Competition among small CROs kept prices steady in 2014 despite higher sponsor R&D spending and greater outsourcing penetration, according to a Citi Research survey.
Rules governing when drugmakers should warn regulators about supply interruptions need to take mitigation plans into account according to European industry groups.
Abenza subsidiary Antitope has extended its relationship and will provide manufacturing cell lines for two developing HIV vaccines from the French National Institute of Health and Medical Research (INSERM); the National Health Agency for Research on AIDS...
Quintiles has said Pfizer will “remain a customer” after analysts said the CRO lost out to a privately-owned contractor in the race to be the drug giant's third alliance partner.
India-based CMO Piramal has acquired US-based sterile injectable CDMO (contract development and manufacturing organization) Coldstream Laboratories for $30.65m.
Following Wockhardt’s decision to cease supplying APIs to the EU market, the UK drug regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has updated its statement of noncompliance to include all APIs made from the India-based manufacturer.
In order to align more closely with ICH’s Q3D guideline for elemental impurities, USP has pushed back until 2018 when its chapter on elemental impurities will apply to industry.
Big pharma and CROs looking to exploit wearable technology in clinical trials will need to overcome reliability and regulatory problems, says an expert.
MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.
Novartis will close an OTC plant in Puerto Rico by 2019 and transfer manufacturing and packaging actives to sites in the US and facilities operated by Eli Lilly and Virbac.
Sanofi has selected Boehringer-Ingelheim to manufacture monoclonal antibodies in an agreement that extends to the French drugmaker's partner Regeneron.
The US Institute of Medicine has come out strongly in favour of sharing clinical trial results and says funding should be withheld from studies which do not make data public.
CMO consolidation is resurrecting the ‘all-under-one-roof’ manufacturing model, but will firms fall into the same inefficiency pitfalls that drove pharma to outsource in the first place?
With a three-year growth rate of 348% and the addition of over 450 jobs from 2012 to 2014, CRO Clinipace is now chasing acquisitions after closing a $50m round of debt and equity financing.
Southern California-based CRO WCCT Global is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) on influenza research.
A Fresenius Kabi plant in New York has been upgraded, and up to five new products could receive FDA approval, almost three years after receiving a warning letter.
The value of the Swiss franc fluctuated today after the country’s central bank abandoned its minimum Euro exchange rate in a shock move that saw shares in Roche, Novartis, Actelion, SGS and Lonza fall.
As the second-largest central labs provider in the world, Quintiles is looking at the LabCorp acquisition of the world’s leading central labs provider Covance as a way to potentially nab more market share.
Industry groups PhRMA, BIO and GPhA are petitioning the Supreme Court to overturn a local law that requires pharma companies to cough up payment for safe disposal of medicines which make their way to one county.
Critical solvents used by the pharmaceutical manufacturers have been excluded from the EPA's final ruling on waste disposal, in a move welcomed by a US industry group.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
The US FDA has rejected Pharmexcil claims it no longer informs Indian regulators of manufacturing plant inspections and said its policy is to invite host-country inspectors to attend visits.
2015 is the year that AMRI loses its royalties for discovering the API of Allegra and the company is now looking to its string of recent acquisitions and new contract revenue to offset the loss.
Quintiles subsidiary Novella Clinical and the academic research arm of the Cardiovascular Research Foundation (CRF) are collaborating to offer pre-clinical to post-market trial services to developers of cardiovascular drugs and devices.
Fareva has added extra micronization capacity citing growing demand and the opportunity to work with customers earlier in the development process as the driver for the investment.
CROs, as well as sponsors, are receptive to, and plan to increase their use of ePRO (electronic patient reported outcomes), according to a survey published Monday from the Tufts Center for the Study of Drug Development.
Industry won’t see much of an initial impact from the US FDA’s newly formed Office of Pharmaceutical Quality, though in a couple of years the agency will have more benchmarks and new technology to find and single out the worst manufacturers.
The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra.
The record number of orphan drugs approved in Europe last year reflects the pharma industry’s need to refill pipelines and scientific advances says Genetic Alliance UK
Shire says its $5.2bn (€4.4bn) acquisition of NPS Pharmaceuticals is a calculated risk, coming just days before the US FDA decides whther to approve the hormone replacement therapy Natpara.
PPD’s recently acquired biotech company X-Chem is launching a multi-target collaboration with Janssen Biotech. Financial terms of the deal were not disclosed.
Chinese service provider WuXi PharmaTech has acquired NextCODE Health, a US and Icelandic genomic analysis and bioinformatics company, for $65m in cash.
