FDA approves new targeted breast cancer drug


WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.


The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.


Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.


"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."


Cobleigh helped conduct the key studies of the drug at the Chicago facility.


The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.


The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.


Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.


FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.


Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.


FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer


Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.


Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.


Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.


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Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.


Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.


Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.


"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.


Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.


But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.


National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.


"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.


OPTIONS BULLS TARGET GAINS


The spending cuts, if they go ahead, could hit the defense industry particularly hard.


Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.


Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.


"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.


The stock ended up 0.6 percent at $88.12 on Friday.


If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.


General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.


EYES ON GDP DATA, APPLE


The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.


U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.


Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.


Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.


On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.


(Additional reporting by Doris Frankel; Editing by Kenneth Barry)



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Italy Set to Vote for a New Parliament





ROME — As Italian voters head to the polls on Sunday and Monday to elect a new Parliament and three regional governments, the prevailing mood is one of anger and disillusionment.




The fledgling, anti-establishment parties that campaigned on promises of radical change could benefit from the voters’ discontent, but the lack of a clear winner could also leave Italy mired in uncertainty.


“Italians feel frustration, anger, but also some hope for renewal,” said Nicola Piepoli, who runs a polling company. They are frustrated, he said, because their taxes are rising but they see no improvements in their “economic and social life,” and they are angry because candidates did not address “concrete problems” during the campaign, focusing instead on “futile, absurd things.”


“But many still hope for some change,” Mr. Piepoli added, explaining the growing support for populists like the comedian Beppe Grillo and his Five Star Movement, and for smaller parties like Civil Revolution, led by Antonio Ingroia, a former prosecutor, and Act to Stop the Decline, a movement guided by Oscar Giannino, a journalist.


Mostly though, the mood is dark among Italians fed up with protracted political scandals and disinclined to believe election promises because they are so rarely fulfilled.


(On Friday, former Prime Minister Silvio Berlusconi, campaigning to return to office, made a new promise: he said that if he won, he would personally refund an unpopular property tax paid by Italians in 2012. “I will take four billion euros of my own fortune and give it to Italians,” he said on television, a pledge of about $5.3 billion.)


“There’s no one to vote for, and if I went to the polls I’d choose the least-worst candidate, so I prefer not to vote,” said Concetta Rossi, a recruiter for hotel employees in Rome. “It’s never been this bad.”


The center-left Democratic Party, led by Pier Luigi Bersani, a low-key former industry minister, is expected to place first but is unlikely to win enough seats to govern without a coalition. The centrist movement backing the current prime minister, Mario Monti, is a possible ally, but even together they might not prevail in the Senate because the electoral law allocates seats based on regional votes. Lombardy and Sicily, where polls suggest that the right is strong, are crucial.


For the past year, Mr. Bersani, a former Communist who has played up his Catholic upbringing, has supported Mr. Monti’s reformist agenda, though sometimes grudgingly. He has backed Mr. Monti’s commitments to the European Union for greater fiscal responsibility, but would review policies that might have hurt workers and retirees.


Investors and economic analysts have their own concerns about the potential instability that could emerge in the absence of a strong government.


In its 15 months in office, Mr. Monti’s technocratic government tried to pass much-needed reforms, but it failed to stimulate the economic growth required to pull Italy out of a persistent recession. On Friday, the European Commission said in its winter forecast that Italy’s economy would shrink by 1 percent in 2013, double its November estimate.


Gains made by anti-establishment parties, including the Five Star Movement, could stall Mr. Monti’s overhauls, and a strong showing by the center-right party led by Mr. Berlusconi could derail the austerity measures meant to keep Italy on a fiscally responsible track.


“The fear remains that the general election produces a significant no-confidence vote on the current austerity plan and the need to reform further,” Raj Badiani, an economist with IHS Global Insight, wrote in a research report last week. “Without the prospect of a stable coalition government with a credible reform agenda, Italy could be forced to reconstruct a technocratic government to keep the markets at bay.”


Alessandro Amadori, the director of Coesis, which conducts marketing and opinion polls, said the “emotional mapping” of Italy highlighted the population’s “disenchantment and rage,” and even its resignation. “People don’t think that much will change. They hope for a sign, but they don’t have high expectations.”


Mr. Amadori added: “These elections will probably mark a moment of transition, rather than long-term change. Italians are looking for something that will shake things up, but what will emerge, we still don’t know.”


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Mindy McCready: A Country Star's Tragic Life and Death






Cover Story








02/23/2013 at 12:40 PM EST



Alone and adrift, Mindy McCready seemed to have little concept of time in the blurry month following the apparent suicide of her boyfriend, songwriter David Wilson, on Jan. 13 at the lakefront home they shared in quiet Heber Springs, Ark.

"She would call you at 2 in the morning and then would call you 20 minutes later and act like she hadn't spoken to you in a week," says a friend of the long-troubled country singer, who had left a court-ordered rehab facility after just one day on Feb. 7.

She didn't talk much about her two sons, 10-month-old Zayne and 6-year-old Zander – both boys had been placed in foster care when she was admitted for treatment – because the subject brought her to tears.

Upset over speculation about her role in Wilson's death, McCready had been spending her days sleeping and her nights drinking and was screaming "about everything," according to a Feb. 6 petition filed by her father, Tim, to have her committed to rehab. But even as her world imploded, McCready sounded resolutely hopeful after watching the Feb. 10 Grammy Awards. Recalls the friend: "She said, 'I'll be there next year. That's a promise.' "

But as with much of McCready's deeply tumultuous life, the moment of optimism was short-lived. Just five days later McCready, 37, was plunged into despair after being served with court papers proposing that her sons be sent to live with her long-estranged mother, Gayle Inge, in Florida.

"The most important thing are my babies must come home," she wrote in an e-mail on Feb. 16 to L.A. private investigator Danno Hanks, who stayed in touch with McCready after working with her during her 2010 stint on VH1's Celebrity Rehab. "She lost all hope," says Hanks. "She said, 'I'm losing my kids. I can't live without my kids!' "

At her request, Hanks had made a video advocating suicide prevention with the song "I'll See You Yesterday," in which she sings, "If tomorrow's gonna be the same/ I'll see you yesterday." Says Hanks: "Mindy told me that it was exactly what she wanted. Then I asked her if I could post it. And Mindy's answer was, 'You'll know when it's right.' "

The next day, McCready shot herself in the mouth on the porch of her home – the very same spot where Wilson, 34, had been found dead, according to a police source.

The suicide marked a brutal end for a singer who had once been among Nashville's brightest stars before a toxic spiral of reckless relationships, arrests, addiction and family fights played out publicly for nearly a decade.

Read More..

FDA approves new targeted breast cancer drug


WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.


The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.


Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.


"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."


Cobleigh helped conduct the key studies of the drug at the Chicago facility.


The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.


The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.


Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.


FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.


Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.


FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer


Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.


Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.


Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.


Read More..

Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.


Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.


Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.


"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.


Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.


But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.


National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.


"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.


OPTIONS BULLS TARGET GAINS


The spending cuts, if they go ahead, could hit the defense industry particularly hard.


Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.


Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.


"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.


The stock ended up 0.6 percent at $88.12 on Friday.


If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.


General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.


EYES ON GDP DATA, APPLE


The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.


U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.


Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.


Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.


On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.


(Additional reporting by Doris Frankel; Editing by Kenneth Barry)



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Russia Sends Aid to Mali as Fighting Flares





MOSCOW — Russia sent a planeload of food, blankets and other aid to war-stricken Mali on Friday, a day after Foreign Minister Sergey V. Lavrov warned about the spread of terrorism in North Africa, which the Russian government has linked to Western intervention in Libya.




Mr. Lavrov met on Thursday with the United Nations special envoy for the region, Romano Prodi, to discuss the situation in Mali, where Russia has supported the French-led effort to oust Islamic militants. But Russia has also blamed the West for the unrest and singled out the French in particular for arming the rebels who ousted the Libyan leader, Col. Muammar el-Qaddafi.


“Particular concern was expressed about the activity of terrorist organizations in the north, a threat to regional peace and security,” the Russian Foreign Ministry said in a statement after the meeting. “The parties agreed that the uncontrolled proliferation of arms in the region in the wake of the conflict in Libya sets the stage for an escalation of tension throughout the Sahel.” The Sahel is a vast region stretching more than 3,000 miles across Africa, from the Atlantic in the west to the Horn of Africa in the east.


In a television interview earlier this month, Mr. Lavrov said, “France is fighting against those in Mali whom it had once armed in Libya against Qaddafi.”


French forces quickly drove Islamist fighters out of the population centers of northern Mali — Timbuktu and Gao, in particular — when France began a military intervention in the country last month. Those dispersed fighters, who are members of Al Qaeda in the Islamic Maghreb and several allied groups, have now begun a small campaign of harassment and terror, dispatching suicide bombers, attacking guard posts, infiltrating liberated cities or ordering attacks by militants hidden among civilians.


On Friday, suicide attackers detonated two car bombs near the town of Tessalit, in Mali’s far north, according to news reports, while Islamist fighters clashed with Malian soldiers further south in Gao, where fighting has flared in recent days.


The twin suicide bombings in Tessalit killed three fighters for the M.N.L.A., an ethnic Tuareg armed group that has allied with the French forces, a spokesman for the group told Agence France-Presse. The attackers were killed as well. On Thursday, a guard and an attacker were killed in a car bombing in Kidal, south of Tessalit, that appeared to target a civilian fuel depot, France’s Defense Ministry said in a statement.


Responsibility for that attack was claimed by the Movement for Oneness and Jihad in West Africa, an offshoot of Al Qaeda in the Islamic Maghreb. The group said it would continue to press its fight, and also intended to retake Gao, hundreds of miles to the south.


“More explosions will happen across our territory,” a group spokesman, Abu Walid Sahraoui, told A.F.P. “Our troops have been ordered to attack,” he said. “If the enemy is stronger, we’ll pull back only to return stronger, until we liberate Gao.”


In central Gao late Thursday morning, Malian and French forces killed about 15 militants from “infiltrated terrorist groups” that had seized the town hall and court, according to France’s Defense Ministry. The initial firefight involved only Malian soldiers and militant fighters, the ministry statement said, but several French armored vehicles and two helicopters were later involved.


Two militants were killed outside a checkpoint north of the city after “sporadically” attacking the Nigerien soldiers standing guard, the Defense Ministry said. As many as six Malian soldiers were reported wounded.


On Friday, sporadic gunfire and at least two rebel rocket attacks were reported in Gao, according to a Malian officer cited by The Associated Press. Most of the militants fled to the east of the city aboard seven vehicles, the officer said.


Russian officials have pointed repeatedly to the unrest in North Africa and political turmoil in Egypt as evidence that the Western-supported Arab Spring has created a dangerous and chaotic situation and potential breeding grounds for terrorists. Russia has also used the examples of Libya and Egypt to justify its opposition to any Western effort to oust the government of President Bashar al-Assad in Syria.


Russia voted in favor of a United Nations Security Council resolution authorizing the deployment of African troops in Mali, but Russia has also stressed that the resolution required the consent of the Malian government.


Russia’s state-controlled weapons company, Rosoboronexport, has been selling small arms to the Malian government and is considering a request to buy additional matériel, including armor and helicopters.


The plane dispatched to the Malian capital, Bamako, by Russian’s Emergency Situations Ministry was carrying about 36 tons of aid cargo, including 45 tents, 2,000 blankets, canned food, cereals and rice.


David Herszenhorn reported from Moscow and Scott Sayare from Paris.



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Jack Nicholson, Dustin Hoffman to Present at Academy Awards









02/22/2013 at 12:40 PM EST







Dustin Hoffman (left) and Jack Nicholson


AP; Getty


Jack's back – at the Oscars.

Legendary actor Nicholson will join Dustin Hoffman as presenters at Sunday's Academy Awards. Both stars are 75.

"Between the two of them, Jack Nicholson and Dustin Hoffman have created more iconic characters than any other pair of actors in the world," says a statement from show producers Craig Zadan and Neil Meron. "Their participation in this year's Oscars completes a list of presenters and performers that truly represents that great breadth and depth of acting talent in film today."

Other presenters include Sandra Bullock, Nicole Kidman, Reese Witherspoon, Salma Hayek Pinault, Melissa McCarthy, Liam Neeson and John Travolta.

Performers for this year's show include Adele, Dame Shirley Bassey, Norah Jones and Barbra Streisand.

The 85th annual Academy Awards will air live on ABC starting at 7 p.m. ET/4 p.m. PT on Sunday, Feb. 24, from the Dolby Theatre in Hollywood.

Read More..

FDA approves new targeted breast cancer drug


WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.


The drug Kadcyla (kad-SY'-luh) from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a double-shot of anti-tumor poison.


Cancer researchers say the drug may offer a clear advantage over older drugs because it delivers more medication with fewer side effects.


The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.


The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.


Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.


FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.


Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.


FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.


Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.


Kadcyla was co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.


Shares of ImmunoGen Inc. rose 33 cents, or 2.27 percent, to $14.63 in midday trading.


Read More..

HP lifts Wall Street, S&P on pace for first weekly loss of year

NEW YORK (Reuters) - Stocks rose on Friday, rebounding off two days of losses as Dow component Hewlett-Packard surged on strong results, but the S&P 500 was on track to end a seven-week-long streak of gains.


The S&P shed 1.9 percent over the previous two sessions, its worst two-day drop since early November, putting the index on pace for its first weekly decline of the year. The retreat was triggered when the Federal Reserve's meeting minutes for January suggested stimulus measures may be halted sooner than thought.


Still, the index is up nearly 6 percent for the year and held the 1,500 support level despite the recent declines, a sign of a positive bias in the market.


"The market is addicted to Fed stimulus and gets withdrawal shakes every time that's threatened, but now we're resuming our course and remain much more attractively valued than other asset classes," said Rex Macey, chief investment officer at Wilmington Trust in Atlanta, Georgia.


Hewlett-Packard Co jumped 9.6 percent to $18.74 as the top boost on both the Dow and S&P 500 after the PC maker's quarterly revenue and forecasts beat expectations. The company cut costs under Chief Executive Meg Whitman's turnaround plan. The S&P technology sector <.splrct> was up 0.8 percent.


The Dow Jones industrial average <.dji> was up 69.41 points, or 0.50 percent, at 13,950.03. The Standard & Poor's 500 Index <.spx> was up 7.74 points, or 0.52 percent, at 1,510.16. The Nasdaq Composite Index <.ixic> was up 18.26 points, or 0.58 percent, at 3,149.75.


For the week, the Dow is off 0.2 percent in its third straight week of slight losses, the S&P is off 0.6 percent and the Nasdaq is off 1.3 percent.


Also buoying tech stocks were gains in semiconductor companies after Marvell Technology Group Ltd forecast results this quarter that were largely above analysts' expectations. Marvell gained market share in the hard-disk drive and flash-storage businesses. The stock rose 2.5 percent to $9.71.


In addition, Texas Instruments Inc raised its dividend by a third and boosted its stock buyback program, lifting shares 5.1 percent to $34.16 while the PHLX semiconductor index <.sox> gained 1.8 percent.


"Dividends growing are another way the market's level is justified, if not especially attractive at these levels," said Macey, who manages about $20 billion in assets.


On the downside, Abercrombie & Fitch dropped 7.6 percent to $45.34 after the clothing retailer reported a drop in fourth-quarter comparable sales, even as its latest quarterly earnings topped estimates.


Insurer American International Group Inc posted fourth-quarter results that beat analysts' expectations. Shares advanced 3 percent to $38.43.


According to Thomson Reuters data through Friday morning, of 439 companies in the S&P 500 that have reported results, 70 percent have exceeded analysts' expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters.


Fourth-quarter earnings for S&P 500 companies are estimated to have risen 6 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.


(Editing by Kenneth Barry)



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