BioSpace News Archive

SyntheticMR AB 0 Segmentation and Quantification of Brain Tissue, and Industry First Myelin Volume Measurements in SyMRI Now FDA Cleared

SyMRI NEURO is the next level of quantitative MR.

January 29, 2018
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2 min read
Drug Development

BerGenBio: Encouraging I-O Clinical Data With Selective AXL Inhibitor Bemcentinib (BGB324) Supports its Potential as Cornerstone of Cancer Therapy

BerGenBio today announced the presentation of data from its broad phase II clinical development programme with its selective AXL inhibitor bemcentinib in two posters at the ASCO-ITC Clinical Immuno-Oncology Symposium.

January 29, 2018
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10 min read
Nordic Nanovector ASA - Allocation of PSUs

The Board of Directors of Nordic Nanovector has on 29th of January 2018 decided to grant 216 550 Performance Share Units to employees in accordance with the authorisation granted at the Extraordinary General Meeting held on 20 December 2017.

January 29, 2018
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3 min read
Policy

Mylan and Biocon Receive Positive CHMP Opinion for Semglee, Biosimilar Insulin Glargine

The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected in April.

January 29, 2018
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7 min read
Pharm Country

Newly Named Pall Biotech Business Unit Focuses on Flexible, Scalable End-to-End Drug Manufacturing Models for All Development Processes

The Pall Biotech business unit has been named to reflect an important strategic direction for the company.

January 29, 2018
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2 min read
Pharm Country

Egalet Announces ARYMO ER Data Published in Current Medical Research and Opinion Journal

ARYMO ER is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

January 29, 2018
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18 min read
Biotech Beach

Sinclair Pharma Release: Aesthetic Surgery Journal Confirms Efficacy and Consumer Acceptance for Absorbable Suture Suspension

The 100-patient study that appeared in the December 2017 ASJ demonstrated high patient satisfaction with Silhouette InstaLift for lifting of the mid-face while improving a number of age related changes.

January 29, 2018
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4 min read
Drug Development

Prometic’s PBI-4050: Phase III Pivotal Clinical Trial Design for Idiopathic Pulmonary Fibrosis (IPF) Finalized

ProMetic Life Sciences announces today the outcome of a successful clinical development Type C meeting with the FDA for its orally active anti-fibrotic lead drug candidate, PBI-4050.

January 29, 2018
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7 min read
Biotech Bay

ITUS Presents Positive Data From its Early Cancer Detection Technology at ASCO-SITC Symposium

Studies over the past decade have demonstrated that there is a dynamic interaction between a patient’s immune system and the existence of a tumor.

January 29, 2018
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7 min read
Policy

MedyMatch Receives Expedited Access Pathway / Breakthrough Device Designation from the FDA to Accelerate Market Access for Intracranial Hemorrhage Software

This software medical device, based on deep learning technologies, automatically analyzes non-contrast head CT images.

January 29, 2018
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3 min read