Cipla has announced that a Phase 3 study demonstrated therapeutic equivalence of its generic fluticasone propionate/salmeterol DPI (100/50 mcg) to Advair Diskus 100/50 mcg. The 15-month trial enrolled 1400 asthma patients in the US. Cipla Global CEO Umang Vohra commented, “I am extremely pleased with the successful completion of the Phase-3 clinical study of … [Read more...] about Cipla announces results of Phase 3 study for generic of Advair Diskus
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FDA approves Cipla’s generic version of Proventil HFA
The FDA has announced its approval of a Cipla albuterol sulfate MDI, a generic of 3M's Proventil HFA for the treatment of asthma. The FDA announcement noted that the agency recently issued a revised draft guidance for generic albuterol sulfate MDIs for products referencing Proventil HFA, as well as ProAir HFA and Ventolin HFA. Earlier this year, the FDA approved … [Read more...] about FDA approves Cipla’s generic version of Proventil HFA
Liquidia NDA for LIQ861 inhaled treprostinil accepted for review by FDA
Liquidia Technologies said that the FDA accepted the company’s 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), with a PDUFA goal date of November 24, 2020. The company announced in March 2019 that the Phase 3 INSPIRE study of the LIQ861 DPI for PAH had met its primary endpoint and then in January 2020 … [Read more...] about Liquidia NDA for LIQ861 inhaled treprostinil accepted for review by FDA
Chiesi acquires rights to Third Pole’s tankless iNO delivery system
Third Pole Therapeutics has announced a deal with Chiesi Farmaceutici giving Chiesi global rights to develop and commercialize Third Pole's tankless inhaled nitric oxide (iNO) delivery system for the treatment of infants with hypoxic respiratory failure in neonatal intensive care. Third Pole had previously announced a strategic collaboration agreement with Johnson … [Read more...] about Chiesi acquires rights to Third Pole’s tankless iNO delivery system
PADAC meeting for review of Trelegy Ellipta sNDA postponed
A meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) that had been scheduled for April 21, 2020 has been postponed due to the COVID-19 pandemic. No new meeting date was announced. The committee was due to discuss a supplemental NDA for GSK's Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, for a label change to claim reduction … [Read more...] about PADAC meeting for review of Trelegy Ellipta sNDA postponed
Bryn Pharma presents data from Phase 1 study of its intranasal epinephrine
Bryn Pharma announced the publication of a poster presenting data from a Phase 1 PK/PD study of its BRYN-NDS1C intranasal epinephrine, which is delivered via an Aptar Pharma Bidose nasal device. In October 2019, Bryn announced that it had raised $17.5 million for development of BRYN-NDS1C, which has received Fast Track designation from the FDA. The study, which … [Read more...] about Bryn Pharma presents data from Phase 1 study of its intranasal epinephrine
Savara acquires global rights to Apulmiq (Linhaliq) inhaled liposomal ciprofloxacin
Savara announced that it has acquired global development and commercialization rights to Apulmiq (Linhaliq) inhaled liposomal ciprofloxacin from Grifols. According to Savara, the deal includes an upfront payment to Grifols and regulatory milestone payments if the product is approved, plus potential royalties and sales milestones. In February 2020, Grifols acquired the … [Read more...] about Savara acquires global rights to Apulmiq (Linhaliq) inhaled liposomal ciprofloxacin
UW–Madison, FluGen, and Bharat Biotech partner to develop intranasal COVID-19 vaccine
The University of Wisconsin–Madison has announced that virologists from the university have partnered with vaccine companies FluGen and Bharat Biotech on development of an intranasal vaccine against unique vaccine against SARS-CoV-2 for the prevention of COVID-19. FluGen, a UW spin off co-founded by faculty member Yoshihiro Kawaoka, will create the vaccine and … [Read more...] about UW–Madison, FluGen, and Bharat Biotech partner to develop intranasal COVID-19 vaccine
Neurimmune and Ethris partner on development of inhaled mRNA-based antibody therapy for COVID-19
Swiss biotech Neurimmune has partnered with German mRNA specialist Ethris to develop inhaled mRNA-encoded neutralizing anti-SARS-CoV-2 antibodies for the treatment of Covid-19, the companies said. The goal is to begin clinical manufacturing of the drug this summer and initiate clinical trials in the fourth quarter of this year. The proposed COVID-19 therapy would … [Read more...] about Neurimmune and Ethris partner on development of inhaled mRNA-based antibody therapy for COVID-19
APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19
Austrian biotech APEPTICO said that it has signed a grant agreement with the European Commission to accelerate the availability of the company's solnatide (AP301), an inhaled peptide, available for treatment of patients with severe COVID-19. APEPTICO had been invited to apply for a grant through the Horizon 2020 “Advancing knowledge for the clinical and public health … [Read more...] about APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19