Industry News

- Read more about BMS and Pfizer Deliver 12 New Eliquis Presentations at AHA Scientific Sessions 2016
Bristol-Myers Squibb Company and Pfizer Inc. announced that 12 Eliquis abstracts will be presented at the AHA Scientific Sessions 2016, to be held November 12-16 in New Orleans. Among these abstracts, the Bristol Myers-Squibb and Pfizer Alliance will present final data from the randomized AEGEAN (Assessment of an Educational and Guidance Program for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study, highlighting adherence and persistence data for nonvalvular atrial fibrillation (NVAF) patients treated with Eliquis to reduce the risk of stroke.
- Read more about Seattle Genetics Receives FDA Breakthrough Therapy Designation for ADCETRIS®
Seattle Genetics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease.
- Read more about FDA give positive response on RedHill Biopharma’s Type B Meeting on RHB-105 Phase III development program
RedHill Biopharma Ltd. announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
Subject to final minutes of the meeting, the FDA has accepted RedHill's manufacturing plan towards filing the CMC package as part of a potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study.
- Read more about Bristol-Myers Squibb, Infinity Pharma clinical collaborate to evaluate Opdivo in combo with IPI-549
Bristol-Myers Squibb Company and Infinity Pharmaceuticals, Inc. announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced solid tumours. The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s phase 1 study is continuing, and the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to begin this fall.
- Read more about Bristol-Myers Squibb Signs Exclusive Worldwide License Agreement with Nitto Denko
Bristol-Myers Squibb Company and Nitto Denko Corporation announced the companies have entered into an agreement granting Bristol-Myers Squibb exclusive worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations, which includes Nitto’s lead asset ND-L02-s0201, currently in Phase 1b study for the treatment of advanced liver fibrosis.
Trovagene, Inc, a developer of circulating tumour DNA (ctDNA) molecular diagnostics, announced that the US Patent and Trademark Office has issued Patent No 9,453,265 entitled "Method for Detection of High Risk Human Papillomavirus." The patent encompasses directed methods of detecting high-risk HPV infections by identifying mutations in the E1 gene of HPV in the urine of a patient, expanding the intellectual property covering Trovagene's Precision Cancer Monitoring (PCM) technology. Trovagene now has 91 patents issued and 72 patent applications pending in the US and internationally.

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"Issuance of this patent further strengthens Trovagene's extensive patent portfolio supporting our Precision Cancer Monitoring platform," said Bill Welch, chief executive officer of Trovagene.

Trovagene is submitting a manuscript this quarter that provides data validating the sensitivity and specificity of its HR-HPV, high-risk human papillomavirus urine test in comparison with the Roche Cobas HPV test. "The data in this manuscript will show that urine sampling is a viable testing alternative, particularly to access women who do not participate in routine screening programs," said Mark Erlander, chief scientific officer of Trovagene

Complementing the recently submitted manuscript, and adding to the body of clinical evidence supporting the sensitivity and specificity of Trovagene's HR-HPV urine-based test, two abstracts have been accepted for presentation at the HPV 2017 31st International Papillomavirus Conference. The first demonstrates clinical performance of urine and cervical samples in a Chinese screening population. These results support the utility of urine testing for cervical cancer screening among this population. The second abstract describes the analytical performance of the Trovagene HPV-HR urine test

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- Read more about Qiagen relaunch GeneReader NGS System in US market
Qiagen N.V., a leading global provider of sample to insight solutions, announced the validation of new and improved sequencing chemistry for its GeneReader NGS System, the world’s first complete Sample to Insight solution making the benefits of next-generation sequencing (NGS) accessible to any laboratory.
- Read more about Mylan and Biocon declare U.S. FDA Submission for Proposed Biosimilar Trastuzumab
Mylan N.V. and Biocon Ltd. announced submission of Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S.
- Read more about BioInvent get verbal notice from FDA for clinical hold on BI-505 phase II study
BioInvent International has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma.

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- Read more about Pfizer Present Results of Phase 3 Studies for XELJANZ® (Tofacitinib Citrate)
Pfizer Inc. announced that 20 abstracts for XELJANZ® (tofacitinib citrate) will be presented at the upcoming 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). Notably, results from the two pivotal Phase 3 OPAL (Oral Psoriatic Arthritis TriaL) studies of tofacitinib – the only Janus kinase (JAK) inhibitor under investigation for psoriatic arthritis (PsA) – will be presented for the first time. OPAL Broaden will be highlighted during a plenary session and OPAL Beyond will be presented during a late-breaking abstract poster session. In addition, new and updated research for XELJANZ in rheumatoid arthritis (RA) will be presented.