BioSpace News Archive

Policy

Celltrion Receives Positive CHMP Opinion for Herzuma for Trastuzumab Biosimilar

The CHMP’s opinion will now be sent to the European Commission (EC) for final review.

December 15, 2017
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2 min read
Orthocell Granted European Tendon Regeneration Patent

Regenerative medicine company Orthocell is pleased to announce it has been granted a key European Patent.

December 15, 2017
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3 min read
Policy

Takeda And Tigenix Announce That Cx601 (Darvadstrocel) Has Received a Positive CHMP Opinion to Treat Complex Perianal Fistulas in Crohn’s Disease

This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe.

December 15, 2017
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12 min read
Beleave Provides Business Update

The issuance of a sales license under the ACMPR is in part dependent upon the completion of a satisfactory pre-sale inspection by Health Canada.

December 15, 2017
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2 min read
OSE Immunotherapeutics Receives a Grant From French Government Program “Fonds Unique Interministériel” to Explore New Cytotoxic Antibodies

This collaborative program is focused on developing innovative tests to explore and to measure the cytotoxicity of monoclonal antibodies.

December 15, 2017
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4 min read
BioMidwest

Aratana Therapeutics Announces Study Results for AT-016

Aratana has received top-line pivotal field effectiveness study results for AT-016, an investigational adipose-derived allogeneic stem cell therapeutic candidate for the control of clinical signs associated with osteoarthritis.

December 15, 2017
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7 min read
Business

PixarBio Corporation Announces Signed Agreement with Lubrizol’s Division, Particle Sciences, to cGMP Manufacture NR14 for Clinical Trials, a 14 Day Post-Surgical Pain Treatment

In 2018, PixarBio will be able to apply to the US FDA for fast track approval through the CDER Breakthrough Therapy designation.

December 15, 2017
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1 min read
Biotech Bay

Endari Update

An administrative matter is causing a minor delay in its release; however, Emmaus is committed to providing Endari to patients as soon as possible and the date of availability will be announced in the near term.

December 15, 2017
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3 min read
Biotech Bay

Avinger Secures Waiver and Consent to CRG Loan Agreement

The PIK loan allows Avinger to conserve cash usage by increasing the principal amount of the loan.

December 15, 2017
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1 min read
Business

Ohr Pharmaceutical Reports Fiscal Year 2017 Financial Results

Management to host a conference call and webcast at 8:30 a.m. eastern time today.

December 15, 2017
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5 min read