News

BMJ targets Pradaxa safety, scolding Boehringer, FDA and EMA alike

The BMJ has set off a kerfuffle--and a Twitter campaign--over the safety of Boehringer Ingelheim's blockbuster anticoagulant Pradaxa.

Can Gilead break into cancer? With Zydelig approval, it gets its chance

Armed with a brand-new FDA approval for its blood cancer drug Zydelig (idelalisib), Gilead will take on the oncology market.

Eli Lilly's Q2 profit sags on patent expirations but beats (low) expectations

Eli Lilly said 2014 would be an extraordinarily challenging year, and judging from its second-quarter earnings, that prediction wasn't wrong. Lilly's revenue dropped 17% to $4.9 billion in the second quarter, largely because the company lost its patent protection on two of its biggest blockbusters: the anti-depressant Cymbalta, which once brought in nearly $5 billion in sales annually, and osteoporosis drug Evista, previously a $1-billion-a-year hit.

Payer pushback aside, Sovaldi, and so Gilead, has another huge quarter

Gilead Sciences' juggernaut, Sovaldi, keeps on rolling along despite the pushback from payers, politicians and health officials over the high price of the hepatitis C cure. It racked up another $3.5 billion sales in the second quarter, on top of the nearly $2.3 billion in the first, a sum that made it the fastest drug launch ever.

$9.9M 'golden hello' awaits Shire chief Ornskov at new AbbVie post

When AbbVie buys out Shire for nearly $55 billion in a deal the two companies agreed on last week, there will be no golden parachute awaiting Shire chief Flemming Ornskov. Instead, there's a signing bonus in order: The helmsman will pocket just under $10 million for staying on with the combined company in a new role.

Pfizer looks to boost Harmonet contraceptive in Asia via loverly brand site

If someone asked who you'd turn to for relationship advice, chances are you wouldn't say Pfizer. But that could change.

Pricey hep C drugs plus thrifty payers equal thorny consequences for patients

We've heard plenty from payers looking to limit access to Gilead Sciences' pricey new hepatitis C treatment Sovaldi. What's the downstream version of that story? Doctors frustrated by reimbursement rejections and patients denied access to a potential cure.

Biogen hikes its forecast as zippy Tecfidera fuels big profits

For Biogen Idec's second quarter, multiple sclerosis star Tecfidera blew analysts' estimates out of the water, as it's been wont to do. But it wasn't Tecfidera alone that helped the Massachusetts biotech trounce sales estimates by about $250 million.

GSK slimming further as sales fall on Advair competition

GlaxoSmithKline says its three-part deal to sell and combine assets with Novartis should wrap up in the first half of next year and is now turning its attention to selling off some of its established drug portfolio, a category which took a 40% sales hit in the U.S. and 10% in the EU in Q2.

Judge refuses to toss off-label Revlimid marketing lawsuit against Celgene

Thanks to a recent court ruling, a former Celgene sales rep's off-label marketing lawsuit will go forward. The rep, Beverly Brown, claims the company pushed its multiple myeloma drugs Thalomid and Revlimid for uses not approved by the FDA--and a judge says she's produced enough evidence to justify a trial.

Avastin nabs second-in-a-row priority review, this time in ovarian cancer

Last week, it was priority review for cervical cancer. This week, it's the fast track for difficult-to-treat ovarian cancer.

Cost-conscious payers are eyeing higher prices on diabetes drugs

A time-honored technique for boosting drug sales is simple: Raise prices. Lately, plenty of drugmakers pressed by patent-cliff losses have done just that. But some notable price hikes on diabetes drugs may be backfiring with payers. With diabetes costs taking double-digit increases--and expensive newer meds launching--insurers are tightening restrictions on drug use.

News flash for biopharma bosses: More than half your employees want to leave

Biopharma employee looking for a new job? You're not alone. In fact, you're not even in the minority, a new report says.

Do testosterone meds boost heart attack risks? FDA asks advisory panels to weigh the data

The FDA has zoomed in on testosterone products for the cardiovascular risks they might pose to consumers, even slapping a new warning on their official labels. Now, the agency has called a special advisory committee meeting to probe two trials that flagged an increased risk of heart attack in men using the meds.

Valeant-style cost cuts create win-win for Allergan shareholders, analysts say

With Monday's announcement that Allergan would chop jobs and cut research, Valeant says its acquisition target is taking a page from its own playbook. Allergan says it's just doing what it can to create value for shareholders. Call it what you want: According to analysts, the move is a win for Allergan investors--whether a deal gets done or not.

Touting a Q2 beat and strong Opsumit launch, Actelion CEO dismisses takeover chatter

In the wake of AbbVie's $55 billion purchase of Ireland's Shire, which should slash the company's tax rate by more than a third, analysts are abuzz over which foreign company will be next on Big Pharma's buy list. Among the targets: Switzerland-based Actelion.

JAMA: Hep C drugs could add $300 to every American's insurance premium

The payer panic over the cost of Gilead Sciences' pricey-and-wildly-successful hepatitis C drug Sovaldi has been well documented. But now, one of the two biggest pharmacy benefits managers in the U.S. says the debate over Sovaldi's $1,000-per-pill price is a symptom of a bigger anxiety.

Gilead litigation says claims by Merck, AbbVie on Sovaldi are patently wrong

Gilead Sciences got to the market first with an interferon-free oral hepatitis C fighter, a category projected to hit $20 billion in sales by 2020. Its Sovaldi has been racking up unprecedented sales, and a raft of litigation, as other drugmakers look for a way to get a piece of that action.

Defensive Allergan plots 1,500 job cuts, hikes forecast to fight off Valeant

Allergan's pulled back the veil on the restructuring it's hoping will lure shareholders away from Valeant's $53 billion hostile buyout bid. Among the blueprints: laying off 1,500 employees, or 13% of its global workforce--and leaving room for some potential acquisitions.

Pharma peer pressure makes tax-friendly M&A targets the new must-have

Talk about peer pressure. First, a couple of U.S. drugmakers pull off trans-Atlantic deals that shift their official HQs and lower their tax rates. Next, some bigger names go for the same tax-inversion strategy. Now, investors want to know why every drugmaker isn't jumping in.