The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.
European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.
Rising drug prices and the subsequent increasing number of drugs ineligible for reimbursement will challenge drug developers to provide clinical superiority evidence.
More drug discovery work will be outsourced this year according to a report which suggests pharmaceutical industry desire to reduce the risk of failure and cut costs persists.
The merger combines the two companies’ data sets in order to expedite clinical trials and has the potential to send “shockwaves” through the industry, says ISR president.
Finding the right patients quickly is an ongoing problem in launching clinical trials, so several companies have formed an alliance to advance precision medicine development.
TxCell is working on new ways of delivering its Crohn's disease therapy Ovasave that will replace the somewhat unusual method it is using in clinical trials.
The slowdown in developing markets has prompted many pharmaceutical firms to focus on specialty drugs according to an IMS Health analyst, who predicted that the trend will accelerate.
Drugmakers seeking to stop “commercially confidential information” being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause says the EMA.
DCAT Week, which will be March 14-17 in New York, is organized by the Drug, Chemical & Associated Technologies Association (DCAT), and brings together key players from across the industry.
There are concerns that pharma companies are not fully prepared to meet the new requirements on risk-assessment for excipients, even though the deadline is just a few weeks away.
With the expectation of new regulatory guidelines, and the need for increased productivity, companies will need to become “comfortable with data,” says Quintiles executive.
Up to 90% of new chemical entities having properties that make them a challenge to successfully formulate, says Juniper Pharmaceuticals which has won a reformulation and manufacturing contract from PharmAust.
Certara’s new consulting firm will rely on modeling and simulation expertise to expedite the drug development process, as China commits to increasing innovation.
India’s CRO industry is playing catch-up to the generic and manufacturing sectors, according to the departing CEO of one of the largest players, Syngene.
Higher quality data could convince pharma firms to pay to trial generic drugs for new indications say researchers calling for diclofenac to be studied as a cancer treatment.
Medidata expects to become a strategic partner to even more pharma firms as Boehringer Ingelheim becomes the latest to transition to its cloud technology platform.
In 2016 clinical trial and real-world data will become increasingly important in the decision to prescribe medicine, Parexel President and COO Mark Goldberg told Outsourcing-Pharma.com.
If even the apparently non-joke, potential US presidential candidate Donald Trump criticizes your behaviour, you must know what you are doing is unpopular.
Clariant will build a CHF10m ($9.7m) moisture control device plant in Cuddalore, Tamil Nadu to cater for the branded and generic drugmakers operating in India.
Pfizer says it will decide in 2018 whether to split its generics and branded businesses but M&A experts are already predicting how the giant will get rid of its established drugs programme.
As World Antibiotics Awareness Week draws attention to the threat of resistance, pharma companies large and small say a worldwide overhaul of payment models will make anti-infective R&D profitable again.
Quintiles and Covance are best placed to benefit from the increasing trend of leveraging existing data to increase trial efficiency, according to an analyst survey.
Drug companies still outsource to make fixed costs variable rather than to try and improve their public profiles through sustainable sourcing according to a Deloitte analyst.
Covance has announced a contract expansion with one of its existing customers signing a multi-year deal to use the CROs trial optimization tech for lab monitoring.
With a flurry of recent deals tied to Sanofi and a string of other collaborations, Germany’s Evotec is seeing a steep rise in revenues from its contract research division and it expects that growth to continue.
Mereo BioPharma Group, a recently-formed specialty biopharma company, has selected CRO (contract research organization) Icon as its sole provider of clinical development services.
"People are the essence of the company going forward," said Teva, referring to the news that the world's largest generic drug maker will purchase Allergan's generics business for $40.5bn, at its Q2 financial results press conference...
As the US regulator awards iclaprim expedited QIDP status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy.
As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.
