US CRO Parexel says the pharmaceutical industry’s desire to access international markets is the key challenge facing regulatory experts in the contract research sector.
US CRO Celerion gained Brazilian National Health Surveillance Agency (Agência Nacional de Vigilancia Sanitaria ANVISA) approval for its bioanalysis labs in Lincoln, Nebraska and in Belfast, Northern Ireland.
Gerresheimer will expand its pharmaceutical packaging plant in the Czech Republic to meet growing demand for plastic systems and to further expand a key training hub.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has welcomed proposed changes to US patent laws that would alter the basis for patent awards.
US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.
GlaxoSmithKline (GSK) has announced plans to buy its joint venture Shenzhen GSK Neptunus Biologicals (GSKNB) to expand influenza vaccine production capacity in China.
US drugmaker Baxter International has been ordered to pay compensation of $625,000 to the estate of man who received a dose of heparin that was contaminated with over-sulfated chondroitin sulphate (OSCS).
Switzerland-based life sciences supplier Lonza says it will invest CHF10m (€8m) to expand a Singapore plant that is part of its custom biomanufacturing business.
Indian drugmakers Serum Institute and Panacea Biotech have reduced what they charge the GAVI for vaccines, prompting similar commitments from several Big Pharma firm.
Indian CRAMS firm Jubilant Life Sciences has renamed HollisterStier Contract Manufacturing and hired a new BD exec in latest stage of North American reorganisation.
Watson Pharmaceuticals has bought Greek generics firm Specifar Pharmaceuticals, bringing to an end a busy month of deal making in the non-branded drug sector.
Quintiles will help South Korea develop its clinical research infrastructure under a new collaboration with the Korea National Enterprise for Clinical trials (KoNECT).
From July the EC will require that gelatin used in parenteral drugs is sourced from countries in World Organisation for Animal Health's (OIE) lowest risk categories for bovine spongiform encephalopathy (BSE).
The US Food and Drug Administration (FDA) has published a list of all the drug manufacturing facilities it has inspected between October 2008 and September 2010 as part of Government transparency efforts.
ACRO has welcomed new draft guidance on SAE reporting in trials issued by India's CDSCO, but has raised some concerns about the determination of causality and compensation.
Biologics Process Development, a wholly-owned subsidiary of Californian contract research organisation (CRO), Viropro, has announced it is to double the size of its bioprocess and scale-up laboratory.
Pharma needs to learn from other sectors and abandon the multistage development paradigm in favour of a two-stage design and manufacturing model to cut attrition rates.
The financial flexibility and quality standards of Indian CMOs should be enough to stave off competition from newer global contract manufacturing hubs, according to market research company RNCOS.
US contract research organisation (CRO) PRA International claims it intends to “reshape how the industry manages trials” after acquiring Indian eClinical software developer, Kinship Technologies, for an undisclosed amount.
Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.
Clinical Financial Services (CFS), a US financial management company specialising in clinical trial management, has launched its new Site Activation Services offering, designed to ‘streamline and automate’ the trial activation process.
India’s Veeda Clinical Research has set up a Phase I unit in Malaysia, joining the growing list of contract research organisations (CRO) attracted to the country.
Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases.
Primary packaging maker Schott has joined the growing list of drug industry companies seeking to tap Russian government demand for increased domestic manufacturing.
Chemicals supplier Aceto Corp has its sights set on opportunities in the generic drug sector after soaring active pharmaceutical ingredient (API) and intermediates sales helped it to a strong set of quarterly financials.
Carbogen Amcis’s Indian plant has met industrial standards for the containment and handling of highly potent active pharmaceutical ingredients (HPAPI).
