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Proveris Scientific

Regulatory

Ritedose launches budesonide inhalation suspension in US, gets FDA approval for albuterol inhalation solution

US-based Ritedose Pharmaceuticals, a subsidiary of CDMO Ritedose Corporation, has announced the launch of generic unit dose budesonide inhalation suspension (0.5 mg/2 ml) packaged for use in hospitals. Also, at the end of December, the FDA approved the company's ANDA for two strengths of albuterol inhalation solution, generic equivalents of Mylan's Accuneb. … [Read more...] about Ritedose launches budesonide inhalation suspension in US, gets FDA approval for albuterol inhalation solution

Only one patent remains in contention in the United Therapeutics effort to delay final FDA approval of Liquidia’s Yutrepia treprostinil DPI

According to Liquidia Corporation, United Therapeutics has agreed to a court judgment finding that Liquidia did not infringe United Therapeutic's US Patent No. 9,604,901. In October 2021, an inter partes review by the US Patent Trial and Appeal Board (PTAB) determined that 7 of the 9 claims in that patent were invalid. United Therapeutics initially filed suit … [Read more...] about Only one patent remains in contention in the United Therapeutics effort to delay final FDA approval of Liquidia’s Yutrepia treprostinil DPI

Kenox says it has completed pre-IND meeting with FDA regarding its inhaled sensitizer for lung cancer radiation therapy

According to Kenox Pharmaceuticals, the company "received a positive response supporting the planned CMC, non-clinical and clinical development strategy" following a pre-IND meeting with FDA regarding the company's KNX018 inhaled sensitizer for use with radiation therapy for the treatment of non-small cell lung cancer (NSCLC). The company said that it now plans to … [Read more...] about Kenox says it has completed pre-IND meeting with FDA regarding its inhaled sensitizer for lung cancer radiation therapy

FDA approves Alembic’s generic formoterol fumarate inhalation solution

The FDA has approved Alembic Pharmaceuticals' ANDA for its formoterol fumarate inhalation solution, a generic of Mylan's Perforomist inhalation solution for the treatment of COPD, the company said. According to the announcement, this is the company's first US approval for an inhaled product. Alembic said that it worked with Indian contract research organization … [Read more...] about FDA approves Alembic’s generic formoterol fumarate inhalation solution

FDA clears IND for Phase 2 study of Tonix’s intranasal oxytocin for the prevention of migraine

According to Tonix Pharmaceuticals, the FDA has cleared the company's IND for a Phase 2 study of TNX-1900 potentiated oxytocin nasal spray for the prevention of migraine headache. Tonix acquired the rights to the intranasal oxytocin for the treatment of migraine from Trigemina in June 2020 and says that it would plan to submit an NDA under the 505(b)(2) pathway. Over … [Read more...] about FDA clears IND for Phase 2 study of Tonix’s intranasal oxytocin for the prevention of migraine

FDA tentatively approves Liquidia’s NDA for Yutrepia treprostinil DPI

According to Liquidia, the FDA has tentatively approved the company's NDA for its Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA had previously issued a complete response letter to the NDA in November 2020. Liquidia refiled the LIQ861 NDA in May 2021, and in August 2021, the agency completed a pre-approval … [Read more...] about FDA tentatively approves Liquidia’s NDA for Yutrepia treprostinil DPI

Switzerland approves Bronchitol DPI as an add-on to other CF medications

According to EffRx Pharmaceuticals, Swissmedic has approved Bronchitol inhaled dry powder mannitol as an add-on to other medications for the treatment of cystic fibrosis in patients 6 years old and older. EffRx acquired Swiss rights to Bronchitol from Pharmaxis in 2019. The company said that it expects to launch the DPI in Switzerland in the second half of … [Read more...] about Switzerland approves Bronchitol DPI as an add-on to other CF medications

Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide

According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF's dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers in the SAD phase and 3 and 6 mg doses twice a day for 5 days in the MAD phase. TFF said that it expects dosing to get underway in November 2021 and … [Read more...] about Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide