Concept Life Sciences has acquired Aquila BioMedical, citing the CRO’s specific skill set, which will allow the company to provide services in areas “not previously accessible,” says executive chairman.
A year after implementing its policy on the publication of clinical data, reports on 50 medicines have been published and more than 80,000 documents downloaded – outcomes achieved through industry collaboration, says EMA.
InMed Pharmaceuticals is developing a gel-based cannabinoid drug for eye diseases such as glaucoma, which it says could be cheaper and more accessible than cannabinoid-based products on the market.
Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
Sponsors using a single-source outsourcing partner could potentially save up to $45m through reduced time to market, according to a recent Tufts study.
Kyomed will evaluate the use of a connected bracelet to diagnose sleep apnea through a “holistic approach” the CRO hopes will become a benchmark for the future – and has been nominated for a MedStartup award.
The US FDA has rejected the muscular dystrophy candidate Translarna (ataluren), telling PTC Therapeutics more trial data is needed to prove the drug works and asking for additional information about how it is made.
Generics industry group Medicines for Europe says proposed supplementary protection certificate (SPC) waiver will help European API manufacturers compete.
The new Changzhou, China-based site adds transition metal catalyst-screening technology to STA’s small molecule process development and manufacturing platform.
“Bring Your Own Device” (BYOD) in clinical trials will be a “critical component” of future research says Bracket CEO following the company’s acquisition of mProve Health.
Parexel has partnered with Microsoft to advance patient-centric technologies and help deliver on the promise of personalized medicine following a need for efficiency and innovation in drug development.
Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.
US FDA inspectors have raised concerns about Akorn Inc’s manufacturing facility on Grand Avenue in Decatur, Illinois in a Form 483 made public this month.
Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.
Evidera has expanded its patient-centered research services, the advancement of which will enable the introduction of better treatments, faster, says team VP.
Clinigen Group plc has acquired the Japanese unlicensed medicines supplier International Medical Management Corporation (IMMC) in order to further develop its market access, says CEO.
The pharma world has converged in Frankfurt, Germany for this year’s CPhI Worldwide. In-Pharmatechnologist is here too to report the latest trends affecting the industry.
Chiome Bioscience has selected ProBioGen to develop and manufacture its monoclonal antibody LIV-1205, which is designed to combat liver cancer and solid tumours.
TriNetX has completed a yearlong project to expand its space from 8,200 to a 20,000 square feet in response to industry demand for its clinical trial services.
Fraunhofer is “redoubling” its efforts to develop new antibiotics and transfer research into clinical trials through a project available to external partners for development.
Vince & Associates Clinical Research is conducting a Phase Ib alcohol interaction study of Amygdala Neurosciences’ ANS-6637 for the potential treatment of substance abuse.
Recipharm has installed serialization technology at its contract production facility in Lisbon, Portugal citing impending US and EU rules as a driver for the investment.
Mutual inspection report recognition is positive, but EU and US FDA alignment on product specs and compendia would help drug firms, says regulatory expert Ajaz Hussain.
Pharmaceutical companies are more likely than their suppliers to cite cost improvement over time as the most effective metric for measuring supplier performance, according to a recent report.
The New Jersey Innovation Institute and Rutgers University have teamed up to establish an institute to promote the development of continuous manufacturing technologies for drug production.
WuXi AppTec’s acquisition of ResearchPoint Global (RPG) follows the release of a new guideline that will enable Chinese companies to accept clinical trial data from other countries.
Back-up generators and secondary manufacturing sites limited the supply and financial impact of Hurricane Maria across J&J’s Puerto Rican pharma facilities, the firm says.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
The VWR Science Portal provides customers with access to the Scientist.com supplier network, including more than 2,200 contract research organizations (CROs).
AMRI is offering its impurity solutions as a stand-alone service in response to new regulatory requirements that set limits for the amounts of elemental impurities in drug products.
