News

Daiichi Sankyo nabs leukemia drugmaker Ambit in $410M deal

Astellas may not have wanted Ambit Biosciences as a development partner, but fellow Japanese pharma Daiichi Sankyo wants it as an acquisition.

ESMO: The latest skinny on drugs from Pfizer, Novartis, GSK, Merck, BMS

The European Society for Medical Oncology meeting may not be as enormous as its U.S. counterpart, but plenty of news is flowing. And some of the new data presented in Madrid over the weekend is pretty dramatic.

Once-rejected drugs in Gilead's Stribild get FDA nod to go it alone

Gilead has been seeking FDA approval for HIV drugs Tybost and Vitekta for a while now, but the agency dealt the drugmaker a setback with Complete Response Letter last year. Now, 17 months later, the two have passed muster.

Roche's Perjeta helps breast cancer patients live a record-setting 15.7 months longer

These days, even expensive cancer treatments don't necessarily deliver show-stopping study results when it comes to actually extending patients' lives. Roche's Perjeta is now a major departure from that trend.

Troubled AMAG snaps up fresh-from-bankruptcy Lumara in $1.25B deal

Troubled KV Pharmaceuticals started a new life earlier this year, emerging from bankruptcy and changing its name to Lumara Health. Now, it's selling out. AMAG Pharmaceuticals agreed to pay up to $1.25 billion for the company's maternal health business and its once-controversial preterm-labor treatment Makena.

Allergan buy Salix? Not so fast, say investors intent on Valeant vote

Valeant Pharmaceuticals isn't the only one who thinks Allergan should hold off on dealmaking till shareholders say their piece at a December special meeting. Three top-15 Allergan shareholders are urging the Botox maker to delay until investors weigh in on Valeant's hostile bid.

FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair

It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis and Roche. Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.

Novo Nordisk blueprints its obesity R&D push in Seattle

Novo Nordisk has made it official: The Danish drugmaker is making a full-fledged go at obesity R&D, looking to build a Seattle hub and hire some investigators as it expands its research palate.

Lew's tax rules prompt AbbVie to weigh financing for Shire deal

U.S. Treasury Secretary Jack Lew hasn't scared Big Pharma away from tax inversion deals altogether. But his new rules limiting the benefits of pharma's latest M&A strategy are having some tangible effects already.

EU panel backs slew of new drugs and uses, boosting Lilly, AZ, Novartis, Gilead and more

When Europe's drug approval gatekeepers meet, they often tick off recommendations for some key Big Pharma products. This week, the Committee for Medicinal Products for Human Use backed a whopping 15 new meds and 3 new indications.

Valeant adds activist shareholder Ubben to board as Allergan takeover bid heats up

In yet another sign that it's not about to abandon its hostile bid to buy Allergan, Valeant has named activist investor Jeffrey Ubben to its board. Ubben is chief executive officer of ValueAct Capital Management, Valeant's second-largest shareholder and a new supporter of the Allergan deal.

Judge tosses RICO claims over AbbVie's Humira, AndroGel copay cards

AbbVie may be under fire from the Federal Trade Commission for delaying AndroGel generics, but it won't have to face racketeering claims over its generics-fighting sales tactics.

Sovaldi's nosebleed price reflects a trend, not an exception to the rule

Gilead Sciences' $84,000-per-treatment-course hep C drug Sovaldi reached blockbuster status twice over in the course of a single quarter. But instead of an aberration, a new report suggests it is a reflection of a trend that has been going on for 5 years and looks to be the new normal.

Actavis agrees to keep making original version of its Alzheimer's drug for a while

Actavis has been switching patients from the original version of the Alzheimer's treatment Namenda IR, which is going off patent, to its new once-a-day version. But the New York Attorney General was not impressed with its plan to just quit making the original version, and now Actavis has agreed to produce it for a couple more months to settle a lawsuit the AG filed this month.

AstraZeneca unloads discontinued injectables to specialty generics maker IGI

Talk about selling off old products. AstraZeneca has unloaded 18 drugs it no longer sells to specialty generics maker IGI Laboratories. Apparently, IGI thinks it can profit from reintroducing meds that weren't worth the trouble for a drug giant.

Pfizer preps its case for FDA pulling Chantix's black-box warning

The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.

Teva closing up women's health unit Theramex, thanks to lousy Zoely sales

We've seen what happens when a big drug goes generic. Plants close, sales reps lose their jobs. As the impending shutdown of a Teva Pharmaceutical Industries unit shows, the same is true for an on-patent drug flop.

Hail GSK's chairman-to-be Philip Hampton: It's a tough job ahead

It's official: GlaxoSmithKline tapped Royal Bank of Scotland chair Philip Hampton to take the reins as chairman.

Hey, Big Pharma: When the feds swoop in, be nice. It worked for Shire

Shire and the U.S. Justice Department have come to terms: The Ireland-based drugmaker agreed to pay $56.5 million to settle a variety of alleged marketing violations. So far, so familiar, given the long list of pharma companies that wrapped up similar investigations.

Copay coupons get the Inspector General treatment

The HHS Inspector General's office says the fine print isn't enough to safeguard against Medicare recipients' coupon use. Drugmakers have to do more--or risk violating antikickback laws.