The FDA informed Perrigo during a May 10, 2018 teleconference that the agency will issue a complete response letter to the company's ANDA for its generic version of Teva's ProAir albuterol MDI, Perrigo said. As a result, the company no longer expects to launch its albuterol inhaler by the end of 2018. Perrigo filed an ANDA for the generic version of ProAir in … [Read more...] about Perrigo expects CRL for albuterol MDI ANDA
News
Cipla to market and distribute Afrezza inhaled insulin in India
MannKind Corporation announced that it has signed a deal with Cipla for marketing and distribution of Afrezza inhaled insulin in India. Cipla will be responsible for getting regulatory approval in India and will pay MannKind $2.2 million up front, plus milestone payments, minimum purchase commitment revenue and royalties on sales in India. Cipla Ltd. Global CEO … [Read more...] about Cipla to market and distribute Afrezza inhaled insulin in India
University of Cape Town engineers design “force reducing attachment” for inhalers
The Medical Devices Group at the University of Cape Town has designed a device to significantly reduce the force required to actuate an inhaler, the university has announced. The device, called "Easy Squeezy," fits over a standard MDI and is meant to make the inhaler easier to actuate for pediatric and geriatric users. A dose counter is also included. An … [Read more...] about University of Cape Town engineers design “force reducing attachment” for inhalers
TFF Pharmaceuticals appoints Glen Mattes as CEO
TFF Pharmaceuticals, which recently announced that it had raised $14 million for the development of DPI formulations, has named former Arno Therapeutics CEO Glenn Mattes as its new Chief Executive Officer. Mattes's career includes management and board positions with a number of pharmaceutical companies, including Johnson & Johnson subsidiaries Tibotec Therapeutics and … [Read more...] about TFF Pharmaceuticals appoints Glen Mattes as CEO
NanoBio changes name to BlueWillow, raises $10 million for development of intranasal vaccines
US biopharmaceutical company NanoBio Corporation has changed its name to BlueWillow Biologics, which the company says "reflects its evolution to a vaccines-focused company, and commitment to advancing its novel intranasal technology to develop new vaccines for several respiratory and sexually transmitted diseases." The company also announced the closing of a $10 … [Read more...] about NanoBio changes name to BlueWillow, raises $10 million for development of intranasal vaccines
Positive results for Phase 3 study of intranasal esketamine for treatment-resistant depression
Janssen Pharmaceutical has announced that data from a Phase 3 study demonstrated significantly significant and clinically meaningful reduction of symptoms in adult patients with treatment-resistant depression who received esketamine nasal spray plus an oral antidepressant compared to those who received placebo plus an oral antidepressant. A second study in patients … [Read more...] about Positive results for Phase 3 study of intranasal esketamine for treatment-resistant depression
Phase 2b study of Staccato alprazolam for epilepsy gets underway
Engage Therapeutics has announced the initiation of the double-blind, randomized Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of inhaled alprazolam in epilepsy patients who have seizures with a predictable pattern. The company said that topline data should be available in the second half of 2019. The primary endpoint for the inpatient … [Read more...] about Phase 2b study of Staccato alprazolam for epilepsy gets underway
Highlights from RDD 2018
Approximately 550 OINDP specialists attended RDD 2018 in Tucson, Arizona, where much of the interest centered around regulatory issues, especially in light of the FDA's recent release of a revised draft guidance on MDI and DPI quality considerations. The RDD organizers capitalized on the release, adding a late breaking presentation by the FDA's Rik Lostritto on … [Read more...] about Highlights from RDD 2018
JDRF awards grant for intranasal insulin study
Leading diabetes research funder JDRF has awarded a 2-year $525,000 grant to International Diabetes Center (IDC) to support a study of intranasal insulin in Type 1 diabetes patients with hypoglycemia unawareness, the first time that JDRF has funded intranasal insulin research. JDRF has previously funded a study of Afrezza inhaled insulin used with an artificial … [Read more...] about JDRF awards grant for intranasal insulin study
Avadel launches Noctiva desmopressin nasal spray
Avadel Pharmaceuticals has announced the launch of Noctiva desmopressin nasal spray for the treatment of nocturia due to nocturnal polyuria (overproduction of urine at night) in adults. Avadel acquired US and Canadian rights to Noctiva from Serenity Pharmaceuticals in September 2017 for $50 million up front, plus milestone payments and royalties. A $20 million … [Read more...] about Avadel launches Noctiva desmopressin nasal spray