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Hovione announces results of FDA pre-approval inspection

Hovione has announced that the FDA has found its Loures, Portugal manufacturing site to be GMP compliant, although the agency issued a Form 483 citing three inspectional observations. The inspection took place from December 1 to December 5, 2014. In October 2013, the company announced that it had completed a successful FDA inspection of the Loures facility with no … [Read more...] about Hovione announces results of FDA pre-approval inspection

Adapt Pharma to develop Lightlake’s intranasal naloxone for opioid overdose reversal

Lightlake Therapeutics has agreed to license its intranasal naloxone for opioid overdose reversal to Adapt Pharma for possible development and sales milestones of more than $55 million, plus royalties, the company said. Lightlake recently announced that it started a new trial of the product with funding from the National Institute on Drug Abuse (NIDA). According to … [Read more...] about Adapt Pharma to develop Lightlake’s intranasal naloxone for opioid overdose reversal

Acorda announces start of Phase 3 study for inhaled L-dopa

Acorda Therapeutics has announced the enrollment of the first patient in a Phase 3 study of CVT-301 inhaled L-dopa for the treatment of OFF episodes in Parkinson’s disease (PD). The study is expected to enroll about 345 patients. CVT-301 was initially developed by Civitas Therapeutics which was acquired by Acorda earlier this year. Acorda Chief Medical Officer … [Read more...] about Acorda announces start of Phase 3 study for inhaled L-dopa

Shire gets $15 million from CFFT for development of aerosolized mRNA therapy

Cystic Fibrosis Foundation Therapeutics (CFFT), a nonprofit associated with the Cystic Fibrosis Foundation, has announced that it will provide Shire with up to $15 million for development of an aerosol messenger RNA therapy designed to produce working CFTR protein in the lungs of CF patients. Gene mutations in CF patients disrupt normal CFTR protein production, … [Read more...] about Shire gets $15 million from CFFT for development of aerosolized mRNA therapy

Lightlake announces new trial of intranasal naloxone for opioid overdose

Lightlake Therapeutics has announced that it has begun a new trial of its intranasal naloxone for the reversal of opioid overdose. According to the company, it plans to file a New Drug Application with the FDA if the results from this study are positive. Earlier this year, Lightlake announced that it had received funding for the study from the National Institute … [Read more...] about Lightlake announces new trial of intranasal naloxone for opioid overdose