BioSpace News Archive

FDA

Inova Diagnostics Wins FDA OK for the First Fully Automated, Random Access Calprotectin Test

QUANTA Flash Calprotectin aids in the diagnosis of inflammatory bowel disease and helps differentiate IBD from irritable bowel syndrome.

January 3, 2018
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3 min read
Valeant Pays Down $300M of Senior Secured Term Loans

In aggregate, Valeant has now reduced its debt by more than $6.5B since the end of the first quarter of 2016.

January 3, 2018
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2 min read
Business

Tandem Diabetes Care Commences Full Manufacturing Operations at New San Diego Facility

In support of the Company’s growing operations, the 50,000-square-foot Barnes Canyon facility doubles its previous manufacturing capacity for both insulin pumps and cartridges and expands warehousing for additional infusion set supplies related to the launch of the Company’s new t:lock™ connector.

January 3, 2018
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5 min read
CanniMed Releases New Letter to Shareholders

Cannimed releases a new letter to shareholders highlighting the benefits of acquiring all of the issued and outstanding shares of Newstrike Resources Ltd. and warning of the risks posed by Aurora Cannabis Inc.’s hostile bid to acquire all of the common shares of the Company.

January 3, 2018
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22 min read
Business

PPD Names Colin Hill, CEO of GNS Healthcare, to its Board of Directors

Hill is the chairman, chief executive officer and co-founder of GNS Healthcare, a leading precision medicine company.

January 3, 2018
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3 min read
Policy

Population Council’s One-Year Contraceptive Ring Advances to FDA Review

If approved, the contraceptive vaginal ring would be the first contraceptive option that provides a full year of protection against unintended pregnancy while fully under a woman’s control.

January 3, 2018
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3 min read
BioMidwest

NxThera Announces Three-Year Outcomes Data Demonstrating Durability of its Minimally Invasive Rezum System for Enlarged Prostate Treatment

The outcomes were recently published in the January 2018 issue of Urology.

January 3, 2018
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5 min read
Business

Clinigen Extends Agreement With Eisai to Supply Halaven, Fycompa and Lenvima Into 10 African Countries

Clinigen Group has extended its exclusive agreement with Eisai Europe Ltd to obtain the marketing authorisation and subsequently launch Halaven, Fycompa and Lenvima into 10 African countries.

January 3, 2018
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2 min read
Policy

Statement From FDA Commissioner Scott Gottlieb, M.D. on New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices

The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan.

January 3, 2018
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6 min read
Drug Development

Rasna Therapeutics, Inc., Announces Follow Up Phase II Clinical Data Confirming Efficacy of Actinomycin D in Patients with NPM1-Mutated Acute Myeloid Leukemia

Rasna Therapeutics today announced follow up Phase II clinical data showing that 4 out of 9 (44%) evaluable AML patients carrying the NPM1 gene mutation treated with actinomycin D (“Act D”), achieved complete remission (CR).

January 3, 2018
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5 min read