As rumblings continued about possible skulduggery between Biogen Inc. and the FDA related to Aduhelm (aducanumab), an already precedent-setting case took yet another turn: Acting FDA Commissioner Janet Woodcock asked acting U.S. Inspector General Christi Grimm’s office to conduct an independent review of goings-on that led to approval of the amyloid-beta-targeting drug in Alzheimer’s disease. Read More
DUBLIN – Having spent more than 150 years devoted to marketing tobacco, Philip Morris International Inc. is now embracing human health and wellness as part of what it calls a “beyond nicotine” strategy, under which it has tabled a £1.50 (US$2.07) per share offer for Vectura Group plc. The offer implies an enterprise value of £852 million or about $1.2 billion for Chippenham, U.K.-based Vectura, which majors in formulation and device development for inhaled drugs. Read More
In an exclusive licensing agreement, Astrazeneca plc will get the global rights to research, develop and commercialize protein stimulator of interferon genes, STING inhibitor compounds, from F-star Therapeutics Inc. Astrazeneca is responsible for currently preclinical STING inhibitor compounds from F-star, which retains rights to all its STING agonists in clinical development for treating cancer. Read More
Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.
Officials at Sigilon Therapeutics Inc. declined to comment beyond a press release on the FDA’s clinical hold for the phase I/II study with encapsulated cell therapy SIG-001 for severe or moderately severe hemophilia A. Shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX) closed at $6.90 on July 9, down $2.34, or 25% after Wall Street learned of the regulatory move, which came because one of three patients treated has developed inhibitors to factor VIII (FVIII). Read More
While second quarter financings pale in comparison to the same timeframe last year, a stellar first quarter more than makes up for the gap, and 2021 has officially raised nearly 10% more than the first half of biopharma’s – and perhaps the world’s – most unforgettable year. Read More
LONDON – Another Novo Seeds start-up has graduated, with Muna Therapeutics ApS closing a $73 million series A to take forward small-molecule treatments for neurodegenerative diseases. Read More
Xilis Inc. closed $70 million in series A financing on July 8 to reduce drug development costs leveraging its technology, with the goal of advancing precision medicine through targeted drug discovery and development. The financing was led by Mubadala Capital with participation from new investors that include GV, formerly Google Ventures, and others. Read More
NICE has said “no” to regular NHS funding for a rare disease gene therapy from Orchard Therapeutics Ltd. in draft guidance – although experience from Novartis AG’s pricey Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy shows this could change. That’s because this week NICE published final guidance that recommends funding for Zolgensma, thought to be the world’s most expensive drug, after an initial rejection late last year. Read More
While U.S. lawmakers continue their debate on reducing spending for prescription drugs, government payers are exploring innovative reimbursement ideas to cover gene and cell therapies that could cost millions of dollars for a cure or a durable effect against rare diseases. Read More
PERTH, Australia – Amaroq Therapeutics Ltd., a spinout out of the University of Otago in Dunedin, New Zealand, has launched after securing NZ$14 million (US$9.7 million) in seed funding to develop long non-coding RNAs as therapeutic targets and diagnostic markers to treat breast, colorectal and liver cancer. Read More
Fresh from showcasing preliminary evidence for the tolerability and potential benefits of its anti-CD137 monoclonal antibody, LVGN-6051, at the American Society of Clinical Oncology’s annual meeting in June, Lyvgen Biopharma Holdings Co. Ltd. is gearing up to move its CD40 agonist LVGN-7409 to clinical trials in China after initial U.S. patient dosing. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aicuris, Akston, Astrazeneca, Atyr, Can-Fite, Daiichi Sankyo, Evaxion, Jiangsu Nhwa, Oncopeptides, Prilenia, Sellas, Trevena. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, ASC, Astrazeneca, Beigene, Biogen, Enveric, Triact. Read More
