In its report on Suzhou Natong Bionanotechnology’s microneedle technology, the Wall Street Journal hits on an interesting problem in the drug-delivery world: Is it a device or a drug? Since often the delivery technology often enters the body along with the drug, the old categories often do not work.
Brian Orelli of The Motley Fool highlights four drugs–AstraZeneca’s Brilinta, Questcor’s Acthar Gel, Savient’s Krystexxa and Novartis’ Gilenia–that could gain FDA approval this month despite some previous difficulties. However, given recent troubles with other approved drugs, the FDA’s cautious nature could cause issues for some of the drugmakers.
Continue reading ‘Four Drugs Look to Pass FDA Muster this Month’
Another week, another series of articles and debates over whether e-cigarettes are drug delivery devices and should be regulated by the FDA. In a follow-up to last week’s report, the Wall Street Journal asks readers: “Should the devices be regulated? Have you tried them?”
Critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America’s biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.
Continue reading ‘Nearly 400 Medicines and Vaccines in Development to Fight Infectious Diseases’
Surgeons tweeted updates during a recent double hand transplant at Jewish Hospital Hand Care Center in Louisville. While the operation would be only the third double hand transplant in the U.S., it’s probably the first accompanied by live tweeting.
Continue reading ‘Surgeons use Twitter during Double-Hand Transplant’
Drug counterfeiting has become a $200-billion business annually, according to the World Customs Organization. By some calculations, the counterfeiting trade has become more lucrative than the narcotics business. It’s a global problem. The World Health Organization estimates that counterfeit drugs make up ten percent of the drug market worldwide. And experts say that solving it–or at least stemming the tide–requires the participation of both government and industry.
Continue reading ‘Drug Counterfeiting – a $200 Billion Business’
More drugs are hitting the recall list these days. As CNN Money reports, the number of recalls hit 1,742 last year–that’s an increase of 309 percent over 2008. “We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988,” says Bowman Cox, managing editor of the Gold Sheet, a trade pub that analyzes FDA data. “That’s a meaningful development.”
Pharmaceuticals promoting their products through Facebook “Shares” have been warned by the U.S. Food and Drug Administration (FDA)… and they’re apparently heeding that warning. Pharmaceutical company Novartis removed it’s Facebook Share after receiving a letter from the FDA warning that the Facebook Share button it is using to promote its cancer medication, Tasigna, violates FDA requirements about disclosure of drug information, and that the information is misleading and “implies superiority over other product.”
When his phone battery ran low, instead of dialing 911 and possibly languishing on hold, Atlanta Councilman Kwanza Hall tweeted, “Need a paramedic on corner of John Wesley Dobbs and Jackson St. Woman on the ground unconscious. Pls ReTweet,” according to WSBTV. Within moments, Twitter followers retweeted his message and several called 911. Paramedics were able to rush the woman to the hospital.
Continue reading ‘Web users see Twitter, Facebook as 911 backup’
With Genzyme in the news, we’ve all been hearing plenty about the wave of M&A deals that’s been rolling through the world’s life sciences industry. Last year, Thomson Reuters tracked more than 1,400 such deals worth $206 billion worldwide, giving the Boston Globe the hard numbers it needs to assert that this is one trend that has yet to crest.
Continue reading ‘Biotech M&A Frenzy Shows no Sign of Slowing’
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