BioSpace News Archive

FDA Grants Orphan Drug Designation for Xeris Pharma’s Ready-to-Use Glucagon

Xeris also announced the publication of a Phase IIa study of a mini-dose of its read-to-use glucagon in Post-Bariatric Hypoglycemia.

February 9, 2018

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5 min read

Policy

Novo Nordisk A/S: Ozempic (Semaglutide) Approved in the EU for the Treatment of Type 2 Diabetes

The marketing authorisation applies to all 28 European Union member states.

February 9, 2018

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2 min read

Biotech Beach

Crown Biosciences: Enhanced MuScreen Platform Revolutionizes Preclinical Development of Immunotherapeutics

Immunotherapies, alone or in combination with other drugs, treat cancer by modulating the immune system to elicit native antitumor immune responses.

February 9, 2018

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2 min read

Drug Development

Aquinox Provides Enrollment Update for LEADERSHIP 301 Clinical Trial of Rosiptor

The announcement was made as part of the company’s analyst and investor event held today in New York.

February 9, 2018

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6 min read

Policy

Effectiveness in Preventing Non-Compliant or Fraudulent Products From Being Placed on the Market Is Questionable, Despite Notified Body Assessment, Says EU Medical Device Expert

CEO of the London-based medical device regulatory consultancy Quality First International - has written a critical examination of Commission Implementing Regulation No 920/2013 on audits and assessments by Notified Bodies.

February 9, 2018

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1 min read

Business

Novo Nordisk Files Annual Report With the SEC

Novo Nordisk has filed its Annual Report 2017 on Form 20-F for the financial year 2017 with the SEC, incorporating by reference parts of the Novo Nordisk Annual Report 2017.

February 9, 2018

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1 min read

Policy

Pacific Biosciences Announces Outcome of First Phase of Patent Litigation Against Oxford Nanopore

The decision by the ITC is based on its interpretation that the term “single-molecule sequencing” is limited to sequencing-by-synthesis approaches, and that Oxford Nanopore’s sequencing approach is therefore not “single-molecule sequencing.”

February 9, 2018

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3 min read

Drug Development

Catalyst Biosciences Announces Positive Top-Line Data from Phase I/II Study of Subcutaneous CB 2679d/ISU304 in Individuals With Hemophilia B

Results from the trial showed a continuous linear increase in Factor IX activity levels following daily dosing of CB 2679d for six days.

February 9, 2018

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6 min read

Deals

CAS Group Supports Improved Vaxart Merger and Enters Into Agreement With Aviragen

The Company previously announced that the special meeting of Aviragen stockholders, originally scheduled for February 6, 2018.

February 9, 2018

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4 min read

Genetown

Oncobindi Therapeutics: Precision Oncology Assets: Fast-Track Development from lead Candidate to Clinic

We are entering an era of rapidly evolving transformation in cancer treatment as it relates to drug development, and a shifting paradigm of standardized health care in which detailed genetic and molecular information regarding a patient’s cancer is being used for personalized precision treatments.

February 9, 2018

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1 min read