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.
Regulators, industry and academia must do more to close the knowledge gap created by a historic shortage of women in clinical trials, according to speakers at AAPS 2009.
US biotech Emergent BioSolutions has bought a manufacturing facility from Maryland’s MdBio Foundation is a bid to expand its production infrastructure.
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.
Icon is currently planning to occupy over a third of the 100,000 sq ft redeveloped hospital in Manchester, UK, which is due to open in 2012 and will become a flagship site for the CRO.
Pharma’s increasing collaboration and budget cuts have made hosted software more attractive to companies, according to Symyx which has made its lab notebook available on this platform.
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.
Parexel has established The Expert Office to provide a single point of contact for clients which want the CRO’s team to assist them with optimising all aspects of the clinical trial process
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.
Lonza has bolstered its protein design capabilities by acquiring Algonomics, a CRO with technologies which predict immunogenicity to improve development of protein therapeutics and vaccines.
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.
Quintiles is continuing to build alliances with large pharmas, inking deals to perform “the majority” of AstraZeneca’s (AZ) clinical pharmacology work and develop six oncology products in Eisai’s pipeline.
MDS’ Central Labs has been rebranded as Clearstone Central Laboratories following its acquisition by Czura Thornton, which is looking to expand the business and that of Chiltern, a CRO also owned by the investment company, into new geographies, according...
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.
Nokia, SAP and G&D are forming a company to provide anti-counterfeiting services which will draw on the firms’ respective expertise in mobile phones, supply chain technology and encryption.
inVentiv Clinical Solutions' new Clinical Global Alliance will help meet industry demand for rapid access to “concentrated patient populations” according to CEO Michael Hlinak.
Quintiles is collaborating with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London to establish a 30 bed Phase I site which will help meet demand for early-stage research conducted in patients.
US headquartered Unilife is targeting pharmaceutical companies with its new Unifill RTF safety syringe and product range and has begun seeking international trademarks.
Australia-based CROs, state government and a clinical trails network are collaborating with a Japanese company to encourage businesses to outsource preclinical and early-stage research to Queensland.
Increased focus on international markets, soaring demand for finished dosage forms and improved capacity usage helped India-based CMO Granules posting record revenues.
