Dec 17 (Reuters) - Quidel Corp :
* Receives FDA clearance for its Amplivue(R) hand-held molecular diagnostic
test for clostridium difficile
* Source text * Further company coverage
((Bangalore Newsroom; +1 646 223 8780))
Tuesday, January 1, 2013
BRIEF-Quidel gets FDA clearance for its Amplivue hand-held molecular diagnostic test for C.difficile
UPDATE 1-Actelion's psoriasis drug meets main goal in trial
* Developing drug to treat chronic plaque psoriasis
* 46 pct of patients saw 75 pct improvement at week 16
* Plan to proceed to late-stage trials
(Adds details, background)
ZURICH, Dec 18 (Reuters) - Actelion, Europe's biggest biotechnology company, said its drug for patients suffering from the skin disease psoriasis met its main goal in a mid-stage clinical trial.
The Swiss company said on Tuesday 46 percent of patients suffering from moderate to severe chronic plaque psoriasis saw a 75 percent improvement in the Psoriasis Area and Severity Index (PASI) at 16 weeks when treated with a 20 milligramme dose of its drug ponesimod.
This compares with a 13.4 percent improvement in patients treated with a placebo. Patients receiving ponesimod continued to show improvement after the initial 16 weeks, Actelion added.
The results are a further boost to Actelion which has seen its future brighten over the past year since its new-generation heart and lung drug macitentan beat expectations in a late-stage trial.
"This is the first time that this mechanism has demonstrated efficacy with psoriasis patients," said Guy Braunstein, head of clinical development at Actelion.
The company said it now plans to start late-stage trials for ponesimod once the data has been fully analysed.
Actelion is banking on macitentan to replace its current main drug Tracleer, which goes off patent in 2015 and is already facing competition from U.S. rival Gilead's L e tairis.
Last week, Acetlion said the U.S. health regulator had agreed to evaluate macitentan for the treatment of patients with a potentially life-threatening lung condition.
(Reporting by Caroline Copley; Editing by Mark Potter)
UPDATE 1-Alexza's agitation drug gets FDA approval
Dec 21 (Reuters) - Alexza Pharmaceuticals Inc said the U.S. health regulators approved Adasuve, making it the first treatment for schizophrenia and bipolar disorder that can be inhaled.
Adasuve, which delivers an older antipsychotic drug called loxapine, passes through the lungs and into the bloodstream faster than a typical pill. Loxapine is available as an oral drug for schizophrenia.
The company said the product will include a boxed safety warning about potentially dangerous side effects including the potential for fatal bronchial spasms in people with asthma or chronic obstructive pulmonary disorder and a higher risk of death in elderly people with dementia-related psychosis.
Adasuve use will be restricted to mitigate the potential harm of bronchial spasms, Alexza said.
The FDA also required Alexza to conduct a large post- marketing clinical trial of patients to assess the real-world use of the drug.
"We believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them," Chief Executive Thomas King said in the statement.
Three injectable drugs, Bristol-Myers Squibb's Abilify, Eli Lilly's Zyprexa and Pfizer Inc's Geodon, are currently approved to calm patients with schizophrenia or bipolar disorder.
Adasuve, Alexza's most advanced drug, will be available for commercial launch early in the third quarter of 2013, the company said.
Earlier this month, European health regulators recommended approval of Adasuve.
The FDA denied approval to Adasuve in May, after it found deficiencies at the company's Mountain View, California manufacturing facility during an inspection.
The company's shares fell 12 percent in the after market trading after the trade was halted at $5.79 before the drug- approval announcement.
Notice - Waiver from Rescission of Unobligated Funds Under the American Recovery and Reinvestment Act of 2009
The White House
Office of the Press Secretary
NOTICE- - - - - - -WAIVER FROM RESCISSION OF UNOBLIGATED FUNDS UNDER THE AMERICAN RECOVERY AND REINVESTMENT ACT OF 2009Consistent with the authority provided to me under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5), as amended by section 1306 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Public Law 111-203), I have determined that it is not in the best interest of the Nation to rescind after December 31, 2012, the unobligated amounts made available in Division A of the American Recovery and Reinvestment Act with respect to the accounts with the following Treasury Account Fund Symbol codes and names, not to exceed the amounts stated:
Department of Defense: 97-0501 -- Military Construction, Defense-wide, $104 million;
Department of Energy: 89-0209 -- Title 17 Innovative Technology Loan Guarantee Program, $96 million;
Social Security Administration: 28X8704 -- Limitation on Administrative Expenses, $148 million; and
Small Business Administration: 73-4268 -- Surety Bond Guarantees Revolving Fund, $15 million.
My determination is based on the following consideration:
The retention of these unobligated balances will allow the executive agencies to continue to execute projects vital to the national interest in a fiscally responsible manner.
Therefore, in accordance with section 1306 of Public Law 111-203, I am waiving the requirements for repayment for the stated amounts of unobligated funds made available in the American Recovery and Reinvestment Act with respect to the accounts described above.
In accordance with section 1603(b) of the American Recovery and Reinvestment Act of 2009, as added by section 1306 of Public Law 111-203, all amounts that are rescinded pursuant to section 1603(b) shall be returned to the General Fund of the Treasury where such amounts shall be dedicated for the sole purpose of deficit reduction and prohibited from use as an offset for other spending increases or revenue reductions.
This notice shall be published in the Federal Register.
BARACK OBAMA
In 2012, working with Joining Forces, American businesses exceeded the President's challenge to hire 100,000 veterans and military spouses and made a greater commitment for the future.
President Obama urges Congress to meet its deadlines and responsibilities, protect the middle class from an income tax hike, and lay the groundwork for future progress on more economic growth and deficit reduction.
Take a look at the videos that have been viewed the most.
view all related blog postsFDA moves closer to approval of GMO fish, critics outraged
* FDA to take comments for 60 days before giving final OK
* Critics seek action from Congress, threaten to sue
Dec 21 (Reuters) - A controversial genetically engineered salmon has moved a step closer to the consumer's dining table after the U.S. Food and Drug Administration said Friday the fish didn't appear likely to pose a threat to the environment or to humans who eat it.
AquAdvantage salmon eggs would produce fish with the potential to grow to market size in half the time of conventional salmon. It would be the first food from a transgenic animal - one whose genome has been altered - that has been approved by the FDA.
The AquAdvantage Atlantic salmon egg was developed by AquaBounty Technology,, to speed up production to meet global seafood demand.
In a draft environmental assessment Friday, the FDA affirmed earlier findings that the biotech salmon was not likely to be harmful. It said it would take comments from the public on its report for 60 days before making a final decision on approval.
AquaBounty officials said they were caught by surprise by the FDA's news that it was a step closer to approval, as years of controversy had followed the company's application for the go-ahead from the regulator.
"We are encouraged that the environmental assessment is being released and hope the government continues the science-based regulatory process," said AquaBounty CEO Ronald Stotish.
Critics say the new salmon is a "dangerous experiment" and have pressured FDA to reject the genetically engineered salmon.
They said Friday they may file a lawsuit to prevent what they fear could be imminent approval of the engineered fish on the grounds that the FDA has failed to conduct a thorough assessment and because it wasn't clear if the fish would pose a threat to people who eat it or to wild fish.
They were also concerned the FDA wouldn't require the fish to be labeled.
"Congress can still keep FDA from unleashing this dangerous experiment," said Wenonah Hauter, executive director of Food & Water Watch, a consumer advocacy group. "Although this latest FDA decision is a blow to consumer confidence, we encourage everyone to contact their members of Congress and demand this reckless decision be overturned."
The Center for Food Safety, another non-profit consumer protection group, was highly critical of the FDA report, and officials said they might sue the regulator over the issue.
"It is extremely disappointing that the Obama Administration continues to push approval of this dangerous and unnecessary product," said Andrew Kimbrell, executive director for Center for Food Safety. "The GE salmon has no socially redeeming value. It's bad for the consumer, bad for the salmon industry and bad for the environment."
FDA spokeswoman Morgan Liscinsky said no final decisions had been made on labeling or on the application for approval.
"The release of these materials is not a decision on whether food from AquAdvantage Salmon requires additional labeling; nor is it a decision on the new animal drug application currently under review. It also does not provide a final food safety determination," Liscinsky said.
(Editing by Bernadette Baum)
Michigan Governor Signs Extreme Anti-Abortion Bill Into Law
Protests against Michigan's HB 5711Michigan Gov. Rick Snyder (R) has approved a controversial package of abortion restrictions that will limit abortion access for women who live in rural areas, require doctors to prove that mentally competent women haven’t been “coerced” into their decision to have the procedure, and enact unnecessary, complicated rules for abortion clinics and providers. The governor signed HB 5711 into law on Friday despite widespread protests against the omnibus anti-abortion measure. Snyder claims that HB 5711 “respects a woman’s right to choose while helping protect her health and safety.” But women’s health advocates warn the law will seriously threaten women’s access to the health services they need by imposing harsh regulations on abortion clinics and providers:
Critics of the Michigan law fear its insistence on new, standalone facilities will hurt women in rural and low-income areas as it could force some clinics to close. They say questioning women on whether an abortion is voluntary subjects them to a type of interrogation.
The Center for Reproductive Rights, an abortion rights group that opposed the measure, said it could force many existing abortion providers in the state to either tear down their offices and rebuild from the ground up — or shutter their practices. [...]
“Safety was never the intention of this law. The only thing this law accomplishes is to make a difficult decision even more difficult,” said Rana Elmir, the communications director for the Michigan ACLU.
Even some state lawmakers who supported HB 5711 acknowledge the law isn’t actually intended to protect women. “This is about protecting fetuses,” one Republican legislator explained.
Michigan legislators were quick to capitalize on this year’s lame duck session to push through controversial abortion restrictions, potentially because five anti-choice state lawmakers lost their seats in November’s election. The majority of Michigan voters support legal access to abortion services.
Big Pharma Bets on Obesity Drug Binge
As Christmas overeating gives way to under-fulfilled new year diets, the pharmaceutical industry's appetite has been whetted for a fresh surge in business.
After years of caution and setbacks, several drug companies are preparing to capitalize on what they hope will be a surge in sales from prescription medicines linked to the growing global trend of obesity.
"It has been a very challenged category, but there is a feeling we have to do something about obesity with the realization that it is a medical epidemic," says Peter Tam, president of Vivus, a California-based biotechnology company. Last autumn it launched Qsymia, the first weight loss drug to win US regulatory approval in 13 years.
In the coming weeks, Arena, another West Coast biotech, is set to launch its drug Belviq after receiving authorization. A third, Orexigen, is preparing to submit for fresh regulatory approval for its experimental medicine Contrave after previous rejections.
"There has been a very significant and rather sudden shift in the views of the regulator over the past year," says Simos Simeonidis, senior biotech analyst with Cowen. "Companies had been laying off staff and putting products on hold. Now there has been a resurgence and a lot of investor interest."
Weight loss drugs have long been viewed with suspicion by healthcare specialists both because of their limited efficacy and the risks of side effects – factors which continue to haunt the field. Qsymia's weight loss impact is slightly more than 10 percent and Belviq's less than 6 percent – both when tested in ideal conditions with strong medical supervision.
Meanwhile, Wyeth, now part of Pfizer, is still fighting claims of heart valve defects and other problems linked to Fen-Phen, a combination of diet drugs withdrawn in 1997 for which it earmarked reserves of $21 billion to cover settlements. Regulators subsequently pulled Abbott's drug Meridia, and – in Europe – both Servier's Mediator and Sanofi's Acomplia, which was linked to suicidal feelings.
Only one prescription weight loss drug has remained on the market in the US: Roche's Xenical, approved in 1999 and also now sold over-the-counter by GlaxoSmithKline as Alli. It appears relatively safe, but only modestly effective and brings unpleasant side effects including oily stools. That has limited its commercial success and frustrated attempts by GSK to find a buyer.
Mr Tam suggests that fresh interest in diet drugs by US regulators began in 2007 with studies on the significant impact of bariatric surgery in reducing not only obesity but related mortality. In recent months, he says high-level scientific meetings coupled with public discussion led by Michelle Obama, the US first lady, may have proved important in urging a more receptive attitude towards medicines.
For now, larger western pharmaceutical companies remain reluctant, with little in their late-stage pipelines except for Novo Nordisk of Denmark, the specialist diabetes company. It is currently testing expanded use of its injectable treatment Victoza for weight loss.
Japanese companies have proved more active: Eisai partnered with Arena and Takeda with Orexigen. Mr Simeonidis suggests this may reflect that until recently the investments in weight-loss biotech companies were "a free option" given high skepticism and low valuations. "I wouldn't be surprised if we start to see more involvement from big pharma now."
For now, Mr Tam says Vivus is rebuffing alliances. "We have preferred to shake off suitors and do it alone to maintain value for our shareholders." But he foresees the prospect ahead of using direct-to-consumer advertising and a larger scale sales force to market Qsymia to doctors – something likely to require a big pharma partner.
The path will not prove easy. Vivus had to agree a tight monitoring program with US regulators to track each user, notably to avoid the risk of its use by pregnant women, since Qsymia can cause birth defects. The more aggressively any of the new diet pills are marketed, the greater the risks of misuse, failure to ensure the drug is accompanied by diet and exercise and danger of consumer disappointment.
Gary Palmer, chief medical officer in the US for Eisai, which will co-ordinate Belviq's launch for Arena, says: "We are still considering whether to use direct-to-consumer advertising. Our approach will start with specialists. This is about being responsible and educating the physicians."
Concerns linger about safety. Sidney Wolfe, head of the health research group at Public Citizen, a US consumer watchdog that has fought approval of the new drugs, wrote recently: "Obesity is unquestionably a serious public health concern, but that doesn't give the FDA licence to ignore the scientific evidence."
European regulators, stung by their recent bad experiences with Acomplia and Mediator, remain skeptical and have so far not approved the newer drugs. And many health insurers in the US remain cautious about reimbursing a medicine with modest efficacy and only potentially very long-term benefits – leaving consumers to pay out of pocket.
Donny Wong, head of metabolic disorders at Decision Resources, a market research agency, predicts rising obesity will increase demand in the years to come. But he warns: "Expectations are really sky high. Patients are expecting at 55 years old to go back to their ideal weight at 20, with a 15-20 per cent loss that is unachievable. They will very rapidly become disappointed."
Obama Pledges To Push For Gun Control Measures If ‘American People Decide It’s Important’
President Obama called the Dec. 14th shooting in Newtown, Connecticut “the worst day of my presidency,” and said during a rare interview on Meet The Press, that he will propose a package of reforms that will likely include new regulations on assault-rifles and high-capacity ammunition clips, and enhanced background checks for gun purchases. A commission headed by Vice President Joe Biden is currently drafting gun safety recommendations.
But Obama stressed that reform cannot happen without broad public support, suggesting that he will rally public opinion for sensible gun safety regulations or drop the effort if Americans are not on board.
“We’re not going to get this done unless the American people decide it’s important and so this is not going to be a matter of me spending political capital. One of the things that you learn having now been in this office for four years. The old adage of Abraham Lincoln’s, ‘with public opinion there is nothing you can’t do and without public opinion there is very little you can get done in this town.’” Watch it:
Obama also rejected the National Rifle Association’s (NRA) call for more guns in schools, arguing that “the vast majority of the American people are skeptical that that somehow is going to solve our problem.” He promised to listen to all sides of the gun debate before making any legislative recommendations.
“It is not enough for us to say, ‘This is too hard so we’re not going to try,’” Obama said. “So what I intend to do is I will call all the stakeholders together. I will meet with Republicans. I will meet with Democrats. I will talk to anybody. I think there are a vast majority of responsible gun owners out there who recognize that we can’t have a situation in which somebody with severe psychological problems is able to get the kind of high capacity weapons that this individual in Newtown obtained and gun down our kids. And, yes, it’s going to be hard.”
Public support for gun control has increased in the wake of the shooting. A USA Today/Gallup poll released Thursday found that support for stricter guns laws is at its highest since 2004, with 47 percent now favor passing new gun laws rather than simply ramping up enforcement of current law. Fifty-eight percent called for stricter gun laws, a 15-point jump since October 2011.
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