News
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Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is… Read more . . .
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Contract research organization Next Breath has announced that it has been certified as a Center for Pharmaceutical Equivalence (EQFAR) by the Brazilian National Health Surveillance Agency (ANVISA) subsequent to a week-long audit of its quality… Read more . . .
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NanoBio has announced that Merck has acquired exclusive rights to NanoBio’s NanoStat nanoemulsion adjuvant for an intranasal respiratory syncytial virus (RSV) vaccine. Merck also acquired non-exclusive rights to the adjuvant for use in an intranasal… Read more . . .
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Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company’s AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014.… Read more . . .
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Non-profit R&D organization Southwest Research Institute (SwRI) has announced that it has received a 28-month contract extension worth $8.3 million from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority… Read more . . .
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Insmed has announced that in a Phase 2 clinical trial of Arikayce (formerly Arikace) inhaled liposomal amikacin for nontuberculous mycobacterial (NTM) lung infections, the product failed to produce a statistically significant reduction in mycobacterial density;… Read more . . .
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Vectura has announced that under a license agreement with “the US division of a leading international pharmaceutical company” signed in 2011, it has reached a milestone associated with the US development of its VR315 salmeterol/fluticasone… Read more . . .
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3M Drug Delivery Systems has announced that Cindy R. Kent has succeeded James Ingebrand as President and General Manager, effective February 2014. Ingebrand will now head 3M’s dental division. Kent joined 3M in October 2013… Read more . . .
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According to a report in the Wall Street Journal, a court in Cologne, Germany has issued a preliminary injunction preventing Sandoz from marketing its AirFluSal Forspiro in Germany. GlaxoSmithKline had argued that Sandoz’s salmeterol/fluticasone DPI… Read more . . .
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According to Mylan, the United States District Court for the Northern District of West Virginia has upheld the validity of all of its patents related to Perforomist formoterol fumarate inhalation solution. The company says that… Read more . . .
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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland