The opening of a global IT centre in India will bring services back in-house, but AstraZeneca says it is not changing its outsourcing strategy for R&D and manufacturing.
The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.
As the US Drug Supply Chain Security Act (DSCSA) traceability requirements become mandatory in 2015, standards group GS1 is offering a 137-page guideline to help manufacturers follow the new stipulations.
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
GlaxoSmithKline will not restart production at a vaccine plant in Belgium until an independent investigation determines how liquid contaminated with polio virus was released into the local sewage system.
The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a third organization in Mexico.
Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.
Pharma service companies looking to access the growing Philippine and Indonesian markets have been invited to join a Public-Private trade mission by the US Department of Commerce.
After much discussion and some confusion, the ICH’s (International Conference on Harmonization) Q3D guideline, which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.
The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.
Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
In a venture with plasma products manufacturer Octapharma, DHL has opened a €3.4m ($4.4m) cold-chain logistics centre in Germany for the pharma and life sciences industries.
CRO (contract research organization) Parexel International has allowed clinical technology companies CRF Health and Clinical Ink to join its Perceptive Partner Program.
As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved, the agency is still implementing a number of the individual modules that make up the over-arching law.
The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.
High importation costs and country-to-country differences in national healthcare systems mean drugmakers will continue to vary the cost of products in Africa according to an industry analyst.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) says Twitter, Facebook and smartphone apps could soon be used to gather adverse drug reactions (ADRs).
Cloud-based solution provider Medidata and CRO Icon have launched a joint initiative to bring new efficiency to the administration of electronic patient-reported outcomes (ePROs) in clinical trials.
A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, announced today it has acquired New England Independent Review Board (IRB).
US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.
Hyperion says it is “shocked and disheartened” after discovering Phase III trial data for a type 1 diabetes candidate was manipulated by employees of recently acquired Andromeda Biotech.
The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to help manufacturers avoid or mitigate drug shortages due to manufacturing or quality issues.
Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall this year of an injectable drug made at the now defunct site.
West Pharmaceutical Services has confirmed it is evaluating potential expansions but says rumours that it plans to pay €100m ($130m) for a facility in Ireland are premature.
Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration...
Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that planned to sell them online say European law enforcement agencies that co-ordinated the swoop.
The US FDA import ban imposed on Apotex in 2009 was legal and the firm was not treated more harshly than generics rival Teva according to a State Department arbitration panel.
Smaller pipelines make keeping to timelines particularly important in biopharmaceutical trials according to Exco InTouch, which says this pressure is driving EDC tech adoption.
Brussels airport has become the first European shipping hub to adopt a cold-chain certification programme for pharmaceutical cargo that industry group IATA claims “goes beyond” GDP requirements.
Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.
Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
Temperature fluctuations during shipping have led to costly clinical data delays and product recalls, but such problems can be avoided through supply chain pre-planning say distribution firms.
Clinverse, a provider of automated financial management tech solutions for clinical trials, has closed a $9.1m (€6.9m) round of funding led by New Jersey-based Edison Partners.
Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.
Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
