Regulatory

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen's Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato "as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement … [Read more...] about CHMP adopts positive opinion regarding expanded indication for Spravato

According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation's benefits applying to both Tyvaso inhalation solution and Treprostinil Technosphere dry powder treprostinil. United Therapeutics also said that the FDA has cleared the company's IND … [Read more...] about United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF

According to ARS Pharmaceuticals, the EMA has accepted the company's marketing authorization application for its Neffy (ARS-1) epinephrine nasal spray for the emergency treatment of anaphylaxis. ARS recently announced that Recordati had acquired marketing rights to ARS-1 in the EU, Iceland, Liechtenstein, Norway, Switzerland, the UK, Russia/CIS, Turkey, the Middle … [Read more...] about ARS submits MAA for Neffy epinephrine nasal spray

Altimmune announced that it has submitted an investigational new drug application to the FDA for a Phase 1 clinical study of its AdCOVID intranasal COVID-19 vaccine candidate, which it is developing in partnership with the University of Alabama Birmingham. The company recently announced that it had signed an agreement with Lonza for manufacturing of … [Read more...] about Altimmune submits IND for AdCOVID nasal vaccine

Liquidia Technologies said that it has received a complete response letter in response to its NDA for LIQ861 treprostinil inhalation powder for the treatment of pulmonary arterial hypertension. The FDA accepted the 505(b)(2) NDA for review in April 2020. According to Liquidia, the letter cites "the need for additional information and clarification on chemistry, … [Read more...] about Liquidia gets CRL for LIQ861 treprostinil DPI

The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI. The agency approved Valtoco for the treatment of seizure clusters in January 2020. After a lengthy effort to reformulate … [Read more...] about FDA issues new product specific guidances for diazepam nasal spray, epinephrine MDI, and tiotropium bromide SMI

Impel NeuroPharma announced that it has submitted an NDA for its INP104 dihydroergotamine mesylate intranasal (DHE) for the treatment of migraine headaches with or without aura, which is delivered via the company's Precision Olfactory Delivery (POD) technology. Impel reported positive results from the STOP 301 Phase 3 trial of INP104 in June 2020. Impel … [Read more...] about Impel Neuropharma submits NDA for its intranasal DHE for the treatment of migraine

The FDA has approved Chiesi's Bronchitol mannitol DPI for the treatment of cystic fibrosis in adult CF patients after a lengthy review process. The FDA issued a complete response letter to the original NDA in 2013, and Chiesi re-submitted the application in December 2018. The FDA’s Pulmonary‐Allergy Drugs Advisory Committee (PADAC) voted to recommend approval of the … [Read more...] about FDA approves Bronchitol mannitol DPI

The EC has granted marketing authorization to Insmed's Arikayce nebulized lipsomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adult patients without cystic fibrosis who have limited treatment options, Insmed said. In the US, the FDA approved Arikayce for the treatment of NTM lung … [Read more...] about EC approves Arikayce for the treatment of MAC lung infections in non-CF patients