Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
Autism spectrum disorder, which affects around 1% of children worldwide, is as complex as the range of genetic and environmental factors that may contribute to it. Its complexity has made it difficult to identify effective treatments. Now researchers at Jazz Pharmaceuticals plc and Berand Neuropharmacology have demonstrated that a complex mixture extracted from Cannabis sativa shows therapeutic potential in one of the few preclinical models that mimics several characteristics of the disorder.
The merger of Protagenic Therapeutics Inc. and Phytanix Bio Inc. combines two different approaches to treating obesity and metabolic issues. The all-stock deal will merge Protagenic’s peptide candidate in IND-enabling development for treating depression, anxiety, posttraumatic stress disorder and additional indications, along with Phytanix’s cannabinoid and cannabinoid-like molecules for bladder pain syndrome and treatment-resistant focal seizures.
Jazz Pharmaceuticals plc is buying Chimerix Inc. for $8.55 a share in cash, bringing the deal in at about $935 million. Jazz expands its cancer pipeline with the new acquisition’s lead candidate, dordaviprone, a small molecule for treating a rare, aggressive glioma that’s often found in children and young adults.
The BioWorld Biopharmaceutical Index (BBI) closed November with a modest 3.58% gain for the year, a sharp decline from its 16.92% rise in September and peak of 25.19% in August. The BBI has now fallen behind the Nasdaq Biotechnology Index, which posted a 6.27% year-to-date gain, and the Dow Jones Industrial Average, up 19.16% at the end of the month.
Jazz Pharmaceuticals plc has identified fatty acid amide hydrolase (FAAH) inhibitors reported to be useful for the treatment of anxiety, autism spectrum disorders, depression, schizophrenia, substance abuse and dependence, psychosis, parasomnia and trauma and stress related disorders.
Redx Pharma plc has closed its biggest transaction to date, selling a preclinical KRAS inhibitor program to Jazz Pharmaceuticals plc in a potential $880 million deal. Of that, $10 million will be paid up front, with the balance to come in development and commercialization milestones. For any product that makes it to market, Redx will in addition receive tiered mid-single digit percentage royalties.
Analysts from the hosting firm talked up their takeaways on biopharma from the J.P. Morgan (JPM) Healthcare Conference and looked ahead to 2024, anticipating a generally better year than those in the recent past.
Jazz Pharmaceuticals plc has disclosed macrocyclic orexin OX2 receptor agonists reported to be useful for the treatment of hypersomnia, narcolepsy and sleep disorders.
