With Opsumit launch rolling, Actelion doesn't 'need' M&A: CEO

Back in 2013, Actelion launched Opsumit, a new-and-improved pulmonary arterial hypertension drug it hoped would help make up sales for its aging Tracleer. And so far, everything is going according to plan.

GOP's Rubio joins the pharma-bashing trend, slamming 'profiteering' on price hikes

The drug-pricing debate has moved to the Republican side of the aisle. GOP candidate Sen. Marco Rubio joined the fray in New Hampshire over the weekend, by slamming "pure profiteering" by drugmakers that charge what the market will bear.

Cipla runs into FDA concerns for plant in India, as well as one it will buy in U.S.

While many of India's other large drugmakers have run afoul of the FDA for plant problems, Cipla has mostly avoided such entanglements. But suddenly the company is facing some FDA issues at two plants, one in India, and one in the U.S. that it intends to buy to gain a foothold in U.S. manufacturing. 

Valeant changes its spots with promises to limit price hikes, spend more on R&D

On Monday, Canadian drugmaker Valeant unveiled some tweaks to its strategy that'll leave it looking less like its old self--and the pricing controversy surrounding the company has more than a little bit to do with it.

Medicare covered $4.6B in hep C scripts for H1, and Gilead's the big winner

Hepatitis C drugs were a big-ticket item for Medicare last year. They're on track to be even bigger this year. As ProPublica reports, Medicare Part D spent nearly $4.6 billion on hep C treatments for the first half of 2015--almost as much as paid for 2014 total. And according to script numbers, Gilead Sciences will reap the lion's share of that spending.

Vocal pricing critic Clinton rakes in big campaign dollars from Big Pharma

Presidential hopeful Hillary Clinton has been taking on the pharma industry during her campaign, laying out tough proposals meant to shield consumers from skyrocketing drug prices. But as it turns out, Clinton is also taking drugmakers' money.

Valeant posts 36% growth amid pricing scrutiny; may sell neurology biz

Valeant may be the subject of current government scrutiny, and it may have recently suffered a stock-price freefall. But the company gave investors some good news Monday with earnings that beat their mark.

Influential cancer group rolls out first set of 'affordability' ratings on cancer drugs

The National Comprehensive Cancer Network unveiled its first set of "evidence blocks" that include cost information on oncology drugs; this first round focuses on chronic myelogenous leukemia and multiple myeloma.

Regeneron doubles investment, adding 200 more jobs to plant in Ireland

Regeneron says it will more than double its investment and hire an additional 200 workers at a plant still under construction in Ireland. That comes even as it is adding space to its campus in Tarrytown, NY, where it expects its headcount this year to grow by 1,000.

J&J chalks up a win in first Tylenol liver-damage case to go to trial

Johnson & Johnson scored a victory in the first case to go to trial over claims that its blockbuster painkiller Tylenol causes liver damage and its dosing doesn't adequately account for the risk. A New Jersey jury ruled that the plaintiff did not prove that she took the painkiller.

Struggling Daiichi plots another 1,000-plus job cuts in U.S.

Japan-based drugmaker Daiichi Sankyo will cut up to 1,200 jobs in the U.S., about half its workforce in its stateside subsidiary, Nikkei reports. The announcement follows a series of layoffs earlier this year at its Parsippany, NJ, operations.

Boehringer looks for Pradaxa boost from now FDA-approved antidote

The lack of an antidote to reverse the effects of new-age anticoagulants has kept some doctors from prescribing them. But now, Boehringer Ingelheim is hoping that'll change.

Pfizer responds to FiercePharma

Tracy Staton wrote an article on Thursday, based on a piece in Forbes. Pfizer took exception to our article and sent a statement.

Pharma's newest nemesis? Nestlé works at the intersection of food and drugs to attack illnesses

If Big Pharma didn't already have enough to worry about, with patent cliffs, drug price investigations and reluctant payers, it now will have to face the onslaught of a large, well-funded company trying to create hybrid pharma and food products company that would treat conditions from stomach disorders to Alzheimer's disease.

In pharma M&A, 2015 trumps red-hot 2014 so far, report says

Global activity in the pharma, medical and biotech spheres over the first three quarters of this year has hit its largest-to-date value since at least 2001, according to new data from intelligence and news service Mergermarket. Over that range, the industries have turned up 954 transactions worth $367.6 billion.

Bernie Sanders rejects Shkreli's campaign donation

Presidential hopeful Bernie Sanders (I-VT) has been slamming pharma on the campaign trail, and Turing Pharma CEO Martin Shkreli--who became the face of pharma's drug-price controversy after hiking the sticker on Daraprim by 5000%-plus--wants to talk it out. He donated $2,700 to Sanders' campaign--the max contribution for an individual--in late September in hopes of securing a meeting with Sanders, he told The Boston Globe. Sanders, though, isn't having it.

U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug

Bristol-Myers Squibb got a go-ahead from the U.K.'s cost gatekeeper for its chronic hep C med Daklinza (daclatasvir), a win for the company as it competes with Gilead Sciences and AbbVie in a fiercely contentious hep C market.

After FDA snub, AZ diabetes combo faces potential years-long delay

Last year, AstraZeneca predicted its forthcoming diabetes combo med could generate peak annual sales of $3 billion. But those revenues will have to wait. The FDA has turned down the drug, which combines AZ's DPP-4 therapy, Onglyza, with SGLT2 contender Farxiga.

India pharma sees trouble for its industry in newly negotiated TPP

India is not part of the recently negotiated Trans-Pacific Partnership trade deal, but that doesn't mean the TPP won't still have a trade impact on its drug industry. As some industry veterans see it, the free-trade agreement spells bad news for the $15 billion drug industry that India has built by being a go-to country for cheap generic drugs.

FDA's review of BI's Pradaxa was 'lax' and 'permissive,' watchdog claims

Boehringer Ingelheim's next-gen anticoagulant, Pradaxa, has been plagued by safety worries that have cropped up since its 2010 FDA approval. And according to one watchdog group, that's because the agency was "lax" and "permissive" in reviewing the drug in the first place.