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Cell Therapy Ltd says that following a pre-submission meeting with the European Medicines Agency (EMA) in September, it now plans to begin applying for a conditional marketing authorization (CMA) for Heartcel, its lead allogeneic stem cell therapy, which has been designed to regenerate the heart. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.
The day after Amgen was dealt another blow at the U.S. Court of Appeals for the Federal Circuit in the company's failed attempt to keep Novartis unit Sandoz from launching its biosimilar Zarxio (filgrastim-sndz), the latter firm moved forward with putting the medicine on the U.S. market – the first biologic copycat available to Americans.
Declaring that if its biosimilar Zarxio (filgrastim-sndz) was further withheld from the US market, cancer patients and purchasers of the biosimilar, including taxpayers, would be harmed, Novartis unit Sandoz on Aug. 31 asked the U.S. Court of Appeals for the Federal Circuit to reject a "perfunctory" emergency motion filed late last week by Amgen, which seeks to block the Sept. 2 launch of the medicine.
Over the past two weeks, little-known UK-based stem cell therapy company Cell Therapy has reported impressive Phase II data with two of its products that target completely unrelated indications – advanced heart failure and severe tendon injury. CEO Ajan Reginald, previously Roche's global head of emerging technologies, spoke to Scrip about why the company chose to remain under the radar until recently, and of his ambitious plans to get a product onto the market in 2017.