WuXi Partners with Pharmacyclics

WuXi News

Shanghai SynTheAll (STA) Pharmaceutical Co., Ltd., WuXi’s STA, WuXi’s wholly owned subsidiary of small molecule process R&D and manufacturing division, has entered into a supply arrangement with Pharmacyclics, Inc. (Nasdaq: PCYC). This follows a successful multiple-year development and clinical manufacturing partnership that supported Pharmacyclics’ IMBRUVICA, with the expedited New Drug Application submission and final approval by the U.S. Food & Drug Administration (FDA). In the GMP pre-approval inspection of WuXi’s manufacturing facilities in August, no Form 483 observations were issued by the FDA.

IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably. IMBRUVICA has been granted three Breakthrough Therapy Designations by the FDA, a first for an oncology drug. These designations are intended to expedite the development and review of drugs for serious or life-threatening conditions. To date, nine Phase III clinical trials have been initiated with IMBRUVICA and 37 clinical trials are currently registered on www.clinicaltrials.gov. More.


U.S. Food and Drug Administration Approves IMBRUVICA™ (ibrutinib) as a Single Agent for Patients with Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

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