A US FDA investigation of CRO PPD did not uncover any violations that might prompt a Form 483 for its work related to Bristol-Myers Squibb’s approved drug, Eliquis.
As GlaxoSmithKline, Bristol-Myers Squibb and Novartis are embroiled in alleged bribery and data falsification in Asia, CROs will have to a take a hard look at whether their investments in the region will pay off as quickly as they once thought.
Ernst & Young (E&Y) analysts will try to illuminate the Sunshine Act for Greenphire's customers in the third collaboration the trial payment technology firm has signed in as many weeks.
A consortium of European vaccine experts, including the Swiss CRO Preclin Biosystems, has received almost €5.5m ($7.1m) from the EU to develop a vaccine against the deadly MRSA bacteria.
Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency (EMA) collaboration chief, Emer Cooke.
AstraZeneca has selected the Sarah Cannon Research Institute (SCRI) to help develop oncology compounds using molecular profiling to more accurately predict a patient's response.
Despite recent progress, the EC underestimated the challenge of getting non-EU regulators to ensure APIs shipped to the European Union (EU) meet new import requirements according to Eucope.
CRO Novotech has added two new clinical research sites in Hong Kong and the Philippines earlier than expected as demand from sponsors, particularly US biotech companies, has spiked.
Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
Critical Pharmaceuticals says its protein and peptide delivery technologies offer long acting injectables and greater compliance, saving money and easing patient administration.
With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.
The latest technology platform from Capsugel's four-month old DFS Unit offers greater bioavailabilty and stability in oral dose formulation, says the company.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
The EU will become more competitive thanks to new clinical trial regulations that include data transparency, says rapporteur Glenis Willmott MEP, though industry is opposed.
US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Proposed UK “animal research” labelling laws may backfire if improvements in culture-based toxicology testing continue, according to in vitro CRO Cyprotex.
Yusen Logistics has launched a new air freight service to help UK drug major AstraZeneca ship its products to Australia in a new agreement announced today.
PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.
Brand-to-generic conversions have been blamed for “somewhat softer than expected” financial results at McKesson, though significant FY2014 direct revenue growth has been predicted.
Tension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any time soon, but both sides seem intent on arriving at a middle ground where micromanagement stays low and the level of quality remains high.
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
Following its acquisition by Mayne Pharma, Metrics says it is to offer proprietary pellet form technology for advanced drug release and to increase bioavailability.
Globalisation, outsourcing and a move towards biopharmaceuticals are leading innovation for pharma distribution companies, according to DHL Global Forwarding.
Merck & Co. has opened a new packaging facility in China to support its emerging market strategy but says it is still committed to traditional regions.
Eisai has tasked a new exec with making trials more likely to succeed just a few months after its candidate ovarian cancer blockbuster failed at Phase III.
An EMA report says increased Russian participation in European submitted clinical trials is part of a trend away from traditional regions, yet fluctuating legislation may affect numbers.
The US FDA has opened for public comment a new ICH draft guideline that aims to help manufacturers identify and control mutagenic impurities during the development of new drugs.
GE Healthcare and iBio are in talks about future projects after confirming they are working on a plant-based vaccine manufacturing site for Brazilian drugmaker Fiocruz/Bio-Manguinhosin.
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.
Drug solubility science, technology and solutions will take centre stage at “The Bioavailability Challenge” a free to attend online event in-Pharmatechnologist.com is hosting on Wednesday, March 20.
The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.