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AMRI Licenses CRISPR from the Broad Institute
AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.
When Marketing and Medicine Collide
Steep price increases for a popular drug have created patient and Congressional backlash.
“Go/No Go” Screening Process Can Help Decide Whether to Switch from Batch to Continuous
A recent paper outlines a methodology to help development teams decide whether switching from batch to continuous mode makes financial and technical sense.
Pfizer to Acquire Medivation
Pfizer will acquire Medivation for approximately $14 billion.
The CRISPR Patent Debate
The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.
Casebia Therapeutics Begins Operations
The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.
Zenith Technologies Expands US Presence
The company is opening two offices in the United States that will offer serialization, automation, and process control services.
Sagent Pharmaceuticals Issues Nationwide Recall
The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.
Alcami Expands US API Capacity
CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.
Fresenius Kabi Expands US Sterile Injectables Capacity
Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.
Cetylev Tablets Recalled
Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.
COC Designated by USP for Pharma Packaging
TOPAS Advanced Polymers announces its COC materials are compliant with new USP standard for pharma plastic packaging systems.
Designing Flexible Aseptic Containment Systems
The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines
Zhejiang Medicine Receives FDA Warning Letter
The Chinese facility was cited for data integrity violations.
Group Reports Progress on an Open Serialization Communication Standard
The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.
Public Health Organizations Pen Letter to House and Senate Committees
Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
South Tees Bio-Incubator Launches in the UK
The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.
FDA CItes Measurement, Validation Deficiencies in its Warning Letter to Noven
Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.
FDA Releases Guidance on Co-Crystal Classification
The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
Janssen Secures Breakthrough Therapy Designation for Depression Drug
The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.
Piramal to Acquire HPAPI CDMO Ash Stevens
Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.
Irvine Scientific Launches BalanCD HEK293 System for Large-Scale Expression of Proteins and Viral Vectors
Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.
US Life Sciences CEOs Upbeat About Industry’s Prospects
A KPMG survey reveals that approximately 84% of pharma and medical device executives plan to add jobs in next 12 months.
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.
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.
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.
Novartis Expands Biologics Production in France
Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.
Allergan Plans to Expand in New Jersey
The EDA offered Allergan tax credits in order to encourage the company to remain in the state.
