A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Hangzhou Yuyuan, Lixte, Obseva, Remegen.
Prescription drug names are generally invented words that are often easier to spell than they are to pronounce. And, for the most part, they’re meaningless until they’ve been associated with a drug.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim, Biomind, Eagle, Elevar, Galectin, Merck & Co., Moerna, Pfizer, Regeneron, Sisaf.
It was a busy day at Moderna Inc. as Merck & Co. Inc. exercised its option to jointly develop and commercialize a personalized cancer vaccine with Moderna in a deal the two companies inked in 2016. Moderna also notched another emergency use authorization (EUA) for its COVID-19 vaccine, this one targeting the omicron variant, for use by those under age 18.
Many industry watchers are looking to 2023’s Humira biosimilar launch in the U.S. as a portent of the future of biosimilars. While it should help raise awareness of biosimilars in general and produce savings in the immunology sector, its distinctness could make it an outlier in the world of current and future biosimilar competition.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Aquestive, Eligo, Gilead, Harm Reduction, Pharming, Rigel, Teraimmune.
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.
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.
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.
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