News

NICE to bypass drugmakers in search of data to support pricey drugs

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.

The pressure's on Novo's marketing force as FDA nod for liraglutide nears

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.

Teva CFO: We're looking to grow sales, not slash and burn costs

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.

Judge: Merck must fight claims that it lied about mumps vaccine benefits

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.

Feds eyed GlaxoSmithKline's Chinese consumer biz for bribery, too

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.

NICE says 'too pricey' to Celgene's Abraxane combo for pancreatic cancer

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.

The top 10 best-selling multiple sclerosis drugs of 2013

Want a surefire way to shake up a drug market? Introduce new medication options that make it easier for patients to manage their disease. MS drugmakers would know; their market is all of a sudden...

FTC takes after AbbVie, Teva for pay-for-delay deal on AndroGel

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.

Europe opens up big new market for Roche's RA therapy RoActemra

Roche just won access to a larger market for its RoActemra treatment for rheumatoid arthritis.

U.K. watchdogs hope to tap social media for drug-safety purposes

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.

Sales layoffs may be ahead as Hospira loses fight against Precedex generics

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.

Latest Allergan buzz puts Ireland's Jazz in its dealmaking sights

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 socks Merck's brand-new Keytruda with PD-1 patent suit

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.

FDA faces pressure to green-light generic versions of AZ's pricey Nexium

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?

Lilly funds lawsuit over CMS Amyvid rejection

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.

FDA still wishy-washy on Low-T drugs' pros and cons

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.

Gilead to offer cheap Sovaldi to 80 countries

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.

GSK, Pfizer partnership wins EU nod for HIV pill weeks after FDA approval

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.

UPDATED: Merck's melanoma 'game-changer' Keytruda likely to bolster drug pricing debate

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.

Feds intercept pharmacist linked to meningitis outbreak as he headed to Hong Kong

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.