Discover innovative single-use mixer for efficient mixing of low shear and particulate sensitive solutions in cGMP environment
ATMI Life Science
News focus
Oral Insulin: All Mouth, or an Injection of Hope for Type 1 Diabetes?
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Can oral insulin succeed where other alternative delivery methods have failed? Dan Stanton, from in-Pharmatechnologist.com assesses its chances. Related news |
News in brief
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
Sandoz has recalled two lots of an injectable drug after vials were discovered to contain foreign matter, though is unsure of the cause for now.
Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
Global Industry News
Update
CROs, Sponsors Look to Service Providers to Comply with US Sunshine Act from Outsourcing-Pharma.com
As CROs and pharmaceutical sponsors must begin collecting data in August to comply with the Sunshine Act, some companies are now looking to service providers for help.
ACRO Joins Coalition to Rejuvenate Funding for Smaller Research Companies from Outsourcing-Pharma.com
The Association of Clinical Research Organizations (ACRO) has joined a small business coalition as part of its effort to halt the decline of capital into biomedical research.
Possible API Contamination at Chinese CMO Leads to Canadian Recalls from Outsourcing-Pharma.com
Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
Aspen & Local CMOs to Benefit from GSK's Aus Packaging Plant Closure from Outsourcing-Pharma.com
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
People on the Move: Outsourcing Jobs from Outsourcing-Pharma.com
Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry, including news from Patheon, Hospira and SCM Pharma.
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... |