With WuXi pushing full steam ahead in its bid to go private, one expert says that the company may be envious of a competing CRO -- Hangzhou Tigermed, which is smaller than WuXi but valued at a higher price on the Shenzhen stock exchange.
Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office...
With the aim of getting new drugs to patients more quickly, a new House draft bill released Wednesday offers a whole set of new ideas around what the NIH and FDA can do to speed drug discovery and development.
Medidata has reported its strongest ever quarter and says strategic CRO partnerships and risk-based monitoring offer opportunities to penetrate more of the market.
Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.
Understanding international regulatory demands, manufacturing standards and overcoming cultural barriers are key for Asian drugmakers looking to enter Western markets, says market access CRO ELC Group.
Pfizer has selected PPD as its third preferred contract research organisation (CRO), but the addition will not affect ongoing relationships with Parexel and Icon, the firm says.
Quintiles on Thursday announced the selection of Hospital Italiano of Buenos Aires, Argentina, as the company’s first “Prime Site” in Latin America, adding to the company’s network of investigative sites worldwide.
Competition in the notoriously tight-lipped CRO (contract research organization) and CMO (contract manufacturing organization) industries is getting fiercer as outsourcing picks up, though that hasn’t stopped one Chinese company from revealing who it...
Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.
Fighting drug fakers relies on collaboration according to supply chain security group RX-360, which says drugmakers put rivalries on hold in the war against counterfeiters.
Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information...
The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.
The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.
Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence to help reverse the trend.
Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).
The CMO (contract manufacturing organization) industry is ripe for consolidation as the rise in outsourcing continues and clients look to simplify their supply chains, DPx CEO James Mullen told Outsourcing-Pharma.com on Wednesday.
The European pharma market isn’t likely to deliver much growth over the next five years as generic markets commoditize, IMS Health VP Graham Lewis warned participants at the DCAT (Drug, Chemical and Associated Technologies) conference on Monday.
Despite legal reporting requirements, the vast majority of results from clinical trials are not reported on ClinicalTrials.gov within a year of their ending, according to a new study from the New England Journal of Medicine.
Following its three acquisitions over the last year, AMRI is now looking to extend its footprint into India further with the acquisition of a FDA-approved API site, William Marth, president and CEO of AMRI, told attendees at the Barclays Global Healthcare...
The European CRO (contract research organization) Federation is calling on the EMA (European Medicines Agency) to not allow for the “unrestricted publication of inspection reports” as only “findings that are of relevance to the public should be made publicly...
Higher capacity utilization is improving prices across the non-clinical research sector according to Huntingdon Life Sciences CEO Brian Cass, who told Outsourcing-pharma.com the preclinical CRO may add scale to US operations.
Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.
Sens. Tom Carper (D-Del.) and Pat Toomey (R-Penn.) reintroduced a bill that would permanently allow CROs (contract research organizations) to capture a share of the R&D tax credit.
The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from the WHO and ICH, academics contend in the British Medical Journal.
The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part of efforts to further protect study subjects, experts say.
The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.
The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's Center for Drug Evaluation and Research Janet Woodcock said in an interview.
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
Being a drug developer not just a service provider differentiates Simbec-Orion from the Big CROs according to CEO Ronald Openshaw, whose firm signed two strategic partnerships last week.
Improving investigative site relationships in 2015 is a top priority for pharma and CRO (contract research organization) execs, according to a roundtable recently hosted by the Tufts Center for the Study of Drug Development.
Novartis has divested, restructured, or mothballed 24 manufacturing plants since 2010 but says its new NBS cost-saving business will not focus on streamlining and consolidating sites.
Investment firm William Blair has upgraded preclinical CRO Charles River Laboratories to ‘outperform’ based on strong toxicology demand and the pending acquisition of Covance.
Competition among small CROs kept prices steady in 2014 despite higher sponsor R&D spending and greater outsourcing penetration, according to a Citi Research survey.
Quintiles has said Pfizer will “remain a customer” after analysts said the CRO lost out to a privately-owned contractor in the race to be the drug giant's third alliance partner.
The US Institute of Medicine has come out strongly in favour of sharing clinical trial results and says funding should be withheld from studies which do not make data public.
