Pharmaceutical Technology Europe
After reviewing further data on the suspected link between cases of narcolepsy and GlaxoSmithKline's pandemic influenza vaccine, Pandemrix, the EMA's Committee for Medicinal Products for Human Use (CHMP) is still unable to establish a causal relationship.
Pharmaceutical Technology Europe
An initiative based in the Netherlands aims to bring together universities, pharma companies, international research institutions and product development partnerships to help develop new diagnostic tests and medicines for neglected tropical diseases.
Pharma's manufacturing and supply chain needs a "radical overhaul" because it is underused, inefficient and ill-equipped to cope with new types of products that will be coming to market in the near future, according to a report from PricewaterhouseCoopers (PwC).
The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US House Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies, called for Congressional action to pass a three-to-five year authorization of current Chemical Facility Anti-Terrorism Standards (CFATS), which are scheduled to expire Mar. 4, 2011.
Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.
HHS Releases a New National Vaccine Plan
Last Wednesday, sanofi aventis agreed to acquire Genzyme for $74 per share in cash, or approximately $20.1 billion.
President Barack Obama released his budget proposal for fiscal year (FY) 2012, which shows an increase in funding for the US Food and Drug Administration.
EMA Outlines Activities for 2011, and more.
Company and People Notes: sanofi to Acquire Genzyme; Lilly Makes Senior Appointments; and More.
US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the "Preserving Access to Life-Saving Medications Act," which is intended to help address and prevent shortages of prescription drug medications.
Equipment and Processing Report
A major pharmaceutical micronizing company consulted Telstar when it needed a mobile, high-containment isolation system suitable for housing 4-, 8-, 12-, or 15-in. micronizing jet-mill systems during the loading, milling, and offloading processes.
Equipment and Processing Report
My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn?t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?
Equipment and Processing Report
Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.
Equipment and Processing Report
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Alfa Laval and GE Healthcare.
Pharmaceutical Technology Europe
The recent India–EU summit was expected to bring news about the upcoming Free Trade Agreement between the EU and India; however, a dispute regarding the supply of generic drugs from India to developing countries has taken centre stage.
Pharmaceutical Technology Europe
According to the UK's Economic and Social Research Council (ESRC), the closure of Pfizer's UK R&D facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals.
Pharmaceutical Technology Europe
India is set to become a "biosimilar powerhouse", with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts at Datamonitor.
According to the UK's Economic and Social Research Council (ESRC), the closure of Pfizer's UK R&D facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals.
Pfizer Acquires Ferrosan's Consumer Health Business; Patheon Appoints Former Biogen Exec as CEO; and More.
On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.
The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US Senate Subcommittee on Superfund, Toxic and Environmental Health, provided support for a bipartisan review of the Toxic Substances Control Act (TSCA) as that subcommittee considers reforming the chemical control law.
Last Thursday, the US Senate scheduled the Patent Reform Act of 2011 for debate after the Senate Judiciary Committee passed the bill.
The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.
Pharmaceutical Technology Europe
Pfizer is to close a UK R&D facility in Sandwich (Kent), affecting more than 2000 positions, as it seeks to reduce expenditure by realigning its R&D division.
Pharmaceutical Technology Europe
The European Medicines Agency (EMA) has published its final 'Road map to 2015', a document that sets out the agency's key drivers for progress and strategic vision of operation for the next 5 years.
Pharmaceutical Technology Europe
Taking inspiration from nature, researchers have devised a way of giving drug-bearing polymer vesicles armored protection that could enhance drug delivery.
President Barack Obama's State of the Union address, delivered last week on Jan. 25, 2011, to the US Congress, was largely well received by the pharmaceutical and biotechnology industries.
The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.
FDA Holds Workshop on Orphan Drugs