Novartis won't have to wait for European regulators to do a full-force data sift before its new heart failure drug becomes available in England. The U.K. will allow Novartis to roll out its Entresto drug under an early-access scheme begun last year.
A few months ago, the European Medicines Agency followed through on a threatened continental marketing halt affecting about 700 drugs in Indian CRO GVK Biosciences' generic lineup due to allegations of manipulated trial results. Now, Germany's regulators have suspended another 54 drugs tested by GVK in accordance with the EMA's recommendations.
Digital health startups attracted $4 billion in venture capital in the U.S. last year, compared with about $110 million in Europe.
As med tech companies target innovative devices that can rapidly diagnose conditions such as sepsis, a team of researchers in Germany and Ireland are developing a device that could slash testing times for urinary tract infections.
U.S. CRO Accelovance is blueprinting a new site in Wales, planning to add 70 positions as it builds out its European ranks.
Chinese drugmaker Jinan Jida has turned to a U.S. company to help it resolve plant issues that led the EU to suspend its certificate of suitability for the antibiotic nitrofurantoin last month.
India has lashed out at the European Union, miffed over the EU ban of more than 700 drugs after finding issues in the clinical trials conducted by India's GVK BioSciences.
When French biotech TxCell shut down its pilot manufacturing facility in Besançon in June, it said it was a decision made with regulators but didn't lay out exactly what an inspection by France's ANSM had found. Now ANSM has filed its report, and it turns out that what it found was a lot of cases of mold contamination and a number of facility problems that probably contributed to it.
Emergent BioSolutions has launched a military-grade intramuscular autoinjector device for self-administered antidotes or other chemical threat treatments. For now, the rollout is only ex-U.S., but the infectious disease specialist said it will seek FDA approval for the device, dubbed Emergard.
U.S.-based generics drugmaker Amneal Pharmaceuticals will recycle a plant in Ireland that Johnson & Johnson abandoned some years ago, with plans to have about 300 workers when it reopens in a few years. The move comes as the 15-year-old company works its way up the ladder of generics makers.