ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company's MAA for Neffy epinephrine nasal spray to the EMA's Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the MAA by mid-2024. The company said that it received Day 180 comments in late 2023 requesting results from a repeat dose study of Neffy under nasal … [Read more...] about ARS Pharma submits Day 180 response for Neffy epinephrine nasal spray MAA and signs distribution agreement with CSL Seqirus
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FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Amneal Pharmaceuticals announced that it has launched a generic over-the-counter naloxone nasal spray for the reversal of opioid overdose after its ANDA for the product was approved by the FDA. Amneal had announced the agency's acceptance of the ANDA in March 2023. The nasal spray is a generic version of Narcan, which was approved for OTC sales later in March … [Read more...] about FDA approves Amneal’s generic version of Narcan naloxone nasal spray
Firebrick Pharma launches Nasodine povidone-iodine nasal spray in the US for “nasal hygiene”
Firebrick Pharma announced that it has launched Nasodine povidone-iodine nasal spray in the US via direct sales through a web site. The company said that it will not make any therapeutic claims so that the nasal spray will not require FDA approval. For now, Firebrick said, Nasodine will be marketed as a "nasal hygiene" product and will be available only on a US web … [Read more...] about Firebrick Pharma launches Nasodine povidone-iodine nasal spray in the US for “nasal hygiene”
Orexo gets additional US patent covering OX640 epinephrine nasal powder
According to Orexo, the United States Patent and Trademark Office (USPTO) has granted US Patent No. 11,957,647 ("Pharmaceutical composition comprising adrenaline"), which covers Orexo's OX640 epinephrine nasal powder product. The USPTO previously issued US patent No. 11,737,980, which also provides protection for OX640, in August 2023. The FDA is currently … [Read more...] about Orexo gets additional US patent covering OX640 epinephrine nasal powder
Mundipharma and Vectura partner on LGWP reformulation of Flutiform MDI
Inhalation CDMO Vectura has partnered with Mundipharma to reformulate Flutiform fluticasone propionate / formoterol fumarate MDI using a lower global warming potential (LGWP) propellant, the companies announced. According to the announcement, the first step in the reformulation will be to identify which LGWP propellant will replace HFA-227 in the … [Read more...] about Mundipharma and Vectura partner on LGWP reformulation of Flutiform MDI
Silo Pharma to acquire exclusive rights to SPC-14 and SPC-15 intranasal therapies from Columbia University
Silo Pharma announced that it will exercise an option for an exclusive worldwide license to develop SPC-14, an intranasal therapy for the treatment of Alzheimer’s disease, from Columbia University. Silo says that it expects the license agreement to be finalized by mid-2024 and that it plans to pursue the 505(b)(2) regulatory pathway. The company's pipeline also … [Read more...] about Silo Pharma to acquire exclusive rights to SPC-14 and SPC-15 intranasal therapies from Columbia University
SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense's nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has received Orphan Drug designation from both the EMA and the FDA. According to SpliSense, the … [Read more...] about SpliSense gets up to $8.5 million from CFF for Phase 2 trial of SPL84 antisense oligonucleotide inhalation solution, FDA clears IND for the trial
Acorda files for Chapter 11 bankruptcy, will sell rights to Inbrija levodopa DPI and other assets
Acorda Therapeutics announced that it has filed to begin Chapter 11 bankruptcy proceedings and said that Merz Therapeutics will serve as a "stalking horse" bidder for Acorda's assets, including the rights to Inbrija inhaled dry powder levodopa. Other potential buyers can submit bids for the company's assets, with the court-supervised sale expected to be completed by … [Read more...] about Acorda files for Chapter 11 bankruptcy, will sell rights to Inbrija levodopa DPI and other assets
Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
Launch Therapeutics will take over management of clinical trials of Teva’s TEV-‘248 fluticasone / albuterol (salbutamol) DPI for the treatment of asthma, the companies have announced. In addition, Carlyle Group subsidiary Abingworth, a Launch Therapeutics backer, will invest up to $150 million toward funding continued development of TEV-'248 and would receive … [Read more...] about Teva partners with Launch Therapeutics on development of TEV-‘248 fluticasone / albuterol DPI, with funding from Abingworth
FTC tells court hearing Teva’s patent infringement case against Amneal that Teva patents listed for ProAir HFA should be de-listed
The US Federal Trade Commission (FTC) recently filed an amicus brief in a patent infringement case filed by Teva against Amneal after Amneal submitted an ANDA for a generic version of Teva's ProAir HFA albuterol MDI in July 2023. In the brief, the FTC contends that the court should grant Amneal's motion to force device and dose counter patents asserted by Teva to be … [Read more...] about FTC tells court hearing Teva’s patent infringement case against Amneal that Teva patents listed for ProAir HFA should be de-listed