FDA starts pilot after AstraZeneca, J&J make case for novel drug delivery excipients Cingulate, gunning for pharma majors, seeks $58M to develop extended-release ADHD drugs Windgap bags $17M to advance smaller, longer-life autoinjectors Ultrasound unlocks blood-brain barrier in cancer clinical trial Citius buys out license to Ontak replacement from Dr. Reddy's for $40M As gene therapy safety faces scrutiny, Broad Institute proposes a safer and more efficient delivery tool Featured Story | By Nick Paul Taylor Academic literature features a steady stream of papers on novel excipients with the potential to improve drug delivery, but they rarely show up in newly approved drugs because companies shy away from the additional risk they entail. Recognizing that, the FDA has created a Novel Excipient Review Pilot Program to clear the logjam. read more |
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Top Stories By Nick Paul Taylor Can drug delivery technology equip Cingulate to win market share from Johnson & Johnson, Novartis and Takeda? That is the question facing investors as they weigh up whether to back Cingulate’s pitch to raise up to $58 million to bankroll its attack on the attention deficit hyperactivity disorder (ADHD) market. read more By Nick Paul Taylor Does size matter in the autoinjector market? Windgap is betting that delivering smaller devices with longer shelf lives will give it an edge—and has parted investors from $17 million to realize its vision. read more By Nick Paul Taylor Researchers have advanced the age-old effort to overcome the blood-brain barrier with clinical trial data suggesting ultrasound can temporarily enable molecules past the blockade. read more By Kyle LaHucik Citius Pharmaceuticals is paying $40 million to acquire the license to a phase 3 asset meant to replace Ontak, the FDA-approved cancer drug that was withdrawn from the market in 2014 due to manufacturing issues. read more By Angus Liu A team led by scientists at the Broad Institute has developed adeno-associated viruses as gene therapy vectors. 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