BioSpace News Archive

Business

Collaboration Project Agreement Between MAB Discovery GmbH And BioNTech AG

Financial terms of the agreement were not disclosed.

November 6, 2017

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2 min read

Business

Mesa Labs Reports Second Quarter Results

The company reported its results for the second quarter ended September 30, 2017.

November 6, 2017

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11 min read

Business

Adaptimmune Marks Official Opening of U.K. Headquarters

Over 400 people will gather to celebrate the official opening of the flagship facility.

November 6, 2017

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3 min read

Business

Organovo and Viscient Biosciences Collaborate to Develop Custom Research Platform for Studying Liver Disease

The partnership is expected to expand upon Organovo’s current service portfolio for compound screening in disease models.

November 6, 2017

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6 min read

Neovasc Receives FDA Approval to Initiate Pivotal Reducer Trial

The trial’s purpose will be to demonstrate the safety and effectiveness of the Company’s novel Reducer system for treatment of patients with refractory angina.

November 6, 2017

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7 min read

Fujifilm Expands Biopharmaceutical Contract Development and Manufacturing Business, Increasing Monoclonal Antibody Capacity for Process Development and GMP Production at U.S.A. and U.K. Sites

FUJIFILM Corporation is to invest a total of 3.2 billion yen on its CDMO*1 sites in the U.S.A. and the U.K. in order to accelerate the expansion of the company’s business for developing and manufacturing biopharmaceuticals under contract for other parties.

November 6, 2017

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8 min read

Policy

Applied StemCell, Inc. Receives ISO 9001 and ISO 13485 Certification

The ISO certification entails extensive documentation and creation of standard operating procedures (SOP) to ensure quality services and products, customer satisfaction, continued improvement in processes, quality and workflow, and conformity to customer and regulatory requirements.

November 6, 2017

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2 min read

Drug Development

Janssen R&D’s STELARA (ustekinumab) Shows Positive Results In Treatment of Systemic Lupus Erythematosus in Phase II Trial

The study met the primary endpoint, with a significantly higher proportion of patients in the STELARA group showing improvements in lupus disease activity as measured by the SLE Responder Index (SRI)-4 response at week 24, compared with patients receiving placebo.

November 6, 2017

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14 min read

Drug Development

Samumed Announces Results of Phase II Trial of SM04690 Demonstrating Evidence of Cartilage Regeneration in Patients With Knee Osteoarthritis

Data support potential of SM04690 as a disease modifying drug for knee osteoarthritis.

November 6, 2017

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3 min read

FDA

UCB’s VIMPAT (lacosamide) Now Approved by FDA to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

This new approval provides clinicians with the option to prescribe VIMPAT to their pediatric patients either as an oral solution or a convenient tablet.

November 6, 2017

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22 min read