DUBLIN – Galapagos NV is in line for a $200 million payday, as positive 24-week data from a phase IIb monotherapy trial in rheumatoid arthritis (RA) testing selective Janus kinase 1 (JAK1) inhibitor filgotinib (GLPG0634) completed the clinical picture and formally set the clock ticking on Abbvie Inc.'s option on the program. Read More
As a trail-blazing pioneer in biologics, Amgen Inc. has the unenviable position of having to mark the patent protection path against biosimilars targeting its legacy products. Read More
Ovid Therapeutics Inc. has completed an oversubscribed $75 million series B financing to support its work to advance the oral extrasynaptic GABA A agonist OV-101 (gaboxadol) into phase II as a potential treatment for both Angelman and fragile X syndromes, as well as development of other internal candidates and pipeline expansions. Read More
Scientists from the Cleveland Clinic have reported that the enzyme proprotein convertase subtilisin/kexin-6 (PCSK6) plays a role in blood pressure. Another member of the PCSK family, PCSK9, is the target of two recently approved cholesterol drugs, Praluent (alirocumab, Regeneron Pharmaceuticals Inc./Sanofi SA) and Repatha (evolocumab, Amgen Inc.). Read More
For Poseida Therapeutics Inc., a new global license agreement with Janssen Biotech Inc., a unit of Johnson & Johnson, to discover, develop, manufacture and commercialize chimeric antigen receptor (CAR) T-cell-based therapies is a signal that "everything's unfolding according to plan," observed Eric Ostertag, Poseida's founder and CEO. Read More
TOKYO – Six months after winning PMDA approval, Eli Lilly Japan and Nippon Boehringer Ingelheim (NBI) recently disclosed plans to launch the first insulin glargine biosimilar in Japan, a market in which biosimilars are advancing, albeit slowly. Read More
Kim Kardashian showed up in an FDA warning letter when the agency's Office of Prescription Drug Promotion (OPDP) cited Duchesnay Inc., of Rosemont, Pa., for Kardashian's social media post promoting its morning sickness drug Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets. Read More
Theravance Biopharma Inc., of South San Francisco, reported second quarter revenues of $7.1 million, including $5 million from collaborative arrangements and $2.1 million from product sales of Vibativ (telavancin). Read More
Benitec Biopharma Ltd., of Balmain, Australia, reduced the number of American depository shares (ADSs) but added warrants in its planned U.S. IPO. The company, whose shares trade on the Australian Securities Exchange as BLT, will seek to raise $25 million by offering 1.9 million ADSs and warrants to purchase 500,000 ADSs at $13.55 apiece. Each ADS includes 0.28 of a warrant to purchase one ADS at the offering price. Read More
Hemispherx Biopharma Inc., of Philadelphia, said it inked an agreement with Emerge Health Pty Ltd., of Australia, to file for approval of Alferon N Injection in Australia and New Zealand and begin distribution in those countries on a named-patient basis, where appropriate. Under the terms, Emerge will coordinate regulatory-compliant programs to inform physicians about Alferon, and Hemispherx will support those programs. Financial details were not disclosed. Read More
Biogen Inc., of Cambridge, Mass., and Swedish Orphan Biovitrum AB, of Stockholm, said interim data from the ASPIRE phase III, open-label extension study were published in Haemophilia, showing that patients on extended-interval prophylaxis regimens with Eloctate (antihemophilic factor [recombinant], Fc fusion protein) experienced low bleeding rates. Read More
