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Sandoz

Latest Headlines

Latest Headlines

What price MS therapy? Thanks to price hikes, $50K-plus, even for decades-old meds

The cost of multiple sclerosis drugs has skyrocketed over the past 20 years, and it's not just new drugs driving that increase. Not one MS drug has a list price of less than $50,000 per year in the U.S., and some treatments cost 7 times more now than they did in 1995, a new study found.

Novartis gets bragging rights on first U.S. biosim. But will its Neupogen copy sell?

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.

Showdown time for Amgen, Sandoz, with Neupogen biosim hearing set March 2

Novartis and its Neupogen biosimilar are steamrolling toward the U.S. market. But Amgen hasn't given up stopping the product in its tracks. The biotech last week urged a California court to block the biosimilar launch, with FDA approval expected as soon as March 9.

Supreme Court pitches patent fight over Shire's Lialda after Teva ruling

The ripple effects from last week's Teva v. Sandoz ruling have begun. The U.S. Supreme Court sent three patent fights back to a lower court in light of that ruling, which ordered the Federal Circuit Court to defer to district-level findings on patent claims unless a "clear error" had been made.

FDA reviewers back Novartis biosim of Amgen's blockbuster Neupogen

Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen. The takeaway? The FDA seems to be softpedaling on whether the biosim is "interchangeable" with Neupogen itself, allowing approval to be based on biosimilarity instead.

Sandoz recalls generic Atacand that Mylan manufactures in India

Novartis' generic division, Sandoz, is having to recall one lot of its generic version of Novartis' blood pressure drug Atacand, but it is a copy that it does not manufacture itself. The drug is made in India by Mylan.

Amgen-Sandoz squabble over Neupogen copy could reshape biosim marketing

The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen therapy Neupogen shows, the two sides don't even agree on the rules.  

Mylan, Momenta, Sandoz join assault on Teva's new-and-improved Copaxone

After trying nearly everything in its power to protect lead product Copaxone from early generic competition, Teva just received some news it least wants to hear: Copycats are going after its new, long-acting version of the drug, too.

Court limits Canada's power over generic drug prices

A federal court in Canada has now agreed with the industry that the country's price setting board has assumed too much authority and severely curtailed its ability to control prices over generic drugs in a case centered on Novartis' generic drug company Sandoz, and a unit of Teva Pharmaceutical Industries, which started as Ratiopharm.

Full steam ahead for Copaxone copies as SCOTUS denies Teva's bid for delay

Last week, generics makers asked the Supreme Court to let them launch their copies of Teva's Copaxone while it hears the Israeli company's appeal over the drug's patents. Now, they'll likely get that chance. Chief Justice John Roberts rejected Teva's bid to block competition until the court clash wraps, meaning generics could hit as soon as next month.