BioCentury | Jul 16, 2020
Regulation

July 15 Quick Takes: Early access in U.K. for Alnylam RNAi; plus Verrica, CytoDyn, J&J and Roche

U.K. clears early access to lumasiran  The U.K.’s Medicines and Healthcare products Regulatory Agency is making lumasiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) available to patients with primary hyperoxaluria type I before its approval by the...
BioCentury | Apr 24, 2020
Product Development

Upbeat Lilly earnings come with positive psoriasis results, delays for two autoimmune programs

Lilly announced positive Phase III data for autoimmune disease candidate mirikizumab and attributed a bump in revenue, adjusted guidance and trial delays to the COVID-19 pandemic. As part of its 1Q20 earnings, Eli Lilly and...
BioCentury | Mar 23, 2020
Product Development

Lilly trial slowdown could include Phase III GI candidate; Syncona among others acknowledging delays

Lilly’s decision to delay most clinical trial starts and suspend enrollment in most ongoing trials makes it the latest and largest biopharma to acknowledge a broad impact of the COVID-19 outbreak on its development plans...
BC Extra | Aug 13, 2019
Clinical News

Taltz tops Tremfya in psoriasis but data may not change prescribing habits

Eli Lilly said Taltz was superior to J&J's Tremfya in treating psoriasis at 12 weeks in the Phase IV IXORA-R trial, but the data may not move the needle on physicians’ prescribing habits. The data...
BC Innovations | Aug 9, 2019
Tools & Techniques

The next frontier for single-cell analysis

With an explosion in scalability, single-cell analysis has begun to invade every aspect of drug development, with early benefits showing themselves in precision targeting. The field’s next challenge is to integrate a wider array of...
BC Extra | Jun 14, 2019
Clinical News

June 14 Clinical Quick Takes: Chi-Med, BeiGene, UCB, Global Blood and more

Chi-Med’s surufatinib meets in Phase III for extra-pancreatic neuroendocrine tumors  Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said it is planning a pre-NDA meeting with China’s National Medical Products Administration (NMPA) after surufatinib (formerly sulfatinib) met...
BC Extra | May 22, 2019
Clinical News

May 22 Clinical Quick Takes: Lilly's mirikizumab meets Crohn's endpoints; plus Novartis, 89bio and more

Lilly's mirikizumab meets in Phase II for Crohn’s  Mirikizumab (LY3074828) from Eli Lilly and Co. (NYSE:LLY) met the primary and secondary endpoints of improving clinical and endoscopic measures of disease activity at week 12 vs....
BC Week In Review | Dec 14, 2018
Clinical News

Tremfya superior to Cosentyx in head-to-head Phase III trial

Janssen Biotech Inc. said Tremfya guselkumab met the primary endpoint of improving PASI 90 response rate vs. Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III ECLIPSE trial to treat moderate to severe...
BC Extra | Dec 12, 2018
Clinical News

Tremfya superior to Cosentyx in head-to-head Phase III trial

Janssen Biotech Inc. said Tremfya guselkumab met the primary endpoint of improving PASI 90 response rate vs. Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III ECLIPSE trial to treat moderate to severe...
BC Week In Review | Aug 3, 2018
Clinical News

Lilly's mirikizumab improves clinical remission in Phase II for ulcerative colitis

Eli Lilly and Co. (NYSE:LLY) reported in June that 200 mg IV mirikizumab (LY3074828) met the primary endpoint of improving clinical remission rate at week 12 vs. placebo in a Phase II trial to treat...
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