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SILVER SPRING, Md., March 20, 2018 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
"Today's approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Prod...
Lymphoma is a cancer that begins in the lymph system, which is part of the immune system that helps the body fight infection and disease. Lymphoma can begin almost anywhere in the body and can spread to nearby lymph nodes. The two main types of lymphoma are Hodgkin lymphoma (also called Hodgkin disease) and non-Hodgkin...
The National Cancer Institute at the National Institutes of Health estimates that 8,260 people in the United States were diagnosed with Hodgkin lymphoma last year and approximately 1,070 patients with non-Hodgkin lymphoma died from the disease in 2017.
Adcetris combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. Adcetris has also been previously approved by the FDA to treat cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic anaplastic l...
The approval for adult patients with previously untreated stage III or IV cHL was based on a clinical trial comparing Adcetris plus chemotherapy (Adriamycin [doxorubicin], vinblastine and dacarbazine, or AVD) to a chemotherapy-only regimen common for cHL treatment (AVD plus bleomycin, also known as ABVD). The trial mea...
Adcetris has a boxed warning that highlights the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, or PML, a rare but serious brain infection that can result in death.
Serious risks of Adcetris include peripheral neuropathy; severe allergic (anaphylaxis) or infusion-site reactions; damage to the blood, lungs and liver (hematologic, pulmonary and hepato-toxicities); serious or opportunistic infections; metabolic abnormalities (tumor lysis syndrome); serious dermatologic reactions and ...
The FDA granted this application Priority Review and Breakthrough Therapy designations.
The FDA granted the approval of Adcetris to Seattle Genetics, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security ...
The street has developed numerous ways of attempting to predict what will happen, estimating various attributes tied to stock performance in order to determine what the future holds for a company's valuation.
After dissecting the data, analysts following a particular stock produce a price target of where they believe the stock is headed. With data from Thomson Reuters, CNBC.com grouped stocks in the S&P 500 with average consensus estimates farthest below their stock prices.
In the S&P 500, the average short interest (as a % of float) stands at 4.11 percent, while the range for companies in the list is between 0.84 percent and 49 percent. All the prices are the latest available, data from Capital IQ and Thomson Reuters as of market close on Sept, 27 2012.
So, which stocks are analysts expecting to have the biggest drops? Click ahead to find out!
Oil prices dropped on Monday after China and South Korea posted surprisingly weak economic data, while fading prospects for a coordinated production cut by leading crude exporters also dragged on the market.
Economic data from China, showing its manufacturing sector contracted at its fastest pace in almost three-and-a-half years in January, added to worries about demand from the world’s top energy consumer at a time when the market is already weighed down by a supply overhang.
Numbers coming out of South Korea were also gloomy, with the country’s exports down at levels last seen at the height of the global financial crisis in 2009.
Reflecting an accelerating slowdown in Asia’s biggest economies, front-month Brent crude was down 56 cents at $35.43 per barrel at 0507 GMT. U.S. West Texas Intermediate was down 42 cents at $33.20 a barrel.
Oil prices came under further pressure because of the dim prospects of a coordinated cut in production by leading exporters like the Organization of the Petroleum Exporting Countries (OPEC) and Russia due to their differences.
“We do not expect such a cut will occur unless global growth weakens sharply from current levels, which is not our economists’ forecast,” Goldman Sachs said.
Also, OPEC-member Iran, which last month was allowed to fully return to markets after years of sanctions, is not willing to participate in any cuts.
In part because of Iran’s return, OPEC oil production has jumped to 32.60 million barrels per day (bpd), its highest in years. This has added to a global glut of over 1 million bpd in excess of demand, which has pulled down oil prices around 70 percent since mid-2014.
Because of the oversupply, analysts at BMI Research said they had reduced their oil price outlook: “We have downgraded our 2016 Brent forecast to $40 per barrel from $42.5 previously.” They expect WTI to average $39.50 this year.
“Counteracting oil’s upside momentum in 2016 will be the weakness of the Chinese yuan, lingering concerns over global economic growth and the well-stocked inventories of crude and fuels,” BMI said, adding that a gradual price rise was expected in the second half of the year.
A belief in higher prices towards the end of the year also shows in the price curve, with Brent for April 2017 delivery $7.8 per barrel above those for April this year, up from a premium of just $5.7 for this time spread on Nov. 1.
A man is set to be charged with assaulting a police officer who was trying to help on a domestic violence call in Sydney's west.
The officer was responding to a family violence matter at the Blacktown home on Sunday before a struggle ensued when police tried to arrest the 29-year-old man.
The senior constable was allegedly struck on his jaw and throat and was taken to hospital.
Two shoppers aggressively pursued this two-bedroom corner suite in late September.
It’s not unknown for buyers to battle over vacancies at Thornwood, a boutique luxury complex just east of the landmark former North Toronto Railway Station, now Ontario’s flagship liquor store. Two shoppers aggressively pursued this two-bedroom corner suite in late September.
“The size of the building and amenities are fabulous … and it’s tucked in from Yonge Street, right in Summerhill,” agent Amanda Gaskey said.
A recent modern makeover resulted in a more open entertaining area with a sleek fireplace.
This more than a decade-old suite provides a 1,450-square-foot plan with semi-private elevator access, two balconies and windows facing south and west.
A recent modern makeover resulted in a more open entertaining area with a sleek fireplace, pocket doors to a second bedroom and open sight lines to the dining area in the kitchen. The latter was also outfitted with a wet bar, pantry and waterfall-style marble countertop on the island.
There are two bathrooms with heated tile floors and ensuite laundry facilities, plus a locker and parking. Monthly fees of $1,243 pay for water and heating costs, as well as concierge and the use of guest suites, fitness and party rooms.
“Most of the condos within that building have more of a traditional feel to it, so this is a unique design,” Ms. Gaskey said.
The Chinese Sturgeon Museum is situated on the islet in Xiaoxita in Yichang. Built in 1982, the Chinese Sturgeon Museum is part of the Chinese Sturgeon Institution of China which is using artificial breeding techniques to try to preserve this endangered species.
The Chinese Sturgeon is an animal strictly protected by the Chinese government. It has a history of 140 million years, and is thought to have lived at the same time as dinosaurs. That is why it is called a "living fossil". The Chinese sturgeon is mainly distributed in the trunk tributaries of the Yangtze River and some...
The dam of the Yangtze has blocked the sturgeon's route, which will have a bad influence on the natural breeding patterns of the Chinese sturgeon. The Chinese government is taking more measures to protect this kind of valuable and rare species.
Forty-five years ago next month a White House conversation took place that will be remembered by history as the one containing the infamous "18-minute gap." That was the day after the Watergate break-in, when 18 and a half minutes of a recorded conversation between former President Richard Nixon and his top lieutenant ...
Many events pertaining to that crime were revealed over the course of the following two years, the story unfolding in fits and starts, but that gap remains one of the most memorable and mysterious of the details that finally led to the resignation of Nixon in August 1974.
Watergate history buffs undoubtedly heard the echoes of that famous occasion on Monday, when they heard the news media's repeated references to an "18-day gap" related to testimony by the former director of national intelligence, James Clapper, and former acting Attorney General Sally Yates before the Senate Judiciary ...
The story is pretty straightforward. Yates met with White House counsel Don McGahn on Jan. 26 and 27 and had one follow-up phone call to inform the administration of the Department of Justice's concerns about Flynn. The Washington Post reported in February that McGahn then "immediately" briefed Trump on the matter. Non...
Yates was fired two days later, on Jan. 30, ostensibly for her statement that she did not intend to enforce Trump's hastily thrown together travel ban. Flynn, however, remained at his post for two more weeks, attending high-level meetings and listening in on calls with other foreign leaders. He was only let go after Th...
To state the obvious, you don't want your national security adviser compromised with the Russians.
Is it possible that the reason that he didn’t fire him then was that, well, if I fire him for talking to the Russians about sanctions, what about all the other people on my team who coordinated? . . . That may be why it took him 18 days — until it came public — to get rid of Mike Flynn, who was a danger to this republi...
We have learned since Flynn's ouster that Trump's son-in-law and senior adviser Jared Kushner also had meetings with the Russian ambassador and Russian bankers. And we know there is an ongoing multiagency counterintelligence investigation of possible collusion by the Trump campaign with the Russian government, involvin...
It's impossible to know what was in Trump's head so it also could be that he just liked Flynn and didn't understand why this information was important. But Yates' testimony hinted at something more about those contacts that are classified. She told the committee that she told McGahn that Flynn's "underlying contact was...
In Trump's overwrought Feb. 16 press conference, when he announced the firing of Flynn, the president said, "When I looked at the information, I said, I don't think he did anything wrong. If anything, he did something right." He went on to explain that it was Flynn's giving incorrect information to Pence that was the p...
The Republicans on the committee behaved like the worst partisan hacks, for the most part refusing to even address the subject of the hearing and instead grilling Yates on the Muslim ban and ranting about "unmasking" procedures and leaks to the press, obviously following the White House line. Sen. Ted Cruz even asked Y...
Yates' answers about the Muslim ban were devastating to committee Republicans' cause and the rest of the yammering about leaks sounds particularly hollow when you consider the timeline that I just outlined above. It's quite clear that if nobody had leaked the information on Flynn to The Washington Post, an obviously un...
Meanwhile, Trump behaved the way he normally does in tight situations. He attempted to smear Yates as the leaker in one of his notorious early-morning tweets. It was later deleted, probably after someone mustered the courage to tell him that he was threatening a witness, a move he probably learned during his days in th...
Meanwhile, according to Axios, Trump has told his people to stop feeding negative stories about Flynn to the media. The official explanation is that Trump believes that Flynn is a good man, that the Russia story is "fake news" and whatever went wrong was Obama's fault. But one cannot help but wonder if Trump's lawyers ...
TEL AVIV • Tel Aviv University yesterday presented a prototype of a miniature heart, which scientists say is the world's first heart created with a 3D printer using human tissue.
Prof Dvir stressed the importance of the heart being made with the patient's own cells and biological materials in order to eliminate the risk of implant rejection.
"But larger human hearts require the same technology," Prof Dvir said.
The next step for the researchers is to culture the printed hearts in a laboratory and "teach" them to behave like hearts. The current state of the primitive heart can be compared to the heart of an embryo.
"The cells need to form a pumping ability; they can currently contract, but we need them to work together," Prof Dvir explained.
"Maybe, in 10 years, there will be organ printers in the finest hospitals around the world, and these procedures will be conducted routinely," Prof Dvir said.
California-USA: The world’s largest aircraft took off over the Mojave Desert in California-USA, the first flight for the carbon-composite plane built by Stratolaunch Systems Corp., started by late Microsoft co-founder Paul Allen, as the company enters the lucrative private space market.
The white airplane called Roc, which has a wingspan the length of an American football field and is powered by six engines on a twin fuselage, took to the air shortly before 7 a.m. Pacific time (1400 GMT) couple of days ago, and stayed aloft for more than two hours before landing safely back at the Mojave Air and Space...
The plane is designed to drop rockets and other space vehicles weighing up to 500,000 pounds at an altitude of 35,000 feet and has been billed by the company as making satellite deployment as “easy as booking an airline flight.” During the inaugural flight, where the plane reached a maximum speed of 189 mph and altitud...
Allen, who co-founded Microsoft with Bill Gates in 1975, announced in 2011 that he had formed the privately funded Stratolaunch. The company seeks to cash in on higher demand in coming years for vessels that can put satellites in orbit, competing in the United States with other space entrepreneurs and industry stalwart...
Sunday view after recovery operations ended at the site of the FIU-Sweetwater UniversityCity Bridge collapse on Sunday, March 18, 2018.
The NTBS investigators, who arrived on Thursday night, began what will likely be an arduous process of reconstructing the accident and assigning a cause. The investigation could take as long as 18 months, the agency said.
Reports that cracking in the bridge had been discovered days before the collapse drew a flurry of attention on Friday, but its significance remains unclear.
The Florida Department of Transportation issued a statement saying the bridge’s engineer had called the agency on Tuesday to report cracking in the concrete at the north end of the span — in the same general area where tensioning work was undertaken on Thursday, two days later. According to the call’s transcript, which...
The design-build team then held a two-hour meeting on Thursday morning, with FDOT participation, during which the cracking was discussed but no safety red flags were raised over it. The meeting broke up at 11 a.m., a couple of hours before the bridge buckled and fell. The precise location of the cracking has not been d...
An NTSB investigator said Friday that a crack in the bridge is not necessarily unsafe. Cracks in new concrete construction are not uncommon, and can be cosmetic or a sign of more serious trouble, experts say.
As crews work to remove the massive slab to retrieve vehicles they suspect hold more victims, investigators will begin combing through debris and document the site. The wreckage itself will likely provide telling details — cracks could reveal the precise location where stresses occurred that caused the bridge to fall.
Interviews with witnesses and video footage could reveal the sequence of events. Investigators may use 3D imaging, preserve larger pieces of the bridge in a local warehouse while the case unfolds and ship other joints or braces back to Washington labs for testing, said NTSB Media Relations Officer Keith Holloway.
“Each accident is different, so it may require different techniques,” he said.
Independent experts focused in on work going on Thursday before the bridge fell. Late Thursday night, Rubio tweeted that he was told by workers at the site that cables connected to the bridge had loosened and engineers were instructed to tighten them.
One subcontractor that provides materials and services for concrete tensioning, Structural Technologies VSL, confirmed on Friday that it had a crew at work on the bridge and that one employee, Navaro Brown, had perished in the accident. Two others were hospitalized.
Whatever did in fact occur to weaken the bridge, one expert said, it could well be tied to work done Thursday. Engineers say that most bridge and building collapses that occur during construction are caused by work errors, not design flaws, though the latter can’t be ruled out this early.
“I assume they were tests to see the resiliency of the concrete, the stress on the material,” Rosenberg said.
Rosenberg said he has not spoken to anyone from the bridge contractor, Munilla Construction Group, a politically connected firm in Miami. Rubio said he had spoken to partner Pedro Munilla amid the rubble of the bridge collapse on Thursday, but not about the possible cause.
The bridge’s 175-foot main span, built by the side of Southwest Eighth Street over a period of months, was hoisted into place over supports at either end in a matter of several hours last Saturday morning — a relatively novel though increasingly common approach known as accelerated bridge construction.
Whatever the case, the collapse is certain to lead to multimillion dollar lawsuits and finger-pointing even as the official investigation proceeds.
Uustal warned that the official probe could drag on into 2019 because of federal budget cuts.
The innovative bridge, set to open in early 2019, was lauded by both the university and the FIGG Bridge Group, the award-winning firm that designed it, as a grand new gesture in both style and construction. University officials said it was intended to tell “the story of the technology of its time” while showcasing the ...
That fast-track construction is now raising questions. The span, made of concrete poured into place as it was constructed by the side of the road, is typically tested as work progresses. It can also vibrate as it’s moved into place, but that would likely be accounted for during design, experts said.
Rosenberg said on Friday that crews had continually monitored stress on the span as it was moved into position across Eighth Street and lifted onto the support columns.
“They were continually monitoring the stress on the concrete with the movement,” he said.
Bridges are typically “tuned” once they are put in place, to adjust the arc, or camber, in the concrete that occurs when tension cables are pulled tight.
The FIU bridge also has an unusual design that might have played a part in its failure. It had a heavy concrete canopy, or roof, connected to the walkway slab by v-shaped trusses — the structural element that the NTSB said crews were working to tighten on Thursday before the bridge collapsed.
An NTSB official said the agency had not encountered a bridge design like it previously.
It’s possible that the roof, bearing down on the span, was at risk of twisting if tension wires were released, one expert said.
The span was incomplete when it fell. A pylon holding up support pipes, not yet installed, was designed to tower over the bridge, but those structural pieces would attach to the canopy, not the walkway itself. A detailed document on FIU’s website says the bridge was designed to be strong enough to hold up without the p...
There could be other causes as well, from contractors failing to follow design instructions to problems in the pre-stressed concrete, which was poured and cured as the span was constructed alongside the Tamiami Trail.
Because concrete is so vulnerable to stress — it’s stronger when compressed than when pulled — cracks may provide important clues as to whether contractors followed design speculations. Engineers would have specifically designed for the angle of stress. So if a piece were moved or twisted, or if it’s picked up in the w...
Using heavy concrete rather than steel has also raised questions.
Investigators will likely collect debris as possible to identify defective material, Chajes said, and then try to distinguish the damage caused by failure verses the fall.
“It’s almost like in a fire trying to figure out what was the initiating cause,” he said.
The exact sequence of events could also quickly lead them to where the stress occurred, which could help reveal what went wrong.
And while the accelerated construction may not wind up being a cause, the collapse may change safety measures.
A final report on the accident may not come for more than a year, Holloway said. But the agency will likely release updates, as it has with other cases like the El Faro investigation, as facts are confirmed.
These are the victims of the FIU pedestrian bridge collapse.
“People work. People make money … You don’t know what a first world economy is”: Judge Greg Borchers, Tennant Creek Youth Court, 6 June 2017.

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