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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.
Examining Blow-Fill-Seal Technology for Aseptic Processes
Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.
PAT: “Gateway Drug” to the 21st Century for the Pharma Industry
Process analytical technology paved the way for continuous manufacturing.
Industry Moves Closer to Continuous Manufacturing
With technology advances, continuous manufacturing shows steady progress to more widespread adoption.
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.
Pharma Wary of Brexit
Pharma has voiced strong opposition against Britain’s departure from the EU.
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.
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.
