Chiasma says a scale-up manufacturing agreement with Capsugel will be unaffected despite Roche pulling out of a commercialisation contract for its oral peptide drug octreotide acetate.
Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.
Big Pharma is still reliant on CMOs despite talk of returning in-house, says AMRI, which has launched into the top ten manufacturers in the US injectables sector following its recent acquisition.
Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.
Icon has picked up new clients and expanded existing contracts in a robust Q2, but the CRO says it has seen no overall shift in its client concentration with strategic partners continuing to make up half its revenues.
Quintiles CEO Tom Pike told investors last week that the company is seeing “very strong demand from the larger pharmaceutical firms because their pipelines are full right now,” and at the same time, small biotech, with their plethora of funding, are starting...
Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.
The worst Ebola virus outbreak in history continues to spread in West Africa as biopharma companies are hampered by funding issues in trying to bring treatments and vaccines to human trials, a scientist says.
Increased emphasis on global clinical trials is promoting consolidation of contract research organisations (CROs), according to an industry report by M&A services firm 11T Partners.
Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.
AmerisourceBergen has reported “outstanding operational and financial performance” for the third quarter 2014, and is set to pass the $100bn revenue mark for the fiscal year.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.
WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.
Philanthropist Ted Stanley has gifted $650m to the Broad Institute as part of a wider attempt to galvanize research on psychiatric disorders and bring new treatments to market.
Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe.
Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.
Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.
Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.
Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).
CRO inVentiv’s Clinical Trial Recruitment Solutions (iCTRS) and the non-profit Alliance for Clinical Research Excellence and Safety (ACRES) are partnering to accelerate the development of a global standards system to improve the conduct of clinical trials...
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
UK-based CRO Chiltern has agreed to acquire Ockham, a North Carolina-based full-service CRO, and the combined company will now compete with mid-sized CROs. Financial terms of the acquisition were not announced.
Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing...
While the overall bioscience industry has seen 7.4% jobs growth between 2001 and 2012, the sector encompassing CROs and other research, testing and medical labs has grown by more than 28%, according to a new report from industry group BIO and Battelle.
The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
Actavis says it is closing facilities in St. Louis, Missouri affecting 190 jobs a week after completing the $28bn (€21bn) acquisition of Forest Laboratories.
Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.
Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.
Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.
Local talent is not satisfying the “tremendous” demand for top-level pharma employees in Asia and recruiters are searching internationally for candidates, a pharmaceutical head-hunter has said.
Teva could halve its manufacturing network as part of its $2bn-a-year efficiency programme says CFO Eyal Desheh, with most cuts hitting its core generics business.
When it comes to pharma acquisitions size does matter, according to analyst Ross Muken who says the momentary lapse in megamergers means business as usual for CROs.
Transparency campaigners have called on the EMA (European Medicines Agency) to rethink regulations set to be approved on Thursday that they say will severely limit clinical trial openness.
Bureaucracy is the biggest problem in accessing the Brazilian clinical research market, according to local CRO Techtrials, who says its expansion into the US was a far easier procedure.
The Puerto Rico Industrial Development Company (PRIDCO) says Actavis’ investment at two facilities is evidence of continued pharma growth, despite a number of recent closures on the island.
Capsugel has installed a commercial-scale dryer in its recently acquired Bend Research R&D facility, citing a rise in demand for non-GMP spray dried dispersion (SDD) services.
European pharmaceutical manufacturing jobs are at risk according to a group representing generic firms which says price caps in EU member states are hurting drugmakers.
Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
Veeva Systems says its new global alignment solution for pharmaceutical companies will bring together data interactions and content into its Commercial Cloud.
Eli Lilly is maintaining greater in-house control as manufacturing processes become more complex, whilst MSD is leveraging external over-capacity to fulfil its needs, the firms told Outsourcing-Pharma.com during a recent visit to Ireland.
Huntingdon Life Sciences has acquired contract research and animal models firm Harlan Laboratories, making it the third largest preclinical research organisation, according to the company.
