Novartis has agreed to pay the largest-ever settlement over allegations of inaccurate or outdated drug-price reporting to the federal government, HHS officials say. That's not saying much, however: This record-breaking settlement amounts to $12.64 million.
A Japan physician testified in a case involving Novartis Pharma K.K. and its Diovan (valsartan) drug for high blood pressure that he falsified a report while participating in clinical trials marketing approval, sources said.
England's cost-effectiveness watchdogs have changed their mind on Xolair. The National Institute for Health and Care Excellence decided to back the Novartis asthma drug as a treatment for chronic hives, after sending the drugmaker back for more data last year.
RNAi leaders Alnylam and Arrowhead Research are publicly disagreeing over the value of Novartis' RNAi assets. Arrowhead acquired the assets, including the rights to three preclinical candidates, for $35 million. Alnylam CEO John Maraganore said the assets were "pretty unuseful."
Novartis execs are rolling up their sleeves for another round of cost cuts. "Very significant" cost cuts, CEO Joe Jimenez tells the Financial Times, partly from the company's ongoing overhaul in back-office operations--and partly from its sale-and-swap with GlaxoSmithKline, which closed last week.
It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's Neupogen from Novartis' generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss pharma's CEO has been first to admit.
Novartis will be the first to hit U.S. shores with a copy of a blockbuster biotech drug, winning FDA approval for its take on Amgen's Neupogen and heralding a new era in biopharma.
While the industry was largely focused on the jaw-dropping sum being paid for Pharmacyclics today, Arrowhead Research has come in to buy up Novartis' cast-off RNAi business for the bargain rate of $10 million in cash and $25 million in stock.
There's a reason immuno-oncology is among the hottest fields in biopharma today--and that's the $20 billion or so in 2022 sales that many analysts estimate. No wonder Bristol-Myers Squibb, Merck, AstraZeneca and Roche are speeding ahead with their research in the field, with Sanofi, Novartis and Pfizer racing to catch up.
The multiple myeloma market already had a couple of meds with third-line nods when the FDA decided to throw a surprise approval into the mix. Can brand-new Farydak from Novartis actually put up a roadblock for Amgen's Kyprolis and Celgene's Pomalyst? That remains to be seen.