Today's Rundown Biogen resurrects aducanumab, arguing expanded data set supports FDA filing in Alzheimer's Novartis' asthma drug fails in phase 3, raising doubts about Gossamer's prospects Bayer backs off running Casebia JV as CRISPR Tx takes over management [Sponsored] Advancing Site-Sponsor Relationships Takeda picks up Cour's celiac treatment, promising $420M in biobucks Intrepida Bio uncloaks with $9.5M and anti-BAG3 cancer programs from Italy Vertex lands blockbuster triple combo nod for CF drug Trikafta—5 months early Featured Story | | | Tuesday, October 22, 2019 Biogen is planning to file for FDA approval of its failed Alzheimer’s disease drug aducanumab. The drug flunked a futility analysis in March, but Biogen resurrected it after factoring in data generated after the cutoff for the interim assessment. |
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Top Stories Tuesday, October 22, 2019 Novartis’ asthma prospect fevipiprant has failed to improve lung function in two phase 3 trials. The negative top-line data deal a big blow to the prospects of a drug analysts tipped to achieve blockbuster sales if it cleared phase 3. Monday, October 21, 2019 Three years after Bayer and gene-editing biotech CRISPR Therapeutics joined forces to launch and run Casebia Therapeutics, the German Pharma is now handing over the full reins of running the biotech to CRISPR. Monday, October 21, 2019 Clinical trials involve massive complexity and, often, systems that lack consistency and discipline. With a new perspective to an old problem, WCG coordinates the execution of six proven strategies to dramatically and consistently bring clinical studies to launch faster and at a lower cost. Tuesday, October 22, 2019 Cour Pharma unveiled data from a phase 2a study showing that its treatment cut levels of inflammation-promoting cytokines and protected the gut against damage in patients with celiac disease. Based on the results, Takeda pulled the trigger on a global license for the program. Tuesday, October 22, 2019 Intrepida Bio launched with $9.5 million from Sofinnova and Canaan Partners to develop anti-BAG3 programs for the treatment of cancer. The funding will support IND-enabling studies for antibodies that target a pathway that is hijacked by tumors to create an environment that promotes their growth and thwarts attacks from the immune system. Monday, October 21, 2019 The triple combo era in cystic fibrosis (CF) is here thanks to Vertex Pharmceuticals' new OK. Five months ahead of schedule, the FDA green-lighted Trikafta for the treatment of CF patients over the age of 12 with either one or two copies of the delF508 CFTR gene mutation. | | Better than the other transgenics.
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