The EMA brought together European and US expert representatives from regulatory authorities, academia, industry and a health-technology-assessment agency on Nov. 18, 2011 to discuss the use and importance of subgroup analysis in the assessment of clinical trials.
Takeda Forms New Global Medical Affairs Department; UCB, NewBridge Pharmaceuticals Partner for Middle East and African Markets; and More.
EMA addresses drug supply shortage.
GlaxoSmithKline announced its intent to increase ownership in its publicly-listed, consumer-healthcare subsidiary in India and in GlaxoSmithKline Consumer Nigeria as part of its emerging-markets investment strategy.
Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.
The European Medicines Agency (EMA) recently conducted a workshop on clinical-trial data and transparency in London following the agency's decision to proactively publish all data from clinical trials and enable interested parties to access to full data sets.
The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring.
Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).
German Court Finds AstraZeneca's Seroquel XR Formulation Patent Invalid; FDA Advisory Committee to Recommend Approval of GSK's H5N1 Influenza Vaccine Candidate; and More.
More favourable conditions for the pharmaceutical industry, including a "golden era of renewed productivity and prosperity" have been forecast in a new report from analyst firm PricewaterhouseCoopers (PwC).
As-found data is a crucial component of pipette calibration for laboratories that must comply with GMP regulations.
FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.
Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The $20-million plant will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing demand in China and other regions in Asia Pacific.
USP announces new drug naming policy and FDA releases two guidance documents.
House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.
The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.
Neptune Provides Update on Incident at its Production Plant; Tekmira and Alnylam Restructure Relationship and Settle All Litigation; and More.
The Italian Medicines Agency lifted a temporary hold on the use of Novartis seasonal influenza vaccines in Italy after affirming the vaccines' safety and efficacy.
The European Fine Chemicals Group has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the European Union market.
FDA provides information on its Enhanced Communication Team created in response to PDUFA V.
An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.
Merck & Co. Resolves Vioxx Lawsuit; Takeda Agrees to Acquire Envoy Therapeutics; and More.
Pharmaceutical companies and public health officials gather at the IFPMA Assembly to urge for greater innovation and private and public partnerships to address global health concerns.
A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
The European Commission has issued final approval for Europe's first gene therapy-a treatment for a rare genetic disorder that currently has no other treatment options.
Watson Pharmaceuticals has completed its EUR 4.25 billion ($5.4 billion) acquisition of the Actavis Group. The combination creates the world's third largest generic-drug pharmaceutical company, with anticipated pro forma combined 2012 revenues in excess of $8 billion, according to Watson.
FDA pushes back goals due to Hurricane Sandy and EMA announces changes to variation regulations.
Boehringer Ingelheim has agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.
USP revises labeling requirements for Heparin.
A Q&A with Yves de Montcheuil, vice-president of marketing at Talend, a provider of open-source integration software.