Walter Armstrong

It's a new year. Even pharma, with its glacial timelines, has its "Out with the old, in with the new" moment. Welcome to 2011!

A new leader, a big acquisition, and a bold investment in HIV may all be in the works at Gilead. But what will it take to restore the glory days?

Berwick's mission: To successfully translate the new healthcare bill into practice.

Lewis Morris, top lawyer in HHS's office of inspector general, explains his new move to target pharma execs for serious and ongoing healthcare fraud.

The Orphan Drug Act of 1983 has been a roaring success. So why is everybody trying to mess with it?

Several leading pharmas may already have a drug for a retrovirus linked to chronic fatigue disease. Has medicine's "problem child" finally earned the industry's respect?

Novartis CEO Daniel Vasella has built the Swiss firm into the fastest growing pharma in the world, and in the process gained a reputation as an outspoken visionary. But is he really as good as all that?

With the biotech industry reeling from the recession, big drugmakers hold all the cards when it comes to making deals, but picking a winner is still a gamble. Here are 10 to place stakes on.

Just when you thought it was safe to go back into M&A, the mega merger returns. What's right about Pfizer-Wyeth, and what's scary.

For aiming to be a game-changer in cardiovascular disease, we recognize comeback kid Crestor as the year's No. 1. Plus three fine finalists.

We know what you're thinking: new president, rotten economy, patent cliff. Do you feel Evel? Well, do you?

Everything you wanted to know about the year's most important deals-and what to watch for in the future

Japan is playing a game of catch-up, dropping big cash on biotechs and risky acquisitions. But with patents expiring and sales falling, can they really pay their way to global success?

A head-to-head comparison of the Drug Vote '08

Young & Partners crunches pharma's filings for, the first half of '08. The results? Ask the Japanese

Could gene silencing be the next great innovation in drug development? Some biotechs are betting on it.

No, it's not as glamorous as its double-helixed offspring. But recent revelations about RNA turn even cold-eyed scientists into lyrical romantics

In our first ever Emerging Leadership Awards, we profile 45 talented young professionals who will lead pharma into the next generation

A plunging currency and other economic turmoil shouldn't phase pharma, right? Yes and no

The contamination of heparin in China cast the drugmaker, its US supplier, and FDA as indifferent and incompetent. Then the story took a very strange turn...

When it comes to developing novel therapies from the animal kingdom, it's mostly a game of pick your poison

With Chantix, Pfizer combined inspired drug design with innovative customer-focused marketing to make the first real medical assault on nicotine addiction.

Approvable letters delay NDAs, cost pharma plenty, and are at an all-time high. Industry says FDA is gun-shy; the agency says it's business as usual. Who's right?

Ever since Jeffrey Kindler rocked our world last December with the news that Pfizer was cutting its sales force by 10,000, we've been waiting for all the other behemoths' shoes to drop. While no precise domino effect has occurred, downsizing, particularly on the sales side, is very much pharma's strategy du jour.

It's testimony to the high anxiety-and hectic activity-in the industry that the merger of German chemicals-to-pharmaceuticals firm Merck KGaA and Swiss biotech Serono elicited only faint fanfare. Both family-owned drugmakers boast an illustrious heritage, but their union garnered none of the pomp and circumstance befitting a marriage of European royalty.

All hell broke loose on May 21 when the New England Journal of Medicine released Cleveland Clinic cardiologist Dr. Steven Nissen's meta-analysis of 42 studies of Avandia, showing a 43 percent increased risk of heart attack.

It's bittersweet being one of the leaders of an industry that is not sustainable," a top pharma CEO recently told Carolyn Buck Luce, Ernst & Young's global pharmaceutical sector leader. Bittersweet is a poignant word for a hard-driving exec to issue.

It was like the end of the arms race last November when Pfizer announced it was slashing its national sales force by 20 percent. Coolly downplayed as cost-cutting by new CEO Jeffrey Kindler, the stunning move was met by industry insiders, Wall Street analysts, and the media with one humongous collective sigh of relief. Big Pharma was seen as having grown dangerously addicted to the detailing game over the past decade, with the top firms plowing more and more of their blockbuster profits into trying to keep up with Pfizer's "flood the zone" strategy and with less and less to show for it.

Medicare Part D's infamous donut hole-the gap in coverage where subscribers have to shell out full drug costs-sparked a national debate long before the first poor, frail, creaky (or so you imagine) senior citizen stumbled into it. Critics of Part D-mostly Democrats, plus advocates ranging from AARP to the Gray Panthers-argue that government price negotiations, which the legislation bans, would lead to savings that could close the gap. Part D backers-mostly Republicans and PhRMA-counter with "Don't fix it if it ain't broke," pointing to surveys showing that as many as 80 percent of the 23 million subscribers are pleased with the program after just the first year. Plus, they say, Part D's so-called consumer-driven design controls costs, which, in fact, came in lower than projected.

The reauthorization of the Prescription Drug User Fee Act (PDUFA) comes but once every five years. Set to expire September 30-and with congressional Democrats riding high and consumer confidence in drug safety at record lows-the deal by which pharma pays FDA to review its products is in for a long hot summer of debate.