European regulators have joined the FDA in suggesting joint plant inspections and training with their Indian counterparts. The offers come as India's industry has lost status in recent years as the FDA and other countries have banned Indian plants from shipping to the U.S. and Europe over quality and data-integrity issues.
After years of setbacks for the antibiotic ceftobiprole, Basilea Pharmaceutica's antifungal isavuconazole is now on the cusp of winning FDA approval. And Basilea thinks it and partner Astellas Pharma have a potential blockbuster on their hands.
Cantargia is moving ahead with plans to list on Nasdaq First North in Stockholm, Sweden. The IPO is intended to give Cantargia the cash to push ahead with development of its lead candidate, an antibody-based cancer therapy that is on the cusp of entering the clinic.
Novartis has admitted that sales of the vitreomacular adhesion drug it licensed from ThromboGenics have failed to live up to expectations. And while various theories have been put forward to explain the drug's relative lack of commercial success, Novartis thinks part of the issue dates back to clinical trials.
The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.
Investors sent Royal Philips down 5% after it disclosed its 2014 earnings report. Analysts on the call clearly remained unconvinced that the $1.2 billion acquisition of catheter-based imaging company Volcano announced in mid-December would help the company. It's in the midst of making the transition to being solely focused on HealthTech, a combination of healthcare and consumer businesses.
Siemens reorganized its board and management in preparation for the long-planned spinoff of its healthcare business. The move comes as profits slip for the conglomerate's healthcare offerings, although revenues for the group continue to grow.
European regulators are recommending approval for The Medicines Company's cangrelor, setting up an overseas nod for a blood-thinning drug rejected by the FDA last year.
In this week's EuroBiotech Report, data arrived to back up what everyone knew: 2014 was financially a much better year for European biotechs. The IPO window finally opened; 15 companies jumped through and €719.8 million ($835.3 million) of public investors' money landed in European biotechs' bank accounts. And more.
The European Medicines Agency has accepted AstraZeneca's application for lesinurad, a gout treatment with a checkered efficacy record, stoking the company's hopes that it can make the drug into a blockbuster.