United States

FDA Alert on Gilead Sciences’ Zydelig

Friday, March 18, 2016

The FDA has issued an alert for healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.

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FDA grants Roche’s cancer immunotherapy Atezolizumab Priority Review

Friday, March 18, 2016

The FDA has accepted Roche’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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MedImmune receives FDA Fast Track for influenza treatment

Thursday, March 10, 2016

AstraZeneca’s global biologics R&D arm, MedImmune, has received Fast Track designation from the FDA for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with type A strain influenza. The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

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Almac opens companion diagnostic laboratory in North Carolina

Thursday, March 10, 2016

Almac Group’s Diagnostics Business Unit has opened a new companion diagnostic development facility located in the Research Triangle Park region of North Carolina. The North Carolina facility will provide a U.S. base to support Almac’s increased demand for its CDx development partnerships as well as a CLIA-accredited laboratory to support the downstream delivery of assays for patient testing.

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Bristol-Myers Squibb, LabCentral partner for startups in Massachusetts

Tuesday, March 8, 2016

Bristol-Myers Squibb and LabCentral, an innovative, shared laboratory space designed as a launch pad for life-sciences and biotech startups, have announced an agreement in which Bristol-Myers Squibb has become a LabCentral platinum sponsor. Bristol-Myers Squibb can nominate up to two innovative life sciences and biotech startup companies per year to take up residence in LabCentral’s Kendall Square facilities. The 2016 nomination process for Bristol-Myers Squibb-sponsored Golden Tickets will launch by the end of the first quarter.

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