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How the Defend Trade Secrets Act Could Better Protect Manufacturers Who Outsource to CMOs
PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.
EU Grants Approval to Remicade Biosimilar Flixabi
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
Xellia Builds Testing Services Lab at Budapest Manufacturing Site
Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.
USGS Study Indicates Pharmaceuticals are Widespread in Small Streams in the Southeast US
The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.
AAPS Grants Five Graduate Student Fellowships
The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.
FDA Issues Warning Letter to API Manufacturer
The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.
EMA Accepts Sandoz’s Regulatory Filing for Biosimilar Rituximab
Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.
Micro-Macinazione Opens New Storage Facility to Meet Growing Business
The new 500-meter-square warehouse will hold incoming materials, including already micronized highly potent substances and cytotoxic products.
CGT and CTM CRC Collaborate on Scaffold Technology Project
Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing to will collaborate on a project to test technology for T-cell stimulation and expansion.
Recipharm Introduces Serialization Pricing Model
The company will offer a standard serialization solution across 14 locations in Europe and more than 70 product lines.
Clinical Development Success Rates Examined in New BIO Report
In the largest-ever report of its kind, drugs entering clinical development in Phase I were found to have only a 1 in 10 chance of FDA approval.
Colorcon Acquires BASF’s Kollicoat IR Coating Systems
Colorcon Acquired BASF’s Kollicoat IR Coating System product line, which includes currently customer business, and inventory.
FDA Accepts Samsung Bioepis' BLA for Remicade Biosimilar
FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).
FDA Issues Warning Letter to German API Manufacturer
FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.
Evercyte and VTU Launch Recombinant Media Supplement
The companies have launched VEGF 165, their first joint product for cell culture applications.
Grace Sells Chromatography Product Line
W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.
Sanofi Makes Changes to Executive Committee
Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.
FDA Releases Guidance on Developing Drugs for COPD
The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.
Removing Troublesome Solubilizing Excipients from Injectables
A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.
FDA Approves Atezolizumab
Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.
Celgene and Agios Collaborate on Metabolic Immuno-Oncology
Celgene will pay Agios $200 million to lead exploratory, research, drug discovery, and early development work for metabolic immuno-oncology.
Althea Patents Method to Crystallize Proteins
The company’s method reduces the time required to crystallize antibodies from weeks to one day.
Well Care Compounding Pharmacy Issues Recall
The company recalls products due to sterility concerns.
NIH to Launch Large-Scale HIV Vaccine Trial
The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen
EMA Publishes Annual Report
The agency detailed its 2015 achievements in an annual report.
AAPS Announces 2016 Award Winners
The awards were presented at the AAPS Biotechnology Conference and included awards for ligand binding, innovation in biotechnology, and graduate student symposiums.
FDA Issues Biomarker Qualification Guidance
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
Jones Packaging and TUKU Develop Web-Enabled Packaging Platform
The companies entered into a commercial collaboration to develop web-enabled packaging for pharmaceutical and consumer goods companies.
Pfizer to Acquire Anacor
Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.
Caribou Biosciences Completes Series B Financing Round
Caribou announced the completion of a $30-million Series B financing round, which included the participation of new and current investors.
