Little more than a month after selling a narcolepsy drug from its portfolio, Jazz Pharmaceuticals plc has replaced it with another. The company entered an exclusive development and commercialization rights agreement Sumitomo Pharma Co. Ltd.’s candidate for treating narcolepsy along with idiopathic hypersomnia and other sleep disorders. Sumitomo retains the rights for Japan, China and certain other Asia-Pacific countries and regions while Jazz gets the rights to everywhere else. Read More
Intent on expanding both the reach and approved uses of its farnesoid X receptor agonist, Ocaliva (obeticholic acid), Intercept Pharmaceuticals Inc. is selling both its ex-U.S. operations and rights to the primary biliary cholangitis drug to U.K.-based Advanz Pharma Corp. Ltd. for $405 million up front. The deal, including an additional $45 million earnout tied to EU regulatory advances, represents an important step toward strengthening Intercept's balance sheet and options, said CEO and President Jerry Durso. Read More
Hansoh Pharmaceutical Group Co. Ltd. has acquired greater China rights to oncology candidate NKT-2152 from Nikang Therapeutics Inc. in a deal worth up to $218 million. Jiangsu, China-based Hansoh picked up exclusive rights to develop and commercialize the candidate in mainland China, Hong Kong, Macau and Taiwan. In turn, Nikang is eligible to receive $15 million up-front cash payment, as well as up to $203 million in potential development, regulatory and sales-based milestone payments, and tiered royalties. Read More
Pharmacy benefit managers (PBMs) were in the spotlight at a May 5 U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations. Read More
The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency. Read More
As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year. Read More
Could investments in biopharmaceutical companies in 2022 be as aggressive as 2021, which saw a record 1,968 biopharma deals worth about $213.5 billion? So far, 2022 may be the lowest financing year since 2017 overall. But, drilling down to venture capital, private companies raised $5.7 billion in Q1 through 129 transactions, making it the second-best first quarter in history with 2021 at the top. BioWorld Senior Analyst Karen Carey explores the data with staff writer Lee Landenberger, explaining what happened in Q1 and where Q2 is headed. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cannvalate, Clover, Editas Medicine, Iqvia, Lanova, Lumos, Microba, Olix, Oxurion, Phathom, Phosplatin, South, Tetra, Tikomed, Turning. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agastiya, Aptose, Aribio, Astrazeneca, Beigene, Ilya, Ipsen, Neuromagen, Novartis, Phathom.
