BioCentury | Jan 18, 2020
Product Development

Charting a course to intercepting Type I diabetes

Arguably, the most important innovations on the horizon for Type I diabetes would replace the insulin-producing cells patients have lost or prevent at-risk individuals from losing the cells in the first place. With Provention planning...
BioCentury | Jan 10, 2020
Product Development

Seeking structural endpoints for OA

As the first disease-modifying therapies for osteoarthritis enter late-stage development, companies are testing new endpoints that can capture effects on joint structure instead of relying on traditional pain-related readouts. Most are converging on MRI imaging...
BC Extra | Dec 10, 2019
Company News

Janssen pays $750M for XBiotech's dermatology candidate after positive Phase II data

After searching for a new candidate to add to its immuno-dermatology pipeline, Janssen Biotech Inc. will spend $750 up front to acquire bermekimab, a clinical anti-IL-1α antibody, from XBiotech Inc. The mAb is first being...
BC Extra | Nov 26, 2019
Company News

Nov. 26 Company Quick Takes: Kyowa, Ardelyx expand partnership; plus ICER, Celltrion, Asahi-Veloxis and Merck

Kyowa, Ardelyx expand collaboration with new targets and $20M investment  Under an expanded partnership, Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) will pay Ardelyx Inc. (NASDAQ:ARDX) $10 million in research support over the next two years...
BC Extra | Jul 24, 2019
Company News

July 23 Company Quick Takes: FDA approves Pfizer’s Rituxan biosimilar; plus Intra-Cellular, OTC Tamiflu, Cimzia and more

Pfizer’s Rituxan biosimilar approved in U.S.  FDA approved Ruxience rituximab-pvvr from Pfizer Inc. (NYSE:PFE) for non-Hodgkin lymphoma, chronic lymphocytic leukemia and granulomatosis with polyangitis and microscopic polyangitis. Ruxience is the second biosimilar of Rituxan, an...
BC Extra | Jun 5, 2019
Clinical News

InflaRx stumbles after C5a mAb fails in inflammatory skin disease study

After reporting a high clinical response rate in a Phase IIa study, InflaRx lost $34.28 (92%) to $3.01 in afternoon trading Wednesday after all doses of IFX-1 failed to meet the primary endpoint in the...
BC Week In Review | Apr 26, 2019
Clinical News

Lilly planning submissions for Taltz in non-radiographic axial spondyloarthritis

Lilly said it plans to submit regulatory applications this year for Taltz ixekizumab to treat non-radiographic axial spondyloarthritis after the drug met the primary and all major secondary endpoints in the Phase III COAST-X trial....
BC Extra | Apr 24, 2019
Company News

AbbVie successor to Humira in psoriasis gains FDA approval

With Humira set to face increasing biosimilar competition internationally this year, AbbVie notched its first U.S. approval for a successor to the blockbuster, Skyrizi risankizumab-rzaa, late Tuesday. FDA approved the IL-23 inhibitor to treat plaque...
BC Week In Review | Apr 5, 2019
Company News

Cimzia approved for non-radiographic axial spondyloarthritis

FDA approved Cimzia certolizumab pegol to treat non-radiographic axial spondyloarthritis. FDA said the drug, from UCB S.A. (Euronext:UCB), is the first approved for the indication. Cimzia, a pegylated humanized antibody fragment against TNFα, is also...
BC Extra | Mar 5, 2019
Company News

Intarcia licenses Numab's autoimmune therapy

Ahead of an NDA resubmission for its Type II diabetes therapy, Intarcia exercised an option to license from Numab exclusive, worldwide rights to autoimmune disorder therapy, ND016. ND016 is a trispecific antibody fragment that blocks...
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