This week's sponsor is Premier Research. | | Rare Cancer Drug Research: What to Know Going In Rare cancer drug research requires oncology and rare disease expertise and careful attention to trial design and regulatory demands. Get started with our white paper. Premier Research. It's what we do. Best. | Today's Rundown Despite FDA hold, Epizyme’s tazemetostat posts positive interim data Teva bows out of chronic cluster headache as CGRP drug fizzles in phase 3 GlaxoSmithKline's head of dermatology joins JAK developer Aclaris X4 targets year-end start for phase 3 WHIM trial after determining dose in midphase readout Bluebird preps E.U. filing for revamped thalassemia gene therapy Calliditas files for $75M IPO to fund kidney disease phase 3 Selecta unveils more data on its gout treatment, commits to phase 3 study launch this year EuroBiotech Report—£2.5B U.K. fund, Alzheimer's failure, Alexion-Complement, Targovax tumbles and Ipsen moves FiercePharmaAsia—Sun’s key Halol plant, Eisai’s new Alzheimer’s center, Takeda-Shire opponents Chutes & Ladders—Alder poaches Juno executive for CEO Featured Story | Friday, June 15, 2018 Despite an FDA hold on its lead program, tazemetostat, Epizyme is trucking along, reporting interim data for a phase 2 trial in follicular lymphoma, working to resolve the hold and looking to file an NDA for a solid tumor indication later this year. |
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| This week's sponsor is Catalent. | | | Top Stories Friday, June 15, 2018 Teva is ending a phase 3 trial testing its calcitonin gene-related peptide (CGRP) blocker in chronic cluster headache after a futility analysis showed it was unlikely to meet its primary endpoint. Friday, June 15, 2018 GlaxoSmithKline’s former head of dermatology R&D, David Gordon, has joined Aclaris Therapeutics as its new chief medical officer. Friday, June 15, 2018 X4 Pharmaceuticals has established the X4P-001-RD dose to take forward into the pivotal stage of its phase 2/3 WHIM syndrome trial. Setting the dose of the CXCR4 inhibitor tees X4 up to start the phase 3 portion of the rare primary immunodeficiency disease trial before the end of the year. Friday, June 15, 2018 With new data from a phase 1/2 trial of its LentiGlobin gene therapy in thalassemia in the bag, Bluebird Bio is pushing ahead with a European filing—and it could be that a follow-up in sickle cell disease is not too far behind. Friday, June 15, 2018 Calliditas has filed to raise SEK 650 million ($75 million) through an IPO in Sweden. The financing will set Calliditas up to start enrolling autoimmune kidney disease patients in a pivotal trial later this year. Friday, June 15, 2018 Selecta Biosciences presented more new data from an ongoing phase 2 trial of its enzyme treatment for gout, which the company said outperformed standard treatment and has convinced it to soldier on to a phase 3 clinical program before the end of the year. Thursday, June 14, 2018 In this week's EuroBiotech Report, U.K. creates £2.5 billion fund, AstraZeneca, Lilly hit by Alzheimer's flop, Complement lands Alexion deal and more. Friday, June 15, 2018 Sun Pharma finally frees its key plant for the U.S. market from FDA restrictions; Eisai will open up a new genetics-driven drug discovery site focused on Alzheimer's disease; opponents to Takeda's $62 billion deal for Shire look to rally enough support to call off the transaction; and more. Friday, June 15, 2018 Alder poaches Juno executive for CEO to prep for its migraine launch, Allergan brings in Abbott vet after investors demand change, and ResTORbio hires Novartis researcher for clinical VP—these moves, plus more hirings, firings and retirings throughout the industry. This week's sponsor is cobra:bio. | | Accelerating Protein Production Since 1995 Cobra’s maxXpress service uses UCOE technology enables rapid production of monoclonal antibodies (mAbs), recombinant proteins and biosimilars while ensuring efficient, stable expression. More... | Enrollment Showcase | Sponsored by: Bioinformatics at UTHealth SBMI UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics. |
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