After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc. The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy. Read More
Fresh off licensing a potential Parkinson’s disease therapy last month, Ipsen SA is again looking to build out its neurodegenerative disease portfolio, this time in Huntington’s disease and Angelman syndrome. An exclusive options deal with Exicure Inc. could bring it two new spherical nucleic acid (SNA) programs for the indications while delivering up to $1 billion for Exicure, plus potential royalties, on top of a $20 million up-front payment. The deal, Exicure's second major SNA collaboration after a hair-loss disorders deal with Abbvie Inc.’s Allergan, sent Exicure shares (NASDAQ:XCUR) up 34.1% to $1.81 on Aug. 2. Read More
LONDON – T-knife Therapeutics GmbH closed a $110 million series B, as it advances plans for the phase I/II trial of its first fully human T-cell receptor (TCR) in the treatment of solid tumors, which is due to start later this year. Read More
Zentera Therapeutics Inc. completed a $75 million series B financing round to help further its candidates in China, as it paves the way for a listing in Hong Kong next year. Read More
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone. Read More
LONDON – More than six years after the technical specification was agreed, the EMA clinical trial information system (CTIS) has cleared the final hurdle and can go live in January 2022, after notice of approval was published in the EU Official Journal on Saturday July 31. The approval, following an independent audit of the system, was the spur for the EMA to intensify the training program it is putting in place for trial sponsors and national regulators, to ensure CTIS’ successful implementation. Read More
Citing a unanimous U.S. Supreme Court ruling in April that denied the Federal Trade Commission’s (FTC) ability to seek restitution or disgorgement, the FTC, on July 30, withdrew its remaining count against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel. Read More
The U.K.’s Competition and Markets Authority (CMA) hit Advanz Pharma Corp. Ltd. and two private equity firms July 29 with fines totaling more than £100 million (US$139 million) for increasing the price of a thyroid drug by more than 6,000% since 2007. Read More
Biopharmas raising money in public or private financings, including: Adagio, Aridis, Bionomics, Cerecor, Cymabay, Eliem, Evotec, Immunovant and Roivant. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Astrazeneca, Beigene, Biogen, Cyclo, Enyo, Lilly, Optinose, RDIF, Vaxart. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acurx, Affimed, Amount, Arcturus, Autolus, Bausch, Carrick, Johnson & Johnson, Moderna, Oligomerix, Polyphor, Roche, Seqirus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Ardelyx, BMS, Erytech, GSK, I-Mab, Imago, Janssen, Junshi, Revolo. Read More
