Indian drugmaker Ranbaxy Laboratories has withdrawn stocks of its acne drug Sotret in the US for the second time this year after some tablets were found to be out of specification.
Synexus has recruited more than 2,000 children in three months for a Phase III rotavirus vaccine study, which it believes validates its methods and demonstrates they are particularly effective in late stage vaccine trials.
The recent wave of M&A will lead to manufacturing over-capacity at pharma companies but only a small number of these sites will be sold to CMOs, in part because of the facilities’ suboptimal locations, according to a report.
Sinovac Biotech has formed a joint venture which will give it cost effective manufacturing capacity for 20m does of live attenuated vaccines and 20m doses of vero cell cultured vaccines a year.
The market for contract manufacturing organisations (CMO) will be worth $33.7bn (€22.4bn) by 2014, according to a report which says developing biologics capabilities is a key imperative for growth.
Millipore has acquired the remaining 60 per cent of its Indian joint venture (JV) to drive growth in the country which it views, along with the other BRICS nations, as a critical part of its strategy.
Sistemic is targeting the US by setting up an office in Boston, Mass, from which it will promote its services that use miRNA to identify and understand a compound’s activity in a simpler way than genomics or proteomics.
Icon is looking to expand its bioanalytical capacity in Asia, notably in China, and bolster its genomics, proteomics and cell-based assay capabilities, according to a VP who discussed diversification of the business.
The drug industry must “fundamentally change” how it sells products and make greater use of advanced analytics to measure performance, according to a report by Deloitte Consulting.
GEA Pharma Systems has extended its agency agreement with India’s Ace Technologies to include its range of lyophil freeze-dryers in a bid to further open up the market.
A five-day international anti-counterfeiting operation involving regulators, police and customs officials from 24 countries has resulted in the seizure of 167,000 counterfeit pills.
Just weeks after completing its billion dollar Wyeth takeover, US drug giant Pfizer has floated the idea of entering Japan’s $5.8bn (€3.9bn)-a-year generic drugs market in 2011 in a bid to further diversify its revenue streams.
PPD’s acquisition of Merck’s vaccine testing laboratory will give it a geographic location from which it can compete for business with its “number one competitor”, which is well established in the north east of the US.
Continued high demand for vaccine manufacturing technologies saw life sciences emerge as one of the few positives for industrial processing specialist Pall in Q1.
It is “legislative madness” to allow reimportation in the US, according to the chair of EAASM who spoke at AAPS about Europe’s “porous supply chain” and how it could affect the standard of medicines in the States.
UK process technologies firm Reaxa has received a £146K (€164K) R&D grant from the Northwest Regional Development Agency (NWDA) to scale-up production of its EnCat nickel catalyst.
Boehringer Ingelheim looks set for a significant windfall with results from Phase III trials indicating that its drug flibanserin can boost sexual desire in women, raising the prospect of a female equivalent to Pfizer’s Viagra.
WuXi PharmaTech’s operating income increased by 35 per cent in the third quarter, underpinned by strong growth in China-based laboratory services, but its manufacturing operations continue to struggle.
Regulatory enforcement efforts to tackle counterfeit and substandard APIs are in disarray, according to Guy Villax, CEO of Hovione, who spoke at AAPS about the scale of the problem.
French drug delivery specialist Galenix has named DSM’s pharmaceutical products unit as its manufacturing and co-marketing partner as it continues to efforts build its global presence.
Pfizer will close six R&D facilities in the US and the UK, reducing its global capacity by over a third following completion of its acquisition of Wyeth.
Genmab has put its Brooklyn Park, Minnesota, US facility up for sale, which will reduce its headcount by 300, and plans to use CMOs to cover for the loss of capacity.
Canada’s Biovail Contract Research says its stand-alone biostatistics unit will help sponsors “anticipate roadblocks ahead of time and create a sound statistical analysis plan for optimal results.”
The ICH says it made progress on its S9 guideline on non-clinical data requirement for late-stage cancer treatments at its most recent steering committee meeting in Missouri, US.
New US Pharmacopeial Convention (USP) monographs designed to prevent adulteration of key excipients with diethylene glycol (DEG) and ethylene glycol (EG) have been published ahead of their official implementation date in February.
Ohio, US-based CTI Clinical Trial and Consulting Services (CTI) has bought German trial staffing specialist CRS Clinical Research Services (CRS) to build its presence in Europe’s contract research sector.
Particulate Systems (PS) and Surface Measurement Systems (SMS) have entered into a strategic collaboration drawing on their knowledge of using analytic equipment for the characterisation of particulate, porous and complex materials.
US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.
US R&D facilities in Rahway and Kenilworth, New Jersey will remain operational as they are vital to the to the newly formed Merck Schering-Plough group, according to CEO Richard Clark.
Welsh contract services firm Penn Pharmaceuticals has reorganised its transport and delivery infrastructure in the first phase of a £12m (€13.3m) expansion at its facility in Tredegar.
Pfizer and Nigerian authorities want Trovan compensation claimants to provide DNA samples to confirm their identity, according to former Nigerian Supreme court justice Abubakar Wali.
Novartis is investing $250m (€170m) to construct a facility in China focused on research, development and manufacture of APIs and has earmarked a further $1bn to expand its R&D activities in the country.
Good news for Human Genome Sciences (HGS) as development partner GSK reports Ph III data showing that their co-owned lupus treatment Benlysta (belimumab) is effective.
Lonza cuts 2009 earning guidance and may reduce its workforce under “Project Bond” cost cutting plan after a Q3 characterized by an “accumulation of unexpected events”
Early-stage CDC research suggests that the anti-inflammatory properties of cholesterol-busting statin drugs can help mitigate the impact of flu infection.
Novavax says its new Indian vaccine plant will be operational in four months with sufficient capacity to help meet local demand for seasonal influenza vaccines.
Late last week Ecuador’s government announced plans to sidestep patents on more than 2,000 drugs, enabling them to produced local or imported as “generics”
Novotech says its new “management hub” in Kuala Lumpur, Malaysia will serve as a base for expansion in the booming Asia-Pacific contract research sector.
