An EMA survey has found that 42% of businesses, with an important step in their regulatory processes occurring in the UK, are not adequately prepared to retain marketing authorisation post-Brexit.
The need to improve visibility, enable faster study execution, and improve study quality, is driving the industry to unify its "broken" clinical trial operating environments, according to a report.
AcuraStem has received $3.7m to develop a small molecule treatment for amyotrophic lateral sclerosis (ALS), which it says could compete with Sanofi’s Riluzole and Mitsubishi Tanabe’s Radicava.
The US Patent and Trademark Office (USPTO) has granted two patents related to VistaGen Therapeutics’ lead asset AV-101, an oral candidate designed to treat CNS diseases and disorders.
Gemphire Therapeutics tapped the Canton, MI-based contract research organization (CRO) MMS Holdings to help support a Phase IIb clinical trial of its first-in-class drug candidate, Gemcabene.
Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.
The US FDA has sent a warning letter to Chinese contract manufacturing organisation Foshan Jinxiong Technology, which makes over-the-counter products for children.
President Trump has condemned pharmaceutical companies, including Pfizer Inc., on social media, tweeting that they have increased list prices of prescription drugs without cause.
Novartis has instigated a voluntary recall of 470,000 packages of drugs, after a child managed to open and swallow a pill from a child-resistant product.
BASi and Seventh Wave Laboratories are joining operations via an asset purchase agreement, through which BASi will lease the CRO's facility in Maryland Heights, MO.
Japan-based ONO Pharmaceutical will use CluePoints’ centralized statistical monitoring platform to lead its RBM strategy over the next four years following a successful pilot study in 2017.
BioIVT adds transporter assay products and services to its ADME-Toxicology portfolio with the acquisition of Optivia Biotechnology – a deal which aligns with the company’s efforts to support drug safety and efficacy, says VP.
Recipharm has revealed that it will be offering a standalone serialization service to companies that have not yet prepared for the upcoming FMD deadline.
GlaxoSmithKline has selected TrialScope to facilitate clinical trial disclosure and transparency – as the benefits of patient centricity are paramount, and the risks of poor compliance magnified, says VP.
CRO Pivotal is collaborating with the non-profit cancer research association APRO to advance investigator-sponsored trials in bladder and prostate cancers.
UDG Healthcare has acquired two healthcare-focused firms, expanding its global footprint and service offerings – including those in health economics and outcomes research – in a deal worth up to $82.4m.
Dr. Reddy’s Laboratories has announced receipt of a US FDA establishment inspection report regarding two active pharmaceutical ingredient plants in Hyderabad, India.
Fermion Oy has completed construction of its manufacturing plant in Hanko, Finland, where it will make highly potent ingredients for ‘main markets’ and a growing client base in India, says president.
Catalent is set to acquire Juniper Pharmaceuticals in a $133m deal, which will provide the CDMO with a new European hub and the ability to win a larger share of early-phase development programs says exec.
The US FDA has announced that over 236,000 bottles of statins will be voluntarily recalled by Dr. Reddy’s Laboratories, after issues were found with impurities.
PPD has launched a new site solution for enrolling patients in clinical studies as it proposes enrolling patients first – before activating sites – via a new enrollment model.
Shared manufacturing equipment and utensils used between non-potent and potent drugs were among the cleaning concerns observed by the US FDA in West Virginia, US.
Patient-centric programs for clinical trials, such as travel assistance, are major deciding factors for patients considering participation – and should be standard for all studies, says BBK.
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.
