PharmTech Europe News
Pharmapack Europe Accepting Applications for 2017 Awards
Pharmapack Europe is inviting pharmaceutical packaging and drug-delivery experts to apply for the 2017 Pharmapack Awards.
Horizon Discovery Signs Subscription-Based Licensing Agreement for Biomanufacturing Cell Lines
Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.
Datwyler Invests in New US Plant
Datwyler is channelling more than CHF 100 million into building a new plant in the US state of Delaware, which will be used to manufacture elastomer components for injectable drug-delivery systems.
Service Gradually Restarts at BASF Plant in Ludwigshafen
BASF announced that steamcrackers are slowly being restarted at the company’s plant in Ludwigshafen.
Oxford Genetics Opens New Facility to Support R&D in Cell and Gene Therapy
Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.
Merck KGaA Expands Biotech Production Capacity in Spain
A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain
EMA Recommends Conditional Authorization of Ocaliva
The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.
US and Europe Collaborate on Patient Treatments
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.
Recipharm to Open New GLP Bioanalysis Laboratory in Sweden
Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.
FDA Warns Swiss Company
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
Scottish Company Receives USFDA Warning Letter
Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
Recipharm Launches Serialization Showcase Line
Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.
Pfizer Comes Up Short in Lyrica Patent Battle
A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica’s pain patent.
EUIPO Report Says Counterfeit Medicines Cost EU €10.2 Billion a Year
A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
SGS Invests in New cGMP Facility
The company invested in a new cGMP facility located in Berlin, Germany.
Carrick Therapeutics Launches in Europe
The new company will focus on R&D of cancer treatments.
Europe Strengthens Collaborations with Japanese Pharmacopoeia
EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.
EMA Appeals Interim Orders by the General Court of the EU
The agency appealed two interim orders to suspend the release of documents requested by third parties.
US and Europe Collaborate on Treatment of Rare Diseases
FDA and EMA set up new working group on the development of treatments for rare diseases.
PCI to Expand Bridgend Facility
The company will add a new clinical services facility at Central Park on Bridgend Industrial Estate.
NICE Recommends Hypophosphatasia Drug
NICE estimates asfotase alfa will cost £367,000 per patient per year.
EMA Determines Certain Drugs Safe from Zika Contamination
The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.
GSK Announces Plans to Address Emerging Global Health Issues
The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.
EMA Stops Import of Products from US Company
EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.
EMA Recommends Approval of 10 Drugs
The agency recommended approval of 11 drugs, including three cancer drugs, in September.
EMA Grants Conditional Approval to Lartruvo
The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.
EMA Recommends Breast Cancer Treatment
The agency has recommended marketing authorization for Ibrance in the European Union.
Merck KGaA Joins the DiViNe Project
The project aims to address challenges facing the development, manufacture, and delivery of vaccines.
UK Approves Glaucoma Drug Product, Delivered with Nemera’s Multidose Preservative-Free Eyedropper
The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.
Opportunities for Pan-European Medicine Product Launches Post-Brexit
Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization
