BioSpace News Archive

Biotech Bay

Ava Unveils New Feature That Detects Bi-Phasic Shift in User’s Monthly Cycle to Help Confirm Ovulation

Starting today, Ava will automatically assess user data to detect a biphasic shift in physiological parameters during a woman’s cycle.

January 30, 2018
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3 min read
Pharm Country

Science Center’s QED Program Awards $600,000 to Advance the Commercialization of Three University Technologies Awards Given to New Jersey Institute of Technology, Temple University and The Wistar Institute

The awardees were selected from a pool of 54 applicants from 12 academic and research institutions in Pennsylvania, New Jersey and Delaware.

January 30, 2018
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6 min read
FDA

Upsher-Smith Receives FDA Approval for Bumetanide Tablets, USP

Upsher-Smith today announced that it has received FDA approval of its ANDA for Bumetanide Tablets, USP, 0.5 mg, 1 mg, and 2 mg.

January 30, 2018
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3 min read
Business

Masimo to Report Fourth Quarter and Full Year 2017 Financial Results after Market Close on Tuesday, February 27

The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Micah Young, Executive Vice President and Chief Financial Officer.

January 30, 2018
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2 min read
Admedus Launches Adapt Technology in India

From 30 January 2018, physicians in India will have access to the transformative power and significant patient benefits of ADAPT engineered tissue and Admedus’ flagship product CardioCel.

January 30, 2018
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2 min read
Business

BioInvent Financial Statement 1 January - 31 December 2017

BioInvent to co-develop dual mechanism anti-cancer drug with Transgene.

January 30, 2018
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4 min read
Business

Tyme Announces Prostate Cancer Collaboration With Dr. Mack Roach III of UCSF

As part of the deal, Tyme will provide support to Dr. Roach to conduct a randomized, investigator-sponsored trial comparing active surveillance to SM-88 maintenance therapy in patients prior to definitive therapy.

January 30, 2018
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6 min read
Policy

EMA Grants Rexgenero’s Lead Product REX-001 Advanced Therapy Medicinal Product Certificate for Manufacturing Quality and Non-Clinical Data

The EMA certification paves the way for the MAA of its lead product REX-001, a novel cell therapy currently in a Phase III programme for the treatment of CLI.

January 30, 2018
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1 min read
Genetown

PCI Synthesis Submits Patent for Synthesizing Azelaic Acid

Azelaic Acid is used for producing industrial products including polyesters, plasticizers and lubricants and is a component in skin-care products.

January 30, 2018
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1 min read
Drug Development

Fibrocell Announces FDA Allowance to Initiate Pediatric Enrollment in Phase I/II Clinical Trial of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

In its submission, Fibrocell reported the interim readout of safety data from three adult patients

January 30, 2018
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6 min read