Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired rights to the formulation from Ferring Pharmaceuticals in August 2017 and is now publishing results from a Phase 2 study sponsored by Ferring that concluded … [Read more...] about Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
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Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a pre-IND meeting for AB569. The study began recruiting volunteers in February 2018. Arch Biopartners CEO Richard Muruve said, “We have … [Read more...] about Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Novus Therapeutics gets FDA guidance on development of nasal MDI for otitis media
Novus Therapeutics said that it recently had a Type C meeting with the FDA regarding its OP-02 intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension for the treatment of otitis media and has received confirmation of its development plans. The company explains that OP-2, which is delivered via a metered dose inhaler, "is intended to … [Read more...] about Novus Therapeutics gets FDA guidance on development of nasal MDI for otitis media
Freeman Technology acquired by Micromeritics
UK-based powder flow characterization specialist Freeman Technology has been acquired by US particle characterization instrument company Micromeritics, the companies have announced. Both companies offer instruments and services that can be used in development of OINDPs. Micromeritics President Preston Hendrix commented, “We are excited to welcome Freeman Technology … [Read more...] about Freeman Technology acquired by Micromeritics
Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Insys Therapeutics said that preliminary data from a Phase 1 pharmacokinetics study comparing its intranasal epinephrine formulation to EpiPen intramuscular epinephrine in 60 subjects with seasonal allergies showed similar bioavailability and rapid drug absorption for the nasal spray. The company did not provide any details. Insys announced initiation of the study … [Read more...] about Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Date set for FDA advisory committee to review Insmed’s NDA for Alis
Insmed has announced that the FDA's Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company's NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Insmed submitted the NDA in March 2018 and … [Read more...] about Date set for FDA advisory committee to review Insmed’s NDA for Alis
Recipharm acquires Sanofi’s UK inhalation contract manufacturing business
Recipharm will pay £45 million to Sanofi to acquire Sanofi's UK inhalation contract manufacturing facility and business "in a bid to expand its inhalation capabilities." The 125,000 sq m facility in Holmes Chapel has more than 450 employees and manufactures primarily metered dose inhalers and nasal sprays. The site also has DPI development capabilities. Recipharm … [Read more...] about Recipharm acquires Sanofi’s UK inhalation contract manufacturing business
Mylan says it expects CRL for its generic version of Advair Diskus
Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan's ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June 27, 2018. According to Mylan, the reason for the CRL is that the FDA "has identified minor deficiencies." Mylan received a previous CRL for its generic … [Read more...] about Mylan says it expects CRL for its generic version of Advair Diskus
Per Bäckman joins Emmace Consulting
Former Mylan Senior Director of Inhalation Biopharmaceutics Per Bäckman has joined Emmace Consulting as Senior Inhalation Consultant, the company has announced. Bäckman also previously held various positions at AstraZeneca, including as Principal Scientist in Inhalation Biopharmaceutics, and at Novo Nordisk. Emmace Consulting CEO Mårten Svensson said, "Per Bäckman … [Read more...] about Per Bäckman joins Emmace Consulting
Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Data from a Phase 1 study of Pulmatrix's PUR0200 lactose-free dry powder formulation of tiotropium has been published online in the British Journal of Clinical Pharmacology. The dose-ranging study in patients with moderate-to-severe COPD compared 3 doses of PUR0200 (3 μg, 6 μg, or 9 μg) to Spriva Handihaler (18 μg) and placebo. All doses of PUR0200 produced a … [Read more...] about Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI