Earlier this month, U.K. politicians asked Prime Minister David Cameron to explain why Novartis' Bexsero, approved as an addition to the country's childhood immunization schedule 8 months back, had yet to be covered by the National Health Service. Now, Cameron has asked Health Secretary Jeremy Hunt to do the same--and Hunt is pointing the finger at the Swiss pharma.
As Pfizer's Trumenba rolls out in the U.S., it may get a head start on Novartis' Bexsero, which is still awaiting FDA approval. But the drug giant still doesn't yet have what it needs to build a considerable lead: a recommendation from the CDC's Advisory Committee on Immunization Practices.
Novartis hasn't been shy about digital. The Swiss drugmaker has rolled out app after app to help patients track their symptoms and stay on their drugs. But CEO Joe Jimenez says the company is about to do a lot more than that.
The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Clinical is asking the drugmaker to pony up more information about the product before recommending it to treat chronic spontaneous urticarial (CSU), or psoriasis.
Months before Novartis can ask the FDA to approve its "megablockbuster" heart failure drug, the company is trumpeting new data--not on efficacy or safety, but on cost. The experimental med cut ER visits by 30% and reduced hospitalizations by 16%, compared with an older standard treatment, elanapril.
Dubbed Intellia Therapeutics, the new company has come up with a $15 million bankroll in a Series A provided by the venture group and the Big Pharma outfit, which is intrigued by the potential this gene editing technology could play in two of the hottest fields in oncology.
Novartis execs have already expressed just how delighted they are in the Phase III efficacy data that's been emerging about the heart failure drug LCZ696. This afternoon, their enthusiasm in the would-be "multiblockbuster" was supported by the addition of some promising pharmacoeconomic data--particularly in cutting the need for acute care.
Novartis continued to build its case for secukinumab (AIN457), an IL-17A inhibitor in development for a range of inflammatory conditions.
FDA's Ophthalmic Devices Advisory Committee panel overwhelming recommended PMA approval of Alcon's ReSTOR Multifocal Toric Intraocular Lens for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.
Ongoing price negotiations between the U.K. government and Novartis have so far kept the meningitis B vaccine Bexsero out of the public's reach, and now members of Parliament are asking where it is.