Indian drugmaker Dr Reddy’s Laboratories has formed a manufacturing partnership with R-Pharm in a bid to strengthen its position in Russia’s fast-growing drug market.
The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.
Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
PR-based strategies emphasising the cost of the disease and local partners are needed to enter the lucrative German vaccine market, according to researchers.
Biopharm is increasingly using the functional service provider (FSP) model, in areas such as medical affairs and statistical services, while continuing to globalise trials, according to Chiltern.
The contract service market failed to recover as hoped in 2010 and consequently many companies made cutbacks. Outsourcing-Pharma rounds up five of the most read of 2010.
Novartis will build a new $500m (€379.9m) pharmaceutical manufacturing plant in St Petersburg, Russia after signing a Memorandum of Understanding (MoU) with the city.
Outsourcing-Pharma presents a round up five of our top articles on strategic partnering, which continued apace in 2010, including deals by Covance, PPD and Parexel.
Contract service providers continued to move into new geographies in search of more efficient R&D and production in 2010. Here we present five of our most popular articles on the topic, including Pfizer in Asia and the BRIC wall.
INC Research has shifted its headquarters to new and larger offices as part of the firm’s wider plan to ramp up its clinical trials outsourcing operations in Research Triangle, US.
PharmaNet has launched its Initiator data capture and PKS analysis platforms in a bid to speed up data acquisition and processing of Phase I trial reports.
US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
PKPD modelling and simulation is now “ingrained” in drug development and its importance will continue to grow as approaches evolve in “very exciting” coming years, according to an Icon VP.
Russia is “becoming dependant” on foreign drugmakers according to Prime Minister Vladimir Putin, who has called for home-grown manufacturers to make more of the country’s medicines.
The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe on route to Africa and Latin America, according to reports.
Understanding cultural and regulatory differences in BRIC countries could help multinational CROs move to the forefront of clinical development and compete with local CROs for drug trial contracts, say researchers.
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.
PRA has relocated its Poland-based early development services and product registration teams into a larger shared office after achieving “solid increases in the placement of clinical studies”.
The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
West Pharmaceutical Services will close a plant in Pennsylvania, US and sell part of a factory Cornwall in the UK to reorganise production operations ahead of impending contract expiries.
An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
Australian Pharmaceutical Industries (API) and Sigma Pharmaceuticals shares’ have been hit by Pfizer’s decision to abandon wholesale distributors in favour of selling drugs direct to pharmacies.
Advinus Therapeutics is to use Corning Epic label-free detection to provide clients in India and abroad with biologically relevant drug discovery data.
Lanxess has opened an ion exchange resin production facility in India to cater for growing pharmaceutical manufacturing sector demand for ultrapure water.
WikiLeaks has published a list of overseas biopharmaceutical facilities considered vital to US national security as part of its release of leaked diplomatic cables.
Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country.
Counterfeit ACT could support the spread of drug resistant malaria strains from South-East Asia, where chloroquine first became ineffective, to sub-Saharan Africa.
The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.
India-headquartered pharmaceutical packaging manufacturer Bilcare has rolled out a new unit, Bilcare Research, which merges its existing films and foil businesses with those of recent acquisition Ineous Films.
Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.
US based healthcare distributer, Cardinal Health, has announced the $470m acquisition of privately held healthcare distribution business Zuellig Pharma China, known locally as Yong Yu.
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
Finland, Brazil and Mexico recruit more patients per site than any other country where clinical trials are frequently conducted, according to EMA data.
ShangPharma expects its cGMP production site, due to open in 2011, and biologics services to drive growth as it builds on a 17 per cent increase in revenues in the third quarter.
UK drugmaker, GlaxoSmithKline and Moscow-based JSC Binnopharm have formed a deal that will see the latter produce GSK’s cervical cancer, rotavirus and pneumococcal vaccines in Russia.
Narrowly defined pharma self-interest and lack of coordinated political effort means, despite the best effort of some, the problem of counterfeiting may be worsening.