BioCentury | Feb 25, 2020
Product Development

NGM pops on additional Phase II NASH data for aldafermin

Positive histology data helped NGM snap a losing streak for NASH therapies and lifted the biotech’s stock on a day where the sector and broader markets saw mostly red. Shares of NGM Biopharmaceuticals Inc. (NASDAQ:NGM)...
BC Extra | Jan 17, 2020
Company News

Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

Label expansion for Novo’s Ozempic  FDA approved Ozempic subcutaneous semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NOVO) to reduce the risk of major adverse cardiovascular events in adults with Type II diabetes and heart disease....
BC Extra | Dec 17, 2019
Company News

Dec. 16 Company Quick Takes: Greenlight for Roche-Spark deal; plus BMS, Gilead, BioMarin, FDA guidance

Roche cleared to complete Spark takeover  The planned merger of Roche (SIX:ROG; OTCQX:RHHBY) and Spark Therapeutics Inc. (NASDAQ:ONCE) has at last been cleared by the U.S. Federal Trade Commission and U.K. Competition and Markets Authority....
BC Extra | Dec 14, 2019
Company News

Dec. 13 Company Quick Takes: Horizon, Intercept, Imfinzi, Evenity and Numab-3SBio

FDA panel backs Horizon's eye disease candidate  FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously Friday that the benefits of teprotumumab to treat active thyroid eye disease outweigh the potential risks. The mAb against...
BC Extra | Dec 9, 2019
Company News

Novartis downsizing internal efforts on CAR T in solid tumors

Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use...
BC Innovations | Nov 27, 2019
Product Development

Early Pfizer data from DGAT2-targeting NASH program lay groundwork for monotherapy and combos

Pfizer thinks Phase I and preclinical data from its DGAT2 program suggest the target could hit NASH's three mechanistic pillars -- dysregulated metabolism, inflammation and fibrosis. The pharma is advancing a next-generation compound both alone...
BC Extra | Nov 26, 2019
Company News

Priority Review roundup: Roche-PTC, Intercept, Zogenix

FDA granted Priority Review to a trio of compounds Monday, accepting NDAs from partners Roche and PTC, as well as Intercept and Zogenix to treat neurological and hepatic diseases. Risdiplam from Roche (SIX:ROG; OTCQX:RHHBY) and...
BC Extra | Oct 30, 2019
Company News

Oct. 29 Company Quick Takes: Incyte’s JAK inhibitor beats expectations; plus Sumitomo-Intercept, Merck KGaA-Pfizer, AMAG, Regeneron-Sanofi

Incyte surges on Jakafi sales, guidance  On the strength of 3Q19 sales of Jakafi ruxolitinib that beat estimates and resulted in an increase in full-year guidance, Incyte Corp. (NASDAQ:INCY) climbed $3.49 to $83.35 Tuesday, adding...
BC Innovations | Oct 25, 2019
Tools & Techniques

NASH: how non-invasive biomarkers promise to displace biopsies

Non-invasive biomarkers in NASH are beginning to show where and how they can upstage liver biopsies, with the first impact appearing in patient recruitment. The biggest value will come when they can serve as regulatory...
BC Extra | Sep 26, 2019
Clinical News

Enanta dips on concerns about pruritus, differentiation of NASH compound

Dose selection for an upcoming trial could prove crucial among Enanta’s next steps for its FXR agonist following a Phase II readout in NASH that raised questions about the compound’s tolerability and differentiation from others...
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