After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus, 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. The approval will lead to a launch at the end of August and comes as a group of potential rivals from the likes of Biogen Inc., Aurinia Pharmaceuticals Inc. and Remegen Ltd are also approaching the market.

Ipsen circles Exicure tech in $1.02B deal for rare neurodegenerative disorders

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 on top of a $20 million upfront 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% by midday.

T-knife adds $110M series B to advance mouse-generated TCR platform

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. The round was completed exactly a year after the $78.3 million series A, a financing the company said at that time would fund planned activities for three years. Moving to close a further round 12 months later is a reflection of the “substantial progress” Berlin, Germany-based T-knife has made over the past year in shaping its programs and positioning to move TCRs on from the treatment of hematological cancers to solid tumors, said Thomas Soloway, CEO.

Zentera completes $75M series B financing as it aims for Hong Kong listing in 2022

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. The company intends to put the funds from this financing to use on furthering three particular candidates in its pipeline.

Antengene wins approval for Karyopharm’s selinexor as first and only XPO1 inhibitor in South Korea

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. It’s indicated for adults who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody. It was also approved as a monotherapy for the treatment of relapsed or refractory DLBCL in adults who have received at least two prior lines of treatment.

EMA’s clinical trial information system to go live in January 2022

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. CTIS will act as the single point for submitting applications to carry out clinical trials anywhere in the EU. It will finally bring to life the EU Clinical Trials Regulation, under which member states will take a harmonized approach to approving and supervising clinical studies.

FTC drops Abbvie suit, relief may be short-lived

Citing a unanimous U.S. Supreme Court ruling that denied its ability to seek restitution or disgorgement, the Federal Trade Commission (FTC) withdrew its remaining case against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel. However, similar relief for other drug and device companies may be short-lived if the U.S. Senate follows the House in passing a bill granting the FTC the express authority to impose monetary penalties for all violations of the laws it enforces.

Advanz fined over massive price increase

The U.K.’s Competition and Markets Authority (CMA) hit Advanz Pharma Corp. Ltd. and two private equity firms July 29 with fines of more than £100 million (US$139 million) for increasing the price of a thyroid drug by more than 6,000% since 2007. As a result, National Health Service (NHS) spending on liothyronine tablets jumped from £600,000 in 2006 to more than £30 million by 2016. In addition to the fines, the CMA decision opens the door for the NHS to seek damages from the companies.

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