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Home » Newsletters » BioWorld

BioWorld

April 17, 2017

View Archived Issues

JAK be not quick: CRL hits Lilly/Incyte on baricitinib, wants more data on dose

Bad news came on Good Friday for Incyte Corp. and Eli Lilly and Co. in the form of a complete response letter (CRL) from the FDA related to once-daily, oral baricitinib for moderate to severe rheumatoid arthritis (RA). Read More

Bench Press: BioWorld looks at translational medicine

Age-related changes to the microbiome contributed to intestinal dysbiosis and inflammation, and the microbiome changes were reversible by reducing levels of tumor necrosis factor (TNF). Read More

Erytech expanding use, production of Graspa with $74.7M placing

LONDON – Three weeks after publishing positive phase IIb results for Graspa (eryaspase) in pancreatic cancer, Erytech Pharma SA has pulled together a €70.4 million (US$74.7 million) placing to finance preparations for phase III. Read More

Fatty liver fighters, virus killers convene at EASL

Lest the upcoming March for Science suggest otherwise, scientists enlisted to combat the globe's scourge of hepatic horrors are less picketers and more paratroopers, swooping into Amsterdam for this week's International Liver Conference (ILC) to swap stories from the front, fighting hepatitis, NASH, NAFLD and other foes. Though light on awe-inspiring victories, this year's European Association for the Study of the Liver (EASL) will feature plenty of small wins, each a part of winning a bigger war. Read More

New target identified for treating TNBCs

A collaborative study by Chinese and U.S. researchers has for the first time identified a critical new regulator of tumor growth, metastasis and immune response, which they showed to be an effective therapeutic target for triple-negative breast cancers (TNBCs) and potentially other cancers resistant to conventional treatments. Read More

Australia demonstrates government, industry can agree on price cuts

PERTH, Australia – Australia will save nearly A$500 million (US$379 million) over the next four years due to a deal hammered out by the federal government and pharmaceutical industry stakeholders. Read More

Thailand's growing market set to attract global pharma firms

HONG KONG – Pharmaceutical companies around the world are eying the Thailand market as it is set to almost double in size over the next few years. Read More

Other news to note

Northern Biologics Inc., of Toronto, is collaborating with Applied Biomath LLC, of Lincoln, Mass., in which the latter's hybrid modeling approach using both traditional pharmacokinetic/pharmacodynamic (PK/PD) models as well as semimechanistic PK/PD models will support an IND for Northern's biotherapeutic candidate in oncology. Applied Biomath will develop models for mouse, cynomolgus monkey and humans with cancer, the latter of which will be used to aid the prediction of first-in-human doses. Read More

In the clinic

CASI Pharmaceuticals Inc., of Rockville, Md., said a decision was reached to stop further patient enrollment in the phase II open-label study of ENMD-2076 in previously treated locally advanced or metastatic triple-negative breast cancer (TNBC) conducted at the University of Colorado, Denver, and the Indiana University Melvin and Bren Simon Cancer Center. Read More

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