| This week's sponsor is Roquette. | |  | Roquette - The Biological Choice
Sole custody of our supply chain ensures a safe, secure and reliable supply of quality raw materials and excipients. Trust Roquette for all your biopharma needs. Learn more. |
Featured Story | | | Wednesday, May 24, 2017 Cel-Sci’s pitch to get a partial clinical hold lifted by the FDA has gone awry. The drugmaker set out a plan to get clinical development of Multikine moving forward again, only for the FDA to pick apart its proposal and switch up its clinical hold from a partial restriction to a full blockade. |
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| This week's sponsor is Precision for Medicine. | |  | Harmonizing biomarker data in clinical studies
Diverse assays. Multiple vendors. 1000s of biomarker data points in separate formats. See the tools pharma is using now to harmonize data and reduce time, costs and mitigate risks.
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Top Stories Wednesday, May 24, 2017 OrphoMed gained a $39 million early funding boost from a Japanese big pharma and a host of VCs as it looks to push on with work on its leading med for forms of irritable bowel syndrome that it hopes can have a better safety profile than those meds on the market. Wednesday, May 24, 2017 Pierre Fabre, the second biggest biopharma in France (after Big Pharma Sanofi), is boosting its cancer pipeline with what it is dubbing “promising” immuno-oncology candidates from California’s Igenica Biotherapeutics. Monday, May 22, 2017 With pressures to fast-track clinical development, the pharmaceutical industry recognizes the value of improving internal clinical data management processes. Learn how using comprehensive analytical capabilities helps to advance clinical trial execution. Wednesday, May 24, 2017 Debiopharm has bought a phase 2 antibody-drug conjugate from ImmunoGen to add to its clinical-phase cancer pipeline. The agreement gives Debiopharm an anti-CD37 non-Hodgkin lymphoma candidate in return for $25 million (€22 million) upfront plus milestones. Wednesday, May 24, 2017 The U.K. has been closing the gap on the leading life sciences sectors in Boston and the San Francisco Bay area, but uncertainty caused by Brexit could undermine those efforts, said the national industry body. Wednesday, May 24, 2017 Otsuka and Proteus Digital Health have refiled for FDA approval of their digital medicine. The filing is intended to address the human factor testing shortcomings that prompted the FDA to reject the original application. Tuesday, May 23, 2017 While vaccines can ward off or dampen flu infection, the virus mutates so quickly that the shots need to be updated each year. Scientists at St. Jude Children’s Research Hospital have pinpointed a cancer drug that stops flu virus from replicating by targeting its effects on cell metabolism rather than the virus itself. Tuesday, May 23, 2017 PPD has just expanded its vaccine sciences lab in Richmond, Virginia, by another 17,000 square feet and added vaccine efficacy testing capacity using cell-based assays and immunochemistry. Wednesday, May 24, 2017 Neurocrine’s Ingrezza, fresh off its first FDA approval and aiming for another, just hit a major roadblock. A trial failure means its hoped-for expansion into Tourette could be delayed for two years. | | | Merck and Sun Pharmaceutical have seen the FDA accept their biologics license app for IL-23p19 inhibitor tildrakizumab in moderate-to-severe plaque psoriasis. Release ProMIS Neurosciences says it has designated PMN350, a mAb targeting toxic prion-like forms of amyloid-beta oligomers, as its second lead product for Alzheimer's disease. Statement Akebia Therapeutics has dosed the first patient in its phase 2 test of vadadustat in dialysis-dependent chronic kidney disease patients who are hyporesponsive to erythropoiesis-stimulating agents. Release | |
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