Clinical Intelligence

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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Trevena receives FDA Breakthrough Therapy for Oliceridine in pain

Tuesday, February 23, 2016

Trevena, a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, has announced the FDA granted Breakthrough Therapy designation to the company’s lead product candidate, intravenous oliceridine (TRV130), for the management of moderate-to-severe acute pain. Following two successful phase II studies, oliceridine is now in phase III development. The ATHENA-1 safety and tolerability study is ongoing, with pivotal studies expected to begin in the second quarter of 2016.

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Novaliq begins phase II dry eye trial

Friday, February 19, 2016

Novaliq, a pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, has begun enrolling patients in a phase II clinical trial that will evaluate the safety, efficacy and tolerability of CyclASol for the treatment of moderate to severe dry eye disease (DED). CyclASol is a clear, preservative free ophthalmic solution of cyclosporine in SFA (semifluorinated alkanes).

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JHL Biotech to start biosimilar trial

Wednesday, February 17, 2016

JHL Biotech has received authorization from the U.K.s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trials for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis. JHL is the first company from the Greater China region to receive European approval for clinical trials of a monoclonal antibody biosimilar.

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Epizyme’s Tazemetostat granted FDA Orphan designation for malignant rhabdoid tumors

Tuesday, February 9, 2016

The FDA has granted Orphan Drug status to Epizyme’s first-in-class EZH2 inhibitor, tazemetostat, for the treatment of malignant rhabdoid tumors (MRTs). In December 2015, the company initiated a phase II study in adults and a phase I study in children with genetically defined tumors, including MRTs. Tazemetostat is also being investigated in an ongoing five-arm phase II study in patients with non-Hodgkin lymphoma.

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