The FDA has cleared BlueWillow Biologics' IND for its BW-1010 intranasal anthrax vaccine, and a Phase 1 trial of the vaccine is planned for later this year, the company said. Earlier this year, BlueWillow (formerly NanoBio) announced that it had received a patent for the anthrax vaccine, which is formulated with the company's NanoVax adjuvant. BW-1010 is in … [Read more...] about FDA clears BlueWillow IND for intranasal anthrax vaccine
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Seelos Therapeutics says it has amended agreement for development of its intranasal ketamine
Seelos Therapeutics has announced an amendment of its agreement with Vyera Pharmaceuticals regarding development of SLS-002 intranasal ketamine. According to Seelos, the company will now not be required to conduct a Phase 3 trial and will make cash and stock payments to Vyera instead of a milestone that would be due on initiation of a Phase 3 trial. Seelos said … [Read more...] about Seelos Therapeutics says it has amended agreement for development of its intranasal ketamine
Bryn Pharma to use Aptar’s Bidose nasal device for epinephrine delivery
Bryn Pharma (formerly Epi-Now) announced that it has signed a deal with Aptar Pharma for worldwide exclusive rights to use Aptar's Bidose nasal delivery device for its BRYN-NDS1C intranasal epinephrine for the treatment of anaphylaxis. The company said that it has recently completed dosing in a pivotal clinical trial using the device. According to Bryn's website, … [Read more...] about Bryn Pharma to use Aptar’s Bidose nasal device for epinephrine delivery
Circassia announces US launch of Duaklir Pressair for the treatment of COPD
Circassia Pharmaceuticals has announced the US launch of Duaklir aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. The FDA approved Duaklir Pressair in April 2019. Circassia acquired the US rights to Duaklir and Tudorza Pressair from AstraZeneca in 2017. Circassia Chief Executive Steve Harris commented, “The US launch of Duaklir represents a … [Read more...] about Circassia announces US launch of Duaklir Pressair for the treatment of COPD
AZTherapies raises $26.3 million in Series C financing
AZTherapies said that the company had closed a $26.3 million Series C preferred equity financing round that will fund completion of a Phase 3 trial of its ALZT-OP1 inhaled cromolyn/oral ibuprofen for the treatment of Alzheimer's disease. The COGNITE study was initiated in 2015 and is expected to be completed by the end of 2020. The company said that proceeds from … [Read more...] about AZTherapies raises $26.3 million in Series C financing
United Therapeutics returns rights to Respira’s RT234 vardenafil DPI
Respira Therapeutics has announced that United Therapeutics will end its collaboration with the company and will return all rights to Respira's RT234 vardenafil DPI, which is in Phase 2 development for the relief of symptoms of pulmonary arterial hypertension (PAH). The companies had announced the licensing deal and an investment by United Therapeutics in Respira in … [Read more...] about United Therapeutics returns rights to Respira’s RT234 vardenafil DPI
English High Court dismisses GSK claims in AirFluSal Forspiro case
According to Vectura, the English High Court has dismissed all claims in a "passing off" case brought by GlaxoSmithKline in which GSK charged that of Sandoz's AirFluSal Forspiro DPI looks too similar to Seretide Accuhaler. Both inhalers and their packaging feature a similar shade of purple. Vectura noted that GSK has filed similar cases in a number of European … [Read more...] about English High Court dismisses GSK claims in AirFluSal Forspiro case
Upsher-Smith launches Tosymra nasal spray in the US
Upsher-Smith has announced the US launch of Tosymra sumatriptan nasal spray. The FDA approved Tosymra for the treatment of migraine with or without aura in January 2019, and Upsher-Smith acquired US rights to the nasal spray from Promius Pharma in June 2019. The Tosymra formulation uses Intravail transmucosal absorption enhancement technology and is delivered via … [Read more...] about Upsher-Smith launches Tosymra nasal spray in the US
Lannett makes deal for distribution of generic Advair in US
Lannett said that it has signed a US distribution agreement for rights to Respirent Pharmaceuticals' generic Advair Diskus. The agreement would begin after FDA approval and would continue for 10 years after distribution begins. Lannett said that it would pay an unspecified upfront payment and future milestones and that it would receive a portion of net profits during … [Read more...] about Lannett makes deal for distribution of generic Advair in US
Currax Pharmaceuticals acquires North American rights to Onzetra Xsail
Currax Pharmaceuticals has acquired US, Canadian, and Mexican rights to Onzetra Xsail intranasal dry powder sumatriptan from OptiNose, which announced that the license agreement includes a $4.8 million upfront payment, plus a 10% royalty on net sales over $3 million in 2020 and a $1 million milestone payment "subject to the achievement of a specified regulatory … [Read more...] about Currax Pharmaceuticals acquires North American rights to Onzetra Xsail