Life Sciences
Top stories summarized by our editors
1/19/2018

Celgene's Otezla, or apremilast, which is being developed as a treatment for pediatric patients with ulcerative colitis, was granted orphan status by the FDA. The drug was previously approved for psoriatic arthritis and plaque psoriasis and is in a midstage study for the treatment of adult patients with UC.

1/19/2018

The FDA has given Orphazyme's Arimoclomol a rare pediatric disease designation for the treatment of Niemann-Pick disease type C.

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Niemann-Pick disease, FDA, Orphazyme
1/19/2018

The National Organic Standards Board has proposed changes to the National List of Allowed and Prohibited Substances, including 29 proposals with 35 National List amendments, and the federal government will accept public comment on those changes until March 19. Proposed changes would add 16 substances to the National List and modify restrictions on 17 substances allowed in organic production or handling.

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Food Safety News
1/19/2018

The Internal Revenue Service and the Treasury Department decided that for the first three quarters of the year, medtech companies will not have to pay penalties for late payments on the medical device tax, the first deposit of which is due Jan. 29. The decision was made on account of "the short time frame between the end of the moratorium period and the due date of the first deposit and in the interest of sound tax administration," the IRS said.

1/19/2018

Smith & Nephew touted data showing positive results for its Episode of Care Assurance Program, or eCAP, a combination of the company's PICO Negative Pressure Wound Therapy and ACTICOAT Flex 7 Antimicrobial Barrier Dressing and its hip and knee implants. The program, now used by 16 US facilities of group purchasing organization Provider PPI, demonstrated a 97% reduction in readmission rates for total joint arthroplasties.

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Becker's Spine Review
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Smith & Nephew
1/19/2018

Enrollment of patients has been initiated by Bluegrass Vascular Technologies for a US trial of its Surfacer Inside-Out Access Catheter System, which is designed for regaining access to blocked veins in patients undergoing dialysis treatment for kidney failure. The 10-site study is expected to evaluate 30 patients in the next year.

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Xconomy
1/19/2018

The Department of Agriculture's speeding up of the regulatory process for biotech crops eliminates the barrier to entry of such crops in agricultural biotech companies and markets. According to USDA regulations, when scientists use CRISPR to alter a plant's DNA but do not add foreign DNA, those plants do not fall within the regulatory purview.

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Gizmodo
1/19/2018

Novo Nordisk is partnering with diabetes advocate and "black-ish" actor Anthony Anderson on the drugmaker's "Get Real About Diabetes" disease awareness campaign. An episode of Andeson's TV show centers on a type 2 diabetes diagnosis as an extension of the campaign.

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FiercePharma
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Novo Nordisk, Anthony Anderson
1/19/2018

Male nurses can provide valuable perspective and insights and should be welcomed into the profession just as anyone else is, but hiring more of them is not the key to easing the shortage of nurses, writes Patricia Davidson of the Johns Hopkins School of Nursing. False perceptions about the career, from the idea that it is women's work to the belief that it is a place for those who couldn't handle medical school, need to change, Davidson writes.

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HuffPost
1/18/2018

Stray dogs and cats shed Toxocara roundworm eggs when they defecate in yards, playgrounds and sandboxes, and children playing in those areas can inadvertently swallow the eggs, which hatch and release larvae into the body and possibly the brain. The CDC estimates that some 16 million people have been exposed to Toxocara, but studies show that pets that receive regular care from a veterinarian rarely carry the parasite.

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Toxocara, CDC