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FDA Issues Warning Letter to Taiwan Facility
The agency cited KO DA Pharmaceutical Co. with cGMP violations.
SGS to Offer HDX–MS at West Chester Facility
The company plans to introduce HDX–MS in quarter three of 2016 at its West Chester, PA facility.
Thermo Fisher Scientific Releases New Biopharmaceutical Characterization Technology
The company showcased new technologies at ASMS for biopharmaceutical characterization.
Catalent Opens cGMP Facility in Japan
The company opened a 200,000-square-foot facility in Kakegawa, Japan to serve the needs of domestic and global clinical trial sponsors.
MilliporeSigma Surveys Biopharmaceutical Executives
MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.
New Contract Research and Manufacturing Firm BioDuro Launches
The new company is the product of a merger with Formex.
Enable Injections Completes its High-Volume Injector Manufacturing Facility
The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.
CMC Biologics Will Manufacture F-star mAb² Bispecific Antibodies
The collaboration will provide GMP manufacturing ahead of future clinical studies.
Fujifilm Diosynth Announces Collaboration With MSD on Large-Scale Biologics Facility
A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.
Avoiding Timing Delays in Biologic Production
Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.
Diverging Results in Clinical Success Rates for Biologics
An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.
FDA Reiterates Decision to Require Suffixes in Biosimilar Naming
The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.
Amyris and Janssen Collaborate on Biosynthetic Drug Discovery
Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.
EMA Encourages Advanced Therapies
The agency published a report on fostering the development of advanced therapy medicinal products.
Mylan and Biocon’s Biosimilar to Herceptin Demonstrates Comparable Efficacy
Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.
FDA Approves Dalizumab
FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.
Dutch System to Track Biosimilar Use and Switching Announced
New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.
Novasep Starts Kilogram-Scale Batch Production at US Facility
Production of kilogram-scale batches of synthetic molecules for early-stage development are now available to US customers.
Using a New CRISPR Effector to Edit RNA
As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.
CHMP Recommends Six Medicines for Approval in EU
During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.
Pharmapack Europe Launches Start-up Hub
The Start-up Hub is designed to give start-up companies the opportunity to network at Pharmapack.
FUJIFILM Opens New Laboratory in North Carolina
The company opened its 62,000 square foot facility, called the BioProcess Innovation Center, in Triangle Park, NC.
Catalent Opens Korean Sales Office
The company opened a new sales office located in Seoul, South Korea.
Juniper Pharma Services Expands Topicals Capacity
The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.
FDA Cites Another Company for Data Integrity Violations
FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.
Jazz Pharmaceuticals Acquires Celator
Jazz will acquire Celator for approximately $1.5 billion.
FDA Approves Buprenorphine to Treat Opioid Dependence
FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.
CordenPharma Receives FDA Warning Letter
The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.
FDA Releases Guidance on Topical Patches
The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.
Patheon Appoints Michel Lagarde President
Lagarde will be based out of the company’s Boston office and will lead Patheon’s global corporate and cross-enterprise operations.
