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News

Koura announces donation of inhalers to Maharashtra government for COVID-19, innovation award for Zephex 152a

Medical propellant maker Koura announced that it has donated 10,000 MDIs to the government of the Indian state of Maharashtra to help meet the demand for inhalers during the COVID-19 pandemic. Specifically, the company said that the inhalers are designated for the Haffkine Institute in Mumbai. Koura also announced that it has won the Chemicals Northwest 2020 … [Read more...] about Koura announces donation of inhalers to Maharashtra government for COVID-19, innovation award for Zephex 152a

iPharma Labs announces addition of GMP testing services, new board members and management hires

Inhalation contract R&D company iPharma Labs has announced the introduction of new GMP testing services for testing and development of OINDPs, including inhaled drugs for the treatment of COVID-19. The company also announced the addition of two board members and two management hires with extensive experience in the inhaled drug delivery industry. The iPharma … [Read more...] about iPharma Labs announces addition of GMP testing services, new board members and management hires

Enerzair Breezhaler approved in EC with optional Propeller Health sensor and app

Novartis's Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone furoate DPI has been approved by the EC for the treatment of asthma, the company said. The inhaler can now be marketed with an optional Propeller Health sensor and mobile app throughout the EU, and in the UK, Iceland, Norway, and Liechtenstein. The EMA's Committee for Medicinal Products … [Read more...] about Enerzair Breezhaler approved in EC with optional Propeller Health sensor and app

CF PharmTech raises additional $50 million

Chinese OINDP developer CF PharmTech announced that it has completed a $50 million Series F financing round approximately six months after completing a $90 million financing round. Investors participating in the latest financing include BioTrack Capital, CICC Qichen, CICC Qide, SAIC Hengxu, GP M&A Fund, and Watson Investment, as well as existing investors Passion … [Read more...] about CF PharmTech raises additional $50 million

PureIMS initiates Phase 1 trial of amikacin DPI for tuberculosis

Dutch inhaled drug developer PureIMS said that it has initiated a Phase 1 clinical trial of its Amikacin Cyclops DPI, which it is developing for the treatment of drug susceptible tuberculosis. The single ascending dose study is expected to enroll eight tuberculosis patients, with results anticipated later this year. The dry powder amikacin formulation is … [Read more...] about PureIMS initiates Phase 1 trial of amikacin DPI for tuberculosis

Positive Phase 1 results for Orexo’s nasal nalmefene

Orexo has announced that a Phase 1 bioavailability study of three formulations of its OX125 intranasal nalmefene compared to intramuscular nalmefene injection showed that all three were well tolerated and well absorbed. Orexo is developing both the nasal formulation of nalmefene and a nasal formulation of naloxone for the treatment of opioid overdose. Orexo VP … [Read more...] about Positive Phase 1 results for Orexo’s nasal nalmefene

Enerzair and Atectura Breezhalers approved in Japan

The Japanese Ministry of Health, Labour and Welfare has approved two Novartis DPIs -- Enerzair Breezhaler glycopyrronium / indacaterol/ mometasone furoate and Atectura indacaterol / mometasone furoate -- for the treatment of asthma, the company said. The two DPIs were part of a batch of five Novartis drugs approved simultaneously by the MHLW. Sosei Heptares, which … [Read more...] about Enerzair and Atectura Breezhalers approved in Japan

Meissa Vaccines provides update on intranasal vaccines for COVID-19, RSV

Meissa Vaccines has provided updates on two intranasal live attenuated vaccines (LAVs) based on its "codon deoptimized RSV vaccine platform with the goal of creating safe, potent, stable, and cost-effective intranasal vaccines." The company said that it held a pre-IND meeting with the FDA regarding its MV-014-210 for prevention of SARS-CoV-2 and that it intends to … [Read more...] about Meissa Vaccines provides update on intranasal vaccines for COVID-19, RSV

ISAM calls on pharmaceutical industry and regulators to prioritize development of inhaled therapies for COVID-19

Over a dozen well-known OINDP specialists have issued a call for accelerated development of inhaled therapies for COVID-19, with the goal of getting these products to patients faster. Writing to the editor of the Journal of Aerosol Medicine and Pulmonary Drug Delivery, members of the Regulatory and Standardization Issues Networking Group of the International Society … [Read more...] about ISAM calls on pharmaceutical industry and regulators to prioritize development of inhaled therapies for COVID-19

Tiziana announces progress on development of TZLS-501 inhaled anti-IL-6R mAb for COVID-19

Tiziana Life Sciences has announced a new agreement with STC Biologics for manufacturing of its TZLS-501 inhaled anti-IL-6 receptor monoclonal antibody. The company said that it is also working with Sciarra Laboratories to develop a nebulizer for delivery of TZLS-501 for the treatment of COVID-19. In addition, Tiziana said that it had submitted a patent application … [Read more...] about Tiziana announces progress on development of TZLS-501 inhaled anti-IL-6R mAb for COVID-19

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