Jerusalem, Israel-based drugmaker Oramed Pharmaceuticals has been granted patent approval for its oral insulin technology by the Japanese Patent office.
The EMA has changed how it monitors the risk-benefit profile of marketed drugs, adopting a single assessment that includes a broader range of API safety reports.
RPS (ReSearch Pharmaceutical Services Inc.) says its JV with Asklep will provide more options for big pharma and biologic companies looking to outsource Japanese or pan-Asian clinical trials.
US Researchers say a new site MyClinicalTrialLocator.com gives patients a simple way of finding clinical trials and may aid sponsor and CRO recruitment efforts.
Lilly says another investment in its Indianapolis facility will add a second insulin cartridge-filling line and is driven by the increasing prevalence of diabetes.
The US FDA has reprimanded and halted all imports from Japanese API manufacturer Asada Milling Co. after finding its manufacturing equipment “corroded, rusted, chipped of paint, and coated with an unidentified white powder,” the agency said in its warning...
Concern over controversial new Indian rules on trial participant compensation for study-related injuries is likely to spark changes that may be difficult and time consuming to implement, according to industry sources.
B-MS' (Bristol-Myers Squibb's) selection of LabCorp as its preferred provider for central lab services could be bad news for rival Icon according to industry observers.
CRO PPD (Pharmaceutical Product Development) is bolstering its bioassay and bioanalytical services in both the US and Brazil, respectively, in preparation for more niche biologic and biosimilar developments.
Following its re-elevation to a ministerial level, the Chinese drug regulatory body has rebranded itself the China Food and Drug Administration (CFDA).
BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
Some of largest pharmaceutical, biotech and CRO (contract research organizations) companies are beginning preparations for a summit in May to focus on how to manage quality in the outsourcing of clinical trials.
ACRO (Association of Contract Research Organizations) is calling on the FDA to clarify draft guidance attempting to mitigate the possible pitfalls in transitioning to electronic source data for clinical investigations.
Sale of medicines on trains and planes is just one reform being considered in a series of simplification measures aimed at increasing industry efficiency by the MHRA.
Sanofi has inked a deal that will see it contract manufacture immunotherapy products for Transgene using a new platform developed by the two companies.
As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between the different companies.
CRO (clinical research organization) employees are switching jobs at dramatically higher rates than their counterparts in other industries, especially overseas, according to a survey on CRO compensation.
Pfizer’s Rifampin injections used to treat TB (tuberculosis) are in short supply as the company says manufacturing issues caused some vials and solutions of the drug to be possibly contaminated.
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.
Canada-based CRO Nordion paid $22.5 million last week to settle a lawsuit by Dr. Reddy’s Laboratories claiming Nordion breached its lab services agreement.
The PRACS Institute has filed for bankruptcy after closing down its US and Canadian research sites, but the question of whether unpaid trial participants will receive payment for their work is still up in the air.
French CMO Indicia production says the acquisition of Biotechnologie Appliquee will strengthen its ready-to-use media manufacturing and add R&D capabilities to its offerings.
Pfizer, Merck, Eli Lilly and a number of other large pharmaceutical companies are calling on the FDA to supplement draft guidance on enrichment strategies for clinical trials with more examples from different therapeutic areas.
Bidders for DNA-sequencing equipment maker Life Technologies may not have to pay too much more than its current market value of $64 per share, or about $11B, according to an analyst.
The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.
The PRACS Institute – the firm that emerged from the ashes of Cetero Research – has shut down operations at all locations according to local media reports.
DKSH says its contract extension with Bayer in Cambodia strengthens its position as a service provider for pharmaceutical companies throughout Southeast Asia.
Drug industry groups welcomed corporate tax cuts and increased research credits set out in the UK budget last night suggesting they are good news for manufacturers.
Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.
The US FDA listed failure to ensure product sterility or explain why some batches were only partially released among criticisms of Apotex in a warning letter published this week.
The European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
