Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
Acacia Pharma has in-licensed exclusive US rights to ultra-short-acting sedative, ByFavoâ„¢ (remimazolam) from Cosmo adding to its portfolio of near-market products
Global Healthcare Opportunities, or GHO Capital Partners LLP, the European specialist investor in healthcare, together with the existing management team has acquired Ardena, a specialist contract development and manufacturing organization (CDMO) focused on early phase drug development, from Mentha Capital.
The Cambridge, UK company has refiled the marketing application for Barhemsys (intravenous amisulpride) and says the US regulator will give it a rapid review with a proposed action date of 26 February 2020.
Acacia Pharma receives a second CRL from the US FDA regarding its NDA, after GMP deficiencies during API production were revealed again.
Acacia Pharma did well on the R&D front — by 2017, it had conducted four positive pivotal clinical trials for its lead drug, Barhemsys. Later that year, it submitted an FDA application to market the drug for rescue treatment of patients who develop postoperative nausea & vomiting (PONV), despite having been given prior antiemetic prophylaxis — only to receive a rejection in October 2018.
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US regulators have accepted for review Cambridge, UK-based Acacia Pharma’s application for post-operative nausea and vomiting (PONV) drug Baremsis.
In a game of hiring Tetris, an Eli Lilly alumni is promoted at Astellas, and former Sanofi chairman is employed by Pertinax Pharma.
Acacia Pharma Group plc (Acacia Pharma), the supportive care company developing products for US and international markets, announces positive results from a pivotal phase 3 study investigating Baremsis (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (PONV). These data further support the efficacy of Baremsis which has previously been shown to prevent PONV alone, and in combination with standard anti-emetics in pivotal phase 3 prophylaxis studies.