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“Communication about how certain treatments are working in certain patients is happening through a multitude of media around the globe. These conversations between and among doctors, patients, researchers, and scientists in academia and industry should be facilitated. This includes the free flow of data, research, and results related to what a therapy or combination of therapies does or does not do well and in what types of patients. We need to harness the power of the Internet and social networks.” That’s how Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) described the importance of open communication between drugmakers and doctors...
SUZHOU, China – Global intellectual property lawyers and consultants are quick to advise U.S. and European biotechs that they need a “China strategy” – guidance that usually generates a response akin to Scarlett O’Hara’s famous “I’ll think about it tomorrow” speech. And who can blame biotechs for procrastinating? They’re beset with the here and now: raising money, managing contract research and manufacturing organizations, submitting grant applications, designing studies, filing patents, meeting with potential partners and seeking consensus with regulators. I had the same skepticism about a hurry-up approach to China. But after networking among some of the 800-plus attendees at...
SAN FRANCISCO – When talking trends in biopharma there’s no shortage of metaphors – Tuesday’s health care debate, for example, went for the timely baseball terms, referencing singles and home runs – or oft-overused industry buzzwords, of which the recent Allicense meeting featured several, among them the apparent new fave, “optionality,” a word not actually found in Webster’s. But during the two-day conference a certain gastronomically charged trend emerged, fitting, I suppose, given San Francisco’s reputation as a destination for foodies. There were appetizers: “When they’re passing out the hors d’oeuvres, use both hands,” said Isaac Ciechanover, CEO of Atara...
Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader societal discussion, FDA Commissioner Margaret Hamburg said. Speaking at the annual meeting of the Pharmaceutical Research and Manufacturers of America, Hamburg ticked off a few issues that we as a society must address. For instance, in the absence of a cure, patients with chronic or terminal diseases want a better quality of the life they have left. But the FDA...
Although it’s taken more than two years, biotech pessimists finally got to utter the phrase, “I told you so!” Yes, it finally arrived – a slip in the sector’s meteoric rise that saw, late in the first quarter, a drop in its collective valuation of around 12 percent. Not much in the scheme of things when you consider that the BioWorld Blue Chip Biotech Index, a price-weighted index that includes 19 of the top biotechnology companies as rated by market cap, remains up 86 percent since the beginning of 2013. Nevertheless, biotech’s fall was enough to sharpen the pins of...
Before its unfortunate drop in quality in its last few seasons, the medical drama House was one of my favorite shows, with its title character, a cranky, possibly drug-addicted doctor solving diagnostic riddles and saving lives with Sherlockian brilliance, and quite often breaking every rule in the book to do it. One episode in particular had House facing off with billionaire investor Vogel, who had thwarted his attempt to enroll a very sick patient in a clinical trial without mentioning to the trial investigator that she wouldn’t fit the criteria, namely having just undergone a C-section. They have an impassioned exchange:...
U.S. and British government agencies are moving toward enabling what would be the first clinical trials of what is, in effect, human germline engineering – genetic modifications that would be passed down through the generations. The modifications would not be made to nuclear DNA. Instead, the procedure being considered is oocyte modification – creating an egg cell with the nuclear DNA of one woman and the mitochondrial DNA of another. The goal would be to allow women with mitochondrial diseases to have babies that share their nuclear DNA, but are not at risk of inheriting their mitochondrial disease. The UK...
It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there still is no telephone competition. The Soviet Union leads a boycott of the Summer Olympics being held in Los Angeles, presumably as payback for the U.S. boycott of the 1980 Moscow Games, which was, in turn, a response to the Soviet war in Afghanistan. Even though Time named the computer the “Machine of the Year” two years ago, personal computers...
What if we paid professional athletes only when they won? What if spectators got their tickets refunded whenever the home team lost? That might make that $1,300 Super Bowl ticket a little easier to purchase. And, hey, perhaps that might assuage some of the crushing disappointment for Denver fans still bemoaning the Broncos’ embarrassing defeat. (Though, on second thought, maybe not. Broncos’ fans are pretty passionate and hard core.) But along those same lines, what if we paid for therapeutics only when they worked? That would keep the cost of health care from further spiraling out of control, right? That...
Who needs Black Friday and Cyber Monday, anyway? True biotech aficionados know they can find the perfect gift for everyone on their holiday list in BioWorld’s 7th Annual Biotech Holiday Gift Guide. Shoppers, start your engines. Personal Health Last year, biotech holiday lists – including ours – featured genomic testing. Thanks to the FDA, the popular 23andMe genotyping service has suspended health-related genetic tests. However, BioWorld Managing Editor Jennifer Boggs pointed out that you can still get your microbiome sequenced at ubiome, learning what bacteria reside in your body, comparing your microbiome to those of other individuals and visualizing yourself...
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19....
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax...
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