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Sandoz

Latest Headlines

Latest Headlines

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.

UPDATED: Novartis recalls some Ritalin over packaging issue

Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.

Generics makers ask SCOTUS to let them proceed with Copaxone copies

Teva wants generics makers to hold off on launching their copies of multiple sclerosis drug Copaxone until the Supreme Court hears its appeal in a patent fight over the drug. And unsurprisingly, those generics companies are not that into the idea.

Novartis names two new leaders to growth drivers Alcon, Sandoz

Novartis, amid a company-wide strategic review, has said some of its underperforming units may be on the way out. But as it draws up its blueprints for the future, it's also working to bolster its star businesses, and Wednesday it announced some changes at the top of two of its key divisions.