The Bristol-Myers Squibb-vs.-Merck match in melanoma is on. Bristol-Myers ($BMY) scored FDA approval for its cancer immunotherapy Opdivo (nivolumab) three months ahead of schedule, setting it up for a head-to-head contest against Merck's ($MRK) recent debut in the same class,Keytruda. Both Keytruda and Opdivo block PD-1, a mechanism cancer cells use to escape detection by the body's immune system, and as cancer immunotherapies, they're among the hottest tickets in oncology these days. Keytruda ...

For years drug companies have been talking about continuous manufacturing, a drugmaking process that is cheaper, faster, easier on the environment, requires smaller facilities, and can be ramped up quickly in remote locations. Did we mention cheaper? Given that the industry has hundreds of billions of dollars invested in plants that do batch manufacturing, a model that has been relatively unchanged for a century, it has been hard for the industry to commit to a new way of making drugs, even one...

There has been talk in recent years about how the industry should expect fewer blockbusters and how drugmakers need to look toward selling more products for fewer dollars, euros, pounds or yen. But it is the big sellers, the blockbusters--no, megablockbusters--that drug execs aspire to develop. And a look at the top 10 best-selling drugs globally can't help but impress with its big numbers. First of all, each of the top 10 best-selling drugs in the world knocked out more than $5.5 billion in sa...

A year ago, FiercePharma published a list of drugs that missed when stepping on the up escalator. A heel got caught, or a sleeve. Bystanders hit the emergency stop button. For whatever reason, escalate they did not. We called it "Top 10 Drug Launch Disasters." It's still one of our most popular special reports. This year, we wanted to take a more positive approach. So, herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma busine...

In a way, the coming year isn't a big one for patent expirations. The total amount of sales jeopardized by patent expirations is $34 billion. That's more than the $28 billion this year, but far less than the $55 billion that hit in 2012. As for 2015? Forget about it. That year, products worth $66 billion will lose IP protection. Plus, the drugs facing new competition won't all take a big hit in 2014. In fact, EvaluatePharma figures that the products newly open to generic competition will only l...

We are in the midst of third quarter earnings reports, and they show with stark detail what the tsunami of patent losses means to the financial underpinning of drugmakers. It's a serious problem that will erode earnings for years to come. Pharmaceutical researcherEvaluatePharma estimates there are $290 billion of sales at risk from patent expirations between this year and 2018. Companies are trying to put the most positive spin they can on the impact, but the effects can take your breath away. ...

It's been a good news, bad news week for Novartis ($NVS) and its oncology business. Monday, the Swiss drugmaker won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder. But Friday, Novartis announced that Afinitor fell short in a HER2-positive breast cancer trial, dashing hopes for what could have been a lucrative new indication. A $1.3 billion drug for Novartis last year, Afinitor (everolimus) already has a tool chest full of indications, includin...

The Federal Trade Commission won't let go of its pay-for-delay suit against AbbVie ($ABBV). The U.S. agency urged a Pennsylvania federal court to move forward with its lawsuit alleging that an AndroGelpatent settlement violates antitrust law. AbbVie argues that it did not delay a generic version of its drug and contends that the suit fails to meet a precedent set last year by the U.S. Supreme Court. In September, the FTC sued Abbott Laboratories ($ABT) and Teva Pharmaceutical Industries ($TEVA...

Actavis CEO Brent Saunders Combining Actavis ($ACT) and Allergan ($AGN) will be no easy task, but the companies think their new leadership team can get the job done. Tuesday, they announced a supporting cast for CEO Brent Saunders, who will play the lead role in his biggest challenge yet. Paul Bisaro, former Actavis CEO and current exec chairman, will stay on in that role while Allergan President Doug Ingram will act as a special adviser to Saunders. According to th...