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Docs plan industry collab to study paclitaxel devices
Non-for-profit org Viva Physicians said yesterday that it will lead a pan-industry effort to study the use of paclitaxel-eluting devices for the treatment of peripheral artery disease in above-the-knee...
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BD launches second-gen ergonomic injection pen
Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable...
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Bellerophon closes $7m round
Bellerophon Therapeutics (NSDQ:BLPH) last week closed an underwritten public offering of 10,000,000 shares of common stock at 70¢ apiece. The Warren, N.J.-based company also gave underwriters a 45-day...
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Circassia inks exclusive ventilator commercialization deal with AIT Therapeutics
Circassia Pharmaceuticals said last week that it inked a deal for the exclusive commercialization rights to AIT Therapeutics’ nitric oxide device, AirNOvent, in the U.S. and China. Using an electric...
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BTG touts use of radiopaque drug-eluting bead
BTG (LON:BTG) said this month that an Australian patient was treated with its radiopaque drug-eluting bead. The DC Bead Lumi product is the first commercial drug-eluting bead that can be loaded with...
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BioCorRx wins $5.6m grant for sustained release naltrexone implant
BioCorRx (OTC:BICX) announced this month that it won a two-year grant from the NIH’s National Institute on Drug Abuse to support the development of its sustained release naltrexone implant for the...
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Lyndra raises $55m for long-acting drug delivery capsule
Lyndra Therapeutics said today that it raised $55 million in a Series B round to support the development of its oral drug delivery system. All of the investors from the company’s $23 million Series A...
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FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine...
Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s...
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Baxter cleared from DoJ antitrust saline probe
Baxter (NYSE:BAX) said yesterday that it has been cleared from a U.S. Dept. of Justice antitrust probe, launched in 2017, investigating companies that market intravenous saline solutions. The probe...
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FDA rejects Alkermes depression drug NDA
Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin,...
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Reva Medical cuts 44% of workforce
Reva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company. In a statement, Reva CEO Reggie Groves cited current market...
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FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to...
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Audion touts Ph1 results for hearing loss drug
Audion Therapeutics touted positive results yesterday from a Phase I trial of the company’s hearing loss drug. In 15 people with mild to moderate sensorineural hearing loss, Audion tested the safety...
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Study: Use of long-acting reversible contraception spiked after 2016 election
Credit: LeiaWonder In a study published this week in JAMA Internal Medicine, researchers reported that use of long-acting reversible contraception increased in the month following the 2016 presidential...
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Flowonix wins FDA nod for infusion pump software
Flowonix Medical said yesterday that it won FDA approval to market the updated software used to program the company’s Prometra infusion system. The clinician programmer software, which Flowonix plans...
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FDA publishes finalized guidance for buprenorphine depots
The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder. The agency is hoping to boost the...
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Bigfoot Biomedical, Owen Mumford ink deal for pen needles
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...
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Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy
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...
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Regeneron touts one-year diabetic retinopathy data for Eylea
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...
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Study: Researchers develop ingestible capsule for insulin delivery
Image Credit: Felice Frankel 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...
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