CORRECTED-UPDATE 3-FDA approves Roche drug for late-stage breast cancer

(Corrects paragraph 5 to show control arm included Xeloda, not Herceptin)

* Drug is first of its kind for solid tumors

* To carry warnings on liver, heart damage

* ImmunoGen shares up 1.9 pct; Roche up 1.5 pct

WASHINGTON, Feb 22 (Reuters) - U.S. health regulators approved a new drug made by Swiss drugmaker Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

The U.S. Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the Kadcyla's potential to cause liver and heart damage or even death. The drug can also cause life-threatening birth defects.

Still, fewer patients in a clinical trial experienced severe side effects than those who received standard therapy.

The approval was based on a study of about 1,000 women who had already been treated with Roche's drug Herceptin and a taxane chemotherapy. Patients who were given Kadcyla survived an average of 30.9 months, compared with 25.1 months for those in the control arm who took Xeloda and GlaxoSmithKline Plc's Tykerb.

The drug will be priced at $9,800 a month, higher than Wall Street analysts had expected but likely acceptable to insurers.

"We don't expect to see significant payer pushback on pricing at launch, given the drug's efficacy and safety," said Simos Simeonidis, an analyst at Cowen and Company, in a research note on Friday.

Kadcyla works by attaching Herceptin, also known as trastuzumab, to a drug called DM1, developed by ImmunoGen Inc , which interferes with cancer cell growth.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr. Richard Pazdur, director of the FDA's office of hematology and oncology products.

Other drugs approved for HER2-positive breast cancer include Herceptin, Tykerb, and Perjeta, or pertuzumab, which is also made by Roche and was approved in 2012.

Kadcyla is a member of a class of drugs known as antibody-drug conjugates, or "armed antibodies." They combine an antibody, Herceptin in the case of Kadcyla, with a killer toxin, in this case DM1, and a link that binds them together to deliver a highly potent bomb within the diseased cells.

The drugs seek out specific cells that express proteins associated with the cancer, while leaving other cells alone.

The first conjugate to be approved was Mylotarg which was pulled from the market in 2010 by Pfizer Inc's after a study showed it did not extend survival for patients with myeloid leukemia, a bone marrow cancer.

In 2011, Seattle Genetics won U.S. approval for Adcentris, a conjugate targeting Hodgkin's lymphoma, several types of T-cell lymphoma and other hematologic malignancies.

Kadcyla is the first armed antibody to be approved to treat a solid tumor.

The approval triggers a $10.5 million payment to ImmunoGen and sets the stage for the company to receive royalties of between 3 and 5 percent, depending on sales. The 5 percent level is triggered when sales top $700 million in the United States. The company also receives 5 percent when sales top $700 million elsewhere in the world.

Analysts estimate the drug could generate annual peak sales of $2 billion to $5 billion, assuming it is used earlier in the disease's progression and for longer periods of time.

John Sonnier, an analyst at William Blair & Co, said he believes the Kadcyla approval validates ImmunoGen's technology and will translate into other partnerships and the development of new wholly-owned compounds.

ImmunoGen's chief executive officer, Daniel Junius, said ImmunoGen has nine other compounds using some version of its TAP technology, which stands for targeted antibody payload. Some are being developed with partners and some are wholly owned by ImmunoGen.

The most advanced is a drug for non-Hodgkin's lymphoma being developed with Sanofi. The company also is conducting mid-stage trials of a proprietary drug for small-cell lung cancer.

"We believe this can be a very important tool for oncologists across a wide variety of indications," Junius said.

An analyst at J.P. Morgan, Cory Kasimov, said the approval of Kadcyla by itself is not enough to warrant owning ImmunoGen's shares.

"To justify a premium valuation, ImmunoGen needs to generate meaningful data with one of its other antibody assets, preferably one that is fully owned," he said in a research note.

Breast cancer is the second-leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013, and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.

The most common side effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.

Shares of ImmunoGen closed up 1.9 percent at $14.57 on Nasdaq. Roche's shares closed up 1.5 percent.

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick, John Wallace, Matthew Lewis and Carol Bishopric)

View the original article here

The Recipe For Prosperity

 Highlight transcript below to create clipTranscript:  Print  |  Email Go  Click text to jump within videoFri 22 Feb 13 | 07:00 PM ET How the sequester might impact the economy, with Rep. Gregory Meeks (D-NY); Mark Simone, WOR Radio Talk Show Host; Robert Costa, National Review; and Gen. Barry McCaffrey, NBC News' military analyst.

View the original article here

In Shift, NY Times Embraces 'Moral Dimension' Provided by Bishops -- at Least for Expanding Obama-Care

Friday's lead New York Times story celebrated "G.O.P. Governors Providing a Lift For Health Law." The most notable convert: Florida Gov. Rick Scott, who reversed his position this week and announced his support for expanding Medicaid.

The Times' Abby Goodnough and Robert Pear credited Scott for the embrace of Obama-care (via "proponents" who "say that doing so will not only save lives, but also create jobs and stimulate the economy") and also found a convenient "moral dimension" in the call by Catholic bishops to expand the Medicaid program, a dimension the paper never found when the Church was opposing the Obama-care requirement that religion institutions provide contraception coverage.

Under pressure from the health care industry and consumer advocates, seven Republican governors are cautiously moving to expand Medicaid, giving an unexpected boost to President Obama’s plan to insure some 30 million more Americans.

The Supreme Court ruled last year that expanding Medicaid to include many more low-income people was an option under the new federal health care law, not a requirement, tossing the decision to the states and touching off battles in many capitols.

The federal government will pay the entire cost of covering newly eligible beneficiaries from 2014 to 2016, and 90 percent or more later. But many Republican governors and lawmakers immediately questioned whether that commitment would last, and whether increased spending on Medicaid makes sense, given the size of the federal budget deficit. Some flatly declared they would not consider it.

In Florida, where Gov. Rick Scott reversed his position and on Wednesday announced his support for expanding Medicaid, proponents say that doing so will not only save lives, but also create jobs and stimulate the economy. Similar arguments have swayed the Republican governors of Arizona, Michigan, Nevada, New Mexico, North Dakota and Ohio, who in recent months have announced their intention to expand Medicaid.

A left-wing supporter of Obama-care was merely titled a "consumer group."

The shift has delighted supporters of the law.

“I think this means the dominoes are falling,” said Ronald F. Pollack, the executive director of Families USA, a consumer group. “The message is, ‘Even though I may not have supported and even strongly opposed the Affordable Care Act, it would be harmful to the citizens of my state if I didn’t opt into taking these very substantial federal dollars to help people who truly need it.’ ”

And the Times conveniently discovered how the Roman Catholic bishops "have added a moral dimension to the campaign" in support of Medicaid expansion.

Religious leaders have added a moral dimension to the campaign in some states. The Roman Catholic bishops of Salt Lake City and Little Rock, Ark., for example, have urged state officials to expand Medicaid.

Oddly, the paper only finds that "moral dimension" when the bishops come out in favor of liberal causes, not when the "moral dimension" involves rejecting the administration's requirement that religion institutions provide contraception coverage.

The last use of the term in a story on Catholic bishops used it in the context of the bishops pushing left-wing issues like "economic inequality" -- "Bishops Open 'Religious Liberty' Drive" on November 15, 2011 (Note the suspicion-arousing quote marks.) Religion reporter Laurie Goodstein even took care to differentiate the "moral dimension" of left-wing causes from the Church's apparently less-admirable traditional opposition to abortion and homosexuality.

The bishops are struggling to reclaim the role they played in the 1980s and into the ’90s as a nationally recognized voice on the moral dimension of public policy issues like economic inequality, workers’ rights, immigration and nuclear weapons proliferation. Since then, however, they have reordered their priorities, with abortion and homosexuality eclipsing poverty and economic injustice.

Clay Waters is the director of Times Watch, an MRC project tracking the New York Times. Click here to follow Clay Waters on Twitter.

View the original article here

Sequestration Cuts To Education Programs Threaten To Widen Education Gap Between Rich And Poor

The achievement gap between school districts in high-income neighborhoods and those in low-income ones is already more canyon than crack, and if $1.7 trillion in automatic sequestration cuts are allowed to go into effect on March 1, that gap could grow even wider.

Dozens of education programs would face reduced funding, but three crucial programs — No Child Left Behind, Head Start initiatives, and the Individuals with Disabilities Act — provide the most assistance to low-income students and also face the sharpest cuts if the sequester is allowed to go into effect, as the Center for American Progress’ Juliana Herman and Kaitlin Pennington detailed in a new report:

Altogether, the sequester would cut approximately $725 million from Title I funding, potentially affecting 2,700 schools, impacting 1.2 million students, and placing 9,880 education staff at risk of losing their jobs. [...]

Head Start and Early Head Start—a similar program for infants—both work to ensure that parental income does not determine whether a child will be able to learn during these influential years. But should sequestration happen next week, approximately 70,000 children will be kicked out of Head Start due to inadequate funding. [...]

If sequestration goes through, funding under the Individuals with Disabilities Act could be reduced by as much as $579 million.

In all, the report estimates, the cuts would impact as many as 1.2 million children, 30,000 teachers and 2,700 schools, the overwhelming majority of which will be from low-income communities.

Recent studies have shown the devastating correlation between income and student achievement. Since the late 1980s, the gap in metrics like college completion between students from high-income and low-income households grew by more than 50 percent.

View the original article here

Global Fight Against Tuberculosis

 Highlight transcript below to create clipTranscript:  Print  |  Email Go  Click text to jump within videoFri 22 Feb 13 | 01:22 PM ET Turberculosis is making a global comeback, including in the United States. Dr. William Schaffner of Vanderbilt University School of Medicine, discusses the concern surrounding the disease.

View the original article here

Cruz: Harvard Law did have Marxists

Sen. Ted Cruz’s office has chided the New Yorker for calling a three-year-old speech news, but has confirmed that the Texas Republican believed that the Harvard Law faculty had numerous self-described Communists.

Cruz, according to the New Yorker, said that there were a dozen Marxists on the law school faculty committed to overthrowing the U.S. government when he attended Harvard during the 1990s. But according to Cruz, there was but a single Republican on the same faculty.

Catherine Frazier, a spokeswoman for the senator, told a conservative website that the Texas Republican's 2010 speech was substantively correct. 

“It’s curious that the New Yorker would dredge up a three-year-old speech and call it ‘news,’” Frazier told The Blaze. 

“Regardless, Senator Cruz’s substantive point was absolutely correct: in the mid-1990s, the Harvard Law School faculty included numerous self-described proponents of ‘critical legal studies’ — a school of thought explicitly derived from Marxism – and they far outnumbered Republicans.”

The New Yorker article came as media reports have discussed what The New York Times called Cruz’s “brash” entrance to the Senate. 

Cruz has played a significant role in the GOP opposition to Chuck Hagel, a former Republican senator from Nebraska and President Obama’s nominee for Defense secretary.

Some Democrats have suggested that Cruz’s campaign against Hagel reminded them of former Sen. Joe McCarthy (R-Wis.) and his crusade against Communism in the 1950s. Cruz has said that he had promised Texas voters he would shake up Washington. 

The New Yorker article had suggested that Cruz might have been discussing critical legal studies, followers of which have said they were influenced by Karl Marx, in his speech. 

Charles Fried, a solicitor general under President Reagan and Harvard Law professor, also chided Cruz, saying the Texas senator had undercounted the Republicans on the law school’s faculty.

View Comments

View the original article here

No, Batwoman’s Engagement Doesn’t Solve DC Comics’ Orson Scott Card Problem

Over at io9, Rob Bricken asks whether Batwoman’s in-costume proposal to her girlfriend Maggie Sawyer will earn DC Comics good-will that it lost by hiring National Organization for Marriage board member and virulent homophobe Orson Scott Card, or “is this too little, too late for the company”?

I’m 99% sure the only reason DC hasn’t mentioned Batwoman’s marriage to the press is because it would call attention to the furor caused by the company’s recent decision to hire Orson Scott Card, scifi author and ardent detractor of gay rights, to write Adventures of Superman. Angry fans and retailers alike are planning to boycott the Superman comic in general, and some DC in particular unless Card is removed.

It’s too early to tell if Batwoman’s proposal will at all mitigate DC’s public relations problems with Card, or even if Card might have a problem collecting a check from a company whose works seemingly condone gay marraige. But at the moment, at least Kate Kane and Maggie Sawyer are happy, even if nobody else is.

I’m always delighted to see more, and richer depictions of gay characters, especially in a medium where they were marginalized by the Comics Code and the disapprobation of Congress, a panic fed by cooked research. But this plot development won’t save DC Comics, and not just because a proposal on the page doesn’t really outweigh the harm Card’s speech and actions cause in the real world. Who gets hired to create content and what content ends up on the page are issues that are often related, but that function separately. People who care about where their money goes and the values of the content that they consume are going to care about both of those elements.

Something I wish I’d said more clearly the first itme I wrote about DC’s decision to hire Card to write Superman is that calls to fire him don’t appeal to me that strongly because it separates out his hiring from DC’s other hiring practices, which among other things, have produced a staff with very few women and no lead African-American writers on any comics titles. A decision by comics stores not to stock the title, demonstrating that Card’s values turn them off from a product that otherwise might have been profitable for them, makes more sense. And what would be most interesting to me is an explanation from DC about what process lead to Card’s selection. What made his pitches’ stronger than other writers? How did they weigh the likely publicity challenges from his employment against what appears to be a larger institutional imperative to modernize the brand by telling stories about committed gay couples? If DC Comics wants its image to be gay-friendly, then it should have been expected to be evaluated for consistency. More same-sex engagements doesn’t eliminate the appearance of a glaring contradiction in DC’s image.

If all DC wants is our money, rather than our social approval, that’s fine. But it needs to recognize that fishing for money on the grounds that it’s producing progressive and game-changing content is going to be a more difficult task if there’s a disconnect between what the content is, and who the money spent on it ends up going to.

View the original article here

Ranbaxy to resume generic Lipitor production for U.S.

Feb 22 (Reuters) - Indian generic drugmaker Ranbaxy Laboratories Ltd said on Friday it will resume production of its version of Pfizer's cholesterol fighter Lipitor for sale in the United States after resolving the issues that led to a November recall. Ranbaxy in November recalled its atorvastatin from the U.S. market and stopped manufacturing the widely used cholesterol lowering medicine after the company discovered contamination with tiny glass particles in certain lots of 10 milligram, 20 mg and 40 mg doses of the drug. Atorvastatin is the generic name for Lipitor. "We are working with the U.S. FDA, and have identified and implemented multiple corrective and preventative actions," Ranbaxy spokesman Chuck Capriello said in an e-mailed statement. "As part of the first step in initiating the manufacturing process to resume supplies to the U.S. market, we have commenced the production of the drug substance for our atorvastatin product," he added. The recall and production halt did not affect Ranbaxy's atorvastatin supply for markets outside the United States, the company said. During its first six months on the market, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to industry analyst estimates. Prior to expiration of Pfizer's patent, Lipitor was the world's top selling prescription medicine with annual peak sales of about $13 billion for the largest U.S. drugmaker. Ranbaxy has been operating under heightened scrutiny to ensure it meets good manufacturing practices following a series of manufacturing problems that nearly derailed it ability to sell atorvastatin in the United States. In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in its drug applications. Ranbaxy said on Friday that it was confident in the continuing safety and quality of its products.

View the original article here

South African Student Who Accidentally Shot Himself Allegedly Used School Guard’s Gun

A 13-year-old student in Durban, South Africa accidentally shot himself in the leg at school this week – reportedly using a school security guard’s gun. Guards are not armed at the school, but this guard had allegedly brought his personal gun from home. IOL reports:

A security guard was on duty at an oThongathi (Tongaat) primary school when the teen allegedly removed the guard’s private gun from his unsecured bag.

The Grade 7 pupil at Hambanathi Primary, sustained a single gunshot wound to his thigh and is reported to be in a stable condition at Osindisweni Hospital, in Verulam.

According to the school principal, he had allegedly removed the gun from the guard’s bag and was attempting to shove it into the waist of his pants, when a shot accidentally went off, said the school principal, Mrs S Mahlinza.

The guard, who was meant to be unarmed, is contracted by the KwaZulu-Natal Department of Education.

He has been arrested and charged for failing to secure his firearm.

The incident has prompted calls for “urgent” action to ban guns in schools, with officials citing the recent Newton, Ct. tragedy. In the United States, meanwhile, the National Rifle Association has urged more armed school guards as a solution to preventing future school shootings, and several states are now considering legislative proposals, in spite of scientific and historical evidence that armed school guards don’t prevent these sorts of incidents. Many states are even implementing programs to arm teachers and add gun courses for students.

The physical danger of armed guards highlighted by this incident is not the only threat posed by the NRA’s plan. Placing more officers in schools has also been correlated with drastic and racially disproportionate upticks in student arrests – often as an alternative means of school discipline. The criminalizing of minor student infractions known as the “school-to-prison pipeline” is already an epidemic in some states, and has the potential to dramatically alter a child’s future by funneling them out of school and into the criminal justice system.

View the original article here

Ranbaxy to resume generic Lipitor production for U.S.

Feb 22 (Reuters) - Indian generic drugmaker Ranbaxy Laboratories Ltd said on Friday it will resume production of its version of Pfizer's cholesterol fighter Lipitor for sale in the United States after resolving the issues that led to a November recall. Ranbaxy in November recalled its atorvastatin from the U.S. market and stopped manufacturing the widely used cholesterol lowering medicine after the company discovered contamination with tiny glass particles in certain lots of 10 milligram, 20 mg and 40 mg doses of the drug. Atorvastatin is the generic name for Lipitor. "We are working with the U.S. FDA, and have identified and implemented multiple corrective and preventative actions," Ranbaxy spokesman Chuck Capriello said in an e-mailed statement. "As part of the first step in initiating the manufacturing process to resume supplies to the U.S. market, we have commenced the production of the drug substance for our atorvastatin product," he added. The recall and production halt did not affect Ranbaxy's atorvastatin supply for markets outside the United States, the company said. During its first six months on the market, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to industry analyst estimates. Prior to expiration of Pfizer's patent, Lipitor was the world's top selling prescription medicine with annual peak sales of about $13 billion for the largest U.S. drugmaker. Ranbaxy has been operating under heightened scrutiny to ensure it meets good manufacturing practices following a series of manufacturing problems that nearly derailed it ability to sell atorvastatin in the United States. In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in its drug applications. Ranbaxy said on Friday that it was confident in the continuing safety and quality of its products.

View the original article here