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, the FDA had cited concerns with quality control, dosing, and a lack of information to support sex-based differences in efficacy.

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FDA accepts second application for Ocular Therapeutix’s drug-delivering implant

Ocular Therapeutix logo

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 positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops.

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Valeritas inks Israeli distro deal with Tritech Biomed

Valeritas logo - updated

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 and patients in the region.

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Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy

Breath Therapeutics logoPrivately-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.

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Medtronic responds to usability concerns for its MiniMed 670G insulin pump

Medtronic logo updatedMedtronic (NYSE:MDT) responded to a study presented this week which highlighted usability concerns with its MiniMed 670G automated insulin pump, writing that the company had “made many enhancements to the system since the study was done which would likely mitigate many of the issues experienced.”

Earlier this week, physicians from Boston Children’s Hospital reported that nearly one-fifth of participants in a real-world study of the MiniMed 670G stopped using the system within months of it being prescribed, citing dissatisfaction with the technical demands of the system.

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Study examines usability of hybrid closed-loop insulin pump

Boston Children's Hospital - updated logoData from an 83-person study of Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop insulin pump showed that nearly one-fifth of participants stopped using the device after struggling with the technical demands of the system, researchers reported.

Medtronic’s MiniMed 670G device is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every five minutes and automating the administration of insulin.

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Novartis launches COPD inhalers in China

NovartisNovartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease.

The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide.

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Novocure launches pivotal ovarian cancer trial

NovocureNovocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.

The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.

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Sage wins historic FDA nod for postpartum depression therapy

Sage TherapeuticsSage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression.

The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June.

Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth in the U.S.

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Surmodics shares down following FDA’s paclitaxel device update

Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices.

In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of its paclitaxel-coated SurVeil balloon.

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