Clinical Intelligence

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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Vaxart begins oral Zika virus vaccine testing

Tuesday, March 8, 2016

Vaxart, a clinical stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, has initiated preclinical testing of an oral vaccine for Zika virus. With no available vaccine or treatment modalities, the World Health Organization (WHO) recently declared Zika virus an international public health emergency.

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Sanofi releases phase I/II Pompe disease study results

Friday, March 4, 2016

Sanofi and its specialty care global business unit Sanofi Genzyme have presented data from NEO1, its phase I/II clinical study evaluating the investigational novel enzyme replacement therapy neoGAA in 24 patients with late-onset Pompe disease. The safety and efficacy data from this study support further development of the therapy. Sanofi Genzyme plans to begin enrolling patients in a pivotal phase III trial for neoGAA in Q2 2016.

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FDA files Genentech’s sBLA of Xolair for pediatric allergic asthma

Wednesday, March 2, 2016

Genentech, a member of the Roche Group, has announced the FDA accepted for review the company’s supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients. The FDA will review Xolair in children from six through 11 years for the treatment of moderate to severe persistent asthma in those patients with a positive skin test or in vitro reactivity to a perennial aeroallergen (airborne allergen) and symptoms that are inadequately controlled with inhaled corticosteroids. Genentech anticipates hearing from the FDA later this year.

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The CenterWatch Monthly, March 2016

Tuesday, March 1, 2016

Slow to negative growth in select emerging markets

A few years ago, Latin America and India were considered among the most promising emerging markets for conducting industry-sponsored clinical trials. Dramatic increases were predicted for both regions, and investigative sites anticipated an influx of new work. Unfortunately, growth in these markets has fallen far short of expectations. The number of industry-sponsored global phase I-IV trials in India has dropped 22.4% annually between 2010 and 2014, according to the 2015/2016 Parexel Biopharmaceutical R&D Statistical Sourcebook’s analysis of the database.

monthly chart

CROs juggle proprietary and commercial systems

Third-party vendors have come to dominate the clinical trial technology sector, which was led by CROs a decade ago. At the same time, many large CROs continue to invest in technology solutions to differentiate their services and offer greater efficiencies in clinical development processes. The eClinical solutions market, which includes electronic data capture (EDC) and clinical trial management systems (CTMS), could generate total global sales of $5 billion by 2018, representing a five-year annual growth rate of 13.5%, according to a recent report from global market research company MarketsandMarkets. Yet much of the growth in clinical trial technologies is expected to come from niche providers rather than in-house systems developed by CROs.

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Seattle Genetics initiates phase I/II trial of Vadastuximab Talirine for MDS

Tuesday, February 23, 2016

Seattle Genetics has initiated a phase I/II clinical trial of vadastuximab talirine (SGN-CD33A; 33A) in combination with azacitidine (Vidaza) in patients with previously untreated myelodysplastic syndrome (MDS). 33A is an antibody-drug conjugate (ADC) targeted to CD33 utilizing Seattle Genetics’ newest technology, comprising an engineered cysteine antibody (EC-mAb) stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer. Azacitidine is a hypomethylating agent (HMA) commonly used in the treatment of MDS. MDS is known to be a precursor to acute myeloid leukemia (AML), and broadly expresses CD33.

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