on the heels of the FDA’s decision to grant Milestone’s CompuFlo epidural […]

Filed Under: Drug-Device Combinations, Featured, Personnel, Pharmaceuticals, Wall Street Beat Tagged With: AstraZeneca plc, Avalon, Biogen Idec, cingulatetherapeutics, foamixpharmaceuticals, Gamida Cell, Ipsen, mannkind, milestonescientific, Novaliq GmbH, portal instruments

Study: Nanomedicine shuts down cells that drive cancer growth in glioblastoma

July 12, 2017 By Sarah Faulkner

Brain

Researchers from Northwestern Medicine have developed lipid polymer-based nanoparticles that target key cancer drivers, called brain tumor initiating cells, in a mouse model of glioblastoma brain tumors. “BTICs are malignant brain tumor populations that underlie the therapy resistance, recurrence and unstoppable invasion commonly encountered by glioblastoma patients after the standard treatment regimen of surgical resection, […]

Filed Under: Drug-Device Combinations, Featured, Nanoparticles, Neurological, Oncology, Research & Development Tagged With: Northwestern University

Synspira’s therapy could boost antibiotics against drug-resistant bacteria in CF patients

July 12, 2017 By Sarah Faulkner

Synspira

Privately-held Synspira touted a study today of its inhaled glycopolymer-based therapeutic with antibiotics as a potential treatment for pulmonary infection caused by the Burkholderia cepacia complex in patients with cystic fibrosis. The study was published in PLOS One. Synspira’s lead polycationic glycopolymer, SNSP113, was studied in combination with tobramycin and meropenem. These antibiotics, as well as ceftazidime, are often […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Preclinical Trials, Research & Development, Respiratory Tagged With: synspira

BioDelivery Sciences, Purdue ink exclusive distribution deal for Belbuca in Canada

July 12, 2017 By Sarah Faulkner

BioDelivery Sciences International

BioDelivery Sciences International (NSDQ:BDSI) said today that it inked an exclusive distribution deal with Purdue Pharma‘s Canada branch for the licensing, distribution, marketing and sale of Belbuca in Canada. The company’s Belbuca buccal film was designed to deliver buprenorphine for patients with chronic pain. It was cleared by Health Canada in June for patients with pain severe […]

Filed Under: Drug-Device Combinations, Featured, Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: BioDelivery Sciences International, purduepharma

First cell and gene therapy for osteoarthritis approved in Korea

July 12, 2017 By Sarah Faulkner

Maryland-based TissueGene said today that Invossa, which it touts as the world’s first cell and gene therapy for degenerative arthritis, won approval from the Korea Ministry of Food and Drug Safety. Invossa is designed to treat osteoarthritis of the knee through a single intra-articular injection. Kolon Life Science (KSDQ:102940), TissueGene’s exclusive licensee for Asia, filed for a […]

Filed Under: Drug-Device Combinations, Featured, Orthopedics, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Kolon Life Science, TissueGene

FDA rejects Ocular’s Dextenza for a second time

July 12, 2017 By Sarah Faulkner

Ocular Therapeutix

Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza. This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza.  In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance, Wall Street Beat Tagged With: Ocular Therapeutix

Equashield seeks to automate hazardous drug handling: a Drug Delivery Business News podcast

July 12, 2017 By Sarah Faulkner

Equashield Pro

Equashield’s Jason Dutcher chats with Drug Delivery Business News editor Sarah Faulkner about the company’s closed system transfer device and its latest move to automate hazardous drug compounding.  Healthcare workers are often tasked with handling hazardous drugs, which give off harmful vapors. Exposure to these drugs has been linked to severe health risks, including infertility, […]

Filed Under: Drug-Device Combinations, Featured, Oncology, Pharmaceuticals, Technology Tagged With: equashield

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