Selecta Biosciences Inc. and Swedish Orphan Biovitrum AB unveiled top-line phase III data from the Dissolve I and II trials testing SEL-212 in adults with chronic refractory gout (CRG) – results that position the companies for a regulatory filing in the U.S. during the first half of next year. SEL-212 could take on Horizon Therapeutics plc’s Krystexxa (pegloticase), a pegylated uric acid specific enzyme cleared by the U.S. FDA for CRG in September 2010. Read More
FDA approval of Aduhelm (aducanumab), as the first disease modifying drug for Alzheimer’s, may have had a distinctly lukewarm reception in some quarters, but it is an important starting point in treating dementia, with a myriad of other avenues now being pursued in discovery and development. Read More
While U.S. policymakers focus on drug prices, mandatory federal spending on Medicare and Medicaid for 2010 through 2020 was actually 9% lower than what the Congressional Budget Office (CBO) projected in 2010. One of the “significant sources” the CBO cited for its off-the-mark projection was less-than-anticipated spending for Medicare Part D prescription drugs due to new generic competition and fewer new brand drugs being launched. In light of reality, the CBO has lowered its long-term projection of health spending through 2033. Read More
Mereo Biopharma Group plc said its path to approval for alvelestat is a phase III study that would preclude an additional confirmatory trial. After meetings with the U.S. FDA and the EMA to discuss next steps, Mereo said it is designing a single, 12- to 18-month, global phase III of the neutrophil elastase inhibitor for treating alpha-1-antitrypsin deficiency-associated lung disease. Read More
Likang Life Sciences Holdings Ltd. received approval from China’s NMPA to start a clinical trial of its candidate, LK-101 injection, for advanced solid tumors. The company claims this is the first personalized neoantigen vaccine and mRNA editing product to enter the clinic in China. Read More
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey. Read More
New hires and promotions in the biopharma industry, including: Akoya, Ankyra, Apie, Beam, Cytovation, Decibel, Gamida Cell, Nextpoint, Sonata, Wugen. Read More
New and updated clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Abbvie, Acelyrin, Arcutis, Concert, Connect, Galderma, Incyte, Inmagene, Leo, Nimbus, Regeneron, Sanofi, Sun, Takeda, UCB. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allarity, Clairvoyant, Enlivex, Genentech, Kangpu, Karuna, Newron, Orsobio, Pharvaris, Rayzebio, Vaccitech, Vaxxinity, Xalud. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alexion, Astrazeneca, Beigene, Devshealth, Disc Enveric, Evofem, Ingenū, Lucy Scientific, Psyence, Quralis, Wesana, Zura. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Aquavit, Arrowhead, Aviceda, Boan, Diamond, Enlivex, Fore, Ichnos, Intellia, Jiangsu Recbio, Luye, Mereo, Prestige, Sanofi, Sensei. Read More
