PharmTech Europe News
Pharmacopeias Continue Harmonization Program
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
EMA and FDA Collaborate on Patient Engagement
The two agencies have set up a working group on involving patients in drug development.
OMCL Network Met Market Demand in Europe During 2015
The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.
Study: Patients Who Have Reactive Responses to Infliximab Should Not Switch to Biosimilar Versions
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
PSUR Repository Becomes Mandatory in EU
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
US and EU Regulators Seek to Reduce Pharma Inspections
Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
EMA Encourages Advanced Therapies
The agency published a report on fostering the development of advanced therapy medicinal products.
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.
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.
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.
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.
EMA Publishes Annual Report
The agency detailed its 2015 achievements in an annual report.
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.
EMA Discusses Drug Prices
The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.
EMA’s SME Initiative Shows Positive Results
The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.
EU Pharma Industry Representatives Pen Letter on Brexit
Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.
Report Shows Increase in Capacity in Cell and Gene Therapy Manufacturing in the UK
The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.
EMA Completes Review of Inhaled Corticosteriods
The agency found no differences in risk of pneumonia for different products.
EMA Approves Gazyvaro for Treatment of White Blood Cell Cancer
The agency extends the indication of the drug in combination with bendamustine.
EMA Approves Antimicrobial Resistance Drug
The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.
EMA Collaborates with Physicians
The agency holds a workshop to strengthen collaboration with healthcare providers.
Plasticell Receives Queen’s Award for Enterprise in Innovation 2016
Plasticell was recognized for its contribution to the advancement of regenerative medicine, cell and gene therapy, as well as other areas of biomedical research.
PRAC to Review Canagliflozin and Direct-Acting Antivirals
PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.
GSK Opens New Respiratory Manufacturing Facility
The facility located in Ware, UK, will be used to manufacture GSK’s Ellipta inhaler.
EMA and EUnetHTA Release Collaboration Report
The agencies detail the results of their three-year collaboration.
EMA Proposes the Use of Data from Adults in Pediatric Drugs
The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.
