BioSpace News Archive

Mallinckrodt Presents Health Economic Data on OFIRMEV (acetaminophen) Injection at ASRA 16th Annual Pain Medicine Meeting

Mallinckrodt announced results from two retrospective, claims-based analyses providing health economic insights on the use of OFIRMEV (acetaminophen) injection - IV acetaminophen - versus oral acetaminophen for managing postoperative pain in patients undergoing bariatric surgery or appendectomy.

November 16, 2017

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9 min read

Biotech Beach

Mirati Therapeutics Announces Pricing of Public Offering of Common Stock

Mirati Therapeutics today announced the pricing of an underwritten public offering of 2,015,901 shares of its common stock at a price to the public of $13.00 per share.

November 16, 2017

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5 min read

Policy

Carestream Shows New Optional Advanced Metal Artifact Reduction Software for OnSight 3D Extremity System

The company’s new metal artifact reduction software is pending FDA 510(k) Clearance.

November 16, 2017

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3 min read

Stryker Nabs FDA OK for Cementless Mako Total Knee

Drug Development

FDA Slaps Breakthrough Tag on Celgene, bluebird’s Multiple Myeloma CAR-T Drug

BTD designation and PRIME eligibility for bb2121 were based on preliminary clinical data from the ongoing phase 1 study CRB-401.

November 16, 2017

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6 min read

Business

Former Williams-Sonoma CMO and Chief Strategy and Business Development Officer Appointed to SleepScore Labs Board of Directors

Connolly joins SleepScore Labs after nearly four decades of leadership in a global, public company and brings significant e-commerce and marketing acumen to SleepScore Labs’ team of science and sleep experts.

November 16, 2017

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3 min read

Policy

FDA Announces Comprehensive Regenerative Medicine Policy Framework

The framework - outlined in a suite of four guidance documents - builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

November 16, 2017

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7 min read

British Columbia Securities Commission Revokes Cease Trade Order on PharmaCyte Biotech Securities

The company is providing a summary overview, corporate history and status report to address a regulatory compliance request from the British Columbia Securities Commission.

November 16, 2017

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9 min read

BioCapital

Lupus Foundation of America Release: Major Lupus Stem Cell Study Receives Funding

The Lupus Foundation of America announced today it will provide $3.8M in funding over the next five years to support the first-of-its-kind clinical trial in the United States to evaluate adult mesenchymal stem cellsas a treatment for lupus.

November 16, 2017

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2 min read

Policy

MMS Selected by Paratek to Support its NDA Submissions for Omadacycline

MMS announced today that it was selected by Paratek Pharma to support the development of its U.S. NDAs for omadacycline.

November 16, 2017

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3 min read

Business

DNAmito to Integrate Genomics-Based Personalized Analysis With Varian’s Oncology Care Management Software Platform to Optimize Physician’s Decisions Regarding Radiation Treatment for Cancer

DNAmito and Varian Medical Systems announced today a development and OEM agreement to integrate Prodecis into Varian’s 360 Oncology care management software platform.

November 16, 2017

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2 min read