Even though the EU had approved more than a dozen biosimilars by 2012, the follow-on biologics were still in their embryonic stage around the world when BioWorld published The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies in early 2013. Now, nearly a decade later, the global biosimilar landscape has matured with many more biosimilars approved across the globe, but the uptake, and thus the savings, is not what some policy makers and people in industry had hoped for or expected. Read More
The next stop for Albireo Pharma Inc. is chats with the U.S. FDA and the EMA following positive phase III data for Bylvay (odevixibat) in treating the rare disease Alagille syndrome. Should Bylvay, a nonsystemic ileal bile acid transport inhibitor, be approved for the indication, it would be the second approval. It was greenlighted by the FDA in 2021 for treating pruritus in progressive familial intrahepatic cholestasis. Read More
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial. Read More
Positive phase I data from Dice Therapeutics Inc. with DC-806 in psoriasis sent shares (NASDAQ:DICE) on a wild ride, closing at $40, up $15.35, or 62%, on Oct. 11, 2022, and bolstered the case for oral drugs in psoriasis – an increasingly busy indication where discouraged patients often find themselves switching between therapies. Read More
Researchers at the University of Cincinnati have published data showing that in patients with dominantly inherited Alzheimer’s disease-causing mutations, high levels of soluble amyloid-β42 (Aβ42) in the cerebrospinal fluid predicted a reduced risk of developing dementia over three years. Read More
CSPC NBP Pharmaceuticals Co. Ltd. entered an agreement that will grant it exclusive rights to Harbour Biomed Co. Ltd.’s anti-FcRn antibody, batoclimab (HBM-9161), in greater China, including Hong Kong, Macau and Taiwan. Read More
NMD Pharma A/S has announced top-line results showing its orally available ion channel inhibitor, NMD-670, has a positive clinical impact in myasthenia gravis (MG), with patients having stronger hand grip and improvements in quantitative MG scores. Read More
At the third time of asking, Scpharmaceuticals Inc. has seen its subcutaneous loop diuretic, Furoscix (furosemide), approved by the U.S. FDA for patients with worsening heart failure, although the news was greeted initially by a shock slump in the firm’s share price. Read More
Upheaval at the Biotechnology Innovation Organization (BIO) has resulted in a sudden leadership change. Rachel King, a longtime member of the organization’s leadership and co-founder and former CEO of Glycomimetics Inc., will serve as interim president and CEO. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinogen, Ascletis, Brainstorm, G1, Hutchmed, Immatics, Iovance, Janssen, Merck KGaA, Morphic, Sciwind, Tenax. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brooklyn, Cara, Christianacare, Cocrystal, Corrixr, Compass, Eli Lilly, Enteris, Eterna, ICER, Karuna, Merck and Co., Muna, Nimbus, Psychogenics, SWK and Synergys. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Everest, GSK, HDT, Innovent, Nanoscope, Novelmed, Pfizer, Scpharmaceuticals, Supernus. Read More
