BioCentury | Jul 1, 2020
Product Development

Histology data builds on growing confidence around Akero’s NASH candidate

Akero’s biopsy data is the positive news the NASH field needed after FDA declined to approve what would have been the first drug for the indication earlier this week. Akero Therapeutics Inc. (NASDAQ:AKRO) rose $8.45...
BioCentury | Jun 29, 2020
Regulation

Intercept: Surrogate endpoint not enough for FDA to approve NASH therapy

Intercept believes FDA’s “evolving” thinking on efficacy endpoints for NASH therapies led to the complete response letter for Ocaliva that destroyed about two-fifths of the company’s market value on Monday. The company said FDA declined...
BioCentury | May 23, 2020
Product Development

Further delays at FDA for Intercept’s NASH therapy

Four months after Intercept disclosed FDA had pushed out the PDUFA date for its non-alcoholic steatohepatitis therapy to June 26, the company is now expecting a further delay in the agency’s review of obeticholic acid....
BioCentury | May 6, 2020
Product Development

Phase II data show Novo’s semaglutide leads the pack on NASH resolution

Novo Nordisk disclosed top-line Phase II data in NASH for semaglutide that puts the GLP-1 agonist in pole position with respect to mechanisms addressing NASH resolution. The readout came as Novo Nordisk A/S (CSE:NOVO B;...
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...
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