An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action […]
FDA rejects Alkermes depression drug NDA
Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have […]
FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film
Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy […]
Researchers question use of antibiotic shunts in hydrocephalus patients
Led by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus. Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess […]
Amneal wins FDA nod for generic rivastigmine transdermal patch
Amneal Pharmaceuticals (NYSE:AMRX) said today that it won FDA approval for a generic rivastigmine transdermal patch. The drug, which is sold under the brand name Exelon, is an acetylcholinesterase inhibitor that is commonly used to treat mild to moderate Alzheimer’s disease and Parkinson’s disease. The Exelon patch reeled in roughly $225 million in U.S. sales […]
Nobilis files IND for trial to study drug-device PTSD therapy
Nobilis Therapeutics said yesterday that it filed an investigational new drug application with the FDA to kick off a Phase IIb trial of its NBTX-001 drug-device PTSD therapy. The Portland, Ore.-based company is developing a portable inhalation device designed to deliver a xenon gas mixture. Nobilis plans to conduct a 200-patient clinical trial with both […]
Acorda wins FDA nod for inhaled Parkinson’s therapy
Acorda Therapeutics (NSDQ:ACOR) said this week that the FDA approved its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s […]
Impel NeuroPharma raises $68m for CNS drug-device tech
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 […]
- 1
- 2
- 3
- …
- 14
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn