According to Quantum Leap Healthcare Collaborative (QLHC), a sponsor of the I-SPY COVID trial, interim analysis of data from a study of Genentech's Pulmozyme dornase alfa inhalation solution for the treatment of severe COVID-19 found that Pulmozyme therapy "is unlikely to achieve statistically significant improvement in efficacy," and the Pulmozyme arm of the trial … [Read more...] about I-SPY COVID trial finds no clinical benefit for use of Pulmozyme in severe COVID-19
News
Jaap Wieling appointed CEO of PureIMS
DPI developer PureIMS has announced the appointment of Jaap Wieling as Chief Executive Officer (CEO), succeeding Bram Van Dijck. According to his LinkedIn page, Wieling founded or co-founded several biopharm companies, including Bioralix, BiosanaPharma, and Antaeus Biopharma, over the past few years. He spent much of his career at Xendo, which he also co-founded. … [Read more...] about Jaap Wieling appointed CEO of PureIMS
Covis to distribute Seebri Breezhaler and Ultibro Breezhaler in Canada
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
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