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Juno could be worth $110/share in takeover: Citi

Juno could be worth $110 per share in takeover, says Citi. After the Wall Street Journal reported tonight that Celgene (CELG) is in talks to acquire Juno Therapeutics (JUNO), Citi analyst Robyn Karnauskas says her analysis indicates Juno could be worth $110 per share in a takeover. The stock in after-hours trading jumped 43%, or $19.50, to $65.10. The analyst, however, points that Kite Pharma had more data at the time of acquisition and was acquired by Gilead Sciences (GILD) for an aggregate price of $11.9B. Karnauskas also notes that Celgene already owns 25% of June’s revenues.

http://bit.ly/2FMi7Um

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Liquid biopsy shows promise for colon cancer

A liquid biopsy detected circulating tumor cells (CTCs) associated with colorectal cancer with overall accuracy approaching 90%, according to a study reported here.

The test’s accuracy varied according to the stage of the disease, including 77% sensitivity for detection of precancerous lesions in the colon. The test had sensitivity exceeding 97%, reflecting a low probability of false-positive result.

If the results hold up in additional testing, the liquid biopsy might offer another option for colorectal cancer screening, Wen-Sy Tsai, MD, of Linkou Chang Gung Memorial Hospital in Taoyuan, Taiwan, reported at the Gastrointestinal Cancers Symposium.

“There is still some reticence among patients to use stool-based tests or have an invasive exam like colonoscopy to detect colorectal cancer,” Tsai said in a statement. “Our results may point to a solution for people who are reluctant to get an initial screening colonoscopy or are not compliant in returning stool-based test kits that they get from their doctors.”

Several recent studies showed that more than 80% of patients who are reluctant to undergo colonoscopy would find a blood test acceptable, said co-author Ashish Nimgaonkar, MD, of Johns Hopkins University in Baltimore. Other studies showed that affordability remains the biggest obstacle to colorectal cancer screening for most people; a liquid biopsy for CTCs might cost less than $100, he added.

Inconvenience, discomfort, and cost all contribute to Americans’ reluctant to undergo colorectal cancer screening, agreed Nancy Baxter, MD, PhD, an American Society of Clinical Oncology expert in gastrointestinal cancers.

“Thought this research needs more investigation, a simple, accurate blood test could help increase screening rates, which could ultimately improve detection of colorectal cancers at earlier stages when treatment is most likely to be curative,” said Baxter, of the University of Toronto and St. Michael’s Hospital.

The study involved 620 adult Taiwanese patients with scheduled routine colonoscopy or colonoscopy for follow-up of confirmed colorectal cancer. Colonoscopy and biopsy confirmed that 111 of the patients had adenomatous polyps and 327 had colorectal cancer, ranging from early- to late-stage disease. The remaining 182 patients had no evidence of adenomas or colon cancer and served as a comparison group.

The liquid biopsy required each patients to provide 2 mL of blood, which was analyzed by a test with proven ability to identify a single CTC within 1 billion cells from an adenomatous polyp. Results were compared with the colonoscopy findings by reviewers who had no prior knowledge of the findings of either test.

Using colonoscopy findings as the definitive result, investigators found that the blood test had an overall accuracy of 88%. The test had a sensitivity of 84.0% among the 182 study participants without adenomas or colorectal cancer, 76.6% for participants with adenomatous polyps, and 86.9% for the patients with colorectal cancer. The test results yielded a specificity of 97.3% in the cancer-free group, the polyp group, and the patients with confirmed colorectal cancer.

“We believe our high specificity results are important because a high number of false-positive results would discourage many people who are considering getting screened for colorectal cancer from doing so,” said Tsai.

Performance analysis showed the test had an area under the curve of 0.87 for the control group, 0.84 for the participants with polyps, and 0.88 for the patients with colorectal cancer.

Following approval of the Cologuard stool DNA test for colorectal cancer screening, gastroenterologists and colon cancer specialists noted the test’s poor performance for detecting adenomatous polyps. In the randomized comparing against fecal immunochemical testing that supported the FDA application, the DNA test detected 92% of colon cancers versus 42% of adenomatous polyps. The study also yielded a 13% rate of false-positives for the DNA test.

Moreover, as one gastroenterologist noted in an opinion piece for MedPage Today, no currently available screening test will replace colonoscopy as the gold standard for diagnosis of colorectal cancer. Even if the initial results with the liquid biopsy hold up in additional testing, the CTC test colonoscopy will remain the standard for definitive diagnosis and to guide biopsy of a tumor or removal of a polyp detected by the liquid biopsy, Nimgaonkar noted.

Nimgaonkar and co-authors disclosed relevant relationships with CellMax Life. Some co-authors are company employees.

White House physician details Trump’s ‘excellent health’

White House physician Ronny Jackson, MD, a rear admiral in the Navy, said President Trump’s overall health is “excellent,” and that the president aced a cognitive screening, during a press briefing on Tuesday.

“All clinical data indicates that the president is currently very healthy and that he will remain so for the duration of his presidency,” Jackson said, while releasing a summary of medical tests he conducted last week.

The 71-year-old president received his first annual physical as commander-in-chief at Walter Reed Medical Center on Friday. The full exam lasted about 4 hours and included 12 consultants.

Jackson described the president’s cardiac performance as “very good” owing to a lifetime of abstaining from alcohol and tobacco. He also reported that Trump did receive a cognitive assessment, showing no impairment.

The president weighs 239 lbs and his height is 6’3″, Jackson said.

The president currently takes rosuvastatin (Crestor) at 10 mg/day to lower his cholesterol, low-dose aspirin for his cardiac health, and Propecia to prevent male pattern baldness. He also uses a cream for his rosacea, as needed, and takes a daily multivitamin, Jackson said.

Trump’s resting heart rate was 68; his blood pressure 122/74 and his heart exam overall was “normal.” Jackson reported a “regular rhythm, no murmurs or other abnormal heart sounds” and his ECG was also “normal” with a sinus rhythm rate of 71 at a normal axis.

His total cholesterol was reported as 223; triglycerides 129; HDL 67; and LDL 143. Hemoglobin A1c was 5%. Trump’s uncorrected visual acuity was 20/30 and his thyroid function was reported as normal.

Trump received a transthoracic echocardiogram which showed an ejection fraction of 60%-65% which Jackson also described as “normal.” There were no signs of ischemia.

Christopher Cannon, MD, a cardiologist at Brigham and Women’s Hospital in Boston, said a standard risk calculator shows Trump with a 16.7% risk of a heart attack or other atherosclerotic cardiovascular disease event in the next 10 years.

That estimate is based on the age, lipid values, blood pressure, and other risk factors described at the briefing, using the American Heart Association/American College of Cardiology risk calculator.

That score is “pretty high, actually,” Cannon told MedPage Today. AHA/ACC guidelines would suggest Trump’s cholesterol needs attention, with a more intensive statin typically recommended for a risk profile like his.

Jackson essentially concurred, reporting plans to make changes in the president’s diet, exercise, and drug regimes to address his major risk factors.

He said he would connect the White House chef with a nutritionist, because he believes the president would benefit from a diet lower in carbohydrates and fats. He also recommended that Trump begin an exercise regime, something “low impact” such as riding a stationary bike or riding a treadmill.

Trump agreed to a goal of losing weight, about 10-15 lbs, Jackson said, adding that he is raising Trump’s rosuvastatin dose “in order to further reduce his cholesterol level and further decrease his cardiac risk.”

“He’s more enthusiastic about the diet part than the exercise part,” Jackson said of the president.

White House spokesman Hogan Gidley said last week that the president’s physical would not include a psychiatric examination, and Jackson said he didn’t think a cognitive exam was clinically indicated, based on his previous interactions with Trump. But he said the president insisted on having a cognitive assessment. (Cognitive and psychiatric assessments are different, Jackson noted.)

Jackson chose the Montreal Cognitive Assessment and the president scored 30 out of 30.

“I’ve spent almost every day in the president’s presence since Jan. 20 … you know last year … I see him one, two, sometimes three times a day, because of the location of my office … I’ve got to know him pretty well and I have absolutely no concerns about his cognitive ability or his neurological function,” he said.

“The reason that we did the cognitive assessment is plain and simple, because the president asked me to do it,” Jackson added.

Prior to the visit a discussion over whether the exam should include a psychiatric or cognitive component, played out online and in the media, after it was reported that the president had been forgetting friends’ names and repeating stories.

Publicly sharing the details of a president’s physical exam is not unprecedented, noted ABC NewsWhen Jackson served under former President Barack Obama, Jackson shared a “detailed summary” of his medical assessment including the then president’s vitals, and a lengthy account of physical tests and laboratory results.

http://bit.ly/2DbQy54

Drastic pension cuts may hit California, Kentucky, other states

The CA Supreme Court will rule on pension cuts. Curiously, the court’s ruling will be irrelevant in case of bankruptcy.

 

California Governor Jerry Brown said legal rulings may clear the way for making cuts to public pension benefits, which would go against long-standing assumptions and potentially provide financial relief to the state and its local governments.

Brown said he has a “hunch” the courts would “modify” the so-called California rule, which holds that benefits promised to public employees can’t be rolled back. The state’s Supreme Court is set to hear a case in which lower courts ruled that reductions to pensions are permissible if the payments remain “reasonable” for workers.

“There is more flexibility than there is currently assumed by those who discuss the California rule,” Brown said during a briefing on the budget in Sacramento. He said that in the next recession, the governor “will have the option of considering pension cutbacks for the first time.”

That would be a major shift in California, where municipal officials have long believed they couldn’t adjust the benefits even as they struggle to cover the cost. They have raised taxes and dipped into reserves to meet rising contributions. The California Public Employees’ Retirement System, the nation’s largest public pension, has about 68 percent of assets needed to cover its liabilities. For the fiscal year beginning in July, the state’s contribution to Calpers is double what it was in fiscal 2009.

“In the next downturn, when things look pretty dire, that would be one of the items on the chopping block,” Brown said.

Pension Cuts Are Coming

It’s refreshing to hear a politician admit the obvious: Pension cuts are coming.

However, whether or not the cuts are “reasonable” is irrelevant in cases of bankruptcy. Bankruptcy is under federal, not state law.

Municipal Bankruptcy State Laws

The above map is from Governing.Com.

Municipalities located in states that are green, generally have a right to declare bankruptcy. Those in purple don’t. There could be bankruptcy legislation at the national level that would supersede state constitutions and I am in favor of that.

Meanwhile, despite the enormous gains in the stock market in the past decade, CALPers is still only 68% funded, and that even assumes 7-8% returns into the future.

Illinois and Kentucky are much worse off.

Even 3% gains would devastate most pension plans. Steep actual losses are likely.

Translation: Things are dire and pension cuts are coming.

Municipalities will resort to bankruptcy if necessary, in states that allow it. Those states that do not allow municipal bankruptcy will be forced one way or another to do so.

http://bit.ly/2EPzy57

Celgene reported in talks to buy Juno

Celgene Corp (CELG.O) is in talks to buy Juno Therapeutics Inc (JUNO.O), which is working on an experimental gene therapy drug to treat cancer, the Wall Street Journal reported on Tuesday, citing sources familiar with the matter. (on.wsj.com/2EMlysO)

Shares of Juno, which has a market value of $5.57 billion, were up 42 percent at $64.59 in extended trading.

Chimeric antigen receptor T-cell therapy, or CAR T, harnesses the body’s own immune cells to recognize and attack malignant cells. Novartis (NOVN.S) received the first U.S. Food and Drug Administration approval for a CAR T drug last year.

Juno does not yet have any FDA approvals for its CAR T drugs, but it released promising data from early trials for a blood cancer treatment in November.

It has had previous setbacks in developing the treatments, and shut down development of one leukemia treatment due to severe neurotoxicity that led to five patient deaths.

Still, CAR T treatments are expected to be blockbusters for drugmakers, costing up to $500,000 and generating billions of dollars in sales.

CELG.ONASDAQ
-1.18(-1.11%)
CELG.O
  • CELG.O
  • JUNO.O
  • NOVN.S
  • GILD.O

Gilead Sciences Inc (GILD.O) bought Juno rival Kite Pharma Inc for nearly $12 billion late last year.

The WSJ report comes days after Celgene said it had agreed to acquire Impact Biomedicines for as much as $7 billion, subject to certain milestones associated with regulatory hurdles and sales performance.

Senior executives from some of the largest pharmaceutical manufacturers told Reuters last week that they expect the Trump administration’s tax overhaul to accelerate major acquisitions by drugmakers in 2018 after a slow year for deals in 2017.

http://reut.rs/2reMDmw

What should you do in case of nuclear attack? ‘Don’t run. Get inside’

he threats seem to come almost daily now out of North Korea — ballistic missile firings, preparations to test a nuclear bomb and routine bravado. In April, state-owned media in the rogue nation vowed a “super mighty preemptive strike,” one that will reduce the U.S. to “ashes.”

On Saturday, residents in Hawaii were sent into a panic when they received alerts on their mobile phones and televisions warning that a ballistic missile was on its way. The warning, which claimed “this is not a drill,” quickly prompted officials to say minutes later that it was sent in error.

Meanwhile, American weapons experts believe Pyongyang is likely a few years from having the capability of firing a nuclear–equipped missile that can reach the U.S. mainland.

Yet some leading emergency response planners view the persistent menace of North Korea as a new opportunity: reason to alert the American public that a limited nuclear attack can be survivable, with a few precautions.

The simplest of the warnings is: “Don’t run. Get inside.” Sheltering in place, beneath as many layers of protection as possible, is the best way to avoid the radiation that would follow a nuclear detonation.

That conclusion has been the consensus of the U.S. emergency and public health establishments for years, though national, state and local governments generally have been less than aggressive about putting the word out to the public.

Officials at the Federal Emergency Management Agency and Department of Homeland Security say the nuclear safety directives are available, including online at Ready.gov, but they have not broadcast them more widely. Asked about spreading the word beyond the website, a FEMA spokesperson emailed a terse response: “At this time time there are no specific plans to do any messaging on this topic.”

Teacher And Children Crouching Under Table
School children and their teacher peer from beneath a table during a state-wide air raid test in Newark, New Jersey, in 1952. Bettmann / Getty Images

Part of the reticence has been out of a fear of alarming the public and part has been an attempt to balance education about “radiation safety” with other messages about threats like earthquakes, hurricanes and floods, say academics who advise the government.

“There is a lot of fatalism on this subject, the feeling that there will be untold death and destruction and there is nothing to be done,” said Irwin Redlener, director of Columbia University’s National Center for Disaster Preparedness. “But the thing that is frustrating for me is that, with some very simple public messaging, we could save hundreds of thousands of lives in a nuclear detonation.”

Duck-and-cover drills a thing of the past

Brooke Buddemeier, a nationally-recognized expert on nuclear disaster preparedness from Lawrence Livermore National Laboratory, said that following the 9/11 attacks, Americans may have suffered a kind of “preparedness fatigue.”

“There was so much information that came out altogether,” Buddemeier said, “but then it’s kind of hard to fit information about nuclear terrorism in with warnings about earthquakes and hurricanes and wildfires and all other emergencies that happen on a regular basis.”

The last time that the threat of imminent nuclear attack gripped the American conscious, John F. Kennedy was in the White House. But duck-and-cover drills soon became a thing of the past and at-home fallout shelters are a rarity.

Local governments abandoned the mass public shelters they built during the Cold War. Parking garages beneath the Los Angeles Civic Center and a subterranean vault beneath a Seattle freeway overpass are no longer designated as safe zones for a retreating public.

While North Korean provocations have received the most attention in recent weeks, government officials remain at least as concerned about the possibility of an attack by terrorists or other “non-state” actors. In these scenarios, a nuclear device might be secreted into a ship, or some other delivery device, and exploded at ground level.

The largest nuclear blasts would create a fireball a mile in diameter and temperatures as hot as the surface of the sun, followed quickly by winds greater than the force of a hurricane, according to the Bulletin of the Atomic Scientists. (North Korea’s past nuclear tests have been far smaller, with the largest an estimated 10 kilotons, less than either of the atomic bombs used on Japan in World War II). Radioactive fallout would be carried for miles by the jet stream and surface winds. While little might be done for immediate blast victims, researchers say that the public’s response will be crucial.

Resist the instinct to run for the hills

Years of novels, television and movie dramatizations have popularized visions of nuke victims flowing out of cities in unruly masses, seeking out radiation-free air. But experts say that finding a route to safety would range from difficult to impossible, given the droves who would be gridlocking freeways.

Survivors of an immediate blast would be much better served by finding cover. A car is better than the open air, while most houses are considerably safer than a car, particularly if there is room to hunker down in a basement.

“Go as far below ground as possible or in the center of a tall building,” says Ready.gov, the website created by FEMA and the Department of Homeland Security. “The goal is to put as many walls and as much concrete, brick and soil between you and the radioactive material outside.” The site recommends staying inside for at least 24 hours, unless authorities recommend coming out sooner.

The sheltering directives go against the basic human instinct to flee and to reunite with family members as quickly as possible, emergency preparedness officials acknowledge. But parents are directed to leave their kids in school or day care, rather than risk driving to them in the radiation-laden atmosphere.

When the Los Angeles area conducted a nuclear-threat exercise in 2010 called Operation Golden Phoenix, Lawrence Livermore’s health physicist Buddemeier presented a model of a possible terrorist attack near Universal Studios Hollywood. His findings showed that 285,000 could die or get radiation sickness. But the vast majority of those, about 240,000, would be spared if they could find their way to basements or other more substantial shelters.

Those findings are common knowledge among public health officials and the subject of routine meetings like the one last month near Washington, D.C., of the National Council on Radiation Protection. Yet there is a “gap” between expert knowledge about these best practices and “getting it all the way into the public consciousness … to keep them and their families safe,” Buddemeier said.

A man wearing protective clothing emerges from a fallout shelter in Medford, Massachusetts in 1961. AP

Deferring to the feds

The cities most often mentioned as possible targets of a nuclear-tipped intercontinental ballistic missile (ICBM) from North Korea are Los Angeles, San Francisco and Seattle. All three rely on the federal government to inform the public about how to prepare for a potential nuclear attack.

Barb Graff, director of Seattle’s Office of Emergency Management, said the city polled residents several years ago and found that they would hear and respond to messages about earthquakes and other threats but would “shut down,” and not take any preparatory action, when informed about nuclear threats.

 

“It’s a hard discussion,” Graff said. “How do we pay attention to something we know is important but might cause people to shut down and not take any action if they are informed about it.”

Her department has received only a few calls in recent weeks, in response to the Korean nuclear provocations. Those residents were referred to Ready.gov. Los Angeles and San Francisco, similarly, refer inquiries to the federal government.

A proactive approach at the local level

Taking perhaps the most aggressive stance toward public notification anywhere in America is Ventura County in Southern California. The county’s health department launched a campaign starting in 2013 to inform citizens about what to do in a nuclear attack. The county created an 18-page educational pamphlet, four videos and a curriculum for schools and a series of community meetings.

At the center of the campaign was the message “Get inside, stay inside, stay tuned.” Dr. Robert Levin, the public health medical director for Ventura County, who led the effort, said concerns about terrifying the public didn’t come to pass. “The response we got over and over again from people was ‘Thank God somebody is finally doing something about this,'” Levin said.

At the annual meeting last month of the National Council on Radiation Protection — a group of public health and emergency officials — the Ventura officials’ efforts were welcomed with repeated applause.

North Korea and the need to know

The question of how government and individuals would respond if a nuclear strike hit the U.S. has become more pressing with the revelation, reported last week by NBC News, that experts believe America’s missile shield system is far from foolproof. The anti-missile defense depends on the ability of America’s own rockets — based in Alaska and at Vandenberg Air Force Base on California’s Central Coast — to shoot incoming rockets out of the sky.

Tests of the “bullet-shooting-a-bullet” technology have not always succeeded, experts noted. And that’s despite the fact that the tests have been conducted under optimum conditions, without the secret launch times and diversionary technology that enemy weapons would likely employ.

David Ropeik, a some-time instructor at the Harvard School of Public Health and an expert in risk assessment said that most public information campaigns about nuclear preparedness have been “too passive” and “not adequate.” The ongoing threats from North Korea “create a huge opportunity to get this on our radar screen.” Ropeik added: “The information is out there, most people just need to be alerted that it is there.”

Redlener, of the National Center for Disaster Preparedness, said informing the public has been slowed by concerns about creating undue alarm. But a worse failing would be to leave people in the dark about simple precautions that could save lives, he said.

“The public should be treated as adults,” Redlener said. “We live in a complicated world and we want people to be prepared.”

http://nbcnews.to/2DtxrVb

Biogen target upped on tax, product factors: OppCo

Biogen price target raised to $380 from $350 at Oppenheimer. Oppenheimer analyst Jay Olson raised his price target for Biogen to $380 from $350, citing stable MS sales and lower tax rate. The analyst reiterates an Outperform rating on the shares.

http://bit.ly/2DDiiAp