BioSpace News Archive

FDA

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

The U.S. Food and Drug Administration today permitted marketing of the DexCom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes.

March 27, 2018
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4 min read
FDA

FDA Advisory Committee Votes in Favor of LUCEMYRA™ (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms

US WorldMeds announced that the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine for mitigating opioid withdrawal symptoms.

March 27, 2018
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3 min read
Pharm Country

PTC Therapeutics Announces Proposed Public Offering of Common Stock

PTC Therapeutics, Inc. announced that it is commencing a public offering of 4,000,000 shares of its common stock.

March 27, 2018
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2 min read
Business

BioAmber Inc. Announces Record Revenues for the Fourth Quarter and Year End 2017

BioAmber Inc. announced operational and financial results for the three months and year ended December 31, 2017.

March 27, 2018
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7 min read
Deals

Impax Shareholders Approve Proposed Business Combination with Amneal

Impax Laboratories, Inc. announced that at its special meeting of stockholders held today, Impax stockholders overwhelmingly approved the previously announced business combination of Impax with Amneal Pharmaceuticals LLC.

March 27, 2018
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2 min read
Deals

Homology Medicines Announces Pricing of Initial Public Offering

Homology Medicines, Inc. announced the pricing of its initial public offering of 9,000,000 shares of common stock at a public offering price of $16.00 per share, before underwriting discounts and commissions.

March 27, 2018
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1 min read
Business

Owens & Minor Names Shana Neal as SVP & Chief Human Resources Officer

Owens & Minor, Inc. is pleased to announce that it has appointed veteran human resources leader Shana Neal as Senior Vice President & Chief Human Resources Officer, effective March 26, 2018.

March 27, 2018
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2 min read
FDA

FDA Authorizes Marketing of the New Dexcom G6® CGM Eliminating Need for Fingerstick Blood Testing for People with Diabetes

DexCom, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up.

March 27, 2018
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5 min read
Pharm Country

PMD Healthcare Releases Top-Line Findings of 2018 Cystic Fibrosis and Pulmonary Fibrosis Patient Online Research Surveys

PMD Healthcare has released top-line findings from their 2018 Cystic Fibrosis and Pulmonary Fibrosis online surveys.

March 27, 2018
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2 min read
Business

The Medicines Company Announces Chief Financial Officer Transition

The Medicines Company announced the appointment of Christopher Visioli as Chief Financial Officer and Treasurer of the Company, effective immediately.

March 27, 2018
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2 min read