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TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia....
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Dance Biopharm raises $24m for inhaled insulin device
Privately-held Dance Biopharm said yesterday that it raised $24.5 million in a private equity round to help fund the development of its inhaled insulin product. SternAegis Ventures was the exclusive...
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Tandem lifts full-year sales guidance
Tandem Diabetes Care (NSDQ:TNDM) increased its full-year sales guidance, citing strong U.S. sales in the third quarter and the launch of its t:slim X2 insulin pump in international markets. The company...
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Valeritas kicks off device registration process in China
Valeritas (NSDQ:VLRX) said today that it began the process to register its wearable insulin delivery device, V-Go, in China. The company noted that it signed an agreement with an unnamed contract...
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J&J inks collab deal to develop MERS vaccine
Healthcare giant Johnson & Johnson (NYSE:JNJ) today announced a new collaborative deal as it looks to develop a vaccine against Middle East Respiratory Syndrome Coronavirus. The collaborative deal...
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FDA counsels on proper insulin injection technique
The FDA issued a safety communication last week detailing the difference between standard pen needles and safety pen needles, both of which are used to inject medicine via pen injectors. A standard pen...
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Ocugen kicks off dry eye disease trial for nanoemulsion eye drop
Ocugen said today that it launched a Phase III trial designed to evaluate its twice-daily 0.2% brimonidine tartrate eye drop in patients with dry eye disease. Ocugen plans to run two identical Phase...
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T2 Biosystems takes aim at sepsis with sensitive diagnostic tech
Sepsis, a complication of an infection caused by foreign cells infiltrating a person’s bloodstream, affects nearly two million people each year in the U.S. If not addressed quickly, the infection...
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Europe OKs Novo Nordisk’s Fiasp for Insulet’s Omnipod
Insulet (NSDQ:PODD) said today that its Omnipod insulin management system is available in Europe for use with Novo Nordisk‘s (NYSE:NVO) Fiasp fast-acting insulin aspart. Novo Nordisk’s Fiasp product...
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Fresenius cleared to jilt Akorn, court rules
The Delaware Chancery Court ruled this week that it can’t force Fresenius (ETR:FRE) to follow through with its $4.75 billion merger with Akorn (NSDQ:AKRX). The deal was designed to help Fresenius move...
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EyePoint Pharmaceuticals raises $29m to fund Dexycu product launch
EyePoint Pharmaceuticals (NSDQ:EYPT) said today that it received $28.9 million in proceeds from the exercise of warrants by EW Healthcare Partners, Rosalind Advisors and another accredited investor....
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Anthem adds Intersect ENT’s Sinuva implant to formulary
Anthem this month added Intersect ENT‘s (NSDQ:XENT) Sinuva steroid-releasing implant to its updated formulary as a Tier 3 product, according to a note from Leerink analysts. The product is designated...
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Kala Pharmaceuticals prices $62m public offering
Kala Pharmaceuticals (NSDQ:KALA) priced an underwritten public offering of 7,500,000 shares of common stock at $8.25 per share. The Waltham, Mass.-based company is expected to reel in nearly $62...
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Medherant wins grant to support manufacturing program for transdermal...
Medherant said today that it was awarded a Medicines Manufacturing Grant from Innovate UK to support the manufacturing of transdermal drug-delivery patches. The company plans to expand its pilot-scale...
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Researchers tout use of closed-loop insulin delivery system
At this year’s meeting of the European Association for the Study of Diabetes, researchers reported that use of a hybrid day-night closed-loop insulin delivery system is better than sensor-augmented...
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Pari Pharma lands FDA nod for Lamira nebulizer
Pari Pharma said this week that its Lamira nebulizer won approval from the FDA to deliver Insmed’s Arikayce amikacin liposome inhalation suspension for the treatment of MAC lung disease. The company’s...
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ivWatch inks development, commercialization deal with ICU Medical
ivWatch said today that it inked a long-term development and commercialization deal to integrate its continuous IV monitor into new medical devices and systems made by ICU Medical (NSDQ:ICUI). The deal...
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Frequency completes enrollment in safety trial for hearing loss drug
Frequency Therapeutics said today that it finished enrolling participants in a single-dose safety trial for its FX-322 hearing loss drug candidate. The company’s drug candidate emerged as part of its...
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Genentech kicks off Phase III trials for eye implant
Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched three Phase III trials evaluating the Port drug-delivery implant in patients with wet age-related macular degeneration and...
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Canada clears Medtronic’s MiniMed 670G insulin pump
Medtronic‘s (NYSE:MDT) Canada subsidiary said today that it won a license from Health Canada for its MiniMed 670G insulin pump system. The insulin pump system is the first device in Canada that...
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