A “quality mark” for firms that source from green API suppliers would add patient choice element to fight against antimicrobial resistance according to DSM Sinochem Pharmaceuticals.
Quotient Clinical has expanded its data sciences capabilities to support growing requirements for data and scientific expertise as studies become more complex.
As part of the company’s continued growth, Charles River’s recent partnership with The Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI) will work to accelerate drug development.
With several systems and process improvement initiatives underway, the growing contract research organization (CRO), Venn Life Sciences, continues to look for earnings enhancing opportunities, says CEO.
CPhI Worldwide is a marathon not a sprint says marketing guru Raman Sehgal who has written a survival guide for folks going to the drug industry’s biggest tradeshow.
Being geographically close to customers reduces excipient costs and timelines says Colorcon, as it prepares to open the doors at its first South American production plant.
Charles River Laboratories has acquired Worcester, MA-based contract research organization (CRO) Agilux Laboratories, further bolstering the company’s early-stage services.
The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
Per the collaboration, Marken’s worldwide depot network will provide the infrastructure needed for Faubel to deliver its smart label technology across the clinical trials supply chain.
The Science and Technology Advisory Group (STAG) was launched as a vehicle to focus R&D initiatives within Envigo and will run across all its service offerings.
Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.
The China Food and Drug Administration (CFDA) has withdrawn 1,184 drug registration applications following a recent yearlong government investigation into clinical trials in the country.
Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.
As the industry works to increase transparency in clinical trial data reporting, researchers have found that data on adverse effects remain largely unpublished.
Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.
BASF is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.
Parexel has entered into a definitive agreement to acquire ExecuPharm, a global functional service provider (FSP), in a deal that it said will add scale to meet growing demand.
Systech International has extended its strategic partnership with the serialization automation supplier ServicePoint as the company looks towards the Russian serialization market.
Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.
The 315 square meter facility will house more than 30 employees in Warsaw, Poland, where the company contract research organization (CRO) has operated since 2008.
Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.
The Obama administration recently finalized new rules that require researchers to make trial data public as the industry grapples with evolving data standards and looks to uphold its pledge to clinical trial participants.
In its first year of operations, IDT Biologika’s contract manufacturing facility in Rockville, Maryland has experienced rapid growth, which it expects to continue as construction carries on.
Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.
Yesterday, Almac Group announced a $5.2m investment in its US-based operations, which its global VP of operations said will support customers “across the drug development lifecycle.”
Digital health devices are increasingly being used by the industry to collect patient-generated data in clinical trials and improve medication adherence – and adoption is expected to increase.
While the demand for new diabetes therapies grows, the development of endocrine drugs is riskier than all other drug development, according to a study conducted by the Tufts Center for the Study of Drug Development.
Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
The collaboration combines Plasticell’s cell culture media for creating fat and bone cells in 2-dimensional cell cultures, with CellSpring’s high throughput 3-dimensional screening assays for drug discovery.
The full-service contract development and manufacturing organization (CDMO) for investigational medicinal products has purchased a new building to expand its high containment manufacturing and development operations.
Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.
iCardiac Technologies and SNBL CPC Japan, a Japanese-based Site Management Organization (SMO), will collaborate on cardiac safety studies in the country.
