Impel NeuroPharma said today that it raised $67.5 million in a Series D financing round, with investments from KKR, Norwest Venture Partners, Vivo Capital, 5Am Ventures and venBio Partners. The Seattle-based company plans to use the round’s proceeds to support clinical development efforts for its intranasal drug-delivery device technology. Impel’s INP104 product is in a Phase […]
BioTime touts preclinical results for hydrogel drug-delivery implant
BioTime Inc. (NYSE:BTX) touted today positive preclinical results for its HyStem hydrogel drug-delivery technology, demonstrating that targeted intracerebral delivery of brain-derived neurotrophic factor may alleviate the effects of ischemic brain injury and reduce neuroinflammation. The study, published in the International Journal of Molecular Sciences, focused on the effects of BDNF on sensorimotor function, infarct volume and neuroinflammation […]
FDA extends decision date for Sage’s postpartum depression injection
Sage Therapeutics (NSDQ:SAGE) said today that the FDA extended its decision date for Sage’s Zulresso brexanolone injection to March 19, 2019. The U.S. regulatory agency was previously slated to decide whether or not to approve the drug as a treatment for postpartum depression by Dec. 19. The Cambridge, Mass.-based company noted that the FDA elected to […]
Medherant touts results for ibuprofen transdermal patch
Medherant said today that it successfully finished two Phase I studies with its ibuprofen transdermal drug-delivery patch. According to the UK-based company, the Tepi patch was well tolerated by the participants of a skin irritation study. The company also touted results from a second study, which compared blood concentrations of ibuprofen following repeated application of […]
Aquestive wins FDA nod for seizure oral film
Shares in Aquestive Therapeutics (NSDQ:AQST) rose today after the company announced FDA approval for its Sympazan oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. The clobazam oral film is the first product of its kind to be approved by the FDA as a treatment for seizures associated with LGS, according to […]
Teva wins FDA nod for migraine prevention drug
Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Teva studied Ajovy in two Phase […]
FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions […]
Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US
Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into […]
Biogen, Eisai shares down after critics voice concerns over Alzheimers drug study
Biogen (NSDQ:BIIB) and Eisai yesterday released six months of detailed results from a clinical study of its BAN2401 experimental drug for treating Alzheimers, but criticisms quickly emerged casting doubt on the results and sending shares in both companies down. Researchers working with Eisai and Biogen released trial results showing that high doses of the drug resulted […]
Acorda’s CEO on failure, perseverance and the profound risks of drug development
Dr. Ron Cohen isn’t easily deterred. The physician-turned-executive has spent decades in the biotech industry and weathered a number of setbacks – he learned in his early years at the now-defunct Advanced Tissue Sciences that to succeed, he needed resilience. “I learned that it took hundreds of millions of dollars if not billions to develop […]
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