By Bill Berkrot (Reuters) - Biogen Idec Inc said on Wednesday sales of its big-selling new multiple sclerosis drug Tecfidera fell short of Wall Street's lofty expectations, and the company confirmed a serious brain infection in a patient who took the oral medication, sending its shares 7 percent lower. Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for 4-1/2 years. The patient, who died of pneumonia, had been suffering severe lymphopenia, a low white blood cell condition, for more than three years, which Biogen said was a risk factor for developing PML. Biogen, which has notified health regulators of the PML case, said 100,000 patients have taken Tecfidera. The drug, which has far exceeded expectations since its March 2013 U.S. approval, had sales of $787 million in the third quarter. Analysts, who in previous quarters had watched Tecfidera sail past their sales estimates, were looking for about $800 million. "We've always expected that Tecfidera's growth rate would moderate over time," Tony Kingsley, Biogen's head of commercial operations, said on a conference call. Shares of the U.S. biotechnology company fell $22.55 to $304.21 on Nasdaq at mid-afternoon. While Tecfidera has had a clean safety record throughout its clinical trials and commercial use, PML has long been a concern associated with long-term treatment of MS drugs. Biogen's injectable MS drug Tysabri was pulled from the market in February of 2005 after three cases of the rare brain infection - two of them fatal - were reported among users. U.S. health regulators allowed it back on the market with certain restrictions in June 2006 after campaigning by patients who felt the medicine was so effective they were willing to take on the PML risk. "We think the risk/benefit is clearly still in favor of using Tecfidera for nearly all patients," said RBC Capital Markets analyst Michael Yee. Biogen reported a higher-than-expected quarterly profit and raised its full-year earnings forecast, primarily on lower business development and research and development spending expectations. It now estimates 2014 earnings per share of $13.45 to $13.55, up from its previous forecast of $12.90 to $13.10, excluding items. "For a company that's been beating and crushing numbers, it's hard to see people getting terribly excited about this," Sanford Bernstein analyst Geoffrey Porges said. "You have to wonder if this is the new normal for Biogen or whether they can resume that spectacular growth." Biogen's net profit jumped to $856.1 million, or $3.62 per share, from $487.6 million, or $2.05 per share, a year ago. Excluding items, Biogen earned $3.80 per share, exceeding analysts' average expectations by 34 cents, according to Thomson Reuters I/B/E/S. Revenue rose 37 percent to $2.5 billion, roughly in line with estimates of $2.48 billion. Tysabri had sales of $501 million, beating analyst expectations of about $485 million. The company's interferon-based MS drugs, Avonex and new longer-acting Plegridy, had combined sales of $745 million, missing Wall Street estimates of about $767 million. Avonex has lost market share to Tecfidera. Biogen said 40 percent of patients switching MS treatments have chosen Tecfidera. "With all of their MS products you have to wonder is there enough incremental revenue to support continued growth or are they just cannibalizing the rest of their franchise every time they launch a new product," Porges said. (Reporting by Bill Berkrot in New York; Editing by Jeffrey Benkoe, Chizu Nomiyama, Paul Simao and Richard Chang)
- Yahoo News
Democrats in Georgia ‘outworked, out-strategized and obviously outperformed’ GOP in Senate runoffs, Kemp’s deputy admits
On the same day that rioters supporting President Trump stormed and vandalized the U.S. Capitol, history was also made in Georgia, where Jon Ossoff and Rev. Raphael Warnock, the two Democrats on the Georgia Senate runoff ballot, defeated the Republican incumbents. One week after Democrats pulled off their improbable feat, Georgians reflected on the impact of the historic win.
- Associated Press
A friendly $100 wager over the 2020 Presidential election has landed in a Florida small claims court. Before the election, Sean Hynes, a Trump supporter from St. Petersburg, reached out to Jeffrey Costa, an acquaintance who is a Biden supporter from Atlanta. The deal was sealed on Facebook Messenger: If Trump won, Costa would pay $100.
- The Week
Federal prosecutors in a new court filing reportedly point to "strong evidence" that rioters who stormed the Capitol building last week aimed to "capture and assassinate elected officials."The prosecutors included this assessment while asking a judge to detain Jacob Chansley, one of the men who was arrested and charged following the deadly Capitol riot, Reuters reports."Strong evidence, including Chansley's own words and actions at the Capitol, supports that the intent of the Capitol rioters was to capture and assassinate elected officials in the United States government," the prosecutors wrote.Supporters of President Trump stormed the Capitol building on the day Congress was meeting to certify President-elect Joe Biden's election win, leaving five people dead. Trump was subsequently impeached for a second time for "incitement of insurrection" after delivering a speech calling on his supporters to march to the Capitol building.The prosecutors in the filing reportedly wrote that the charges against Chansley "involve active participation in an insurrection attempting to violently overthrow the United States government," adding that the "insurrection is still in progress." They also revealed that Chansley, who was photographed wearing horns at Vice President Mike Pence's desk, allegedly left a note for Pence that warned, "it's only a matter of time, justice is coming," Reuters reports. The filing, Politico writes, "spells out clearly the government's view of an ongoing 'insurrection movement' that is reaching a potential climax as Biden's inauguration approaches." More stories from theweek.com Do Democrats realize the danger they are in? America's rendezvous with reality What 'Blue Lives Matter' was always about
- The Independent
Local newspapers turn on Lauren Boebert as 68 state politicians demand investigation into Capitol riot role
Lauren Boebert is under fire for sharing details about the location of the House speaker during the Capitol riots
The United States stands by Taiwan and always will, the U.S. ambassador to the United Nations Kelly Craft said following a call with Taiwan President Tsai Ing-wen, who told her the island would continue to seek access to U.N. meetings. Craft had planned to visit Taipei this week, in the teeth of strong objections from China which views the island as its own territory.
- Associated Press
A Florida waitress who noticed bruises on an 11-year-old boy flashed him a handwritten note asking him if he needed help, and when he nodded yes, she called the police, authorities said. Orlando police credited Flaviane Carvalho, a waitress at Mrs. Potato Restaurant, with coming to the boy's aid on New Year's Eve when the child’s parents weren’t looking. Police took the boy to a hospital where doctors found bruises on his face, earlobes and arms.
- The Telegraph
Palestinian leaders have announced that they expect their first batch of coronavirus vaccines to arrive by March, as the West Bank and Gaza face an anxious wait to receive jabs while Israel presses ahead with its record-setting vaccination drive. This week the Palestinian Authority said it had secured a provisional agreement with AstraZeneca and was seeking doses from Moderna, as well as the Russian-made Sputnik V vaccine. The Palestinians are also working with the World Health Organisation to receive free vaccines under the Covax scheme. It came as Palestinian officials accused Israel of “ignoring” its duties as an occupying power to assist them in protecting their people from the disease. “The search by the Palestinian leadership to secure the vaccines from various sources doesn’t exempt Israel from its responsibilities towards the Palestinian people in providing the vaccines,” the Palestinian foreign ministry said in a statement. Israel refutes this and says it has no legal obligation to provide vaccines for the West Bank and Gaza, as the Oslo peace accords state that this is the duty of Palestinian leaders. However, according to Israeli media reports, the Israeli government provided the Palestinian authorities with around 100 vaccine doses earlier this month as a “humanitarian gesture.” Israel has already given the first coronavirus jab to more than two million people - around 20 per cent of the population - as part of the world’s fastest vaccinations programme. The 1990s-era Oslo accords grant the Palestinian Authority limited self-rule in the West Bank while the Gaza strip is controlled by Islamist group Hamas. While the accords say Palestinian authorities should vaccine their own citizens, they also says both sides are required to “cooperate in combating” epidemics and contagious diseases. Arab-Israeli citizens, and Palestinians who live in East Jerusalem, are already able to receive vaccines from the Israeli programme. But human rights groups, such as Amnesty International, are putting pressure on the Israeli government to provide further assistance. In a recent statement, Amnesty’s deputy regional director for the Middle East, Saleh Higazi, accused Israel of “instutionalised discrimination.” “While Israel celebrates a record-setting vaccination drive, millions of Palestinians living under Israeli control in the West Bank and the Gaza Strip will receive no vaccine or have to wait much longer,” he said. Husam Zomlot, a senior Palestinian diplomat in London, described the situation as “vaccine apartheid” in a post on Twitter, a charge that Israel denies. Palestinian officials said on Wednesday that they had recorded 30 deaths from coronavirus in the past 24 hours, while more than 90 people are in intensive care units. To date, coronavirus has caused around 1,800 deaths in the Palestinian territories.
- The Independent
Karl Racine ‘extremely confident’ US president’s eldest son broke law
Sen. James Lankford (R-Okla.) has apologized to Black Oklahomans for challenging Joe Biden's Electoral College victory, saying he did not realize his actions would be seen as "casting doubt on the validity of votes" in predominantly Black cities like Atlanta, Philadelphia and Detroit.The big picture: Lankford was part of a group of 11 senators, led by Sen. Ted Cruz (R-Texas), who planned to object to the Electoral College certification unless Congress launched a commission to audit the election results. He later withdrew his objection after the pro-Trump siege of the Capitol.Get smarter, faster with the news CEOs, entrepreneurs and top politicians read. Sign up for Axios Newsletters here.Between the lines: "Lankford has been more involved with Black Tulsans, and particularly the historic Greenwood District, than any statewide Republican officeholder in decades," Tulsa World writes. * However, after Lankford's comments on the Senate floor, several state Black leaders said he should be removed from the 1921 Tulsa Race Massacre Centennial Commission, which is dedicated to educating communities about the massacre that killed 300 people. * Other Republicans involved in the election challenges, including Cruz and Sen. Josh Hawley (R-Mo.) have faced massive backlash.What they're saying: "My action of asking for more election information caused a firestorm of suspicion among many of my friends, particularly in Black communities around the state," Lankford wrote in a letter addressed to "my friends in North Tulsa." * "I can assure you, my intent to give a voice to Oklahomans who had questions was never also an intent to diminish the voice of any Black American," he continued. * "I should have recognized how what I said and what I did could be interpreted by many of you. I deeply regret my blindness to that perception, and for that I am sorry."Go deeper: GOP Sen. Josh Hawley under fire after Electoral College challengeBe smart: sign up FREE for the most influential newsletter in America.
- Yahoo News Video
A racing pigeon has survived an extraordinary 13,000-kilometer (8,000-mile) Pacific Ocean crossing from the United States to find a new home in Australia. Now authorities consider the bird a quarantine risk and plan to kill it.
- Architectural Digest
When it came to the lighting in his home, Pardo drew inspiration from the insides of fruits, nuts, and seeds, as well as sea creatures and machine parts.Originally Appeared on Architectural Digest
- Associated Press
Pakistani authorities sacked a local police chief and 11 other policemen for failing to protect a Hindu temple that was set on fire and demolished last month by a mob led by hundreds of supporters of a radical Islamist party, police said Friday. The 12 policemen were fired over “acts of cowardice" and “negligence" for not trying to stop the mob when it attacked the temple, with some having fled the scene. Another 48 policemen were given various punishments following a probe into the attack, the police statement said.
A U.S. appeals court ordered that the last two scheduled federal executions under President Donald Trump's outgoing administration could proceed on Thursday and Friday, overturning a stay from a lower court delaying them until March to allow the two condemned men to recover from COVID-19. The U.S. Department of Justice announced last month that Corey Johnson, 52, and Dustin Higgs, 48, had been diagnosed with COVID-19 but that it would proceed with their executions set for Thursday and Friday. Both men, convicted in separate murders, are being held on death row at a federal prison in Terre Haute, Indiana.
- The Telegraph
The fisheries minister has raised eyebrows by disclosing she was busy organising a nativity trail on Christmas Eve when the Brexit deal on fish was agreed. Victoria Prentis insisted that the agreement was beneficial for UK boats when she appeared before the Lords EU Environment Sub-Committee on Wednesday, but conceded some quarters of the fishing industry had been hard done by. During the session Lord Teverson, the Lib Dem chairman of the committee, asked her: “Did your jaw drop as well when you saw this agreement that had been delivered in fisheries, when really this is such an iconic subject?” Ms Prentis replied: “No, the agreement came when we were all very busy on Christmas Eve; in my case organising the local nativity trail. We’d been waiting and waiting. It looked like it was coming for probably four days before it actually arrived.” Opposition MPs seized on her comments. Scottish Lib Dem Alistair Carmichael told The Daily Record: “Surely she could have taken a little time away from the festivities to look after her own departmental responsibilities?”. However, it was pointed out that the legal text of the post-Brexit deal was not published until several days later at which juncture Ms Prentis, a former Government lawyer, read it at once. She had been party to draft proposals on fisheries in the run up to the UK-EU agreement being finalised. On Christmas Eve the minister, who has organised the nativity play in her village church for the past 17 years, is understood to have been out of the house for only an hour and a half attending to the task. During the rest of the day she read the briefing note on the Brexit deal prepared for her by officials, and held calls with colleagues. At 6pm she hosted a cross-party Zoom briefing, to which all MPs and peers were invited. Over the past fortnight British seafood exporters have battled disruptions that began when the Brexit transition period ended on December 31. Companies have reported having to delay and cancel shipments to the continent owing to problems gaining the requisite approvals at EU ports. Scottish firms have been among the worst hit. Boris Johnson on Wednesday promised to compensate Scottish fishermen as he said there were “teething problems” with the new post-Brexit arrangements.
- The Week
Ivanka Trump and Jared Kushner have spent the past few years living in a six bedroom, 6.5 bathroom rented home in Washington, D.C.'s exclusive Kalorama neighborhood. The family could count high-profile officials and even one former president among their neighbors — as well as their own Secret Service detail, who had to rent a nearby apartment to use the bathroom because they weren't allowed inside the Kushner-Trump home, neighbors and law enforcement sources tell The Washington Post.It's not unusual for Secret Service agents to stay out of the typically expansive homes they're guarding, instead using a garage or auxiliary building as their home base, the Post notes. But Kushner and Trump took that to an extreme, forcing the Secret Service to install a porta-potty outside their home just so they had somewhere to relieve themselves, sources said. The unsightly outdoor bathroom was taken down after neighbors complained.That's when the Kushner-Trump detail started using a bathroom in the Obama family's nearby garage. But they were kicked out when "a Secret Service supervisor from the Trump-Kushner detail left an unpleasant mess in the Obama bathroom," the Post notes. Agents then headed to to Vice President Mike Pence's home a mile away to use the toilet or, when time was short, counted on nearby restaurants and even knocked on neighbors' doors. One of those neighbors eventually ended up renting a $3,000/month basement studio to the agents, making $144,000 in taxpayer money by the time the lease expires this September.A White House spokesperson denied Trump and Kushner barred Secret Service from their home, saying it was the force's choice not to come inside — something one law enforcement officer disputed. Read more at The Washington Post.More stories from theweek.com Do Democrats realize the danger they are in? America's rendezvous with reality What 'Blue Lives Matter' was always about
- Associated Press
President-elect Joe Biden will no longer be taking an Amtrak train to Washington for his inauguration because of security concerns, a person briefed on the decision told The Associated Press on Wednesday. The president-elect’s decision reflects growing worries over potential threats in the Capitol and across the U.S. in the lead-up to Biden's Jan. 20 inauguration.
As authorities begin to charge the rioters in the Jan. 6 siege of the U.S. Capitol, court documents paint a picture of a diverse mob that included both citizens with mainstream careers - police officers, a flower shop owner, a state lawmaker, military veterans, even an Olympic medalist - as well as Americans on the fringe. One was a member of the Proud Boys, a far-right extremist group. They traveled from as far as Hawaii to join the protest of Congress certifying Democrat Joe Biden’s election win, which Republican President Donald Trump has falsely claimed resulted from widespread election fraud.
A chunk of stimulus payments are missing in action, thanks to a mix up that put as many as 13 million checks into invalid bank accounts.Why it matters: The IRS (by law) was supposed to get all payments out by Friday. Now the onus could shift to Americans to claim the money on their tax refund — further delaying relief to struggling, lower-income Americans.Get smarter, faster with the news CEOs, entrepreneurs and top politicians read. Sign up for Axios Newsletters here.What's going on: The newest COVID-19 relief bill — signed in the final days of 2020 — mandated the $600 payment to those making up to $75,000 per year (or 150,000 for joint filers) get out by Jan. 15. * The fast turnaround meant “some payments may have been sent to an account that may be closed or, is or no longer active, or unfamiliar,” according to the IRS website.To get a sense of the speed: It took 19 days to distribute half the first-round payments last spring, but two-thirds of payments were out the door just a week after the latest bill became law, according to an analysis by the Committee for a Responsible Federal Budget. * Billions of those dollars are in the process of being returned to the IRS by tax preparers because of the error, though the IRS would not say how many payments were incorrectly deposited. * Jackson Hewitt estimates funds were deposited in 13 million accounts that were no longer open.How it works: These accounts are typically set up by tax prep companies, most often used by financially constrained taxpayers to get their refunds faster. * Some tax preparers told CNBC that the money would be deposited starting Feb. 1. What’s next: It’s up to those whose payments haven’t been disbursed by today to claim what’s owed on their tax return. * “You can wait until the money shows up, or you’re going to file your return and claim your money there,” Janet Holtzblatt, a senior fellow at the Tax Policy Center and former official at the Treasury Department’s Office of Tax Analysis, tells Axios. * “There’s going to be confusion” about which option to pick.Of note: Any refunds that also claim the earned-income tax credit — which offsets tax bills for lower income workers — can’t be issued before mid-February, prolonging the delay as the Washington Post points out.What to watch: The incoming Biden administration wants to issue another round of direct payments. Depending on the timing, the IRS could be juggling those checks at the height of tax season. * “I can never say with IRS that things are impossible, but it's going to be a challenge to get those payments out during filing season,” Holtzblatt says.You can check the status of your stimulus payment — and whether you can expect it by paper check, debit card or direct deposit — here.Be smart: sign up FREE for the most influential newsletter in America.
- The Telegraph
Wearing a giant furry hat, black leather jacket and a beaming smile, North Korean leader Kim Jong-un introduced “the world’s strongest weapon” – a new submarine-launched ballistic missile – at a nighttime parade on Thursday in Pyongyang. The display of North Korea’s military might followed a rare congress of the ruling Workers' Party, during which leader Kim denounced the United States as his country's “foremost principal enemy” and vowed to strengthen the North’s nuclear war deterrent. On Friday, the reclusive regime’s state media released 100 photos of a mass celebration of the national armory, including tanks and rocket launchers, all flanked by rows of marching soldiers, noticeably not wearing masks. Military aircraft were illuminated by LED lights as they flew overhead in formation. “They’d like us to notice that they’re getting more proficient with larger solid rocket boosters,” tweeted Ankit Panda, a North Korea expert and author of ‘Kim Jong Un and the Bomb’, as the parade unfolded in Pyongyang’s Kim Il Sung square. As the spectacle reached its climax, the military rolled out what analysts said appeared to be new variants of solid-fuel short-range ballistic missiles – which are more quickly deployed than liquid-fuelled versions - and four Pukguksong-class submarine-launched ballistic missiles (SLBMs).
- Associated Press
NASA declared the Mars digger dead Thursday after failing to burrow deep into the red planet to take its temperature. Following one last unsuccessful attempt to hammer itself down over the weekend with 500 strokes, the team called it quits. "We’ve given it everything we’ve got, but Mars and our heroic mole remain incompatible,” said the German Space Agency's Tilman Spohn, the lead scientist for the experiment.