Boehringer Ingelheim to start late-stage hepatitis C drug trial
















BOSTON (Reuters) – Boehringer Ingelheim said on Saturday it plans to initiate a late-stage clinical trial of its experimental hepatitis C treatment following promising results from earlier studies.


The company announced final data from a mid-stage trial of its treatment regimen which showed that 69 percent of patients in the study were free of the virus 12 and 24 weeks following the end of treatment.













Hepatitis C is a blood-borne infectious disease of the liver that can lead to liver failure and transplant.


Historically, hepatitis C has been treated with pegylated interferon and ribavirin, but treatment lasts as long as 48 weeks and interferon is associated with flu-like side effects.


The goal of drugmakers now, including Boehringer, Vertex Pharmaceuticals Inc, Gilead Sciences Inc and Bristol-Myers Squibb Co is to develop products that do not need to be combined with interferon. Most analysts consider Gilead to currently be at the forefront of the race.


Full results from Boehringer’s trial, known as SOUND-C2, were presented at the annual meeting of the American Association for the Study of Liver Diseases in Boston. Preliminary data were presented earlier this year.


Boehringer’s trial tested a combination of BI-201335, a protease inhibitor, BI-207127, a polymerase inhibitor, and ribivirin.


Boehringer is a privately held company headquartered in Ingelheim, Germany.


(Reporting By Toni Clarke; Editing by Marguerita Choy)


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FBI probe of Petraeus began with 'suspicious emails'

WASHINGTON (Reuters) - The FBI investigation that led to the discovery of CIA Director David Petraeus' affair with author Paula Broadwell was sparked by "suspicious emails" that initially did not contain any connection to Petraeus, U.S. law enforcement and security officials told Reuters on Saturday.


But the CIA director's name unexpectedly turned up in the course of the investigation, two officials and two other sources briefed on the matter said.


It was "an issue with two women and they stumbled across the affair with Petraeus," a U.S. government security source said.


The Washington Post reported on Saturday that the FBI probe was triggered when Broadwell sent threatening emails to an unidentified woman close to the CIA director.


The woman went to the FBI, which traced the threats to Broadwell and then uncovered explicit emails between Petraeus and Broadwell, the Post said.


Attempts by Reuters and other news media to reach Broadwell, an Army reserve offer and author of a biography of Petraeus, have not been successful.


The FBI and CIA declined comment on Saturday.


Many questions in the case remain unanswered publicly, including the identity of the second woman; the precise nature of the emails that launched the FBI investigation; and whether U.S. security was compromised in any way.


Nor is it clear why the FBI waited until Election Day to tell U.S. Director of National Intelligence James Clapper, who oversees the CIA and other intelligence agencies, about its investigation involving Petraeus.


The CIA director announced his resignation suddenly on Friday, acknowledging an extramarital affair and saying he showed "extremely poor judgment.


The developments likely ended the public career of one of the United States' most highly regarded generals, who was credited with helping pull Iraq out of civil war and led U.S. and NATO troops in Afghanistan.


Meanwhile, new details emerged on Saturday about developments in the final days leading to Petraeus' departure from atop the CIA.


Clapper was notified by the FBI on Tuesday evening about 5 p.m. - just as returns in the U.S. presidential election were about to come in - about "the situation involving Director Petraeus," a senior intelligence official said. Clapper and Petraeus then spoke that evening and the following morning.


WHITE HOUSE NOTIFIED WEDNESDAY


"Director Clapper, as a friend and a colleague and a fellow general officer, advised Director Petraeus that he should do the right thing and he should step down," the official said.


Clapper is a retired Air Force lieutenant general; Petraeus served nearly four decades in the U.S. Army.


On Wednesday, Clapper notified the National Security Council at the White House that Petraeus was considering resigning and President Barack Obama should be informed, the official said.


U.S. law enforcement and intelligence officials agreed to discuss the Petraeus matter only on condition of anonymity because of the issue's sensitivity and because it is the subject of a law enforcement investigation.


Once Petraeus' name turned up in the investigation, the importance of the FBI inquiry was immediately escalated, as investigators became concerned the CIA chief somehow might have been compromised, the law enforcement official said.


However, the official and two sources briefed on the matter said no evidence has turned up suggesting Petraeus had become vulnerable to espionage or blackmail. At this point, it appears unlikely that anyone will be charged with a crime as a result of the investigation, the official said.


The FBI investigation began fairly recently - months ago rather than years ago, when Petraeus would still have been in uniform as one of the U.S. Army's top field commanders, the official said.


Representative Peter King, Republican chairman of the House of Representatives' Homeland Security Committee, said in an interview on MSNBC the FBI was "investigating or monitoring ... the director of the CIA for four or five months."


Several officials briefed on the matter said senior officials at the Pentagon, CIA and Congress knew nothing of the FBI's investigation of Petraeus until Thursday afternoon at the earliest, and some key officials were not briefed on the details until Friday.


There is no evidence at this time that anyone at the White House had knowledge of the situation involving Petraeus prior to the U.S. presidential election on Tuesday, which saw Obama elected to a second four-year term.


Another U.S. government security source said it was not until Friday afternoon that some members of the House and Senate intelligence oversight committees were notified about Petraeus' resignation by Clapper's office.


The congressional committees were told that it was a personal issue that Petraeus had to discuss with his wife. When pressed, a representative of the Office of the Director of National Intelligence said it involved another woman.


(Writing by Warren Strobel; Additional reporting by Doug Palmer and Matt Spetalnick; Editing by Todd Eastham)


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Syria opposition bloc elects Christian as leader
















DOHA, Qatar (AP) — Syria‘s main opposition group in exile has elected a Christian Paris-based former geography teacher as its new president.


George Sabra said Friday that his election as head of the Syrian National Council is a sign that the opposition is not plagued by sectarian divisions.













Sabra says the SNC‘s main demand is to receive weapons from the international community. The U.S. and some other foreign backers of rebels fighting the regime of President Bashar Assad have so far refused to send weapons for fear they can fall into the wrong hands.


Middle East News Headlines – Yahoo! News



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Frankfurt gears up for Gangnam Style at MTV awards
















FRANKFURT (Reuters) – The MTV Europe Music Awards will rock Frankfurt’s Festhalle concert venue on Sunday, with Barbadian R&B singer Rihanna leading the nominations and all eyes on Korean dance sensation Psy.


Psy‘s hit “Gangnam Style“, which is up for the Best Video award, has been viewed more than 670 million times and received a record-breaking 4.9 million “likes” on Facebook since being released in mid-July.













The satirical video featuring Psy‘s horse riding-inspired dance has sparked a wave of copycat versions from Eton schoolboys to Californian lifeguards and has even caught the attention of United Nations chief Ban Ki-moon.


Psy will become the first South Korean artist to perform at the annual awards, one of the pop industry’s biggest nights outside the United States, when he takes the stage on Sunday.


German model and presenter Heidi Klum, who this year filed for divorce from singer husband Seal, will host the awards and said she had been practicing her Gangnam moves in case she gets called on to dance.


“My kids are obsessed with the song, even though it’s Korean and they have no idea what he’s talking about,” she told reporters ahead of the event.


Klum, who comes from the town of Bergisch Gladbach just two hours away from the 2012 host city, is also looking forward to some home comforts.


“I’ll be eating a lot of German food,” she said, adding jokingly that she would probably eat too much schnitzel and “gain a few pounds.”


Despite being billed as the Europe Music Awards, the vast majority of nominees are traditionally North American, and 2012 is no exception.


Alongside Psy, acts due to take the stage at the show include country singer Taylor Swift, 14-time Grammy winner Alicia Keys, the Killers and Carly Rae Jepsen.


“OLD WAYS” STILL COUNT


In a world where careers are so often launched by social media websites like YouTube, some young artists said there was still a role for more established platforms such as MTV and mainstream television.


American indie-pop band fun., who are up for three awards, hit the big time after the song “We Are Young” was featured in an advert for Chevrolet during the U.S. Superbowl.


“I don’t think that you can ever replace the impact that music videos have,” the band’s guitarist Jack Antonoff told Reuters when asked about the importance of MTV against social media channels.


“I think the more that social media takes over, the more importance you put upon the old ways.”


MTV said this week that it had become the first company to reach one million followers on Instagram, the fast-growing photo-sharing application developer.


Heading the nominations is party-loving Rihanna, with nods in six categories, including Best Song and Best Video for “We Found Love”.


Following close behind with five nominations is country star Swift, and other top nominees include Justin Bieber and Katy Perry, with four each, while Lady Gaga, who cleaned up last year with four prizes, is in the running for three awards.


Rihanna is favorite for Best Song and Best Female, according to odds offered by British bookmakers William Hill, while Gangnam Style is tipped to win Best Video.


The EMA awards were last held in Frankfurt in 2001. Last year’s awards in Belfast attracted 23 million viewers on all platforms and 158 million votes worldwide.


Following are the main nominations in 2012:


BEST SONG: Carly Rae Jepsen/Call Me Maybe; Rihanna feat. Calvin Harris/We Found Love; Gotye/Somebody That I Used To Know; Pitbull feat. Chris Brown/International Love; fun. feat. Janelle MonĂ¡e/We Are Young


BEST NEW: Rita Ora; fun.; One Direction; Lana Del Rey; Carly Rae Jepsen


BEST FEMALE: Rihanna; Katy Perry; P!nk; Taylor Swift; Nicki Minaj


BEST MALE: Justin Bieber; Kanye West; Flo Rida; Pitbull; Jay-Z


BEST POP: Justin Bieber; No Doubt; Katy Perry; Taylor Swift; Rihanna


BEST LIVE: Taylor Swift; Lady Gaga; Jay-Z & Kanye West; Green Day; Muse


BEST HIP HOP: Jay-Z & Kanye West; Nas; Rick Ross; Drake; Nicki Minaj


BEST ROCK: Linkin Park; Green Day; Muse; The Killers; Coldplay


BEST ELECTRONIC: David Guetta; Swedish House Mafia; Avicii; Skrillex; Calvin Harris


BEST ALTERNATIVE: Jack White; The Black Keys; Arctic Monkeys; Florence + The Machine; Lana Del Rey


BEST VIDEO: M.I.A./Bad Girls; Lady Gaga/Marry The Night; Katy Perry/Wide Awake; Rihanna feat. Calvin Harris/We Found Love; PSY/Gangnam Style.


(Reporting by Victoria Bryan and Maria Sheahan; editing by Mike Collett-White)


Music News Headlines – Yahoo! News



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Celgene’s Abraxane improved pancreatic cancer survival in trial
















(Reuters) – Celgene Corp said on Friday that a clinical trial of Abraxane, its drug to treat breast and lung cancer, improved survival in patients with pancreatic cancer.


The company did not give details of the extent of the improvement, saying it would do so at a medical meeting in January, but said the results were statistically significant.













Patients were given either Abraxane plus the chemotherapy, gemcitabine, or gemcitabine alone. Those in the Abraxane group on average survived longer.


Patients with advanced forms of pancreatic cancer, such as those tested in the Celgene trial, typically live 5.6 to 6.8 months following diagnosis, according to Dr. Daniel Von Hoff, a professor of medicine at the Mayo Clinic and lead investigator on the trial.


In the United States, about 46,000 patients are diagnosed with late-stage pancreatic cancer each year, he said, and 40,000 die. Only 5.5 percent of all pancreatic cancer patients live for five years.


The side effects seen in the trial were similar to those seen in earlier trials, Von Hoff said, and included a decrease in white blood cells, which can increase the chance of infection, numbness and tingling in the fingers, and nausea.


Analysts welcomed the news.


“This positive result comes somewhat earlier than we had expected, and will come as a surprise to many investors and analysts,” said Geoff Porges, an analyst at Sanford Bernstein, in a research note. “It has become almost axiomatic in the oncology world that “nothing works in pancreatic cancer” and this trial has certainly proven an exception to that rule.”


The company expects to release detailed data from the trial at a medical meeting in January and plans to file an application with regulators to market the drug to treat pancreatic cancer, as well as breast and lung cancer.


Porges estimates the potential revenue for Abraxane in pancreatic cancer alone could be as much as $ 1 billion worldwide.


(Reporting By Toni Clarke in Boston. Editing by Andre Grenon)


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Was Petraeus affair linked to lax Libya response?

CIA Director David Petraeus abruptly resigned Friday, citing an extramarital affair and the need to sort out the “personal and professional issues” involved.


The former commander of forces in Iraq and Afghanistan had built a stellar and nearly unassailable reputation – but mounting criticism of the Central Intelligence Agency’s response to the Benghazi, Libya, terrorist attack in September was beginning to tarnish that reputation.


Word of Mr. Petraeus’s resignation sent ripples of stunned surprise through both the intelligence and military communities, raising questions that revolved around how long the affair had been going on and how an officer known for his rigorous self-discipline – and attention to his reputation within the media — could have made such a lapse in judgment.


RECOMMENDED: 5 ways events overseas could shape Obama's second term


In a letter of resignation accepted by the White House, Petraeus said he had been married 37 years but had exercised “very poor judgment” in choosing to enter into an extramarital affair.


Petraeus, who was widely celebrated as a military commander and even occasionally mentioned as a potential presidential candidate, was sworn in as head of the CIA in September 2011 – and had kept a low profile since. Now speculation is sure to proliferate over whether that low profile resulted from Petraeus focusing on America’s intelligence gathering or on personal matters.


In particular, members of Congress and other officials demanding answers about the Benghazi attack on the US consulate that resulted in the deaths of four Americans – including the US ambassador to Libya, Christopher Stephens, and two CIA agents – will want to know if there was any link between Petraeus’s extramarital activities and what has been increasingly criticized as the CIA’s weak performance on the night of the Benghazi attack.


More broadly, the reason for Petraeus’s departure will raise questions about any compromising of US covert operations and intelligence. The potential for blackmail of intelligence officers is always a concern about the spy corps, but the involvement of the nation’s top spy in an extramarital affair takes the concern to a new level.


The Federal Bureau of Investigation has been probing Petraeus and the potential security risks posed by his affair, CNN reported late Friday afternoon.


In the weeks since the Benghazi attack, officials have leaked information, including how Petraeus kept information on the CIA’s role in Benghazi so private that even Secretary of State Hillary Rodham Clinton was left to call Petraeus as the attack unfolded to try to get intelligence information from him.


Last week, CIA officials revealed that in fact, the intelligence agency’s operations in Benghazi dwarfed diplomatic operations at the consulate and that the CIA maintained what was described as an “annex,” about a mile from the diplomatic mission.


State Department officials have said there was an informal understanding that the annex and its agents would come to the assistance of the consulate (which had private contractors providing security) if a need arose. CIA officials insist their agents responded to the consulate’s distress calls within a half-hour.


In a statement released Friday afternoon, President Obama praised Petraeus for his “extraordinary service” to the country, adding, “By any measure, through his lifetime of service, David Petraeus has made our country safer and stronger.”


In a statement, Sen. John McCain (R) of Arizona highlighted Petraeus’s role in Iraq, saying that his “inspirational leadership and his genius were directly responsible – after years of failure – for the success of the surge in Iraq.”


But Petraeus’s success in Iraq and Afghanistan was a result to a certain extent of his focus on a counterinsurgency strategy that involved large numbers of troops fighting the enemy by incorporating nation-building into the battle. When Mr. Obama named Petraeus to head the CIA, it was widely interpreted as the president’s signal that he intended to wind down America’s wars and shift from a counterinsurgency strategy to counterterrorism.


Obama did not cite Petraeus’s reason for resigning but did say, “Going forward, my thoughts and prayers are with Dave and Holly Petraeus, who has done so much to help military families through her own work. I wish them the very best at this difficult time.”


Mrs. Petraeus is the assistant director of the Consumer Financial Protection Bureau, where she supports veterans and troops facing difficulties as a result of the financial crisis.


Obama initially tried to convince Petraeus not to resign, according to some souces. “I am told that President Obama tried to talk Petraeus out of resigning, but Petraeus took the samurai route and insisted that he had done a dishonorable thing and now had to try to balance it by doing the honorable thing and stepping down as CIA director,” Tom Ricks reports in his blog “The Best Defense.”


Such a move is in keeping with the military culture in which Petraeus rose to the rank of four-star general.


Under the Uniform Code of Military Justice, adultery is a punishable offense for soldiers if the conduct is shown to be detrimental “to good order and discipline in the armed forces or was of a nature to bring discredit upon the armed forces.”


Obama said that Michael Morell, deputy director of the CIA, would take over as acting director. Mr. Morell served briefly as acting director after Leon Panetta left the agency last year to become Defense secretary.


Petraeus was set to testify Thursday at a closed-door session of the Senate Intelligence Committee on the Benghazi attack, but it was unclear if his resignation would alter that schedule.


Sen. Dianne Feinstein (D) of California, the Intelligence Committee chair, told NBC News that Petraeus’s personal mistake should not have led to his resignation.


“I would have stood up for him,” she said. “I wanted him to continue. He was good, he loved the work, and he had a command of intelligence issues second to none.”


Obama, after winning reelection Tuesday, was already expected to make some changes in his national security team for a second term, but early speculation had been that Petraeus would stay on at the CIA. Now the job of spy chief will be added to the new-team mix.


RECOMMENDED: 5 ways events overseas could shape Obama's second term



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Myanmar says Obama to visit later this month
















YANGON, Myanmar (AP) — President Barack Obama will make a groundbreaking visit later this month to Myanmar, an official said Thursday, following through with his policy of rapprochement to encourage democracy in the Southeast Asian nation.


The Myanmar official speaking from the capital, Naypyitaw, said Thursday that security for a visit on Nov. 18 or 19 had been prepared, but the schedule was not final. He asked not to be named because he was not authorized to give information to the media.













The official said Obama would meet with opposition leader Aung San Suu Kyi as well as government officials including reformist President Thein Sein.


It would be the first-ever visit to Myanmar by an American president. U.S. officials have not yet announced any plans for a visit, which would come less than two weeks after Obama’s election to a second term.


Obama’s administration has sought to encourage the recent democratic progress under Thein Sein by easing sanctions applied against Myanmar’s previous military regime.


Officials in nearby Thailand and Cambodia have already informally announced plans for visits by Obama that same week. Cambodia is hosting a summit meeting of the Association of Southeast Asian Nations, and Thailand is a longtime close U.S. ally.


The visit to Myanmar, also known as Burma, would be the culmination of a dramatic turnaround in relations with Washington as the country has shifted from five decades of ruinous military rule and shaken off the pariah status it had earned through its bloody suppression of democracy.


Obama’s ending of the long-standing U.S. isolation of Myanmar’s generals has played a part in coaxing them into political reforms that have unfolded with surprising speed in the past year. The U.S. has appointed a full ambassador and suspended sanctions to reward Myanmar for political prisoner releases and the election of Nobel laureate Suu Kyi to parliament.


From Myanmar’s point of view, the lifting of sanctions is essential for boosting a lagging economy that was hurt not only by sanctions that curbed exports and foreign investment, but also by what had been a protectionist, centralized approach. Thein Sein’s government has initiated major economic reforms in addition to political ones.


A procession of senior diplomats and world leaders have traveled to Myanmar, stopping both in the remote, opulent capital city, which was built by the former ruling junta, and at Suu Kyi’s dilapidated lakeside villa in the main city of Yangon, where she spent 15 years under house arrest. New Zealand announced Thursday that Prime Minister John Key would visit Myanmar after attending the regional meetings in Cambodia.


The most senior U.S. official to visit was Hillary Rodham Clinton, who last December became the first U.S. secretary of state to travel to Myanmar in 56 years.


The Obama administration regards the political changes in Myanmar as a marquee achievement in its foreign policy, and one that could dilute the influence of China in a country that has a strategic location between South and Southeast Asia, regions of growing economic importance.


But exiled Myanmar activists and human rights groups are likely to criticize an Obama visit as premature, rewarding Thein Sein before his political and economic reforms have truly taken root. The military — still dominant and implicated in rights abuses — has failed to prevent vicious outbreaks of communal violence in the west of the country that have left scores dead.


Asia News Headlines – Yahoo! News



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Exclusive: Google Ventures beefs up fund size to $300 million a year

SAN FRANCISCO (Reuters) - Google will increase the cash it allocates to its venture-capital arm to up to $300 million a year from $200 million, catapulting Google Ventures into the top echelon of corporate venture-capital funds.


Access to that sizeable checkbook means Google Ventures will be able to invest in more later-stage financing rounds, which tend to be in the tens of millions of dollars or more per investor.


It puts the firm on the same footing as more established corporate venture funds such as Intel's Intel Capital, which typically invests $300-$500 million a year.


"It puts a lot more wood behind the arrow if we need it," said Bill Maris, managing partner of Google Ventures.


Part of the rationale behind the increase is that Google Ventures is a relatively young firm, founded in 2009. Some of the companies it backed two or three years ago are now at later stages, potentially requiring larger cash infusions to grow further.


Google Ventures has taken an eclectic approach, investing in a broad spectrum of companies ranging from medicine to clean power to coupon companies.


Every year, it typically funds 40-50 "seed-stage" deals where it invests $250,000 or less in a company, and perhaps around 15 deals where it invests up to $10 million, Maris said. It aims to complete one or two deals annually in the $20-$50 million range, Maris said.


LACKING SUPERSTARS


Some of its investments include Nest, a smart-thermostat company; Foundation Medicine, which applies genomic analysis to cancer care; Relay Rides, a carsharing service; and smart-grid company Silver Spring Networks. Last year, its portfolio company HomeAway raised $216 million in an initial public offering.


Still, Google Ventures lacks superstar companies such as microblogging service Twitter or online bulletin-board company Pinterest. The firm's recent hiring of high-profile entrepreneur Kevin Rose as a partner could help attract higher-profile deals.


Soon it could have even more cash to play around with. "Larry has repeatedly asked me: 'What do you think you could do with a billion a year?'" said Maris, referring to Google chief executive Larry Page.


(Editing by Muralikumar Anantharaman)


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“Dancing” co-host Brooke Burke has thyroid cancer
















LOS ANGELES (Reuters) – “Dancing with the Stars” co-host Brooke Burke said on Thursday that she has been diagnosed with thyroid cancer and will need surgery.


The television presenter and model said in a three-minute video posted on the website Modernmom.com that she will need her thyroid removed.













“I need to have thyroid surgery and a thyroidectomy, which means I’m going to have a nice, big scar right here on neck,” Burke said, drawing a finger across her throat.


Burke, a former winner of ABC’s celebrity ballroom dancing competition, said she had a biopsy in July, but it had taken her months to go public with the results.


“I’m ready to deal with it, and I’m going to be fine,” she said.


There was no word on when the surgery would take place, but Burke’s publicist said her work schedule for “Dancing with the Stars” would not be affected.


Burke, 47, said in July that her doctor suggested she undergo a thyroid ultrasound after he felt a lump in her neck during a routine physical.


The thyroid is a gland in the neck that produces hormones that regulate vital body functions, such as heart rate and blood pressure.


Burke’s co-host Tom Bergeron said on Thursday during an appearance on the CBS chat show “The Talk” that he had known about her condition for several months. “We are all there with her,” he said.


“I’ve known about this for a few months … I have had experience with this in my family. You never want to hear the word cancer. But thyroid cancer is one of the most treatable cancers. It has an incredibly high success rate,” he said.


(Reporting By Eric Kelsey; Editing by Jill Serjeant)


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FDA panel recommends approval of Novo degludec insulin
















(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Thursday voted to recommend approval of Danish drugmaker Novo Nordisk‘s new ultra-long-acting insulin degludec, despite signals of possible cardiovascular risk.


The panel of outside medical experts unanimously recommended that the company undertake a large study, possibly after the basal insulin is approved, to verify heart safety of the once-daily drug.













Panel members said during an all-day meeting that they were concerned about a trend toward higher incidence of cardiovascular events with degludec than other drugs in 16 large clinical trials, even though the difference was not statistically significant.


But they expressed enthusiasm for degludec’s 24-hour duration of action, saying it was perhaps unmatched by other drugs and would allow patients to take the insulin at a different time of the day if they missed taking it at their usual time.


“Currently available basal insulins are imperfect and don’t last 24 hours,” said Dr. David Cooke, a panel member who is an associate professor of pediatrics at Johns Hopkins University School of Medicine.


“A true basal that gives constant coverage for 24 hours would make a difference,” Cooke said.


Dr. Kenneth Burman, chief of endocrinology at Washington Hospital Center in Washington, D.C., said the drug’s duration of action “seems unique. Instead of a 12-hour half life, it’s probably 24 hours.”


But Sanford Bernstein analyst Tim Anderson said degludec’s sales potential was “meaningfully impaired” by the panel’s concern about the drug’s cardiovascular risks and the likelihood they will show up in its package insert label.


“An approved label in the United States is highly likely to call out the unknowns about the cadiovascular signal seen,” Anderson said in a research note.


The panel began weighing the benefits and risks of the medicine two days after FDA staff members said combined data from the 16 studies suggest degludec may increase the risk of cardiovascular death, non-fatal heart attacks and strokes and unstable angina, compared to standard insulins.


Moreover, FDA staff reviewers had suggested degludec may offer no strong advantage over other drugs in avoiding hypoglycemia — dangerously low blood sugar levels that are a common side effect of insulin. Some members of the FDA advisory panel echoed those concerns on Thursday.


But the panel voted 8 to 4 to recommend degludec’s approval, despite concerns about heart safety, saying its benefits appear to outweigh its risks. The FDA usually follows the recommendations of its advisory panels.


The stakes are high for Novo, the world’s largest insulin maker, because Wall Street deems the medicine capable of generating annual sales of $ 1.5 billion by 2016 if it is approved in the United States.


It would compete with Lantus, Sanofi’s dominant long-acting insulin, which had sales last year of about $ 5 billion. U.S. drugmaker Eli Lilly is developing a similar medicine that is a few years behind in development.


The company’s many completed studies of degludec did not enroll enough patients, or last long enough, to ascertain heart risks. A large trial with thousands of patients could reliably assess its safety, but could take a number of years to complete.


The panel did not vote on whether the trial should be conducted before, or after, degludec is approved.


Novo officials on Thursday, speaking at the advisory-panel meeting in Silver Spring, Maryland, said they were committed to working with the FDA on a post-approval cardiovascular outcomes trial.


The negative commentary from FDA staff members on Tuesday sent shares of the Danish drugmaker sharply lower. It plans to sell degludec under the brand name Tresiba.


The European Medicines Agency last month recommended degludec’s approval, and it has already been approved in Japan.


(Reporting By Ransdell Pierson; editing by Jim Marshall)


Medications/Drugs News Headlines – Yahoo! News



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