United States

Report: 2015 broke R&D records

Monday, May 23, 2016

The Biotechnology Innovation Organization (BIO) has released a new report, “Emerging Therapeutic Company Investment and Deal Trends,” highlighting 10 years (2006-2015) of biotechnology funding and deal making across five areas: venture capital, IPOs, follow-on public offerings, licensing, and acquisitions. The report also offers clinical pipeline snapshots to provide context on the degree of industry partnering and the contribution of emerging companies.

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FDA’s proposed Expanded Access Navigator points to progress, not panacea

Monday, May 23, 2016

In response to the increasing demand for access to investigational drugs, creation of a clearinghouse to provide information on the request process has been proposed by the Reagan-Udall Foundation for the FDA. Dubbed the Expanded Access (EA) Navigator, the educational tool is the government’s latest effort to increase the efficiency of the complex process of requesting unapproved drugs outside of clinical trials for “compassionate use.”

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INC Research, CISCRP launch ideathon to boost awareness of clinical research

Friday, May 20, 2016

INC Research Holdings, a global phase I to IV CRO, together with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process, have announced an innovative new initiative designed to promote greater awareness of the importance of clinical trial participation in advancing public health.

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FDA grants Genentech’s cancer immunotherapy Tecentriq (atezolizumab) Accelerated Approval

Friday, May 20, 2016

The FDA granted Accelerated Approval to Genentech’s Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has 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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NIH funds new studies on the impact of genomic information

Tuesday, May 17, 2016

Four new grants from the National Institutes of Health will support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic information. The awards will fund researchers at interdisciplinary centers through the National Human Genome Research Institute’s (NHGRI) Centers of Excellence in Ethical, Legal and Social Implications Research (CEER) program.

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