News

FDA flags particle problems in latest Hospira warning letter

Hospira's FDA woes have moved to Australia. The agency scolded the U.S.-based company in a warning letter based on an injectables plant inspection in late February and early March, according to a Wednesday securities filing.

Sunshine fact: $3.5B + 546,000 docs equals one unwieldy database

A few things are certain about the Sunshine Act data that hit the Internet Tuesday afternoon. One, it's incomplete. Two, it's controversial. Three, the numbers are pretty staggering, with $3.5 billion in payments to 546,000 doctors and 1,360 research institutions over a 5-month period.

Eliquis bleeding antidote aces PhIII study, threatening to beat rivals to market

On Wednesday, Pfizer and Bristol-Myers Squibb got some positive data on an undo med for their market trailer, Eliquis. And that antidote could be on the way in the not-too-distant future.

Judge won't toss dinner-party kickback claims against Novartis

Note to sales reps: You might think twice about inviting the same doctors to the same speaker events over and over. Particularly when those events involve pricey dinners at Nobu and Smith & Wollensky.

Warning to Gilead, AbbVie and BMS: France has a new tax for pricey hep C meds

European countries are known for wresting price cuts from drugmakers. Usually, it's a straightforward cost-effectiveness argument. But France has come up with a new strategy: Arm-twisting taxes.

FDA slaps Valeant with a warning letter. Will Allergan slap it, too?

Tuesday, Valeant Pharmaceuticals said the FDA had served up a warning letter about its Sculptra Aesthetic manufacturing, citing problems it observed during a June 2014 inspection. The missteps from manufacturing standards might just fuel the fire from hostile buyout target Allergan.

Orphan drugs may be pricey, but payers are barely balking

Some orphan drugs to treat rare diseases can cost as much as $400,000 a year. Those hefty price tags have sparked a lively debate in recent years about whether the American health care system can shoulder the burden of treating rare diseases over the long term.

Gilead preps new 500-employee plant near current San Dimas site

Gilead Sciences is plotting a new, 400,000-square-foot manufacturing site near its current plant in San Dimas, CA, local media reports.

MSF urges Indian PM to stand firm against Big Pharma's patent lobbying

As Indian Prime Minister Narendra Modi travels to the U.S. to meet with officials, Doctors Without Borders (MSF) has one message for him: Don't back down on drug patents.

Sunshine today: The deadline for doc-payment data release arrives

Today's the day for the U.S. government to open the books on pharma payments to doctors. The Sept. 30 deadline has arrived, and the payment data mandated by the Sunshine Act will soon be public.

UPDATED: Allergan's next tug-of-war move: Attack Valeant's rosy Q3 forecast

Allergan may or may not bow to requests from some of its largest shareholders to wait on M&A until after December's special meeting. But in the meantime, it's continuing its barrage on predator Valeant's sales model, which it says will yield a tough Q4.

Salix's Relistor has its chance to get a jump on AZ's new constipation med

Salix Pharmaceuticals nabbed the new Relistor approval it was counting on. The FDA blessed the injectable drug as a treatment for all patients with constipation caused by opioid pain relievers, boosting its target market more than tenfold.

AbbVie to employees: We're definitely merging with Shire, new tax rules aside

Just days after rumors emerged that AbbVie was looking for additional financing to cover its planned $55 billion takeover of Ireland's Shire, the company is going to great lengths to reassure employees that the deal is a go.

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.