ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.
Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.
Arecor has entered a £45m ($56m) agreement to develop once daily injection of Cadila Pharmaceuticals’ basal insulin product using its reformulation technology.
Biomedical Systems has announced a strategic partnership with RadMD through which the companies will collaborate on clinical trials and augment their imaging capabilities.
Charles River Laboratories and Nimbus Therapeutics have entered a multi-year strategic partnership to advance programs from early hit identification through Investigational New Drug (IND) submission.
Ohr Pharmaceutical has raised enough money to complete a Phase III trial of its AMD drug - Squalamine – just days after NASDAQ officials gave it 180 days to regain the exchange’s minimum listing price.
Synergy Pharmaceuticals Inc has launched a set of smartphone emojis – the Poop troop – to help chronic constipation sufferers express the physical and emotional impact of their disease in text messages.
Sumitomo Dainippon Pharma Co Ltd has ordered cell culture technologies from Hitachi as part of its effort to develop a treatment for Parkinson’s disease.
Diteba has developed a novel in vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.
Proposed legislation would enable contract research organizations (CRO) to claim an R&D tax credit – increasing incentive to conduct clinical trials in the US.
Industrial action at a Pfizer Ireland Ltd plant in Ringaskiddy, County Cork has ended after the firm agreed to let 35 new staff to join the company pension scheme.
Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.
A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.
India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.
The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.
The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.
The International Air Transport Association (IATA) has certified a DHL air freight station in Leipzig, Germany for the cold storage and shipment of APIs and finished pharmaceuticals.
Charles River Laboratories has launched a triple-immunodeficient mouse model – a humanized mouse model, the likes of which are “the future of oncology research,” says CRO.
The EMA has launched a technical anonymization group (TAG) that will help it develop best practices for clinical report anonymization following recent policy changes.
Mylan has recalled batches of its EpiPen in the US over concerns the auto-injector device made by Pfizer’s Meridian Medical Technologies unit is faulty.
