Shire shares slumped Thursday after a U.S. Appeals Court denied its latest attempt to fend off generic versions of its ulcerative colitis treatment Lialda. The drug is one of Shire's top sellers--and the case is one of the first reviewed under a U.S. Supreme Court patent-law ruling.
SINGAPORE-- India is not a member of the 12-nation Trans-Pacific Partnership, but its intellectual property rules governing pharmaceutical patents lie at the core of a dispute ginning up this year to reach a final agreement. India's resistance to relaxing its rules has been a model for the emerging-market members of the TPP to seek similar compulsory licensing arrangements for generic drugs.
The FDA's new due diligence on generic drugs now has one victim: Mallinckrodt, which makes a knockoff version of Johnson & Johnson's ADHD drug Concerta. The Dublin-based drugmaker says the FDA is questioning whether its generic actually measures up to the brand.
The Alabama Supreme Court won't back away from a controversial ruling against Pfizer, in a liability case closely watched by the rest of the pharma industry.
FDA actions against India's Ranbaxy Laboratories ostensibly are keeping U.S. consumers safer, but much poorer. The plant bans have also shined a spotlight on how complex drug laws in the U.S. can work against consumers' best interests.
Generic drugs underpin the U.S. prescription drug market, making up 80% of the prescriptions written in the country and saving payers billions of dollars annually. But there have always been questions about whether some generics are as effective as the drugs they copy, and the FDA last year kicked off a program to find out.
South Africa's Minister of Health, Aaron Motsoaledi, lashed out on Friday at a report that Big Pharma is funding a PR campaign aimed at opposing new patent provisions favoring generic drugs, calling it "a conspiracy of satanic magnitude" that would lead to "genocide."
U.S. healthcare spending is on the rise. But for the fourth year in a row, in 2012, those increases were comparatively modest, a new report says. As to whether it's the Affordable Care Act or lingering effects of the recession that's principally responsible for the slower spending growth, officials are divided. One thing they agree on: Falling drug prices had something to do with it.
Patients, pharmacy benefits managers and drugmakers alike are trying to figure out how to save money through further generics use and better prescription adherence.
The good news from IMS Institute for Healthcare Informatics: Using prescription medicines properly could save $200 billion in annual U.S. healthcare costs. More good news, at least for the pharma business: The institute's ideas for saving money don't all translate to less spending on drugs, branded or otherwise.