Insmed has become the first company to receive approval through the limited population pathway for antibacterial and antifungal drugs set up by the US FDA in 2016.
The middle-market private equity firm Nautic Partners has acquired Mikart, an Atlanta, GA-headquartered contract development and manufacturing organization (CDMO).
The identity and access management firm Exostar has acquired UK-headquartered Pirean Limited to provide the pharma industry with simplicity, speed, and security, says VP.
LabKey and Linguamatics have designed an integrated NLP data management solution to help accelerate clinical data abstraction and curation of unstructured notes and reports for clinical research.
Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.
MSD has warned regulators to expect a shortage of its Parkinson’s medicine, Sinemet, due to production constraints at a contract manufacturer’s facility.
The issue of pricing is a familiar discussion for the pharma industry and Ruchin Kansal, of Virtusa, believes that there is the potential for a win-win situation.
Previous setbacks in Alzheimer’s disease research for disease-modifying treatments have set the stage for a pipeline of new medicines now moving into clinical trials, according to a recent PhRMA report.
As previously reported, researchers have determined that ketamine has potential as a treatment for patients at imminent risk for suicide, and as a therapy for treatment-resistant depression.
After making waves with its launch in June, Javara this week has signed a letter of intent to design an operating model to integrate clinical trials at a medical center in Winston-Salem, NC.
The European Medicines Agency has unearthed a ‘sartan’ medication, in losartan, that contains low levels of the carcinogenic substance, N-nitrosodiethylamine.
Gilead says launching generic versions of its pricey hepatitis C drugs more than a decade prior to patent expiries will more closely align product list prices with their cost.
Clinical trials that support FDA approvals of new drugs have a median cost of $19m – representing less than one percent of the average drug development cost, which is estimated at between $2 and $3bn.
The drug development consultancy Certara this week has purchased a pharmacometrics modeling workbench and released a cloud-based platform to allow therapeutic decision-making apps to be delivered at the point of care.
The price of running a clinical trial to obtain FDA approval is a fraction of the total drug development cost – challenging traditionally held beliefs about the amount of money required to study prescription drugs, according to new research.
As aging populations grow and treatment paradigms shift, the industry must prepare for greater challenges in the rare disease clinical trial space, says CRO executive.
In this first part of a two-part investigation, we look at how NDMA receptor antagonists, such as ketamine, could be poised to make a breakthrough in the treatment of depression – an area where the pharma industry has struggled to identify new targets...
Medicen Paris Region and Cap Digital announced are encouraging their members to support Hu-PreciMED, a precision medicine project launched by Oncodesign, Servier, and Intersystems.
The platform will be designed to help life sciences organizations improve productivity, efficiency, and innovation in early stage drug development, says Accenture executive.
Iqvia is expanding its alliance with Salesforce through which the companies will release SaaS and technology-enabled services to automate clinical trial processes and reduce patient burden.
Major pharmaceutical companies have defended their accounting and tax policies following the release of an Oxfam report, which claims some of industry’s major players hid profits in overseas tax havens.
The US FDA has issued a warning letter to contract testing laboratory Pharmaceutical Laboratories and Consultants, Inc., after a microbrewery was found to be operating in shared space.
With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
Deception among clinical research participants is prevalent and a global issue, say researchers, with self-reported adherence found to be largely inaccurate.
The topic of antimicrobial resistance is back in the spotlight after the US FDA released a new website and a number of proposals to encourage the drug development in the area.
GSK has invested $27.8m into manufacturing operations in Canada, including a technology transfer of Voltaren products from facilities in Switzerland to Mississauga.
The clinical development services provider Phesi is looking to patent its method and system for developing clinical trial protocols – which enables faster patient enrollment and study completion, says CEO.
VGXI, a subsidiary of GeneOne, signed a licensing agreement with Houston Methodist Research Institute to produce RNA one of the most valued clinical ingredients.
The European Patent Office has upheld protection relating to Gilead’s costly Hepatitis C drug Sovaldi, which Médecins du Monde claims prevents patients from receiving affordable treatment.
