CSafe Global has opened a new service center in Chicago, IL to support life science companies moving temperature-sensitive products in the Midwest US market.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
This past year, the clinical trials landscape continued to shift and adapt to promising trends—including mobile technology, real-world data, and patient engagement—that can help us build a stronger clinical trials system.
The pharmaceutical industry made significant advancements towards global regulatory harmonization in 2017 – despite a highly-charged political environment on both sides of the Atlantic.
Outsourcing models examined, market shifts scrutinized, and trial tribulations analyzed – take a look back at some of the top reports published in 2017.
A piece of glass found in a vial of generic injectable product Pantoprazole Sodium has prompted AuroMedics Pharma to issue a nationwide voluntary recall.
Spark Therapeutics has received US approval for Luxturna (voretigene neparvovec-rzyl), its one-time gene therapy treatment for an inherited form of vision loss.
In 2018, the industry can expect risk-based everything, cloud-first strategies, and a focus on modernization as companies look to stand out amongst the competition, say Veeva Systems execs.
UK regulators have banned Apotex Research Private Limited from shipping drugs made at its plant in Bangalore, India to the EU after inspectors raised concerns about the potential for cross contamination.
By Doug Peddicord, PhD, executive director of the Association of Clinical Research Organizations (ACRO)
As the great Yogi Berra once said, “It’s tough to make predictions, especially about the future.” But it is safe to say that after a year of considerable consolidation and change, the CRO industry anticipates continuing and potentially rapid evolution...
Only eight of the top 40 CROs are Privacy Shield Framework-certified, says Science Exchange CEO as the company continues to rack up partnerships with pharma companies looking to streamline outsourcing efforts and mitigate risk.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
DHL Global Forwarding has certified seven of its air freight stations according to the CEIV Pharma Standard of the International Air Transport Association (IATA).
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
The US FDA says it observed quality documents in the teeth of a staff room shredder and lenient computer access at Glenmark’s Baddi facility in India, which was issued a Form 483 last week.
Australia’s consumer commission has accused GlaxoSmithKline and Novartis of marketing and pricing two of its Voltaren pain relief products – which contain the same active ingredient – differently.
Slovakian contract manufacturer Saneca says the opportunity to tap the Russian market is huge despite protectionist policies and changing GMP inspection requirements.
Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
Systech International has teamed with NKP Pharma to expand track and trace services in India, saying it hopes to “wean” Indian pharmaceutical firms away from local serialisation providers.
There are several opportunities for the industry to introduce connectivity into the pharmaceutical supply chain, but a one size fits all solution will likely not be the answer, says Novartis head.
Viagra Connect will be available without prescription in the UK following a request from drugmaker Pfizer, which is preparing a manufacturing site in France for the demand.
The UK government has outlined its industrial strategy as it prepares to leave the European Union and boasts of investments and collaborations driving the life science sector.
WIRB Copernicus Group (WCG) has expanded its portfolio of companies to include the pharmacovigilance and drug safety solution provider Vigilare International.
Avista Capital Partners has signed an agreement to acquire United BioSource (UBC), adding another pharmaceutical service provider to the firm’s list of current and historical investments.
The US FDA has issued Establishment Inspection Reports (EIRs) closing out inspections at Biocon’s biomanufacturing plant in Bangalore and a Divi’s Lab facility in Visakhapatnam.
AmerisourceBergen Corporation will buy US wholesaler H.D. Smith, which it says will boost capabilities and help secure the pharmaceutical supply chain.
ArisGlobal has launched a new platform to report potential adverse events in response to technology trends, which necessitate the immediate availability of information.
Avantor, Inc. has completed its previously announced acquisition of VWR Corporation to create a global provider of “discovery-to-delivery” solutions, says CEO.
European member states have selected Amsterdam as the post-Brexit home of the European Medicines Agency, following a secret ballot vote in Brussels yesterday.
Acorda Therapeutics has halted enrolment for a trial of its Parkinson’s disease candidate tozadenant after the emergence of serious adverse events, including five deaths.
Pharma firms making product benefit claims on Twitter must incorporate risk information within the same tweet regardless of character space limitations, says the US FDA.
Interpol has seized more than 300kg of counterfeit pharmaceutical products in West Africa’s Cote d’Ivoire, and uncovered a packaging site for fake medicines.
The Danish Medicines Agency (DKMA) has banned Europharma from performing manufacturing activities citing a general lack of will and ability to adhere to GMP.
Marken’s new online tool enables patients to track home deliveries of clinical trial materials, which the company said will improve the direct to patient experience.
