Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]
Surmodics ticks up on renewed SurVeil DCB trial enrollment
Surmodics (NSDQ:SRDX) shares have ticked up today after the company updated on the TRANSCEND clinical trial of its SurVeil drug-coated balloon, saying that it has resumed patient enrollment. Last month, the Eden Prairie, Minn.-based company paused enrollment after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease […]
Pulmatrix, Cipla Technologies ink deal for inhaled anti-fungal
Pulmatrix (NSDQ:PULM) said yesterday that it inked a deal with Cipla to co-develop and commercialize an inhaled iSperse formulation of the anti-fungal drug itraconazole, intended for treating allergic bronchopulmonary aspergillosis in asthma patients. Lexington, Mass.-based Pulmatrix said that it in the deal, Cipla’s Cipla Tech subsidiary will make an upfront payment of $22 million to Pulmatrix […]
Fe3 Medical touts first transdermal anemia patch study
A Fe3 Medical study has shown that its Fe3 patch successfully delivers iron through the skin. The study was designed to test the safety and tolerability of Fe3’s iontophoretic transdermal technology that bypasses ionic resistance build up in the skin. The human study comes after a series of successful preclinical studies that demonstrated the safe […]
Drug delivery tech dev Modular Medical raises $4m
Drug delivery tech developer Modular Medical has raised $4.2 million in a new round of equity financing, according to a recently posted SEC filing. The stealthy Escondido, Calif.-based company is developing a new medication delivery technology to “remove the burden of daily injections” and compliment individual lifestyles, according to its website. Modular Medical has not […]
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device. The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management. The newly cleared device […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
FDA accepts second application for Ocular Therapeutix’s drug-delivering implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is […]
Valeritas inks Israeli distro deal with Tritech Biomed
Valeritas (NSDQ:VLRX) said today that it inked an exclusive distribution deal with Tritech Biomed to commercialize its V-Go wearable insulin delivery device, designed for patients with Type 2 diabetes, in Israel. Through the deal, the Bridgewater, N.J.-based company said that Tritech Biomed will have rights to promote, market and sell the V-Go system to diabetes clinics […]
Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy
Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome. The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer. The Boston-1 trial is slated to enroll people with BOS […]
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