BioSpace News Archive

Philips Wins FDA Nod for Small Parts Ultrasound Tr

FDA

Shire Gets FDA Clearance for myPKFiT for Advate to Help Personalize Care for Hemophilia A

The myPKFiT for ADVATE software represents an innovative approach to estimating a patient’s PK curve, a key measure for assessing drug exposure over time.

December 19, 2017

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6 min read

Stryker Nabs FDA OK for Cementless Mako Total Knee

FDA

Prescient Surgical Scores FDA 510(k) Clearance for Its Novel CleanCision Wound Retraction and Protection System

Developed by surgeons and infection control experts, CleanCision is the first in a new class of advanced technology designed to fight and defend against the most pervasive sources of surgical infection.

December 19, 2017

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5 min read

BioMidwest

Clinical Study Shows Cost Savings and Fewer Interventions With Esophageal Cooling Therapy Using Attune Medical’s EnsoETM

The study, published in the journal Therapeutic Hypothermia and Temperature Management, compared the EnsoETM to both surface and endovascular temperature modulating devices in a total sample of 32 patients

December 19, 2017

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3 min read

Genetown

Fractal Antenna Systems, Inc. Release: Uncloaked: New Patent Illuminates Applications of Invisibility

Fractal Antenna Systems, Inc. announced its new patent 9,847,583 covering electromagnetic cloaking/deflection of satellites, rockets, towers, antennas, vehicles, body coverings, people, ships, spacecraft, and many others, each uniquely recognized as novel inventions.

December 19, 2017

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3 min read

Pharm Country

Pfizer Invites Public to View and Listen to Webcast of January 30 Conference Call With Analysts

Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EST on Tuesday, January 30, 2018.

December 19, 2017

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1 min read

Business

Virginia Bio Welcomes New Members to Its Board of Directors Effective on January 1, 2018

The election took place on December 14, 2017 at the Virginia Bio Annual Membership meeting in Richmond, Virginia.

December 19, 2017

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6 min read

Drug Development

Flexion Therapeutics Enrolls First Patient in Study Evaluating the Pharmacokinetics and Safety of ZILRETTA in Osteoarthritis of the Shoulder and Hip

Known as the “"HIP” study, the randomized, open-label, Phase 2 trial is expected to recruit approximately 48 patients in total, including 24 patients with OA of the shoulder and 24 patients with OA of the hip.

December 19, 2017

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6 min read

Drug Development

OSE Immunotherapeutics Presents New Data Analysis Supporting Continued Development of OSE-127 in Inflammatory Bowel Diseases

The presentation reported results from a transcriptomic analysis of colon biopsies in more than 500 patients and 100 controls in a large database available for specialized bioinformaticians.

December 19, 2017

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7 min read

FDA

Amphastar Announces Approval for Sodium Nitroprusside Injection, USP

Amphastar announced that today the FDAgranted approval of its ANDA for Sodium Nitroprusside Injection 25mg/mL, 2mL single dose vial, indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis.

December 19, 2017

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3 min read

Drug Development

REGENXBIO Announces IND Active for Phase I/II Trial of RGX-121 to Treat Mucopolysaccharidosis Type II

RGX-121 has received orphan drug designation as well as rare pediatric disease designation from the FDA.

December 19, 2017

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7 min read