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Regulatory

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

FDA agrees to new Phase 2 trial design for Aridis’ AR-501 inhaled gallium for CF

According to Aridis Pharmaceuticals, the FDA has agreed to allow a Phase 2a trial of the company's AR-501 nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients to skip a SAD study and move directly into a multiple ascending dose study. Aridis said that it proposed the new design after successfully completing a Phase … [Read more...] about FDA agrees to new Phase 2 trial design for Aridis’ AR-501 inhaled gallium for CF

FDA publishes product specific draft guidances for esketamine and sumatriptan nasal sprays

Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder. The August 2020 revised product guidances include budesonide nasal spray and ketorolac tromethamine nasal spray. In … [Read more...] about FDA publishes product specific draft guidances for esketamine and sumatriptan nasal sprays

Lupin’s generic version of ProAir HFA approved by the FDA

The FDA has approved Lupin's generic version of Teva's ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India. Lupin CEO Vinita Gupta commented, “Approval of our generic albuterol MDI is a significant milestone in our complex generics evolution and a validation of … [Read more...] about Lupin’s generic version of ProAir HFA approved by the FDA

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