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
Regulatory
FDA approves Bronchitol mannitol DPI
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
EC approves Arikayce for the treatment of MAC lung infections in non-CF patients
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
FDA clears Neuronasal IND for intranasal N-acetylcysteine
According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC for the treatment of mild traumatic brain injury (mTBI, or concussion) and expected a pilot study to begin the next month. The pilot study has … [Read more...] about FDA clears Neuronasal IND for intranasal N-acetylcysteine
CHMP recommends approval of Trixeo (Breztri) Aerosphere
According to AstraZeneca, the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere formoterol fumarate/ glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination. Trixeo Aerosphere is known … [Read more...] about CHMP recommends approval of Trixeo (Breztri) Aerosphere
US PTAB institutes inter partes review of Tyvaso patent
Liquidia Technologies said that the US Patent Trial and Appeal Board (PTAB) has issued decisions on two patents related to Tyvaso treprostinil inhalation solution, which is marketed by United Therapeutics for the treatment of pulmonary arterial hypertension (PAH). Liquidia filed petitions with the US Patent and Trademark Office seeking to invalidate the two patents in … [Read more...] about US PTAB institutes inter partes review of Tyvaso patent
Spirovant’s inhaled gene therapy for CF gets orphan drug and rare pediatric disease designations
The FDA has granted orphan drug and rare pediatric disease designations to Spirovant Sciences's SPIRO-2101, an inhaled adeno-associated virus (AAV) gene therapy for the treatment of cystic fibrosis, the company said. SPIRO-2101 works by replacing defective cystic fibrosis transmembrane conductance regulator (CFTR) genes and is meant for CF patients who are unable to … [Read more...] about Spirovant’s inhaled gene therapy for CF gets orphan drug and rare pediatric disease designations
FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma's ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they "are committed to bringing this important product to the US market and remain confident in the submission." Hikma said that … [Read more...] about FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
FDA approves Trelegy Ellipta for the treatment of asthma
GlaxoSmithKline and Innoviva have announced that the Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI has been approved by the FDA for the treatment of asthma in adult patients. The approved doses for the treatment of asthma are 100/62.5/25 mcg and 200/62.5/25mcg FF/UMEC/VI. The FDA approved Trelegy Ellipta for the treatment of COPD in September … [Read more...] about FDA approves Trelegy Ellipta for the treatment of asthma
Marinomed submits MAA for xylometazoline decongestant nasal spray
Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company's Carragelose red algae extract. The company currently markets a range of non-prescription nasal sprays based on Carragelose, including Coldamaris; the xylometazoline spray will be its … [Read more...] about Marinomed submits MAA for xylometazoline decongestant nasal spray