Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.
Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes.
LiveLeaf, Inc. has announced a collaboration with the contract research organization (CRO), Emery Pharma, to advance its development of novel prodrugs for FDA approval.
Medical device clinical trials have increased 63% since 2012 and a market void for mid-size device CROs could present a significant opportunity for growth.
BioCelerate has partnered with Accenture to develop a platform that will aggregate and analyze preclinical and clinical information to "drive additional industry value."
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.
