It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.
The first ever drug to treat smallpox has been approved by the US FDA, after having been created by SIGA Therapeutics in coordination with several US departments.
Antoxerene and investor firm Juvenescence have collaborated to form FoxBio Inc., an offshoot focused on small molecule drug discovery for the pathways of ageing.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
WCG and InformedDNA have established a new center for genetics and precision medicine in clinical trials – the increasing complexity of which, while potentially daunting, also creates the opportunity for transformational value, say industry experts.
The Scientist.com and HealthEconomics.com partnership connects real-world evidence (RWE) and health economic outcomes research (HEOR) sponsors and providers to help democratize pharmaceutical research, says company exec.
The Russia-based CRO Atlant Clinical has received certification in the organization and management of clinical trials – demand for which continues to increase despite political and economic challenges.
The US FDA announced a task force has been formed to prevent the shortage of drugs, by addressing the ‘underlying structural concerns’ that allow this to happen.
Velos has released a new clinical research analytics platform in which the source information is reorganized and reclassified to make it “considerably more useful for clinical research,” says CEO.
Synteract has acquired the dermatology CRO Cu-Tech, opening a fifth center of development as part of its strategy to develop “highly-expert therapeutic areas of focus,” says CCO.
Pfizer has announced a major shakeup of its business by splitting into three units: Innovative Medicines, Established Medicines and Consumer Healthcare.
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.
