Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year. Read More
Now that Avadel Pharmaceuticals plc has final U.S. FDA approval for its narcolepsy drug Lumryz, the company has priced the sodium oxybate formulation to match the cost of competitor Xywav from Jazz Pharmaceuticals plc. Avadel said it plans to charge $64.67 per gram for Lumryz. The annual cost based a 9-gram dose would be about $212,441 per patient. Three daily dose levels, 6 grams, 7.5 grams and 9 grams, were evaluated during a phase III study the final approval was based on. Read More
A precancerous condition caused by the human papillomavirus (HPV) affects up to 300,000 American women who are diagnosed each year, and yet there are no treatments, just preventive vaccines introduced in 2006 – targeted to younger generations prior to the first sexual encounter. That leaves a large proportion of the female population stuck with a “wait-and-see” approach that involves continuous monitoring of their HPV infection through pap smears to detect cellular changes that could lead to cervical cancer. South San Francisco-based Antiva Biosciences Inc. is seeking to find a better response to this condition known as high-grade cervical intraepithelial neoplasia (CIN2,3) with its lead topical therapeutic, ABI-2280, a prodrug of an acyclic nucleoside phosphonate that is currently in phase I trials. Read More
With its sights set on a series A and an IPO following a £3.5 million (US$4.4 million) investment round in 2021, Scottish biotech ILC Therapeutics Ltd. is hoping to make waves with a sublingual interferon antiviral to treat COVID-19. The USP for the company’s lead, Alfacyte, is the fact that it’s an artificial version of interferon, so it has less of a propensity to cause the flu-like symptoms that can come from treatment with natural kinds, which hike levels of cytokines and interleukins. As a hybrid interferon that is composed of interferon alpha-10 and interferon alpha-12, Alfacyte is “up to 10,000 times less likely” to cause adverse effects, according to ILC CEO Alan Walker. Read More
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices. Read More
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New hires and promotions in the biopharma industry, including: Amphista, Curve, Day One, Find, Glycoera, Newron, Obseva, Oramed, Resolution, Syneos, Tris. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Almirall, CG, Eli Lilly, Horizon, J&J, Lipella, Pliant, Urogen, Zambon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquavit, Arcutis, Ascendis, Atsena, Biomea, BMS, Cabaletta, Erasca, Kiromic, Medincell, Neurosense, Onquality, Sanofi, Teva. Read More
