Biogen hits snag after Alzheimer’s drug fails to win support from FDA panel

first_img– Advertisement – A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen‘s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company.In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s. Two other panelists said it the data was “uncertain.”The FDA could still approve the drug, which would make it the first drug approved to slow cognitive decline in people living with the disease and the first new treatment for Alzheimer’s in nearly 20 years.- Advertisement – Biogen headquarters on Binney Street on Thursday, March 21, 2019 in Cambridge, Massachusetts.Nicolaus Czarnecki | MediaNews Group | Getty Images Biogen’s intravenous drug targets a “sticky” compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease. Biogen has previously estimated about 1.5 million people with early Alzheimer’s in the U.S. could be candidates for the drug, according to Reuters.Some Alzheimer’s experts and Wall Street analysts have been skeptical about the drug’s benefits, especially after Biogen reversed its decision to seek regulatory approval in 2019.The company shocked investors in October of that year by announcing it was seeking regulatory approval after all after pulling the plug on the drug in March. Biogen scientists said at the time that a new analysis of a larger data set showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”There are currently no drugs cleared by the FDA that can slow or reverse the mental decline from Alzheimer’s, which is the sixth leading cause of death in the United States. The U.S. agency has approved Alzheimer’s drugs aimed at helping symptoms, not actually reversing or slowing the disease itself.During the meeting on Friday with the Peripheral and Central Nervous System Drugs Advisory Committee, Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said there was an “enormous unmet medical need.” “Currently approved treatments do not target the underlying pathology of Alzheimer’s disease and their beneficial effects are modest,” he said, adding there has not been an approval of a treatment for the disease since 2003.In a letter sent to the FDA ahead of the meeting, the Alzheimer’s Association said the publicly released data so far “justifies approval accompanied by a Phase 4 post-marketing surveillance study.”“The alternative, requiring completion of an additional Phase 3 trial, would deny broad access up to four years while it is completed. A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease. A four-year delay is too long to wait for millions of American caregivers,” the organization said.The FDA’s final decision on Biogen’s drug is expected by March.This is a developing story. Please check back for updates.center_img Shares of Biogen were halted Friday ahead of the meeting of outside experts.Biogen shares had surged Wednesday after FDA staff gave a positive review of the drug. In a 343-page document, the FDA said results from Biogen’s late-stage trial were “highly persuasive” and the study was “capable of providing the primary contribution to a demonstration of substantial evidence of effectiveness” of aducanumab. “Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval,” the FDA added.Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates more than 5 million Americans are living with the disease.- Advertisement – – Advertisement –last_img read more

UGM students receive death threats over discussion on removing presidents from office

first_img“Can you tell your child? Or teach your child to be a good person?” another message read. “Please, just turn yourself in. I will kill your whole family.”Muhammadiyah Klaten has denied that it was in any way involved in the messages and condemned such threats as violations of academic freedom.“The regional leadership of Muhammadiyah Klaten urges the National Police to conduct a complete investigation into the crimes of impersonation, defamation, threats, terror and intimidation toward the organizers’ of the discussion,” the group said in a statement on Sunday. Read also: Fears of repression grow in virus-crippled IndonesiaOne of the students also had their WhatsApp account hacked on Friday. The hacker sent a message saying that the discussion had been canceled to a group of around 300 participants. The hacker also kicked out all participants from the group afterward.The other student’s Gojek account was hacked and was used to order GoCar and GoFood services to the student’s house. Aditya’s Instagram account and the CLS’s official Instagram account were hacked as well, though Aditya managed to recover his account.Constitutional law professor of the Indonesian Islamic University (UII) Nimatul Huda, who was a speaker at the discussion, was also reportedly threatened.“Professor Nimatul called me on Thursday night, and reported that several people had visited her house at 11 pm and knocked on her door and rang the bell repeatedly until 6 am,” UII’s School of Law dean Abdul Jamil said in a television interview.He added that Nimatul also received a death threat via text message.Following the threats, the committee officially canceled the discussion on Friday for security reasons. UGM’s School of Law dean Sigit Riyanto condemned the acts of intimidation as well as those who said the discussion was an act of treason.“This is a serious threat to academic freedom. These people arbitrarily and brutally defined the discussion as treason even before it started. The students are now experiencing psychological shock from the threats,” Sigit said in a written statement.He said he appreciated and supported the students’ initiative and contribution to offering different perspectives through discussion.“It’s also a part of freedom of speech. The School of Law also encourages the public to respect freedom of speech and academic freedom,” he said.The National Human Rights Commission (Komnas HAM) also condemned the incident and urged the police to find and arrest the perpetrators.“This is important so that serious crimes like this are not repeated,” the commission said in a statement on Saturday.National Police spokesperson Insp. Gen. Argo Yuwono said on Sunday that the police had yet to receive an official report about the intimidation, but were ready to start an investigation once it had. Topics : On Thursday, a poster of the discussion went viral after a man named Bagas Pujilaksono, who identified himself as an UGM academic, wrote an opinion article denouncing the discussion as an act of treason.According to the CLS statement, on Friday, two members of the discussion’s organizing committee started to receive threats in various forms including text messages, phone calls and the hacking of their accounts.Individuals claiming to be members of the Klaten branch of the Islamic mass organization Muhammadiyah sent death threats to the committee members’ parents through text messages.“Tell your child they will be charged with treason,” one message said. “I will kill your whole family if you can’t teach your child.”  Yogyakarta’s Gadjah Mada University (UGM) has canceled a planned online discussion about the constitutional mechanism for removing a president from office after students and a professor received death threats and faced other forms of intimidation.The Constitutional Law Society (CLS), the student community that organized the discussion, said the event, scheduled for Friday, was meant to be a response to recent public discussions about the possibility of dismissing the President for what some perceive as his inadequate handling of the COVID-19 outbreak.“The aim of the discussion was to inform the public about the dismissal of a president from a constitutional law point of view,” CLS head Aditya Halimawan said in a written statement obtained by The Jakarta Post on Saturday.last_img read more

Intoxicated driver investigation leads to cocaine arrest

first_imgSt. Paul, In. — An investigation into an intoxicated driver at the Love’s Truck Stop in St. Paul resulted in the arrest of an Indianapolis man for cocaine possession Friday.Indiana State Police located a car driven by Vasillis Alexander pulling away from the truck stop around 11:20 p.m. and began to follow. While following Vasillis allegedly drove erratically and crossed the center line several times. After stopping Vasillis police say he showed signs of intoxication.During the traffic stop police found a glass pipe, two pills believed to be Xanax and a container with 6.5 grams of a white powdery substance believed to be cocaine.Vasillis now faces multiple drug-related charges.last_img read more

West Indies Set to Tour Sri Lanka for White-ball Series

first_imgCOLOMBO, Sri Lanka (CMC) — West Indies will clash with Sri Lanka in a white-ball series for the first time in nearly 4 ½ years when they arrive next month for five limited-overs matches.The Caribbean side takes on the hosts in three One-Day Internationals (ODI) and two Twenty20 Internationals, from February 22 to March 6.West Indies will play one-day warm-up matches in Colombo and Katunayake, before the series gets underway with the opening ODI at the Singhalese Sports Club.The two teams will meet in the second ODI in Hambantota on February 26, with the final match carded for Kandy on March 1.Both T20 Internationals will also be played in Kandy on March 4 and 6.Sri Lanka dominated the last ODI series here in a 3-0 whitewash while the two-match T20 series ended in a 1-1 tie.When the two teams last met during last year’s International Cricket Council (ICC) 50-over World Cup in England, Sri Lanka came away with a 23-run victory at Chester-le-Street.Both West Indies and Sri Lanka are closely wedded in the ICC ODI rankings. While the Asian side are eighth, West Indies languish in ninth.The positions reflect their recent form, West Indies having won just 10 of their 28 matches last year and Sri Lanka, seven of their 21 matches during the same period.Both teams have also fallen upon hard times in the T20 format, with Sri Lanka ranked eighth and West Indies 10th.TOUR SCHEDULEFebruary 17 – warm-up at P Sara OvalFebruary 20 – warm-up vs SLC President’s XI at CMCG, KatunayakeFebruary 22 – 1st ODI at Singalese Sports Club, ColomboFebruary 26 – 2nd ODI at Mahinda Rajapaksa International Cricket Stadium, HambantotaMarch 1 – 3rd ODI at Pallekele International Cricket Stadium, KandyMarch 4 – 1st T20I at Pallekele International Cricket Stadium, KandyMatch 6 – 2nd T20I at Pallekele International Cricket Stadium, Kandylast_img read more