More than six million pet dogs are diagnosed with cancer every year – posing researchers with the opportunity to co-develop drugs for humans and animals.
The FDA has proposed a study to create a non-animal based model for drug development as part of its overall commitment to reduce the number of animals used in research.
It’s a phrase we’ve all heard a thousand times – often from clients explaining why they didn’t go with your business as they’ve opted for the assumed ‘safe bet’ of a global leader.
Charles River is eyeing M&A opportunities in every segment of its business, fueled by global market demand and a “fundamental shift” in the pharmaceutical industry, says CEO.
The US opioid crisis has been driven by early use in standard care, says Opiant director Gabrielle Silver, who urges pharma to ‘think differently’ to enable change.
Sandoz is the latest Zhejiang Huahai Pharmaceutical customer to issue a nationwide recall after trace amounts of a probable carcinogen were found in the supplier’s API.
Vertex was granted marketing authorization for its cystic fibrosis therapy in a combination regimen, marking the company’s third treatment for the condition to reach the market.
CROs this month have made significant new hires with WCG adding eight to its scientific leadership team, PPD hiring four, and BioIVT filling its new-created role of CCO.
Also, making the move from Bioclinica, David Kiger has been named...
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.
Clinical trial transparency efforts are falling short, with half of trials left unreported, according to a recent UK parliamentary committee report, which calls on the government to take action.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
Takeda is in talks to sell Shire’s experimental inflammatory bowel disease pipeline in an effort to meet European regulators approval for the acquisition.
A consumer rights watchdog is calling on regulators to suspend research at a Minnesota-based medical facility in response to concerns surrounding informed consent for a study involving Ketamine.
President Donald Trump signed the SUPPORT Act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn't the only crisis.
Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.
President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.
AAPS PharmSci 360 is a new conference this year, created in response to a desire for “fresh science,” specifically with chemical and biomolecular components. So what can you expect?
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
LabCorp sees significant opportunity to grow its Covance Drug Development business in the face of a potentially challenging 2019 and is on track to deliver costs savings as part of its LaunchPad initiatives.
An MHRA audit of Recipharm’s facility in Ashton-under-Lyne has revealed the CDMO was deficient in certain manufacturing procedures for potent products.
Changes at the state and federal level are paving the way for increased participation in clinical trials by providing patient reimbursement for study-related costs.
A review of ‘disabling and potentially long-lasting side effects’ reported in relation to treatments of fluoroquinolone and quinolone prompted the PRAC recommendation.
New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.
As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.
According to the US FDA, a facility inspection revealed operators leaned their heads and torsos over open containers while clearing bottle jams, before restarting the aseptic line.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased transparency.
The outsourced pharmaceutical services industry is getting out of its comfort zone, leveraging resources and partnership and focusing on how to make improvements – as demand continues to increase, says CRO.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
