Packaging Coordinators Inc (PCI) has announced its acquisition of Welsh contract development and manufacturing organisation (CDMO) Penn Pharmaceutical Services in a £127m ($215m) deal.
Reckitt Benckiser’ opioid addiction drug Suboxone delivered by sublingual film has shown a 'surprising' level of resilience against generic competition, the firm says as it plans to spin-out its pharmaceutical business.
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.
Analytic science company Waters has acquired all of the assets of MediMass, which includes its Rapid Evaporative Ionization Mass Spectrometry (REIMS) technology, as well as patent applications, software, databases and REIMS expertise.
SRI International was awarded a seven-year, $49m contract from the NIAID (National Institute of Allergy and Infectious Diseases), which is a division of the NIH (National Institutes of Health), for preclinical HIV/AIDS work.
The US Food and Drug Administration (FDA) is inviting public comment on plans to allow drug companies to reserve proprietary names for medicines as early as the end of Phase II trials.
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.
Strategic partnerships are “flexible, cost-effective and will become the trend over the next few years,” says CRO DZS, which has signed a multi-year deal with SBI Pharmaceuticals.
Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term, despite the transfer of equipment across its sterile injectables network.
The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.
GlaxoSmithKline has issued upbeat guidance despite a 12% fall in sales of its blockbuster asthma and COPD drug Advair, as new products enter the respiratory drug market.
Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.
Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.
Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.
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.
Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.
Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.
MonosolRx has found a new US licensee for its oral film ondansetron product, Zuplenz, signing up Galena BioPharma nearly four years after previous partner Strativa handed the drug back.
Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.
Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe.
As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency.
Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.
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.
Botox maker Allergan announced sales and earnings per share growth above the high end of its expectations, but it will cut 1,500 jobs, or about 13% of its workforce as it continues to avoid a $54bn hostile takeover bid from Valeant Pharmaceuticals.
A Swiss association has recognized the European Centre for Clinical Research Training (ECCRT), a SynteractHCR company, for training investigators and sub-investigators on GCP (good clinical practice).
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).
PhRMA (Pharmaceutical Research and Manufacturers of America) has warned that illegal medicines rejected at the US border will continue to be resubmitted for importation unless a proposed law allows their destruction.
Labs involved in EU-wide assessments of animal-free alternatives to drug quality and batch tests may soon be able leverage their work when seeking clearance to offer such methods as a service.
The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).
With its expected sale of 42.5m shares for $20.50 each, CDMO (contract development and manufacturing organization) Catalent is looking to become a public company.
The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.
Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.
Pharma groups and patients have objected to US Food and Drug Administration (FDA) plans to destroy prescription medicines personally imported into the US by patients.
Pfizer and Sun Pharmaceutical Industries have boosted their sterile injectables businesses through the respective acquisitions of InnoPharma and the CMO Pharmalucence.
Preclinical CRO Harlan Laboratories has partnered with French CRO Fluofarma to strengthen the companies’ drug discovery and translational medicine services.
