Covis Pharma Canada announced that it has signed a 7-year promotion and distribution agreement with Novartis Pharmaceuticals Canada for exclusive rights to Seebri Breezhaler glycopyrronium DPI and Ultibro Breezhaler indacaterol / glycopyrronium for the treatment of COPD in Canada. In November 2021, Covis announced that it had acquired global rights to market … [Read more...] about Covis to distribute Seebri Breezhaler and Ultibro Breezhaler in Canada
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Pfizer gets ex-US rights to Biohaven’s zavegepant nasal spray
Pfizer is paying Biohaven Pharmaceutical a total of $500 million upfront plus up to $740 million in potential milestone payments for the rights to market Biohaven's rimegepant (Nurtec ODT) and zavegepant (BHV-3500) outside of the US. Rimegepant is an oral drug approved in the US and several other countries for the prevention and treatment of migraine; zavegepant is a … [Read more...] about Pfizer gets ex-US rights to Biohaven’s zavegepant nasal spray
MannKind announces further investment in Thirona Bio
MannKind Corporation said that it has purchased an additional convertible note issued by Thirona Bio, and MannKind CEO Michael Castagna has joined the Thirona board of directors, extending a June 2021 deal between the two companies for development of an inhaled dry powder formulation of Thirona's FBM5712 TGF-β inhibitor. As part of that deal, MannKind acquired an … [Read more...] about MannKind announces further investment in Thirona Bio
Intravacc and Leiden University Medical Center announce planned Phase 1/2 study of Nanovac intranasal vaccine against coronaviruses
Intranasal vaccine developer Intravacc and Leiden University Medical Center (LUMC) have announced a planned Phase 1/2 trial of LUMC's Nanovac intranasal vaccine against coronaviruses, including SARS, MERS, and SARS-CoV-2. The trial is expected to begin by the end of 2022 with initial results available in the first half of 2023. In September 2021, Intravacc … [Read more...] about Intravacc and Leiden University Medical Center announce planned Phase 1/2 study of Nanovac intranasal vaccine against coronaviruses
SpliSense inhaled antisense oligonucleotide for CF gets orphan drug designation from both FDA and EMA
Israeli biopharm SpliSense has announced that both the FDA and the EMA have granted orphan drug designation to the company's SPL84-23-1 inhaled antisense oligonucleotide (ASO) for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. According to the company, preclinical studies have demonstrated that treatment with SPL84-23-1 can "enable … [Read more...] about SpliSense inhaled antisense oligonucleotide for CF gets orphan drug designation from both FDA and EMA
Iliad Biotechnologies gets Fast Track designation for its intranasal booster vaccine against pertussis
According to Iliad Biotechnologies, the FDA has granted Fast Track designation to Iliad's BPZE1 live attenuated intranasal vaccine against pertussis (whooping cough), which is in Phase 2 development as a booster vaccine to prevent both colonization by B. pertussis and disease caused by the bacterium. Iliad licensed the intranasal pertussis vaccine, which was … [Read more...] about Iliad Biotechnologies gets Fast Track designation for its intranasal booster vaccine against pertussis
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
Pieris announces progress in clinical development of PRS-060/AZD1402 DPI for the treatment of moderate-to-severe asthma
Pieris Pharmaceuticals said that part 1a of a clinical trial of PRS-060/AZD1402, a dry powder IL-4 receptor alpha inhibitor which the company is developing with AstraZeneca for the treatment of moderate-to-severe asthma, has been completed. Pieris said that it now expects AstraZeneca to start enrolling patients with asthma that is insufficiently controlled by medium … [Read more...] about Pieris announces progress in clinical development of PRS-060/AZD1402 DPI for the treatment of moderate-to-severe asthma
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
EnBiotix raises $11 million in financing round led by Vectura for further development of ColiFin, murepavidin
EnBiotix, which is in the process of merging with inhaled murepavadin developer Polyphor, announced that it has raised $11 million in a financing round led by inhaled drug CDMO Vectura. Sanford Biosciences and the Cystic Fibrosis Foundation (CFF) also contributed to the financing, which will fund further development of ColiFin nebulized colistimethate sodium in … [Read more...] about EnBiotix raises $11 million in financing round led by Vectura for further development of ColiFin, murepavidin