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Agilent Plans Expansion of Oligo Manufacturing Capacity
Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.
Judges for the CPhI Pharma Awards 2016 Named
CPhI Pharma Awards’ panel doubles in size and welcomes experts from around the world.
Scientists Examine CRISPR as a Therapeutic Approach for Treating Blood Disorders
A new study reveals a potential new approach to treat sickle cell disease and beta thalassemia using CRISPR-Cas9 gene-editing technology.
Mallinckrodt to Merge with Stratatech Corporation
Mallinckrodt announced a planned merger agreement with Stratatech Corporation, a regenerative medicine company.
EMA Adopts Biologics Pharmacovigilance Practices
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
Allergan Plans to Expand in New Jersey
The EDA offered Allergan tax credits in order to encourage the company to remain in the state.
Novartis Expands Biologics Production in France
Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.
Funding for Zika Vaccine Hinders Development
Zika vaccine development is hindered by technical challenges and funding shortfalls.
Biogen Announces Name of Hemophilia Spin-Off Business
The company announced that Bioverativ will be the name of its new hemophilia spin-off business, which is expected to launch in early 2017.
NICE Draft Guidance Recommends Secukinumab for Treating Ankylosing Spondylitis
NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.
EMA Releases Data Integrity Guidance
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
Testing Laboratory Receives Warning Letter
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
Hospira Recalls Bupivacaine Hydrochloride Injection, USP
The company is voluntarily recalling one lot of product due to particulate matter.
PharmaTech Recalls Product Due to Contamination Risk
The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.
European Commission Publishes Pharmacovigilance Report
The three-year report emphasizes the roll of collaboration in drug safety.
Collaboration Develops More Efficacious Antibodies
Catalent Pharma Solutions teamed with Zumutor Biologics to develop antibodies with enhanced ADCC activity.
MilliporeSigma to Provide Development and Manufacturing Services to Y-mAbs
MilliporeSigma will provide support to Y-mAbs for the development of its monoclonal antibody for the treatment of pediatric brain cancer.
Phase III Trials for Bristol-Myers’ Opdivo Fail to Meet Primary Endpoints
Opdivo did not meet primary endpoints in Phase III trials investigating the drug as a monotherapy for untreated advanced non-small cell lung cancer in patients whose tumors expressed PD-L1.
FDA Releases First Doses of Sanofi Pasteur Influenza Vaccine for Shipment
Sanofi Pasteur will deliver the first of more than 65 million influenza vaccines to the United States throughout the 2016–2017 flu season.
EMA Publishes Report on Adaptive Pathways Pilot Project
The report addressed how the agency might support medicine development for patients’ unmet medical needs.
EMA Launches Public Consultation on Guidance for New Tuberculosis Treatments
The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.
NIH Launches Zika Vaccine Clinical Trial
The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.
Alnylam Moves Forward on Multi-Product RNAi Facility
Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.
Ribociclib Receives Breakthrough Therapy Designation
The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.
Astellas Transfers Manufacturing Subsidiary to Avara
The manufacturing subsidiary of Astellas Pharma in Oklahoma has been transferred to CMO Avara and renamed Avara Pharmaceutical Technologies.
FDA awards LIU for research into variability
A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
Creative Fiction, Other Data Integrity Problems Listed in FDA Warning Letter to Chinese API Manufacturer
Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.
Portable Device Delivers Biopharmaceuticals on Demand
An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.
GSK, Verily to Set Up Bioelectronics Joint Venture
Galvani Bioelectronics will be based in Stevenage, UK, and headed by Kris Famm, GSK's vice president of bioelectronics R&D
Pfizer Strengthens its Gene Therapy Program by Acquiring Bamboo Therapeutics
The North Carolina-based company will expand Pfizer's capabilities in gene therapy research
