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12/8/2017

As 2017 draws to a close, WIB invites you to join us in celebrating a year of growth and success. Chapters around the country will be hosting holiday parties during the month of December, and you are invited to join the festivities. Holiday parties offer a relaxed and friendly environment for networking. Hear the accomplishments of this past year and learn about what is in store for the year to come. Register for a Women In Bio holiday party today!

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r.smartbrief.com
12/8/2017

Eli Tomar (Akin Gump Strauss Hauer & Feld LLP) examines how off-label promotion's evolving regulatory landscape applies to the promotion of other prescription drugs as compounded drugs though they have not been deemed safe and effective by the Food and Drug Administration (FDA) as such. Read online.

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fdli.org
12/8/2017

Functioning as a reference and as a teaching tool, this text highlights the laws and regulations governing the development, marketing, and sale of food, medical products, tobacco, and cosmetics. Purchase today.

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fdli.org
12/8/2017

A clinical trial application was filed by CRISPR Therapeutics for its CRISPR gene-edited CTX001, to be developed for the treatment of patients with B-thalassemia. The company plans to initiate a Phase I/II study of the drug in Europe and submit an investigational new drug application to the FDA for sickle cell disease indication, both in 2018.

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Reuters
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CRISPR Therapeutics, FDA
12/8/2017

Acorda Therapeutics' new-drug application for Inbrija, which is being developed as a treatment for off periods in patients with Parkinson's disease who are receiving a carbidopa/levodopa regimen, was refiled with the FDA. The updated filing addressed two issues cited in a Refusal to File the company received from the FDA, which concerned an inquiry related to the submission of the drug master production record and the date that the production facility would be prepared for inspection.

12/8/2017

Concentric Analgesics' drug candidate CA-008, which is intended to treat postsurgical pain, was granted fast-track designation by the FDA. The company anticipates results from a Phase Ib safety, pharmacokinetics and tolerability study in the first quarter of 2018.

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eMPR
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FDA
12/8/2017

The National Institute for Health and Care Excellence recommended for use through the Cancer Drugs Fund Roche Holding's Tecentriq for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who cannot receive cisplatin-based chemotherapy. The institute said Tecentriq is likely to extend patients' lives by more than three months.

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PharmaTimes (U.K.)
12/8/2017

A nationwide recall was issued for 13,236 pounds of Creative Contract Packaging's HERB-OX brand beef bouillon because it could contain milk, an allergen, not declared on the label. The recalled products are in four-ounce jars with "best if used by" dates of September to October 2020.

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Creative Contract Packaging
12/8/2017

The FDA cleared the extension of the life of VitalConnect's VitalPatch disposable peel-and-stick health sensor to five days from four. The Bluetooth-enabled device allows for real-time monitoring of eight vitals, including heart rate, ECG, skin temperature and respiratory rate, in outpatient and inpatient hospital use.

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MobiHealthNews
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FDA, VitalConnect
12/8/2017

The FDA gave Camber Spine clearance to market its SPIRA-C Open Matrix Cervical Interbody device, which is designed to facilitate fusion at up to two contiguous levels from C3 to C7 in degenerative disc disease patients. It is the second FDA-cleared device in the company's SPIRA family of devices, which are made of titanium for improving fusion.

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Becker's Spine Review
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Camber Spine, SPIRA