The radiopharmaceutical revolution rolls on as Eli Lilly and Co. builds on its prowess in the space with a deal that could bring Aktis Oncology Inc. $1.1 billion. The two plan to develop radiopharmaceuticals targeting cancer. Privately held Aktis also is getting $60 million in cash up front along with an equity investment. The big money would come from preclinical, clinical, regulatory, commercial milestones and tiered royalties. Lilly will select the targets. Read More
Altrubio Inc. secured up to $225 million in an oversubscribed series B financing round, led by BVF Partners LP. The full amount is dependent on Altrubio meeting certain undisclosed milestones. New investors RA Capital Management, Cormorant Asset Management and Soleus Capital, and existing investors Amoon Fund and Blackstone Multi-Asset Investing, as well as other new and existing investors, also participated in the financing round. Read More
Pheon Therapeutics Ltd. is poised to start the first of three clinical trials of its lead antibody-drug conjugate (ADC), after closing a $120 million series B. The company is taking a “three-pronged approach” in order to stake out as much of the ground as it can for its next-generation ADC, which delivers an in-house-designed topoisomerase inhibitor to a novel undisclosed transmembrane protein target. Read More
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list. Read More
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15). Read More
Théa Open Innovation, a subsidiary of France’s Laboratoires Théa SAS, returned rights to South Korea’s Curacle Co. Ltd.’s CU-06, an oral diabetic macular edema drug candidate. Curacle posted positive top-line phase IIa data of CU-06 just three months prior. Read More
GSK plc’s interleukin-5 (IL-5) portfolio got boost as depemokimab, an ultra-long-acting biologic targeting IL-5, hit its endpoints in two phase III trials in severe asthma, setting up potential filings for the first therapy that could allow patients a six-month dosing schedule. Read More
The Department of Health and Human Services (HHS) has no rulemaking authority over the 340B prescription drug discount program, the U.S. Court of Appeals for the District of Columbia Circuit said May 21 as it handed the government its second big loss in the ongoing debate over whether drug manufacturers have to give unlimited contract pharmacies the steep discounts the program provides to certain health care providers. Read More
The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards. Read More
New hires and promotions in the biopharma industry, including: Alto, Avadel, Be, Contineum, Cour, Engitix, Idorsia, Inspirna, Kincell, Kronos, Sona, Valneva. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Anokion, Arcturus, Arecor, Arrowhead, Astrazeneca, Chiesi, CSL, Cymabay, Dyne, Endeavor, Esperion, Gigagen, Gilead, Intercept, Janssen, Kamari, Nkgen, Oak Hill, Pharmatrophix, Rila, Sonnet, South Rampart, Vicore. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alloy, Alvotech, Biontech, Cipla, Dr. Reddy’s, Dragonfly, Effector, Ensysce, Evergreen, Exelixis, Formation, Indapta, Index, Lilly, Lyra, Medigene, Merck, OpenAI, Quotient, Qurient, Sanofi, Trialspark. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprinoia, Atara, GC, Lisata, PTC, Sound, Spinogenix, Wugen, Zai Lab. Read More
A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren’t attractive enough for Fibrobiologics’ management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O’Heeron said was worth the effort. “We couldn’t be more happy with the outcome,” he said. Read More
