pharmaceuticals

How to Approve 'Biosimilar' Drugs? The FDA Has to Figure That Out

Unlike generics, which are the exact chemical copies of a brand-name drug, biosimilars have large and often complex proteins that are made in living cells, and tiny differences can play havoc with the product. It may take years for the FDA to create an approval process.

Growing Interest
in Achillion's Hepatitis Drugs

At a liver disease conference in Boston, one of the highlights is expected to be reports from Achillion about its novel hepatitis C treatments, especially ACH-1625. The buzz is growing stronger that the little biotech is attracting the attention of some players in Big Pharma.

Russia Investigates Alleged Spam Kingpin

Russia%u2019s police may have cut down the amount of spam in your inbox by opening an investigation of an alleged spam kingpin. Russian officials began the investigation of Igor A. Gusev Tuesday, The New York Times reported. Officials said Gusev likely fled the country.

DuPont Earnings Drop, but Raises Outlook

DuPont (DD) reported third-quarter earnings of 40 cents per share, down from 45 cents per share a year earlier. Sales grew 17% from a year earlier to $7 billion, the company said in a statement. Sales grew 22% in emerging markets.

A New Antidepressant Maker Has Lots of Folks Excited

Tiny, little-known biotech Clinical Data has developed a potential blockbuster drug called Vilazodone. If OK'd, it would be the first new depression treatment in 15 years. Its potential is so huge that several Big Pharmas are said to looking to buy the startup.

Biotechs and Big Pharma Squabble in Sweden

At a recent life-sciences conference in Stockholm, execs of several U.S. and foreign biotechs clashed with Big Pharma in a lively debate on the merits of their respective goals and products. The result, however, was a stand-off.

Sanofi Denies Offering $69-$80 Price Range to Genzyme

There's a new plot twist in the takeover battle between French pharmaceutical giant Sanofi-Aventis and U.S. drugmaker Genzyme. A regulatory filing made by Genzyme on Thursday claims Sanofi may be willing to go much higher than its current $69 bid -- a claim the French company disputes.

World Drug Sales to Hit $880 Billion in 2011

Global pharmaceutical sales are expected to grow by 5% to 7% in 2011 to around $880 billion, thanks to robust growth in emerging markets, especially China, as well as new innovative treatments, and despite patent expirations and budget pressures in the developed world.

J&J to Acquire Vaccine Maker Crucell

Giant drugmaker Johnson & Johnson has agreed to buy Dutch vaccine maker Crucell. The deal will give J&J a bigger piece of the vaccine market and better access to emerging markets.

Novartis Halts Two Drug Development Programs

Swiss pharmaceutical company Novartis announced Tuesday that it had discontinued the development of two drugs -- the hepatitis C treatment Zalbin, and antifungal agent Mycograb. The company will take impairment charges of approximately $590 million in third quarter of 2010.

Pharmas Probed Over Foreign Bribery Allegations

Federal investigators are looking into allegations that major drug companies, including Merck, AstraZeneca, Bristol-Myers Squibb and GlaxoSmithKline, paid bribes overseas to boost sales and accelerate approvals.

Sanofi-Aventis Inks 10-Year R&D Deal with Covance

French pharmaceutical company Sanofi-Aventis announced a 10-year agreement with Covance on Thursday under which the Princeton, N.J.-based contract research firm will provide it with drug development services. Sanofi-Aventis will pay Covance between $1.2 billion to $2.2 billion.

Endo to Acquire Generics Company Qualitest for $1.2 Billion

Endo Pharmaceuticals (ENDP) agreed to buy generics company Qualitest Pharmaceuticals for $1.2 billion cash. Qualitest is the sixth-largest U.S. generics company as measured by prescriptions filled. Qualitest will add about $400 million to Endo%u2019s annual revenue and 40 cents per share in annual adjusted earnings, Endo said in a statement.

Under the Radar: China's Biggest Drugstore Chain Looks Cheap

Here's a stock that is the largest drugstore operator in China, but still has huge growth ahead of it. The company just got costs under control, and has a new CEO. Plus, the stock is traded on the NYSE and sports a hefty dividend. Yet few know about it.

Novartis Sells U.S. Rights to Enablex for $400 Million

Novartis (NVS) agreed to sell the U.S. rights to bladder medicine Enablex for $400 million. Ireland-based Warner Chilcott will take over the marketing, sales and manufacturing of the drug in the United States, Novartis said in a statement. The deal is expected to close by the end of October.

Four Cash-Rich Pharma Picks From Goldman

While a new report from Goldman says health care is in a state of flux that most of the sector's companies haven't adjusted to yet, it also pinpoints four that have plenty of cash that could be put to good use for investors.

Sanofi Is in No Rush to Reach Deal With Genzyme

Sanofi-Aventis CEO Chris Viehbacher said Wednesday that he believes his French pharmaceutical company will eventually buy U.S. biotech company Genzyme at a reasonable price. However, he expects it will take some time to agree on a deal, and he won't rush into anything.

Almost Half of All Americans Are on Drugs

The Centers for Disease Control and Prevention released data that found that almost half of all Americans took at least one prescription drug per month in 2008, up from 43.5% a decade ago.

Allergan Pays $600 Million to Settle Botox Charges

Pharmaceutical firm Allergan has settled criminal and civil charges that it promoted Botox for uses the FDA hadn't approved, agreeing to pay $600 million and enter into a "corporate integrity agreement." Allergan also dropped its related First Amendment lawsuit against the FDA.

Roche Announces Cost-Cutting Plan

Giant Swiss pharmaceutical company Roche has outlined a cost-cutting plan to help it offset pricing pressures in the U.S. and Europe, and following several setbacks in its late-stage research pipeline.

Setback for Roche and Immunogen Breast Cancer Drug

The FDA denied accelerated approval of Roche's trastuzumab-DM1 (T-DM1) license application. T-DM1 is a potential breast cancer treatment. Roche will continue with its trials and plans a global regulatory submission in mid-2012.