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
Regulatory
ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis. The CRL included a request for a repeat dose nasal allergen challenge study of Neffy, which was completed … [Read more...] about ARS Pharma submits response to the CRL issued by the FDA to the NDA for Neffy epinephrine nasal spray
Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
Liquidia Corporation announced today that the expiration of United Therapeutics' new clinical investigation exclusivity for the use of Tyvaso treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) on March 31, 2024, along with court rulings on March 28 and March 29, has cleared the way for the FDA to issue final … [Read more...] about Liquidia says FDA is now free to issue final FDA approval of Yutrepia treprostinil DPI
Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray for the treatment of PSVT
Milestone Pharmaceuticals announced that it has resubmitted its NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA had issued a Refuse to File letter in December 2023 in response to the NDA, which the company had submitted in October 2023. In February 2024, Milestone announced that it had held a Type A meeting … [Read more...] about Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray for the treatment of PSVT
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
Tonix gets Rare Pediatric Disease Designation for TNX-2900 intranasal potentiated oxytocin for PWS
According to Tonix Pharmaceuticals, the FDA has granted Rare Pediatric Disease Designation to TNX-2900 intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. Tonix licensed TNX-2900 from the French National Institute of Health and Medical Research (Inserm) in February 2021, and the FDA granted orphan drug … [Read more...] about Tonix gets Rare Pediatric Disease Designation for TNX-2900 intranasal potentiated oxytocin for PWS
FDA approves Optinose’s Xhance nasal spray for the treatment of chronic sinusitis without nasal polyps
According to Optinose, the FDA has approved the company's sNDA to extend use of Xhance fluticasone propionate nasal spray to include the treatment of chronic sinusitis without nasal polyps. Xhance was approved by the FDA for the treatment of nasal polyps in 2017. Optinose submitted the sNDA in February 2023. The FDA accepted the sNDA in May 2023 and set a PDUFA date … [Read more...] about FDA approves Optinose’s Xhance nasal spray for the treatment of chronic sinusitis without nasal polyps
Milestone says it will resubmit its NDA for etripamil nasal spray
Milestone Pharmaceuticals says that it held a Type A meeting with the FDA following receipt of a Refuse to File letter in December 2023 in response to the company's NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). According to Milestone, the agency did not request any additional clinical trials. The company says that … [Read more...] about Milestone says it will resubmit its NDA for etripamil nasal spray
United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
In addition to ongoing litigation against Liquidia Corporation alleging infringement of patents covering Tyvaso inhaled treprostinil by Liquidia's Yutrepia treprostinil DPI, United Therapeutics Corporation announced that it is now suing the FDA over its handling of Liquidia's sNDA to add PH-ILD as an indication for Yutrepia. United Therapeutics calls the sNDA … [Read more...] about United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which … [Read more...] about ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL