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Regulatory

Ryaltris nasal spray gets marketing approval in 13 countries in Europe, UK

Glenmark Pharmaceuticals said that its Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis has received final marketing approval in 13 countries in Europe and the UK. Earlier this year, the company announced that Ryaltris had received approval in 16 European countries and the UK through the decentralized … [Read more...] about Ryaltris nasal spray gets marketing approval in 13 countries in Europe, UK

BreatheSuite MDI monitoring system gets 510(k) clearance

BreatheSuite announced that the FDA has cleared the company's disposable BreatheSuite MDI device, which attaches to the top of a standard metered dose inhaler canister to provide inhaler usage monitoring and feedback to the patient and to health care providers through an associated mobile app. According to BreatheSuite, the device has also been cleared by Canadian … [Read more...] about BreatheSuite MDI monitoring system gets 510(k) clearance

Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities

According to Ampio Pharmaceuticals, the Drugs Controller General of India (DCGI) has approved the protocol for AP-019 Phase 2 trial of the company's inhaled Ampion biologic for the treatment of respiratory distress caused by COVID-19. Ampio announced in June 2021 that it had initiated the Phase 2 AP-019 clinical trial in the US and noted that the FDA had approved … [Read more...] about Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities

Pulmocide’s PC945 inhaled opelconazole gets orphan, Fast Track, and QIDP designations

Pulmocide announced that the FDA has granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations for its PC945 inhaled opelconazole for the treatment of invasive pulmonary aspergillosis (IPA). Pulmocide launched in 2013 to develop inhaled anti-fungal therapies, and PC945 is its sole product. According to the company's web site, nebulized … [Read more...] about Pulmocide’s PC945 inhaled opelconazole gets orphan, Fast Track, and QIDP designations

FDA and EMA launch parallel scientific advice pilot program for complex generic products

The EMA and the FDA have launched a pilot program in which the agencies will give parallel scientific advice (PSA) to applicants submitting MAAs for hybrid products and ANDAs for complex generic products, including inhalers and nasal sprays. The program began on September 15, 2021 and will continue to accept meeting requests "until a sufficient number of PSA meetings … [Read more...] about FDA and EMA launch parallel scientific advice pilot program for complex generic products

Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance

According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort MDI, includes the ability to capture clinical data in addition to inhaler usage data. Adherium says that the additional capability for monitoring asthma and COPD … [Read more...] about Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance

FDA approves Trudhesa DHE nasal spray for the treatment of migraine

According to Impel NeuroPharma, the FDA has approved the company's Trudhesa dihydroergotamine mesylate nasal spray for the treatment of migraine. Impel submitted the NDA for Trudhesa (INP104) in November 2020, and the agency accepted the application in January 2021. The company said that it plans to launch Trudhesa in the US in early October 2021 and that it will … [Read more...] about FDA approves Trudhesa DHE nasal spray for the treatment of migraine

Aerami’s inhaled imatinib for PAH gets orphan drug designation

The FDA has granted orphan drug designation to Aerami Therapeutics's AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the company said. Aerami initiated a Phase 1 trial of AER– 901 in June 2021, with results expected by the end of the year. In June 2020, Aerami announced a partnership with inhalation CDMO Vectura for … [Read more...] about Aerami’s inhaled imatinib for PAH gets orphan drug designation

FDA pre-approval inspection of Liquidia manufacturing facility has been completed

According to Liquidia Corporation, the FDA has completed a pre-approval inspection of Liquidia's facility in Morrisville, North Carolina, USA, where the company will manufacture LIQ861 dry powder treprostinil if approved. No Form 483 observations were issued. The company added that it has received notice that the agency will also require a pre-approval inspection of a … [Read more...] about FDA pre-approval inspection of Liquidia manufacturing facility has been completed

Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier

Virpax Pharmaceuticals said that it is encouraged by the FDA response to its IND for MMS019 "high-density molecular masking spray" which the company is developing as an anti-viral barrier. According to Virpax, the company now intends to begin clinical development with the goal of submitting an NDA for MMS019 to the FDA's Office of Non-Prescription Drugs. The company … [Read more...] about Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier

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