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Home » Newsletters » BioWorld

BioWorld

May 24, 2018

View Archived Issues

Appointments and advancements

Logicbio Therapeutics Inc., of Cambridge, Mass., appointed Dean Falb chief scientific officer. Read More

Financings

Orbit Discovery Ltd., of Oxford, U.K., said it closed a £6.9 million (US$9.2 million) series A financing with the round being led by Oxford Sciences Innovation, joined by new investors RT Ventures, Borealis Ventures and Perivoli Innovations, along with further investment from all existing investors and Oxford University.  Read More

Other news to note

Windtree Therapeutics Inc., of Warrington, Pa., received $700,000 grant under a previously awarded 2016 phase II Small Business Innovation Research grant valued at up to $2.6 million from the National Heart, Lung, and Blood Institute to support the Aerosurf phase IIb trial in premature infants 26 to 32 weeks gestational age receiving nasal continuous positive airway pressure for respiratory distress syndrome. Read More

Clinical data for May 23, 2018

Read More

BIA: 'We need action' as customs quarrel holds up Brexit talks

LONDON – With little more than 330 days to go until Brexit, the U.K. government is split down the middle on future customs arrangements, and life sciences – along with every other sector – is still waiting to hear what future trading regime they should prepare for. Read More

Brain stimulation affects glucose tolerance, study finds

Deep brain stimulation (DBS) improved insulin sensitivity in multiple tissues in both diabetic and nondiabetic patients who were receiving DBS to treat obsessive-compulsive disorder (OCD), researchers reported in the May 23, 2018, issue of Science Translational Medicine. Read More

Lava lands $19M for an alternative 'Bite' at cancer

DUBLIN – Lava Therapeutics BV raised €16 million (US$18.8 million) in a series A round to take forward its bispecific gamma-delta T-cell engager technology for training a gamma-delta T-cell response on solid and liquid tumors. Read More

FDA's Gottlieb previews agency plans to tackle gene therapy challenges

Speaking to Alliance for Regenerative Medicine (ARM) board members at what he called a "key point" in the ascendancy of cell and gene therapies, FDA Commissioner Scott Gottlieb said his agency is working to address a number of challenges facing the nascent field. New guidance documents that will articulate a framework for the manufacturing and clinical development of gene therapies are already underway, he said, including the outline of potential accelerated approval endpoints for certain therapies. Read More

Apogenix resurrects asunercept filing plans on five-year survival data

DUBLIN – Apogenix AG plans to file late next year for conditional approval in Europe for its CD95 antagonist, asunercept (formerly APG-101), following a review of a phase II trial in recurrent glioblastoma, which uncovered a five-year overall survival rate of 7 percent for patients who received the drug in combination with radiotherapy. While that may not seem an overly dramatic efficacy signal, it is, by some distance, superior to the 0 percent rate for patients in the control group, who received radiotherapy only. Read More

Preparing for the unknowns, HELP breathes new life into PAHPA

Reflecting on lessons learned from the Ebola threat in Congo, last year's devastating hurricanes and the 2009 H1N1 flu pandemic, the Senate Health, Education, Labor and Pensions (HELP) Committee Wednesday overwhelmingly approved the reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA), which is set to expire in September. Read More

Cara lines up Korsuva for global launch in potential $540M Vifor/Fresenius JV deal

Shares of Cara Therapeutics Inc. (NASDAQ:CARA) rocketed 42.8 percent Wednesday on word of the Stamford, Conn.-based company's global licensing deal with Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), a chronic kidney disease (CKD)-focused joint venture (JV) formed by Vifor Pharma Group and Fresenius Medical Care. The arrangement covers the injectable formulation of difelikefalin (CR-845), conditionally branded Korsuva, to treat CKD-associated pruritus (CKD-aP), which has advanced into a pivotal phase III program. Read More

Regulatory actions for May 23, 2018

Read More

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