Hikma Pharmaceuticals said that the FDA has approved an amendment to the company's ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of the inhaler. The FDA initially approved the ANDA in December 2020, and the company said that it was launching the DPI at that time. Hikma … [Read more...] about Hikma re-starts launch of its generic version of Advair Diskus
Regulatory
United Therapeutics submits NDA for Tyvaso DPI
United Therapeutics said that it has submitted an NDA for its Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and has applied a priority review voucher that it acquired for $105 million in December 2020. With the use of the priority review voucher, the FDA could issue a decision regarding the NDA by the end of 2021. In 2018, … [Read more...] about United Therapeutics submits NDA for Tyvaso DPI
Teva’s Seffalair Spiromax and BroPair Spiromax approved in Europe
According to Teva Pharmaceuticals Europe, the company has received marketing authorization in the EU for duplicate DPIs Seffalair Spiromax salmeterol xinafoate/ fluticasone propionate and BroPair Spiromax salmeterol xinafoate/ fluticasone propionate for the treatment for asthma in patients aged 12 and older. The company said that the Spiromax device "has been well … [Read more...] about Teva’s Seffalair Spiromax and BroPair Spiromax approved in Europe
Respirent submits ANDA for generic version of Advair Diskus
Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to Lannett, which acquired US rights to the generic version of Advair Diskus in October 2019. Lannett said that the term of that deal has recently been extended to 12 … [Read more...] about Respirent submits ANDA for generic version of Advair Diskus
FDA approves Tyvaso inhalation solution for the treatment of PH-ILD
According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension since July 2009. United Therapeutics submitted the sNDA for the PH-ILD indication in August 2020, … [Read more...] about FDA approves Tyvaso inhalation solution for the treatment of PH-ILD
Study of Union’s intranasal niclosamide for the treatment of COVID-19 in kidney patients gets UPH designation
The UK National Institute for Health Research has designated the PROTECT-V trial of Union Therapeutics' UNI91103 niclosamide nasal spray for the treatment of COVID-19 in kidney patients as an Urgent Public Health (UPH) priority, the company said. Union announced the initiation of the PROTECT-V trial in February 2021. Union co-founder Morten Sommer commented, "We … [Read more...] about Study of Union’s intranasal niclosamide for the treatment of COVID-19 in kidney patients gets UPH designation
Insmed’s Arikayce inhalation suspension approved in Japan for the treatment of NTM lung disease caused by MAC
The Japanese Ministry of Health, Labour and Welfare has approved Insmed's Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in patients who have not been successfully treated with a multi-drug regimen, and the company says that it expects to launch Arikayce … [Read more...] about Insmed’s Arikayce inhalation suspension approved in Japan for the treatment of NTM lung disease caused by MAC
FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Meissa Vaccines announced that the FDA has cleared the company's IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND meeting with the agency regarding an intranasal vaccine against SARS-CoV-2 in June 2020. The Phase 1 study is expected to enroll 130 healthy … [Read more...] about FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
Canadian biotech SaNOtize said that a Phase 2 trial of its nitric oxide nasal spray (NONS) in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours post dose and by more than 99% within 72 hours. In addition, clearance of the SARS-CoV-2 virus was 16 times faster for patients using NONS than for those given a placebo. Based … [Read more...] about SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
Court rules in favor of AstraZeneca in Symbicort patent dispute, FDA tentatively approves Viatris/Kindeva generic
The US District Court for the Northern District of West Virginia has upheld claims in three patents protecting Symbicort budesonide / formoterol. AstraZeneca sued Mylan (now Viatris) in October 2018, and subsequently 3M (now Kindeva Drug Delivery), for patent infringement after Mylan filed an ANDA for a generic version of Symbicort. The judge concluded that "Mylan … [Read more...] about Court rules in favor of AstraZeneca in Symbicort patent dispute, FDA tentatively approves Viatris/Kindeva generic