BioSpace News Archive

FDA

Roche receives FDA clearance for cobas® CT/NG for cobas® 6800/8800 Systems

First moderate complexity molecular test for sexually transmitted infections on fully automated, high throughput platform

April 16, 2018

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5 min read

Deals

Boston Scientific Announces Acquisition Of nVision Medical Corporation

Acquisition launches women’s health focus on cancer and may lead to new diagnostic options for ovarian cancer

April 16, 2018

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8 min read

FDA

Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

FDA’s target action date for the ALKS 5461 NDA is Jan. 31, 2019.

April 16, 2018

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6 min read

Job Trends

Clovis Oncology Announces Proposed Offerings of Convertible Senior Notes and Common Stock

Clovis intends to offer, subject to market and other conditions, $200 million aggregate principal amount of its convertible senior notes due 2025 in an underwritten registered public offering.

April 16, 2018

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5 min read

FDA

Exemplar Genetics Rare Neurological Disease Model Cleared by FDA for Commercial Research Use

FDA has exercised enforcement discretion in regard to the ExeGen®ATM MiniSwine model clearing it for commercial use as a research model.

April 16, 2018

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4 min read

Drug Development

Preclinical Data Presented at AACR 2018 Shows Esperance Pharmaceuticals’ EP-100 Is Synergistic with PARP Inhibitor Olaparib in Ovarian Cancer

Studies Conducted by MD Anderson Cancer Center Elucidate the Mechanisms by Which EP-100 Kills Ovarian Cancer Cells on Its Own and Synergistically in Combination with a Leading PARP Inhibitor

April 16, 2018

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5 min read

Biotech Bay

AcelRx Announces Completion of the Human Factors Study for DSUVIA and Confirms Plans to Resubmit NDA in Q2 2018

This study was recommended by the FDA following the Company’s application of FDA recommended changes to the DSUVIA DFU to ensure the safe and proper administration of DSUVIA to patients by healthcare professionals in medically supervised settings.

April 16, 2018

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3 min read

Biotech Beach

Ivantis Announces Results of Landmark Prospective, Randomized Comparative MIGS Clinical Trial

International Multi-center Study Compares Effectiveness of the Hydrus® Microstent to Two iStent® Trabecular Micro-Bypass Stents in Standalone Glaucoma

April 16, 2018

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5 min read

Policy

MediMergent and FDA Launch New Stakeholder Initiative against Medication Non-Adherence/Persistence Crisis

There are approximately 117 million Americans who have chronic diseases requiring lifelong medications; the non-adherence rate to their medicine by six months post initiation of therapy is approximately 50%.

April 16, 2018

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4 min read

FDA

Eagle Pharmaceuticals’ Vasopressin ANDA Accepted for Filing by the FDA

Product is the generic version of Endo International plc’s original Vasostrict® formulation

April 16, 2018

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3 min read