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5/18/2018

House lawmakers are scheduled to vote next week on a Senate-passed bill that would allow terminally ill patients to request access to experimental drugs that have yet to receive FDA approval. "I am proud we will send this historic legislation to President Trump and offer hope to individuals and families facing dire circumstances," said House Majority Leader Kevin McCarthy, R-Calif.

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The Hill
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President Trump, Kevin McCarthy, FDA
5/18/2018

Amneal Pharmaceuticals' abbreviated new drug application for the generic version of Welchol, or colesevelam hydrochloride, tablets was approved by the FDA. The drug was developed to lower cholesterol and improve glycemic control in patients with type 2 diabetes.

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MD Magazine online
5/18/2018

The FDA granted orphan drug status to Dicerna Pharmaceuticals' synthetic double-stranded RNA oligonucleotide conjugated to N-acetyl-D-galactosamine aminosugar residues, which is being developed to treat patients with primary hyperoxaluria.

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Seeking Alpha
5/18/2018

The European Commission approved Ipsen's Cabometyx, or cabozantinib, 20 mg, 40 mg and 60 mg as a first-line therapy to treat intermediate- or poor-risk advanced renal cell carcinoma in adults. The drug was previously approved for advanced RCC in adults who had prior vascular endothelial growth factor-targeted treatment.

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StreetInsider
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Ipsen, European Commission
5/18/2018

Approximately 720 pounds of chicken tortilla soup were recalled by Blount Fine Foods because of undeclared wheat, which is an allergen. Products included in the recall have the lot code number 04251819C, a use-by date of July 24 and were distributed to Connecticut, Massachusetts and New Jersey.

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Food Safety News
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Blount Fine Foods
5/18/2018

Stimguard's sacral nerve stimulation system, designed for the treatment of chronic, intractable symptoms of overactive bladder, was granted CE mark approval by European regulators. The system, which does not have an implanted battery source and is 95% smaller than products currently available in the market, comes with wireless, upgradeable programming via the Apple iPad and is expected to be launched this summer.

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StimGuard
5/18/2018

The TrapLiner catheter was launched by Teleflex in Europe for use in vascular procedures. The device, which comes with an integrated balloon for trapping standard 0.014-inch guidewires inside a guide catheter, is intended to be used as an alternative approach to the trapping technique, as well as to reach coronary or peripheral vasculature regions and facilitate interventional device placement and exchange while keeping the position of the guidewire.

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MassDevice (Boston)
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Teleflex
5/18/2018

Novo Nordisk has entered into multiple research partnerships to advance a cure for type 1 diabetes using stem cell therapies. The company is also working on stem cell treatments for Parkinson's and chronic heart failure, and is focused on accelerating research and development for "other serious chronic diseases," says Novo Nordisk's Mads Krogsgaard Thomsen.

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Endpoints News
5/18/2018

A round of Series B funding brought in $20.5 million for EIP Pharma. The Phase IIb REVERSE-SD study, in which 150 patients are being enrolled, will evaluate EIP's drug candidate neflamapimod as a treatment for Alzheimer's disease.

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BioCentury
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Alzheimer's disease
5/18/2018

The FDA's safety review deadline for Impossible Foods' veggie burger ingredient that makes the product taste like meat was extended by 90 days. The reason for the change was not disclosed.

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Impossible Foods, FDA