Teva's $4-billion-a-year multiple sclerosis treatment Copaxone is slated to lose patent protection next year, and the Israeli drugmaker is struggling to move the needle on its planned replacement, enduring another rejection from European reviewers.
After an FDA rejection and an earlier negative opinion, Novartis' cardio treatment serelaxin has again failed to sway European regulators, and the drugmaker has resigned that its breakthrough-designated therapy will not hit any market this year.
Reversing an earlier rejection, European regulators are recommending early approval for PTC Therapeutics' ataluren, a treatment for Duchenne muscular dystrophy, news that more than doubled the biotech's share value in premarket trading.
After a manufacturing issue spiked its pitch for FDA approval, a new diabetes drug from Eli Lilly and Boehringer Ingelheim has secured European clearance, lining up to compete in a crowded market.
In the latest EuroBiotech Report, while critics of Pfizer's attempt to buy AstraZeneca spent the week celebrating a major blow to the deal, an awkward question remains: Exactly what has been "saved" from Pfizer's clutches? And more.
St. Jude Medical bucked the trend of bad renal denervation news, touting the newly released data from its studies of the CE-marked EnligHTN renal denervation system at the EuroPCR cardiovascular interventions conference in Paris.
Merck KGaA has been investing steadily in its manufacturing operations the last couple of years, and now a fill-finish plant in Italy is slated to get a €50 million infusion as Merck forges ahead in preparation for selling more biologic drugs.
The FDA talks a lot about how working with other countries, sharing information and insights, can allow it to stay on top of of the ever-expanding global supply chain while working within a finite budget. But even with Europe, whose geography includes countries as different as the U.K. and Romania, it can be harder to walk the walk than to talk the talk.
Now that the ovarian cancer drug vintafolide has crumbled in Phase III, Merck and its partner Endocyte have pulled their conditional marketing application in Europe and are moving to close down the study.
BBI Diagnostics Group provided details off its plans to be traded on the London Stock Exchange in June 2014 in a May 19 statement. The IPO will consist of the sale of the 25% indirect ownership interest in BBI held by parent company Alere.