Actor Chuck Norris Sues Medical Device Manufacturers for Allegedly Poisoning His Wife
The actor claims the gadolinium contrast dye used during MRIs nearly cost Gena her life. Source: BioSpace
Sarepta Therapeutics and Nationwide Children’s Hospital Announce FDA Clearance of the IND Applica…
Nationwide Children’s Hospital is on track to initiate a Phase 1/2a clinical trial in individuals with Duchenne muscular dystrophy by year-end 2017. Source: BioSpace
Amgen, Novartis Rev Up for New Alzheimer's Study
Novartis announced they have expanded their collaboration with the Banner Alzheimer’s Institute to launch a new clinical trial in ALZ's. Source: BioSpace
FDA Slaps Four Companies for Marketing Cannabidiol Products as Disease Treatments
The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Source: Drug Industry Daily
House Tax Reform Bill Axes Orphan Drug Research Tax Credit
House Republicans’ $1.51 trillion tax reform bill released Thursday would repeal the orphan drug tax credit, which currently allows drug manufacturers to claim a credit equal to 50 percent of…
CMS Cuts 2018 340B Reimbursements to ASP Minus 22.5 Percent
The Centers for Medicare and Medicaid Services reduced the amount Medicare Part B will pay hospitals for purchasing drugs through the 340B discount program — cutting reimbursements down to the…
FDA’s Morrison Says ORA Reorganization Will Mean More Foreign Inspections
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, a high-ranking agency official told an FDAnews regulatory conference. Source: Drug Industry…
FDA Updates Generics Correspondence Guidance for GDUFA II
The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Source:…
Cambridge's Proteostasis Slashes R&D Jobs in Focus Shift
As part of strategic restructuring, Proteostatis is laying off 46 percent of its R&D workforce, or 13 positions. Source: BioSpace
One-Time CAR-T Leader Juno Shows Off Promising New Clinical Data
The company submitted 15 abstracts to be presented at the upcoming ASH Conference. Source: BioSpace
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