Discover innovative single-use mixer for efficient mixing of low shear and particulate sensitive solutions in cGMP environment
ATMI Life Science
US House Bill Aims to Expand Release of Clinical Trials Data
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US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected. Related news |
News in brief
Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
Global Industry News
Exclusive interview
Quintiles’ Lead Medical Expert: Real World Patient Data Hold Enormous Potential from Outsourcing-Pharma.com
Supplementing prospective randomized, double-blinded clinical trial data with real-world patient data holds “an enormous amount of potential” for CROs and trial sponsors, according to an expert.
ADC Bio Expands Lab Services in Response to Demand from Outsourcing-Pharma.com
ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Dispatches from Interphex
TFS Sees Increase in Modularization, Shorter Construction Timelines from Outsourcing-Pharma.com
Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.
PRA Prepares to Go Public with Confidential SEC Filing from Outsourcing-Pharma.com
US CRO PRA is proposing to go public again, more than six years since it was taken private, according to a confidential draft registration statement submitted to the US SEC.
Covance Pushes Further into Biologics Development, Lead Optimization from Outsourcing-Pharma.com
Although preclinical work for CROs has fallen flat in recent quarters, Covance is looking to take advantage of the industry’s shift to early biologic developments and lead optimization.
Spotlight
  Dispatches from Excipient Fest in Baltimore - UPDATEConfusion Abounds in Elemental Impurities Testing for Pharma, ExcipientsAs the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and... |
 Dispatches from Excipient Fest in BaltimoreChina Looks to Tighten Excipient Regulations with Limited ResourcesChina’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have... |
 Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for PfenexInjex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax... |
 GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020... |