Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.
Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.
Eurofins Genomics has installed next generation DNA and RNA sequencing systems by Roche and Illumina, citing growing sponsor demand for high throughput services.
UDG Healthcare has sold its share in a pre-wholesale supply chain JV to partner Alliance Boots and outlined plans to invest some of the €82m ($110m) proceeds in its packaging and marketing businesses.
All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.
Northern Ireland-based contractor Almac will create 348 jobs over the next five years in its pharma and clinical services business according to UK enterprise, trade and investment Minister, Arlene Foster.
Roche has tapped into its antibiotic stockpile to aid Red Cross relief efforts in Yunnan, China which was struck by a major earthquake earlier this month.
The ICH is looking for a new manager for its MedDRA international regulatory terminology standards system to replace current contractor, aerospace and defence technology giant Northrop Grumman.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
GSK has stopped using an ethanol storage tank at a US R&D facility and agreed to pay a fine to settle US Environmental Protection Agency (EPA) allegations that it broke waste management laws.
Supply chain specialist Marken announced last week the opening of their newest clinical trials depot in Sao Paulo, Brazil to help sponsors and CROs looking to conduct trials there and elsewhere.
For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).
In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.
The Center for Lawful Access and Abuse Deterrence (CLAAD) is working with the US Food and Drug Administration (FDA) on legislation for abuse-deterrent technology in opioids, its directors tell in-PharmaTechnologist.com.
The European Medicines Agency (EMA) has issued a concept paper on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of...
Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.
BioClinica, a provider of clinical trial management tools, is helping Isis Pharmaceuticals and its antisense drug development program bring on more and larger clinical trials, including 16 trials for 2014.
McKesson Corporation, a healthcare services and information technology company, today announced a three-year extension to its pharmaceutical distribution agreement with CVS Caremark.
Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.
Packaging Coordinators Inc (PCI) has announced its acquisition of Welsh contract development and manufacturing organisation (CDMO) Penn Pharmaceutical Services in a £127m ($215m) deal.
The US Food and Drug Administration (FDA) is inviting public comment on plans to allow drug companies to reserve proprietary names for medicines as early as the end of Phase II trials.
AmerisourceBergen has reported “outstanding operational and financial performance” for the third quarter 2014, and is set to pass the $100bn revenue mark for the fiscal year.
The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.
Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.
Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.
WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.
Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.
Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.
PhRMA (Pharmaceutical Research and Manufacturers of America) has warned that illegal medicines rejected at the US border will continue to be resubmitted for importation unless a proposed law allows their destruction.
Labs involved in EU-wide assessments of animal-free alternatives to drug quality and batch tests may soon be able leverage their work when seeking clearance to offer such methods as a service.
The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).
The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.
Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.
Pharma groups and patients have objected to US Food and Drug Administration (FDA) plans to destroy prescription medicines personally imported into the US by patients.
Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.
The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances.
Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.
