The FDA wants more time to deliberate on Novartis' panobinostat, a multiple myeloma treatment that failed to impress a panel of independent experts, signaling a delay that could nearly negate the agency's previous promise of a speedy review.
Glaxo shareholders will soon have the chance to weigh in on an asset swap between GlaxoSmithKline and Novartis worth more than $20 billion.
Novartis is well on its way to leading a new class of anti-inflammatory treatments, convincing European regulators to recommend approving its injected therapy for psoriasis and putting the company in line for transatlantic launches next year.
BioNano Genomics has restocked its coffers to fund an assault on the genome analysis sector. The San Diego, CA-based genome mapping firm raised a $53 million war chest from Novartis' venture fund and other investors to accelerate uptake of its Irys DNA analysis device and accompanying software.
The U.K. and Novartis have been negotiating for months now on a fair price for the Swiss pharma's meningitis B shot, Bexsero, which the country plans to add to its childhood vaccination schedule. So what's the holdup?
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.