Focused market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial launch Represents 90% increase from the prior quarter...
Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each episode occurring over seven days, a reduction...
Standardizes and improves product reimbursement process New HCPCS Level II code J1105 to be effective January 1, 2024 NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc....
Meetings scheduled with FDA in October and November for TRANQUILITY and SERENITY III programs Company strengthens IGALMI„¢ market exclusivity through receipt of two Notices of Allowance ...
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it has received FDA approval for its generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, and plans to launch in the very near future.
Milla's Generic Dexmedetomidine HydrochlorideReceives Approval in the U.S.
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NEW HAVEN, Conn., Aug. 01, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the National Institute on Drug Abuse, part of the National Institutes of Health (NIH), has awarded Columbia University a multi-year NIDA grant to fund clinical testing of BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid withdrawal. The initial grant provides approximately $3.3 million for the project from August 1, 2022 through July 31, 2024 to support a 4-arm Phase 2b study comparing BXCL501 180 mcg and 240 mcg BID to placebo and Lucemyra™, to be followed by approximately $4.5 million to support a registrational study upon the completion of certain milestones.
BioXcel Therapeutics, a New Haven, CT biotech, announced the approval early Wednesday for its lead program dexmedetomidine, a sublingual film taken orally. The drug, which will be known as Igalmi, is indicated to treat agitation associated with schizophrenia and bipolar I or II disorder and is the company’s first drug to get past the FDA finish line.