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ACRO has welcomed new draft guidance on SAE reporting in trials issued by India's CDSCO, but has raised some concerns about the determination of causality and compensation.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.
The US Association for the Advancement of Medical Instrumentation (AAMI) has adopted the latest version of the ANSI14155 standards for medical device trials.
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.
Quintiles has signed a deal with Population Genetics Technologies (PGT) that, it says, will bring large-scale genomics analysis into the drug development mainstream.
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.
Pharma industry wishful thinking and the fact too many developers have been chasing too few targets are behind an increase in Phase II failures in recent years according to a new study.
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).
Last week non-clinical CRO CIT bought Canadian counterpart LAB Research. Outsourcing-pharma.com spoke with CIT executive chairman Jean-Francois Le Bigot about the deal and the plan going forward.
Tax benefit from the sale of its US Phase I business helped CRO Charles Rivers Laboratories (CRL) to grow profits in the first quarter despite falling revenues and low demand.
eResearch Technologies (ERT) posted first quarter gains after the contribution from recently acquired respiratory biz and cost controls helped offset a higher project cancellation rate.
