The U.K.'s drug price watchdog, the National Institute for Health and Care Excellence, says that from now on, NICE will request clinical trial data directly from European regulatory authorities whenever it feels a company isn't providing adequate information to make sound coverage decisions, according to a statement.
Novo Nordisk may be nearing the regulatory finish line with an obesity-fighting dose of liraglutide, up for debate by the FDA's advisers this week.
On Monday, Teva CFO Eyal Desheh told listeners at the Morgan Stanley Global Healthcare Conference in New York that the Israeli drugmaker has no new plans for major job cutbacks.
Merck tried to block two lawsuits claiming it lied about the efficacy of its mumps vaccine--but the pharma giant couldn't stop them. A federal judge in Pennsylvania refused to dismiss the lawsuits, filed by a pair of whistleblowers and a group of doctors and payers. Next stop: Trial.
GlaxoSmithKline may have a bigger problem in China than previously thought. Before news about potential corruption in its pharma business surfaced, U.S. officials were already looking into possible bribery in its consumer healthcare unit. And so was GSK.
The U.K.'s cost-effectiveness watchdogs are cracking down on expensive cancer treatments yet again. This time the ax is falling on Celgene, which learned today that the National Institute for Health and Care Excellence (NICE) won't back the company's drug Abraxane to treat metastatic pancreatic cancer.
Even as the FDA is questioning the widespread use of testosterone-boosting drugs for men, the Federal Trade Commission has sued AbbVie and Teva Pharmaceutical Industries for keeping a generic of one out of their reach for years. It is one of the first actions brought by the FTC since the Supreme Court last year said that so-called pay-for-delay deals are not inherently illegal.
Roche just won access to a larger market for its RoActemra treatment for rheumatoid arthritis.
Now, it's U.K. drug regulators who are devising plans to eavesdrop on social media. But unlike the FDA, which plans to monitor the world of online sharing to see whether its communications are hitting their targets, the Medicines and Healthcare Products Regulatory Agency plans to search for drug safety info.
Hospira's reprieve from generic Precedex competition was short-lived. The U.S. district court that temporarily stopped Precedex generics has now decided to let the copycats roll. And that could mean Hospira will soon be sharpening its job-cutting ax.
Forget Salix Pharmaceuticals and long-gone Shire. No. 1 on Allergan's list of defensive acquisition prospects could be Ireland's Jazz Pharmaceuticals.
Bristol-Myers Squibb is doing its best to rain on Merck & Co.'s immunotherapy parade. No sooner had Merck won FDA approval for its brand-new cancer drug Keytruda (pembrolizumab) than Bristol-Myers and its partner Ono Pharmaceutical slapped it with a patent-infringement lawsuit.
Back in 2008, Indian generics maker Ranbaxy made a deal with AstraZeneca to launch its Nexium copycat in May of this year. So why are Americans still unable to buy cheap versions of the blockbuster heartburn pill, which brought in more than $2 billion in U.S. sales last year?
Eli Lilly's Alzheimer's imaging agent, Amyvid, can't get very far sales-wise without coverage from the Center for Medicare and Medicaid Services (CMS). And as per a September decision, that's something it doesn't have. Now, however, it's fighting back, funding litigation it couldn't file itself.
With a Sept. 17 meeting on the horizon to discuss the risks and benefits of testosterone-raising meds--so-called Low-T drugs--the FDA has posted a review on the topic. But its stance is neither here nor there.
Turns out it's not just India and Egypt that will be getting price breaks on Gilead's hep C star, Sovaldi. The drugmaker is close to reaching an agreement with generics makers to bring low-cost versions of the $84,000 wonder drug to about 80 developing countries, according to EVP Gregg Alton.
Hot on the heels of its FDA approval, a new combo pill from the HIV-focused partnership of GlaxoSmithKline and Pfizer, has won approval in Europe. ViiV Healthcare said that the EU had given a green light to its once daily combo pill Triumeq, an approval that will help it reach the $5 billion in peak sales it has been forecast to capture.
Analysts and doctors hailed the arrival of Merck's Keytruda, the first cancer drug in the U.S. to block the PD-1 pathway--a powerful new way to mobilize patients' immune systems to fight their disease. Then came this news: Merck said Keytruda (pembrolizumab) would cost $12,500 per patient per month, or $150,000 per year.
It is not often that drug company employees get hauled off an airplane leaving the country and arrested. But it is not often that a drug company's products are tied to the deaths of dozens of people, like the compounded steroids that are believed to have given more than 750 people fungal meningitis in 2012.