The European Medicines Agency (EMA) has highlighted the quality APIs manufactured outside the EU as an area of concern in the draft 2015 road map it unveiled this week.
Merck KGaA has opened a new centre in India to showcase its range of technology solutions to the country’s rapidly expanding pharmaceutical and cosmetics industries.
in-Pharmatechnologist presents a roundup of the latest deals and acquisitions in the pharmaceutical sector with news from Optima, SPI and DPS Engineering.
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.
An agreement to provide exclusive toxicology services, pharmaceutical analysis and bioanalytical services are at the heart of a new partnership signed by life sciences company Bioanalytical Systems (BASi) and clinical-stage pharmaceutical company Pharmasset.
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.
US CMO Affinity Life Sciences has completed the expansion of its manufacturing plant, adding capacity for cGMP lyophilisation and biomarker development.
Followed the news in 2010? Then test your knowledge of biopharm in 2010 against colleagues, peers and our community of readers in our exclusive map-based quiz.
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.
Outsourcing-Pharma presents five of our top audio-visual articles of 2010, including a timeline of Lilly’s outsourcing, the need for US capacity and why biomarkers are indispensible.
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.
Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles 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.
Big pharma continued to cut in 2010, closing plants and laying off staff in an attempt to cut costs and adjust post-merger. in-PharmaTechnologist presents a round up of five of the most read in 2010.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Catalent, Quintiles, ACM and Premier Research.
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.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including a new head of vaccines at Sanofi and another exec moving from Pfizer to AstraZeneca.
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.
in-PharmaTechnologist presents five of our top audio-visual articles of 2010, including a map of Pfizer’s plant closures, gangsters in the pharma industry and a look inside SAFC’s HPAPI plant.
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.
ProJect Pharmaceutics has opened its Munich headquarters and laboratory facilities in Martinsreid, Germany, beginning business operations to transform proteins, peptides and small molecules into novel drugs.
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.
