Researchers from Harvard University have developed an insulin formulation using two ionic liquids they say could lead to the development of a pill for diabetics.
The US FDA has issued Henan Lihua Pharmaceutical Co. Ltd. a warning letter and imposed an Import Alert 66-40 following inspections at two manufacturing facilities in Henan, China.
Innovations in drug development positively affect clinical trial timelines, market launch likelihood, and patient access – though adoption remains low, says report.
Emulate is further developing its Human Emulation System and building a team of experts to help drive broad adoption of its Human Emulation System in the pharmaceutical industry.
Clinipace has launched a new branding for its collaborative approach to clinical trial management, which will “contribute to its goal of becoming the industry’s premier mid-sized CRO,” says CEO.
There is an increased need for transparency to improve the conduct of pediatric clinical trials and enhance the site investigator experience, says Syneos executive.
Iqvia has launched a new suite of virtual study options to challenge the traditional clinical research mindset with a patient-centric approach, says company executive.
UK-based GW Pharmaceuticals has been given marketing approval by the US FDA for its product, Epidiolex, to be used for the treatment of two severe forms of epilepsy – Lennox-Gastaut syndrome and Dravet syndrome.
Javara today has emerged as the latest company to take on the clinical trials industry – though backed by a group of industry veterans, it is not a startup, and its goals not short of transformational.
Indivior has requested a temporary restraining order against Dr. Reddy’s Laboratories to prevent further sales of its generic buprenorphine and naloxone sublingual film product in the US.
LabConnect and Symphony Clinical Research are teaming up to improve the delivery of home-based clinical trials by co-developing new processes and tools.
Orion Contract Manufacturing will make, package, and supply Peptonic Medical’s over-the-counter VagiVital product, which is set to launch later this year.
The contract bioanalytical testing services company BioAgilytix is expanding its technology suite with the addition of Sword Bio’s detection platform for immunoassays.
ACM Global Laboratories has acquired ABS Laboratories to better serve its clients in the clinical trial market with an expanded "scientific acumen," says company president.
Elligo Health Research is partnering with Flatiron Health and the University of Chicago to develop and pilot a common data architecture as part of an FDA-led project.
A growing client base in the US and healthy demand for highly potent active pharmaceutical ingredients (HPAPIs) are driving expansion at the UK-based CDMO Sterling Pharma Solutions.
The rule designed to increase protection for clinical trial participants was set to go into effect next month, but another delay announced today has pushed this date back an additional six months.
Real-world evidence, digital endpoints, and patient centricity are among the top trends in clinical trials – the benefits of which will be realized in part through advances in eClinical technology.
This year’s DIA Global Annual Meeting will focus on the latest global trends and showcase the "diverse group of key individuals driving the life science ecosystem forward," says DIA Americas managing director.
Mylan says ‘minor deficiencies’ in its abbreviated new drug application for its proposed generic version of GSK’s Advair Diskus have prompted the US FDA to issue a complete response letter.
Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.
Providing a coherent and persuasive risk assessment and a “well-messaged outline of key communication points” are key to winning US FDA Advisory Committee approval, say industry consultants.
The drug development “finish line” is not regulatory approval, says Syenos Health chief scientific officer Judith Ng-Cashin, MD, who discusses bringing the payer and patient voice into the process.
DSP has released its generic Atorvastatin drug product within the EU with additional markets to be added later this year the firm looks to become a full-service generics company.
The NIH has halted funding for a clinical trial – funded in part by several beverage and brewing companies – after a review found employees violated NIH policies in soliciting gift funding.
Evotec is integrating Sanofi’s infectious disease unit into its organization and will collaborate to launch new "open innovation" initiatives aimed at accelerating infectious disease research.
A lack of ‘basic documentation’ and ‘dubious’ environmental control system reports at Taiwan Biotech’s manufacturing plant were cited in the US FDA warning letter.
Medidata is acquiring Shyft Analytics for $195m, creating a new platform that will combine clinical development with commercial and real-world data analytics in a first for the industry, says a company executive.
The Croatia-headquartered contract research organization (CRO) has opened its first office in the US and plans to further expand its footprint organically and through potential acquisitions.
Oral tolerability concerns have prompted the US biotech to close Ph II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).
Saama has launched a set of artificial intelligence (AI) capabilities designed to understand "typical life science domain questions" to better support clinical trial planning, feasibility, and conduct.
Marken this week has announced the relocation of its Chicago logistics hub into a new, larger facility equipped with cold chain technology for clinical trial materials shipments.
Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.
Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.
