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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.
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
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.
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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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.
Mallinckrodt pharma leading global specialty pharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for OFIRMEV® (acetaminophen) injection available in an intravenous (IV) bag presentation, which will provide health care providers an additional delivery option.
MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug development company, announced that the company has been issued patent No. 9,475,874 by the United States Patent and Trademark Office (USPTO) for its clinical stage HuMab5B1 fully-human monoclonal antibody that forms the basis for the company's MVT-5873 and MVT-2163 clinical development programs. Both programs are currently enrolling patients in phase 1 clinical trials.
Emmaus Life Sciences, Inc., announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.
Data from the company's Phase 3 sickle cell disease trial demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction in cumulative days hospitalized, and a lower incidence of the life-threatening acute chest syndrome.
Amryt, a clinical-stage specialty pharmaceutical company focused on best-in-class treatments for orphan diseases, is pleased to announce that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to the Company's drug compound, AP102, which has the potential to treat patients with acromegaly. Acromegaly is a rare endocrine disorder in which the body produces excessive growth hormone, leading to abnormal growth throughout the body over time.
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