US formulation services provider Bend Research says a new safety file for the bioavailability enhancing drug excipient, HPMCAS, can now be referenced by its clients in FDA filings.
US drug discovery group Deltagen has acquired Benten BioServices, a contract services organisation that offers a suite of regulatory-compliant manufacturing and testing services to support biopharmaceutical development and commercialisation.
Sanofi Aventis has revamped operations at its sterile injectables plant in Le Trait, France, adding three new production units that double syringe making capacity and diversify its vaccine manufacturing capability.
GSK halted production in Rajahmundry, India and Eisai postponed the opening of a facility in nearby Vizag on Saturday after days of unrest over plans to create a new state, Telangana, within Andhra Pradesh.
Intercell’s needle-free patch delivery technology has the potential to change the way vaccines are delivered, according to Jean Stephenne, president of GSK Biologicals.
Canadian CMO Patheon will consolidate its Puerto Rican activities at its facility in Manati and sell or close its plant in neighbouring Caguas by 2011.
CMO Avid Bioservices’ year-on-year revenues increased by 440 per cent in the second quarter, leading to the company planning expansions in Asia-Pacific, biosimilars and analytical services.
Amcor has unveiled its proposed management shake up in preparation for the $2.025bn takeover of Alcan – three days before the European Commission is due to deliver its verdict on the deal.
PRA International has called on Netherlands-based software group Quintiq to help manage the Ph I research projects it takes on and better allocate resources in the challenging early-phase trial sector.
GE Healthcare says its new range of sample collection cards reduce sample volumes needed for drug metabolism across pharmacokinetics (DMPK) in all stages of drug development process.
Officials carried out another set of surprise inspections at pharma companies yesterday, in the latest stage of the European Commission's clampdown on anti-competitive practices.
Swiss drug major Roche has called in biomarker testing lab Rules-Based Medicine (RBM) to help give its candidate schizophrenia drugs a commercial edge.
The EU industry commissioner has said the scale of pharmaceutical counterfeiting “exceeded our worst fears” and the EPHA has weighed into the debate on the development of the draft directive.
Medidata says the latest addition to its EDC platform, the Rave Safety Gateway, will cut the time it takes to report adverse events during trials and help CROs and their sponsors comply with increasingly stringent reporting rules.
Almac has entered into a partnership with FACIT.org to gain PRO and QoL assessments which it believes will help it recruit patients and generate high quality data for regulatory submissions.
Preclinical drug testing specialist Absorption Systems has branched out and opened a new surgical lab designed to help pharmaceutical firms assess the safety of biomaterials and medical devices.
India’s Ministry of Health and Family Welfare (MHFW) want to make the collection biometric data from all clinical trial participants standard across the country’s research sector.
inVentiv Health has rolled-out FlightPath, a new bespoke service designed to help pharmaceutical and biotechnology companies chart a clear course to commercial launch.
Watson Pharmaceuticals gained US rights to market a generic version of Lipitor (atorvastatin) in 2011 with the acquisition of non-branded drugmaker Arrow Group late last week.
Synexus has agreed to acquire Clinpharm, giving it access to 10 clinical trial sites in Germany, Austria and Ukraine and increasing its patient population reach in Europe by 100 per cent.
PPD is targeting growing demand for contract data analysis with a new biostatistics infrastructure that, it says, offers improved security and reporting.
India-based CRO Ecron Acunova will support its geographic expansion and strengthen its service offering after receiving Series B financing from OrbiMed’s Caduceus Asia Mauritius.
CMO Vetter Pharma has expanded its manufacturing capacity with a new in Illinois, US that it says brings it closer to customers and will allow it to collaborate with clients earlier in the drug development process.
Indian API maker Avon Organics’ share price rocketed 10 per cent on the Bombay exchange yesterday after the US launch of a generic herpes treatment by Ranbaxy Laboratories.
A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
Patheon and JLL are to end the legal actions between them by entering into a litigation settlement which establishes a board of directors and limits JLL acquiring additional restricted voting shares before April 27 2012.
US CRO Life Science Research has become a private company with the completion of its acquisition by Lion Holdings, an investment vehicle owner by CEO Andrew Baker.
World Courier has GxP compliant status for its whole distribution network, covering more than 140 offices in 50 countries, which it believes no other business in the sector has achieved on such a large scale.
IQWiG says Pfizer’s refusal to make some data available “hindered” its report on antidepressants and called for EU mandated trial registration and publication rules.
Sanofi-Aventis plans to participate with a Russian state-owned corporation in a project to attract innovative drug manufacturers to the country, using its insulin facility as a pilot initiative.
Unilife Medical Solutions has filed US patents for Unifill Select, which it claims is the first ready-to-fill (RTF) syringe specifically designed for vaccine delivery.
Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.
Indian drugmaker Ranbaxy Laboratories has withdrawn stocks of its acne drug Sotret in the US for the second time this year after some tablets were found to be out of specification.
Synexus has recruited more than 2,000 children in three months for a Phase III rotavirus vaccine study, which it believes validates its methods and demonstrates they are particularly effective in late stage vaccine trials.
The recent wave of M&A will lead to manufacturing over-capacity at pharma companies but only a small number of these sites will be sold to CMOs, in part because of the facilities’ suboptimal locations, according to a report.
Sinovac Biotech has formed a joint venture which will give it cost effective manufacturing capacity for 20m does of live attenuated vaccines and 20m doses of vero cell cultured vaccines a year.
The market for contract manufacturing organisations (CMO) will be worth $33.7bn (€22.4bn) by 2014, according to a report which says developing biologics capabilities is a key imperative for growth.
Millipore has acquired the remaining 60 per cent of its Indian joint venture (JV) to drive growth in the country which it views, along with the other BRICS nations, as a critical part of its strategy.
Sistemic is targeting the US by setting up an office in Boston, Mass, from which it will promote its services that use miRNA to identify and understand a compound’s activity in a simpler way than genomics or proteomics.
