martes, 2 de febrero de 2016
lunes, 1 de febrero de 2016
Students Are Battling to Make Elon Musk’s Hyperloop a Reality
SpaceX's competition in Texas this weekend will be the world’s loopiest, way-out science fair.
Baby boomers had NASA and the Apollo moonshots to inspire them to dream big a half-century ago. Kids these days have Elon Musk.
When the Tesla Motors Inc. and SpaceX chief executive officer first unleashed his outlandish idea for a Star Trek-style capsule transporting passengers on a cushion of air at 700 miles an hour, it seemed like pure fantasy. Well, guess what? A lot of people—many of them young engineering students—took him seriously. More than 1,000 of them are gathering this weekend at Texas A&M University in College Station, Texas, where SpaceX is sponsoring its first-ever, two-day Hyperloop Pod Competition, which promises to be the world’s loopiest, way-out science fair.
A sketch of the Hyperloop from Elon Musk's original 2013 paper.
"There are a lot of crazy ideas out there, but when ideas are associated with someone like Elon Musk it feels like, OK, this is something," said Anshuman Kumar, 22, leader of the Hyperloop team at Carnegie Mellon University in Pittsburgh and one of 20 CMU students traveling to Texas this weekend. "Everyone wants to be associated with the Hyperloop movement. It’s a once-in-a-lifetime opportunity."
Arriving from 20 countries, about 120 college teams and three from high schools will descend on the vast Texas campus to present their designs. They’re flying in from India’s Birla Institute of Technology and Science, Egypt’s Cairo University, Delft University of Technology in the Netherlands and Imperial College London, to name a few. U.S. Transportation Secretary Anthony Foxx is scheduled to deliver the keynote address.
Musk already has something of a cult following among a new generation of engineers, thanks to his work on electric cars, solar power and reusable rockets for eventual travel to Mars.
And now, the Hyperloop. Musk’s latest bright idea may or may not ever solve the world’s transportation challenges, but it’s certainly smart marketing. And the competition will bring the best and brightest engineering minds from around the globe under one roof, where SpaceX recruiters will have their pick of the crop.
The frenzy began with Musk’s Hyperloop Alpha, his 57-page manifesto released in 2013. The 44-year old Musk pulled an all nighter to finish his paper, which envisions a capsule hurtling on a cushion of air between San Francisco and Los Angeles in 30 minutes. Musk is the first to admit that pulling off such a feat will be no easy task.
"Short of figuring out real teleportation, which would of course be awesome (someone please do this), the only option for super fast travel is to build a tube over or under the ground that contains a special environment," Musk wrote. "This is where things get tricky."
A sketch of the Hyperloop from Elon Musk's original 2013 paper. Source: Elon Musk
After the paper was made public, the number of people following Musk on Twitter skyrocketed. At least two startups are trying to commercialize the idea on their own. But last June, when SpaceX itself announced a competition to build a pod, the idea caught fire. Within a week of the announcement, the company received 700 entries; the final total was 1,751, with 123 advancing to this weekend’s design competition.
The conference will be held in the 30,000-square foot Hall of Champions, next to Texas A&M’s football stadium. Many demonstrations and talks will be live-streamed. Booths will be brimming with students, some bearing prototypes, eager to talk about their designs and secure corporate sponsorship. An as-yet-undetermined number of teams will advance to a finals competition to be held this summer at SpaceX headquarters in Hawthorne, California, where they will demonstrate their full-scale designs on a one-mile working test track.
"It’s rare to get the opportunity to design something, for the first time, from scratch," said Liam Richardson, 19, an aerospace-engineering student at California Polytechnic State University in Pomona, who spent most of winter break Skype-ing with his teammates about design specs. "A lot about the Hyperloop is still unknown, and there’s no reference to go off of, besides Elon’s paper.”
Each team comes to the fair with its own interpretation of Musk’s idea. Stanford University students, for instance, are opting for a passive magnetic levitation, or maglev, system, said Kendall Fagan, 21, a mechanical-engineering student at the California school.
“Transportation is really exciting right now because of autonomous cars," he said.
"But the Hyperloop is the most out-there idea in transportation. Part of the excitement is that this is something that has never been done before. Is it even possible? There are different schools of thought as to how the levitation is going to work."
While SpaceX’s competition is geared toward university students, a few high school teams made the cut. Six students from St. John’s, a private high school in Houston, call themselves the "HyperLift." Their parents are driving them to the event.
"We decided to go with air bearings because that’s what Elon proposed in his paper, and it wouldn’t be true to his vision if we just modified a maglev train,” said Andrew Awad, 17, a junior. “The integration between our cooling system and the air-bearing system is revolutionary.”
jueves, 28 de enero de 2016
Do you need a calculator: Five handy calculator apps for Windows
If the built-in Windows Calculator doesn't quite meet your needs, one of these alternatives might.
One of the built-in Windows apps I find myself using the most frequently is Calculator. As handy as it is, however, plenty of other calculator apps are available. These apps, many of which are freeware, often provide functionality that doesn't exist in the built-in Windows tool. Here are five choices that are worth a look.
1: Moffsoft FreeCalc
Moffsoft FreeCalc (Figure A) is a free calculator that's designed to act as an alternative to the built-in Windows Calculator. Although this app can't really do anything beyond basic arithmetic, it does have one feature I really like. The interface includes a side panel that the utility refers to as a tape. All calculations are written to the tape, and the tape can be saved to a text file for future reference.
Figure A
2: Calc98
Calc98 (Figure B) is another free calculator. Although its interface feels a bit cluttered, the application is lightweight and works well. It supports basic arithmetic as well as a few scientific functions, such as sin, cos, and tan.
Figure B

This calculator's best feature is the integration of copy and paste buttons.
3: Biromsoft Calculator
Biromsoft Calculator (Figure C) is a basic calculator for performing arithmetic, square roots, and percentages, but not a lot more. The good thing about this app is that it's designed to be accessible on demand. You can launch it from the system tray and once it's running, it occupies a minimal amount of desktop real estate. The interface fades and blends in with the desktop until you need it. With a simple click, the calculator becomes fully visible and ready to go.
Figure C

Biromsoft Calculator sells for $14.95, but a free trial version is available for download.
4: Graphing Calculator 3D
Graphing Calculator 3D (Figure D) is a great tool for anyone who has to graph functions. It can graph a wide variety of functions in either 2D or 3D. The graphs are colorful and can be rotated, customized, and even exported.
Figure D

It's worth noting that you must have Java installed on your computer to use Graphing Calculator 3D.
5: AllerCalc
The thing that sets AllerCalc (Figure E) apart from other calculators is its sheer number of built-in functions. There are more than 100.
Figure E

This awesome (and free) calculator also has a huge number of built-in constant values and a built-in conversion engine that can assist with common measurements.
jueves, 21 de enero de 2016
Millennials, Here's What Your First Home Might Look Like
A homebuilder aims to entice young buyers with adaptable space and an outdoor kitchen.

The contemporary farmhouse, designed for buyers age 35 and younger, has an open plan design, an outdoor kitchen, and a suite of rooms accessible by a side entrance. That way, the owner can take on a lodger or, if she decides to start a family, give the tenant the boot and reincorporate the rental space into the home.
Is that what millennial homebuyers want?
It’s one idea. Pardee Homes, a subsidiary of Irvine, Calif.-based Tri Pointe Group, built the concept home1 to show off at the National Association of Home Builders trade show in Las Vegas this week. Its estimated price tag in the “mid-$300,000s” makes it more expensive than a traditional starter home in the Las Vegas market. In return for the higher price, Pardee is selling the idea of a home that can serve young buyers from one life stage to the next.
“Millennials are really interested in customizing their space,” said Klif Andrews, president of Pardee’s Las Vegas division. “We designed the house so that over time, it can be remodeled for minimal investment.”
Andrews said the Responsive Home, which is how Pardee is branding the farmhouse along with a second, upmarket concept called a "contemporary transitional," evolved based on years of research. In addition to incorporating spaces that are "preengineered" for easy adaptation, the houses are built for outdoor entertaining, Andrews said. They sacrifice closet and cabinet space for living areas because "research shows millennials are not big acquirers."
There was a time not so long ago when many in the real estate business worried that millennials—scarred by the housing crisis, drawn to apartment living in big cities—might never buy homes at the rate of earlier generations. Those fears seem to have dissipated, mostly because millennials keep telling pollsters that they want to buy homes and that actually, living in the suburbs wouldn't be so bad.
Still, the generation has been slower to enter the housing market than previous cohorts. That's probably because they're starting families later in life and because income growth hasn't kept up with rising home prices.
Can the idea of adaptable space persuade young buyers to take the jump? Pardee will get some feedback this summer, when it starts completing homes based on the Responsive Home concepts—about 80 of each in the Las Vegas area.
The traditional starter home—smaller, cheaper, and further from the city center—is also making a comeback.
miércoles, 28 de octubre de 2015
10 Swiss startups you need to watch
Many aspects of Switzerland make it a good place to start a company. Here are 10 startups from Switzerland that you should keep an eye on

The land known for its chocolate and watches is becoming increasingly known as a hotbed for new startups. Switzerland's startup scene is alive and thriving due to strong engineering schools and myriad possibilities for funding.
Yannick Guerdat is a member of the Alp ICT, an organization that seeks to grow business innovation in Switzerland. He said public-private partnerships are common in the country, and many startups can partner with universities as well. Additionally, most regions also have incubators, he said.
While investors typically don't take the same risks as investors in the US, he said, they are committed to the long term growth of the company.
"Beyond having the right people, technical solutions and infrastructure, the country's heritage in banking and confidentiality surely contributes to some extent," he said.
Guerdat said small business is integral to the Swiss economy. How fitting that the country where the World Wide Web got its start at CERN is now continuing its tradition of small business growth in technology and web-based businesses.
Here are 10 innovative new Swiss startups that are poised to do some big things.
1. ProtonMail
Former CERN employees developed ProtonMail, a secure email service that offers end-to-end encryption and other security features. The technology was developed in partnership with another research institution and even ProtonMail employees can't access user data. Forbes called it "the only e-mail system the NSA can't access."
2. Bestmile
Bestmile has built out a platform to manage fleets of autonomous vehicles. They don't build the vehicles themselves, but they provide the infrastructure for connecting and operating these vehicles. A clean UI makes the product easy to get started with and use.
3. Silent Circle
The secure smartphone known as the Blackphone was created by Swiss startup Silent Circle. The company's second iteration, the Blackphone 2, was released in September 2015. Potentially more secure than any other phone in the market, it runs a proprietary OS called Silent OS.
4. Dacuda
Dacuda turns your phone into a mobile 3D scanner. You can use the company's app 3DAround to take food photos, or its app called 3DSelfie to turn yourself into a 3D printed figurine. Their SLAM Scan technology applies robotic algorithms to recreate the images captured in three dimensions.
5. Threema
For the privacy and security conscious, Threema offers end-to-end encryption on all your messages, group chats, files, and status messages. Users are given a Threema ID to keep everything fully anonymous. The app also features a polling tool so users can poll their friends to help them make decisions.
6. Squirro
Squirro tackles a company's unstructured data to provide new insights into customer trends, service trends, and risk. A cloud solution, Squirro takes a look at both internal and external data to provide analysis.
7. Starmind
Starmind's "Brain Technology" is an AI tool that uses self-learning algorithms to make an information map of an organization. It can analyze and answer anonymous questions from employees, or point them to the top expert on a particular subject within their company.
8. HouseTrip
Similar to the increasingly popular Airbnb, Switzerland's HouseTrip helps users find and rent holiday homes in Europe, Asia, Africa, North America, South America, and Australia. The company went live in early 2010 and has since helped book millions of rooms.
9. Monetas
Monetas provides a platform for financial transactions to occur. The platform supports transaction in both national and digital currencies, and even offers Bitcoin integration. The company's website said it uses cryptographically secured digital notary to enable the transactions.
10. L.E.S.S.
L.E.S.S. develops and sells nan fiber lighting systems. The company offers applications in the automotive, industrial, and medical industries, among others. They provide both high and low-angle illumination systems.
The land known for its chocolate and watches is becoming increasingly known as a hotbed for new startups. Switzerland's startup scene is alive and thriving due to strong engineering schools and myriad possibilities for funding.
Yannick Guerdat is a member of the Alp ICT, an organization that seeks to grow business innovation in Switzerland. He said public-private partnerships are common in the country, and many startups can partner with universities as well. Additionally, most regions also have incubators, he said.
While investors typically don't take the same risks as investors in the US, he said, they are committed to the long term growth of the company.
"Beyond having the right people, technical solutions and infrastructure, the country's heritage in banking and confidentiality surely contributes to some extent," he said.
Guerdat said small business is integral to the Swiss economy. How fitting that the country where the World Wide Web got its start at CERN is now continuing its tradition of small business growth in technology and web-based businesses.
Here are 10 innovative new Swiss startups that are poised to do some big things.
1. ProtonMail
Former CERN employees developed ProtonMail, a secure email service that offers end-to-end encryption and other security features. The technology was developed in partnership with another research institution and even ProtonMail employees can't access user data. Forbes called it "the only e-mail system the NSA can't access."
2. Bestmile
Bestmile has built out a platform to manage fleets of autonomous vehicles. They don't build the vehicles themselves, but they provide the infrastructure for connecting and operating these vehicles. A clean UI makes the product easy to get started with and use.
3. Silent Circle
The secure smartphone known as the Blackphone was created by Swiss startup Silent Circle. The company's second iteration, the Blackphone 2, was released in September 2015. Potentially more secure than any other phone in the market, it runs a proprietary OS called Silent OS.
4. Dacuda
Dacuda turns your phone into a mobile 3D scanner. You can use the company's app 3DAround to take food photos, or its app called 3DSelfie to turn yourself into a 3D printed figurine. Their SLAM Scan technology applies robotic algorithms to recreate the images captured in three dimensions.
5. Threema
For the privacy and security conscious, Threema offers end-to-end encryption on all your messages, group chats, files, and status messages. Users are given a Threema ID to keep everything fully anonymous. The app also features a polling tool so users can poll their friends to help them make decisions.
6. Squirro
Squirro tackles a company's unstructured data to provide new insights into customer trends, service trends, and risk. A cloud solution, Squirro takes a look at both internal and external data to provide analysis.
7. Starmind
Starmind's "Brain Technology" is an AI tool that uses self-learning algorithms to make an information map of an organization. It can analyze and answer anonymous questions from employees, or point them to the top expert on a particular subject within their company.
8. HouseTrip
Similar to the increasingly popular Airbnb, Switzerland's HouseTrip helps users find and rent holiday homes in Europe, Asia, Africa, North America, South America, and Australia. The company went live in early 2010 and has since helped book millions of rooms.
9. Monetas
Monetas provides a platform for financial transactions to occur. The platform supports transaction in both national and digital currencies, and even offers Bitcoin integration. The company's website said it uses cryptographically secured digital notary to enable the transactions.
10. L.E.S.S.
L.E.S.S. develops and sells nan fiber lighting systems. The company offers applications in the automotive, industrial, and medical industries, among others. They provide both high and low-angle illumination systems.
jueves, 15 de octubre de 2015
In North America's Costliest City, Rich Chinese Take the Blame
- > Vancouver voters look for political fix in Canadian election
- > Coping with affordability crisis means roommates over families
James Hankle, a 50-something software engineer sporting blue jeans and a Green Party T-shirt, is explaining his fix for Vancouver’s runaway property prices when he’s interrupted by an eavesdropping passerby: “Stop allowing people from China to buy our houses and leave them vacant,” she says and walks away.
- Despite British Columbia’s aversion to pipelines and affection for pot, housing affordability has pushed both aside as the number one issue raised by area residents in the run-up to Canada’s election this month. It’s not completely surprising given that Vancouver has become North America’s most expensive city.
- Surging purchase prices have triggered protest movements like #donthave1million, started by a group of young professionals frustrated at being shut out of home ownership. They complain of having to delay starting families as they remain bunked in with roommates, often into their 30s and beyond.
- The affordability issue speaks to broader campaign themes: the difficulty young people face getting established in the labor market, the economic anxieties of the middle class, growing concerns about income inequality, support for families with children. Residents also increasingly point fingers at wealthy Chinese immigrants and investors whose lavish embrace of the Pacific metropolis of 2.5 million has inspired reality TV shows with such gaudy names as “Ultra Rich Asian Girls in Vancouver.”
- Vancouver, with its C$2.23 million ($1.7 million) average price tag for a detached home is playing an unusual role in the national election to be held Oct. 19. British Columbia is the only place where all four national parties are competitive -- the Conservatives, Liberals, New Democrats and Greens -- and, given the tightness of the race, its choices could spell the difference. As of now, the New Democrats and Liberals look likely to take some seats away from the Conservatives in the region, according to poll aggregator ThreeHundredEight.com.
- Campaign Fodder
- The top contenders for prime minister, incumbent Conservative Stephen Harper, Liberal Justin Trudeau and New Democrat Tom Mulcair, have all given voice on campaign stopovers to the city’s particular anxiety by promising they will, if elected, gather data on foreign ownership of its pricey condos and bungalows. “There are real concerns that foreign, non-resident real estate speculation is the reason some Canadian families find house prices beyond their budgets,” Harper said Aug. 12 in Vancouver. “That is a matter we can and should do something about.”
- Though no expert on the subject, Hankle, like just about everyone else across the city, is obsessed with the topic and increasingly resigned to never owning a house himself. Standing in Yaletown, a one-time industrial site where nearby two-bedroom apartments can go for C$1.8 million, he calls on political parties competing for his vote to build more low-cost housing and introduce programs to guarantee people a livable minimum income.
- He also picks up on the theme of the passing woman, saying governments need to begin collecting data on exactly who’s coming into the city and their impact on affordability. “There’s a huge concentration of wealth and it just isn’t sustainable,” he says.
- Bubble Unburst
- Unlike the U.S., Canada didn’t experience a housing price collapse with the global recession and has defied predictions ever since that the bubble is about to burst. With the exception of declines in 2009, 2012 and 2013, housing prices have risen in each of the past 15 years, with the cost doubling from August 2005 to 2015, according to the Real Estate Board of Greater Vancouver, out-pacing wage gains.
- “Our big challenge is affordable housing,” said Vancouver Mayor Gregor Robertson, in a Sept. 25 interview at Bloomberg headquarters in New York. “It’s been difficult to deal with more affordable housing for a younger work force in particular.”
- The Economist Intelligence Unit has named Vancouver the most expensive city to live in North America and a 2014 study by consultancy Demographia cited it as the second-least affordable housing market in the world after Hong Kong. Rising prices in Vancouver pushed housing affordability to “risky levels” in the second quarter as the costs of owning a bungalow rose to an unprecedented 86.9 percent of household income, an August report by RBC Capital Markets said.
- “There’s national trend on affordability and it gets especially bleak in Vancouver,” said Paul Kershaw, an associate professor at the University of British Columbia who studies the impacts of public policy on housing. “The dynamic is signaling a change in the standard of living and home ownership that has been the norm for previous generations.”
- Record Debt
- Vancouver’s 25-to-34 year old cohort earns less and carries more debt than a generation ago, Kershaw said, meaning it now takes 10 working years to save for a down payment versus two years back then.
- Although harder pressed, Vancouver families are in good company in borrowing more and more to get ahead. The debt of the average Canadian household now stands at a record 165 percent of disposable income, according to Statistics Canada, about 30 points higher than before the recession and matching the levels of U.S. debt when its housing market crashed. Still, in Vancouver at least, prices are galloping ahead so quickly, they “make it a stretch” for a typical household to get into the market.
- “It’s possible to live decently here as long as you’re single and don’t have dependents,” said Scott McFadyen, a 38-year-old audio designer in the video game industry who moved to Vancouver from Alberta. “Truthfully, I’m thinking twice about starting a family here.”
miércoles, 14 de octubre de 2015
2,000% Drug Price Surge Is a Side Effect of FDA Safety Program (BusinessWeek)
> Drugs used for decades are licensed, branded in safety drive
> Prices jump as makers given monopolies on approved versions
> Prices jump as makers given monopolies on approved versions
Colchicine, a gout remedy so old that the ancient Greeks knew about its effects, used to cost about 25 cents per pill in the U.S. Then in 2010 its price suddenly jumped 2,000 percent.
That’s just one of the side effects of a U.S. Food and Drug Administration plan to encourage testing of medicines that have been around longer than the modern FDA itself, and so have never gotten formal approval. Companies that do the tests are rewarded with licenses that can temporarily give them monopoly pricing power as most rivals are eased or kicked off the market. The result has been a surge in the cost of drugs used in treatments from anesthesia to heart surgery and eye operations.
It can bring big paydays for the producers. URL Pharma, the small Philadelphia drugmaker granted rights over colchicine, was bought for $800 million by Takeda Pharmaceutical Co. in 2012. Asia’s biggest drugmaker has since brought in $1.2 billion in revenue from the branded drug, Colcrys, which went on the market at a wholesale price of almost $6 a pill. Takeda says testing for FDA approval made the drug safer.
But patients and hospitals are feeling the pinch, and politicians have begun to notice. Hillary Clinton’s recent promise to address the issue sent pharmaceutical stocks plunging. Critics say the FDA plan lets entrepreneurs make windfall profits on drugs where there was never much concern about safety or efficacy.
In many cases, the program “almost had the opposite effect as intended,” said Joseph Biskupiak, a professor at the University of Utah College of Pharmacy. “The only drugs that got studied are the ones that don’t have a problem.”
The FDA’s rationale is that some drugs have never been measured against modern safety standards. The program “has been a success” that has removed dangerous drugs from the market, said Michael Levy, deputy director in the compliance office of the FDA’s drug evaluation unit.
The agency acknowledges that approving branded versions of old generic drugs may make them more expensive when a sole manufacturer remains to make a medication, but says that’s outside its remit. “FDA does not regulate according to economic factors, nor do we have control over drug pricing,” spokesman Christopher Kelly said.
The FDA program, which got under way in 2006, is only one reason why prices of old generic drugs have risen. Others include mergers that reduced competition, and a business strategy by some drugmakers of acquiring niche medicines and raising prices sharply, even without any rebranding.
‘Business Model’
A price survey of more than 21,000 generic drugs for Bloomberg News by DRX, a unit of Connecture Inc. that tracks drug prices, found that more than 3,500 have doubled or more since late 2007, ranging from basic chemotherapy medicines to old antibiotics.
John Lewin, director of the critical care and surgical pharmacy at Johns Hopkins Hospital in Baltimore, said in many cases there are no obvious benefits to offset the higher prices.
“We’re not paying for innovation, we’re not paying for fewer side effects, and we’re not paying for better care,” he said. “We’re paying for somebody’s business model to make a profit.”
Glenn Spann, a longtime user of colchicine for his gout, says he never paid more than $10 a prescription -- until he was hit with a $300 bill when his insurer stopped covering the treatment after its price spiked. “There is no justification for it,” said Spann, a 55-year-old self-employed artist in Culver City, California. “There is nothing different except the marketing,” and the ownership.
Shares Rise
Investors who bet on the industry have benefited from the sales increases. Since the end of 2009, a Bloomberg Intelligence index of specialty-generic drugmakers has almost quadrupled -- gaining about four times as much as the S&P 500 Index.
It was outperforming this year, too -- until last month, when Clinton tweeted that “price gouging” in some specialty drugs was “outrageous.
Since then, shares in Flamel Technologies SA are down about 25 percent. The company won FDA approval in May 2013 for Bloxiverz, a brand-name version of neostigmine, used to reverse the effects of anesthesia after surgery. According to DRX, Bloxiverz costs more than six times as much as its unapproved predecessors, which have been removed from the market under what the FDA says was a voluntary commitment by their makers.
Products like Bloxiverz are designed “to produce cash flow,” Michael Anderson, Flamel’s chief executive officer, told investors in June. Flamel’s revenue soared to $49.8 million in the second quarter of 2015, from $4.3 million the previous year.
The price of Bloxiverz reflects the costs of getting it approved, including an FDA filing fee of more than $2 million, Bob Yedid, a Flamel spokesman, said by phone. “We’ve been very careful not to have what I’ll call ‘irresponsible’ price increases,” he said. Flamel uses its profit to invest in developing new drugs.
Vasopressin Prices
Another drug to jump in price is vasopressin, a blood-vessel constricting agent used in emergencies. Vasostrict, a branded version approved last year and owned by Endo International Plc, costs $116 per milliliter wholesale, more than 10 times the wholesale price of unapproved versions three years ago, according to DRX.
Such increases are causing problems for hospitals. Johns Hopkins has set up a task force to identify which established drugs could be next in line for the FDA program.
Tenet Healthcare Corp., the fourth-largest U.S. operator with almost 500 treatment centers, says it’s started refrigerating vasopressin because that can increase its shelf-life to two years from less than 12 months, so it doesn’t have to replace the drug as often.
Vasostrict was developed by Par Pharmaceutical Holdings Inc., which was bought by Endo last month. Keri Mattox, senior vice president at Endo, said in an e-mail that Par “invested significant time and resources to demonstrate the safety and efficacy of its reformulated product.” The company’s reformulation of the drug "corrected key overage and necessary refrigeration attributes of the old unapproved product," she said.
Benefits of Testing
In the case of colchicine, the FDA and Takeda say the tests yielded benefits. Unapproved versions had labels that recommended dangerously high doses or neglected potential side effects, the FDA’s Levy said. The approved version hit the market in 2009, and the next year the FDA moved to take the lower-cost versions off the market. The testing process has “significantly changed the manner in which colchicine is prescribed,” said Linda Calandra, a Takeda spokeswoman.
But Aaron Kesselheim, a researcher at Harvard Medical School, studied colchicine prescriptions before and after the FDA intervention, and found no difference in the rate of doctors prescribing the medication along with another drug that could have dangerous interactions. His survey was published in April in the Journal of General Internal Medicine.
“This is a good example of market exclusivity being given to a company that didn’t really deserve it,” Kesselheim said. The company tested “a dosing regimen that people already knew about -- and showed it worked, which everyone already knew.”
Calendra said Takeda can’t comment on studies conducted by outside parties. She said the testing had produced new dosing and safety information.
Bringing drugs that predate the modern FDA under regulation isn’t a bad idea in principle, Kesselheim said. But “the trade-off you get, of ridiculously higher prices, I don’t think is a great trade-off.”
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