It was out with the old and in with the new Tuesday as the 114th U.S. Congress gave way to the 115th. Among the new delegates taking their seats in the House were a few more doctors, a dentist and the head of a Texas company that commercializes medical-related technologies. And the Senate welcomed a member who has done a stint as an attorney for a major hospital. The new members won’t be a novelty in a Congress that’s already home to more than a dozen doctors, nurses, a pharmacist and other health care providers. That’s a far cry from...
After a bruising U.S. presidential campaign and, let’s just say, less than conventional preparation for the nation’s 45th president, we could all use a bit of holiday cheer. In a neighborly gesture, Peter Winter, Ottawa-based editor of BioWorld Insight, suggested U.S. citizens might treat themselves to a gift of Canadian real estate. “The timing couldn’t be better,” Winter quipped. “Low interest rates and a favorable exchange rate between the U.S. dollar and the Canadian dollar make buying a home in Canada very affordable. What better way to give yourself peace of mind for the next four years?” If that idea...
For decades the biotech industry has been hounded by activists over animal testing. Most notably, a campaign against Huntington Life Sciences in the late 1990s through 2000s included arson, harassment, threats and alleged fire bombings. Less severe, but still troubling for biotech, animal rights activists join with anti-GMOers most years to protest at the Biotechnology Innovation Organization (BIO) convention. But as biotech has branched into cultured meat and alternatives to animal testing, the companies and scientists involved have been praised by animal rights groups. Chip technologies unite animal activists and biotechs Biotechs developing chip technologies are at the forefront...
The day before news broke of the lawsuit against Valeant Pharmaceuticals International Inc. – lodged by former shareholders of Sprout Pharmaceuticals Inc. over Valeant’s non-promotion of Addyi (flibanserin) for female sexual dysfunction – officials of Palatin Technologies Inc. groused to me about that very topic. “It’s just there, doing nothing,” he said of Addyi, a non-hormone agonist at the 5-HT1A receptor and an antagonist at the 5-HT2A receptor. Palatin hoped that Valeant’s $1 billion buyout last year of Sprout in order to get its hands on then just-approved Addyi would mean a big push for greater awareness of the drug...
As a veteran health care journalist, I appreciate the need for biopharmas to recoup R&D costs and to operate profitably, so it’s hardly surprising to me when newly approved drugs are priced at a premium. But I’m also a consumer and a caregiver. In the context of those roles, the convoluted prescription drug supply chain with its multitude of handoffs seems purposely designed to obscure the true cost of branded drugs and, in turn, the true value of patient assistance programs (PAPs). The mysteries of drug pricing and efforts to mitigate patient out-of-pocket costs through PAPs hit home at the...
Add this to the list of things the 114th U.S. Congress likely won’t get done before it fades into history on Jan. 3: Providing relief from the inter partes review (IPR) intimidation racket. It’s not for want of trying. But the only attempts were specifically aimed at keeping drug companies from being pushed around by the government-sanctioned playground bullies who use the threat and filing of IPR patent challenges to demand a lot more than lunch money. The trouble is a lot of lawmakers didn’t want to stand up for drug companies, who aren’t the most popular kids on the...
Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...
The challenges of drug development are vast and demanding. Keeping up with scientific advances, the competition, clinical trial roller coasters, global regulatory hurdles, financing innovation, pricing … the list is endless. But have the myriad responsibilities distracted us from the assumed main reason for developing new medicines? Is improving the human condition in a way that prioritizes the largest problems first too lofty a goal? What risks should sick patients take in the name of science and who is protecting the vulnerable? Who decides what’s right and safe in tinkering with our genetic makeup? Though watchdogs aplenty monitor various parts...
We’re still a few weeks away from the summer solstice, at least in the Northern Hemisphere, but with BIO around the corner that trip to San Francisco justifies a good read. Whether you’re in the mood for the story of a scientist coming of age or of a world leader seeking to thwart the Axis powers, a street child’s search for his father or a neurologist’s look at psychosomatic illness, BioWorld’s Summer Reading List – our 10th annual – is certain to have something to pique your interest. We culled the top suggestions from our writers and readers, in some...
In the annals of popular literature, TV shows and movie scripts, only a handful of pigs have achieved mega stardom: Napoleon, who took over a farm and assassinated his political rivals; Arnold, who epitomized the couch potato at Green Acres; Miss Piggy, who used her feminine wiles and street smarts to become the piglet diva of the Muppets; Babe, who used his sheep-herding skills to survive and land a starring role in a movie; and Wilbur, who had the best ad agent of them all. While other famous pigs were almost human in their aspirations and lifestyle, Wilbur was, well,...