Vindon says its investments in its Irish and Californian facilities come as pharma companies shift to outsourcing stability storage in order to save costs.
Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.
The long-term distribution deal with Walgreens and Alliance Boots is expected to add an incremental $28 billion in revenues, according to AmerisourceBergen.
As the dissolution of Angel continues, its core manufacturing facility has been bought by AB Technology ensuring long term operations and rescuing 23 jobs.
Fraudulent manipulation of preclinical trial data is rare and the regulations that cover this type of research do not need to be revised according to the UK MHRA.
The US Environmental Protection Agency (EPA) says Teva still needs to address environmental issues at Missouri API plant landed with a $2.3m civil penalty.
The UK’s CCRA (Clinical Contract Research Association) says the number of Phase 1 clinical trials in the UK has “decreased substantially” since 2003 and is likely to be further diminished in the next few years.
Marketed drugs will not need to be tested under final guidelines on 'tablet scoring' for branded and generic medicines issued by the US Food and Drug Administration (FDA) this week.
Following last week’s shuttering of a manufacturing plant administrators have sold Angel Biomedical to new company Collbio as they start offloading CMOs assets.
Pennsylvania-based Calvert Laboratories and Particle Sciences are combining their expertise in preclinical drug development to provide clients with more streamlined options.
Progenitor Cell Therapy (PCT) has started testing to see if an RNA-based characterization tech developed by Sistemic can improve cell therapy production.
Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.
India’s Ministry of Health & Family Welfare will create two new independent committees to oversee policy, guidelines and SOPs (standard operating procedures) for clinical trials, drug approvals and FDCs (fixed-dose combinations).
Cost competition and the financial crisis have slowed the growth of the global API marker over the past four years according to new data released by the CPA (Italian Chemical Pharmaceutical Association).
Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.
Pfizer, GlaxoSmithKline, Roche and 26 other large pharmaceutical companies will provide about $5.85m (3.5m Euros) over three years to fund an Interpol initiative to combat pharmaceutical counterfeits and crime.
CROs and sponsors that apply a risk-based algorithm to monitoring clinical study sites could reduce the deployment of research associates and target more high-risk patients and sites, according to a new report from PricewaterhouseCoopers (PwC).
The EC should add the US and Japan to list of countries exempt from new API import laws and intensify talks with China and India to prevent shortages according to EFPIA.
Novo Nordisk says “there is still room for improvement” in the development and delivery of insulin as it awaits FDA approval of its challenge to Lantus.
California-based CRO Agility Clinical and EU-based PSR Orphan Experts have partnered to allow orphan drug companies to utilize their safety and regulatory knowledge in both markets.
CRO WuXi PharmaTech has announced 22% net revenue growth in 2012 as its China-based lab services grew significantly. That trend is expected to continue with double-digit growth in 2013.
Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.
The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.
The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger FDA.
Merck Serono says “fast progress” in its restructure programme helped double its net savings guidance for 2012 though headcount dropped by almost 2,000 with more cuts to come.
Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).
WuXi PharmaTech has expanded its partnership with Open Monoclonal Technology (OMT) to use its transgenic rats and mice in China and other Asian countries.
A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
Welcome to Outsourcing-Pharma.com’s round-up of CRO focused partnerships and collaborations including news from Particle Science and Agility Clinical Partners.
Ajinomoto says its flexible approach to tech licensing differs from rivals who are more focused on locking customers into manufacturing services contracts.
The US FDA has completed its re-inspection of Hospira’s Rocky Mount, North Carolina, plant and cited the company with 20 violations, three of which were repeat observations, according to an SEC filing.
As anticipation swells over how the biosimilar market will shape up in the US, some contract biologic manufacturing executives don’t seem to think the size of the market is worth all of the hype yet.
Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
