FDA clears Gelesis weight-loss hydrogel pill Plenity

 

plenity-gelesis

[Image from Gelesis]

Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.

The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.

“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and CEO of Gelesis, said in a press release. “With Plenity, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”

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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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Cigna lowers insulin price to $25 per month

Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients.

Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. Insulin list prices regularly increase by double digits annually, according to the FDA, which attributed the price hikes to a lack of competition.

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Teva wins EU nod for Ajovy migraine prophylactic

Teva Pharmaceuticals logo - updated

Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month.

The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor.

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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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Dyve Bioscience touts proof-of-concept study for transdermal painkiller

Dyve Bioscience logoDyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare.

The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the placebo group were given lotion without sodium bicarbonate or menthol. Investigators told the participants to report to the clinic within 36 hours of flare onset.

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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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