The Food and Drug Administration on Wednesday approved the first new drug to treat lupus in 56 years. It's not terribly effective: It only worked for 35% of the patients tested. But experts say the approval could prompt the development of more effective drugs.
In an update Tuesday, Pfizer said it is discontinuing 15 of the projects in its development pipeline. The news comes a month after the world's largest pharmaceutical company announced large research and development cuts were on the way.
To get potentially lifesaving drugs to patients faster, the U.S. Food and Drug Administration is allowed to approve some drugs -- those that address unmet medical needs -- based on fewer trials than usual. But it turns out that many of the pharmaceutical companies fail to conduct follow-up trials to prove the drugs work.
When Merck halted a late-stage study of its potential clot-preventing drug vorapaxar in stroke victims last week, it didn't explain why. Now, the company has confirmed it stopped the study after concerns that the drug increased the risk of bleeding in some patients.
Mergers, acquisitions and major restructurings made Big Pharma a much smaller and leaner sector, with some 54,000 jobs lost. At least that's better than 2009's 61,000 layoffs.
The FDA disappointed AstraZeneca and its investors by not approving its heart drug Brilinta, a blood-thinner that the company -- facing a severe patent cliff -- has high hopes for. If approved, it could be a multibillion-dollar blockbuster. But the FDA wants to see more analyses of results from a major study.
According to the latest leaked U.S. diplomatic cables from WikiLeaks, Pfizer hired investigators to try to uncover evidence of corruption in order to pressure the Nigerian attorney general to drop the case against it.
As part of its efforts to expand into the biotech market, Johnson & Johnson is making a long-anticipated bid for Dutch vaccine maker Crucell -- in spite of Crucell's recent manufacturing troubles.
After the U.S. Food and Drug Administration rejected two other weight-loss pills earlier this year, an advisory panel has recommended the approval of Orexigen Therapeutics's Contrave. If the FDA follows the recommendation, Contrave could become the first diet drug to win approval in a decade.
Novartis will discontinue studies of an experimental lung-cancer cancer drug because of disappointing trial results.
Drugmaker Alkermes said Tuesday it has received U.S. approval to market its addiction medication for use in patients addicted to narcotics like heroin and morphine. Vivitrol, a monthly injection, is already approved for alcoholism.
Drugmaker Bristol-Myers Squibb plans to buy ZymoGenetics, its partner in developing a hepatitis C treatment, for $885 million. The move is part of a trend of pharmaceutical acquisitions as several big patents face expiration soon.
Two federal agencies are investigating whether drugmaker Merck & Co. violated the Foreign Corrupt Practices Act, which bars U.S. companies from bribing foreign officials.
Now that they are nearly done squeezing Swiss bank UBS for information about its wealthy tax-dodging clients, the IRS and the Justice Department are moving on to new tax fraud targets: Clients of London-based bank HSBC Holdings, mostly those with ties to India and Singapore.
InterMune shares soared over 60% after hours after it came closer to FDA approval of its experimental treatment for a fatal lung disease. An advisory panel voted to approve the drug despite questionable effectiveness, given that the disease has no cure and patients need reason to hope.
The Supreme Court in January gave corporations unlimited power to spend money on political campaigns, a move that could sway politicians in favor of big companies. As a result, Washington could become more inclined to rule in favor of the companies that it is supposed to regulate. The result could be ominous.
