18 May

Coronavirus live updates: Eli Lilly to supply US with 300,000 vials of antibody drug

first_imgnarvikk/iStockBy MORGAN WINSOR, ABC News(NEW YORK) — A pandemic of the novel coronavirus has now killed more than 1.1 million people worldwide.Over 44 million people across the globe have been diagnosed with COVID-19, the disease caused by the new respiratory virus, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. The actual numbers are believed to be much higher due to testing shortages, many unreported cases and suspicions that some national governments are hiding or downplaying the scope of their outbreaks. The criteria for diagnosis — through clinical means or a lab test — has also varied from country to country.Since the first cases were detected in China in December, the virus has rapidly spread to every continent except Antarctica. The United States is the worst-affected nation, with more than 8.7 million diagnosed cases and at least 226,864 deaths.Nearly 200 vaccine candidates for COVID-19 are being tracked by the World Health Organization, at least 10 of which are in crucial phase three studies. Of those 10 potential vaccines in late-stage trials, there are currently five that will be available in the United States if approved.Here’s how the news is developing Wednesday. All times Eastern:Oct 28, 11:47 amWisconsin football on pause following 12 COVID-19 casesThe University of Wisconsin football team is pausing all activities for at least one week following an “elevated number” of COVID-19 cases, the team announced. As of Wednesday morning, 12 people — six athletes and six staff members — had tested positive within the last five days, the team said.Wisconsin was set to plan Nebraska on Saturday but the game has been canceled.Oct 28, 10:29 amFrance braces for possible nationwide lockdownFrench President Emmanuel Macron is expected to announce further restrictions to curb a second wave of the coronavirus pandemic.Macron is slated to make a televised address on Wednesday evening, after holding emergency meetings with government officials to discuss the COVID-19 response. A four-week nationwide lockdown is reportedly among the options being considered, according to French media.French Interior Minister Gerald Darmanin told France Inter radio on Tuesday that citizens “must expect difficult decisions.”Macron’s announcement would follow an alarming spike in deaths from COVID-19 as well as record numbers of new cases across France. Nighttime curfews have already been imposed in many areas, including Paris.France’s public health agency has confirmed 1,198,695 cases of COVID-19 since the start of the pandemic, including 35,541 deaths.Oct 28, 9:07 amPoland sees record rise in new casesPoland confirmed another 18,820 new cases of COVID-19 on Tuesday, its highest single-day increase yet.An additional 236 fatalities from COVID-19 were also registered across the Central European country in the past 24 hours, according to the Polish Ministry of Health.Poland’s cumulative total currently stands at 299,049 cases with 4,851 deaths.Meanwhile, nearly 14,000 COVID-19 patients remained hospitalized in Poland as of Wednesday morning, including 1,150 who are on ventilators, the health ministry said.Oct 28, 8:03 amEli Lilly to supply US with 300,000 vials of experimental antibody drugEli Lilly and Company announced Wednesday an initial agreement with the U.S. government to supply 300,000 vials of one of its experimental antibody treatments for $375 million to help fight the coronavirus pandemic.The federal government will accept the vials of bamlanivimab, a monoclonal antibody drug, if it is granted emergency use authorization by the U.S. Food and Drug Administration. The initial agreement also provides the option for the federal government to purchase up to an additional 650,000 vials through June 2021, according to a press release from Eli Lilly and Company.The Indianapolis-based pharmaceutical firm submitted a request earlier this month for the FDA to authorize emergency use of bamlanivimab in non-hospitalized, high-risk individuals with mild to moderate cases of COVID-19.“The U.S. is experiencing a surge in COVID-19 cases and associated hospitalizations,” said David Ricks, chairman and CEO of Eli Lilly and Company, “and we believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”If the FDA authorizes use of the therapeutic, the federal government will allocate the doses to state and territorial health departments which will then determine which health care facilities receive the drug for use in outpatient care. The government-purchased doses would become available to Americans at no cost, though health care professionals could charge for administering the intravenous infusion, according to a statement from the U.S. Department of Health and Human Services.“This agreement with Eli Lilly is part of Operation Warp Speed’s efforts to position the federal government to distribute potential therapeutics, allowing faster distribution if trials are successful,” said Secretary of Health and Human Services Alex Azar.The deal comes after the National Institute of Allergy and Infectious Diseases announced Monday that it has stopped testing a combination of bamlanivimab with the antiviral medication remedesivir in hospitalized COVID-19 patients, after an independent review of results found a “lack of clinical benefit.” Eli Lilly and Company said that all other studies of bamlanivimab, including its own phase 3 clinical trials, will continue and that it remains “confident” that the drug may help prevent progression of COVID-19 for individuals earlier in the course of their disease.Oct 28, 6:06 amRussia’s daily death toll reaches record high for second straight dayRussia registered 346 more deaths from COVID-19 in the last 24 hours, setting a new national record, according to the country’s coronavirus response headquarters.The country’s previous record of 320 deaths in a 24-hour reporting period was set just a day earlier.An additional 16,202 new cases of COVID-19 were also confirmed in the past day, down from Sunday’s peak of 17,347, according to Russia’s coronavirus response headquarters.Moscow remains the epicenter of the country’s outbreak and recent surge. More than 22% of the new cases — 3,670 — and over 21% of the new deaths — 61 — were reported in the Russian capital.The nationwide, cumulative total now stands at 1,563,976 cases with 26,935 deaths, according to Russia’s coronavirus response headquarters.The Eastern European country of 145 million people has the fourth-highest tally of COVID-19 cases in the world, behind only the United States, India and Brazil, according to a real-time count kept by Johns Hopkins University.Oct 28, 5:52 amSouth Africa’s president enters self-quarantineSouth African President Cyril Ramaphosa is under self-quarantine after a guest at a dinner he attended over the weekend tested positive for COVID-19.“The President is showing no symptoms at this time and will, in line with COVID-19 health advice, be tested should symptoms manifest,” Ramaphosa’s office said in a statement Wednesday. “The President will perform his duties remotely and will observe the guidelines that apply to self-quarantine.”Ramaphosa attended a fundraising dinner for the Adopt-a-School Foundation at a hotel in Johannesburg on Saturday evening. Thirty-five guests were in attendance at the event and were the only people hosted by the venue at that time.“The event adhered stringently to COVID-19 protocols and directives on screening, social distancing and the wearing of masks,” Ramaphosa’s office said. “As was the case with all guests, the President himself removed his mask only when dining and addressing the guests.”On Tuesday, the Adopt-a-School Foundation advised the dinner guests that an attendee had tested positive for COVID-19 after showing symptoms on Sunday. The South African president had already attended two other events Tuesday morning before being alerted of the infected guest, who is currently “receiving medical attention,” according to Ramaphosa’s office.“The President is screened regularly by the South African Military Health Service and subjects himself to screening at venues where he participates in engagements,” his office said.South Africa has confirmed more than 717,000 cases of COVID-19 since the start of the pandemic, including at least 19,053 deaths. The country accounts for almost half of all diagnosed cases on the African continent, according to data from the Africa Centers for Disease Control and Prevention.Oct 28, 5:19 amRussia’s foreign minister in self-isolationRussian Foreign Minister Sergei Lavrov is self-isolating after coming into contact with someone infected with COVID-19.Lavrov, however, is “feeling well,” according to Russia’s Ministry of Foreign Affairs.“Following a contact with an individual infected with Covid-19, Sergei Lavrov will opt for self-isolation,” the ministry said in a statement Tuesday. “The visits and meetings planned earlier are postponed.”Oct 28, 4:24 amUS reports over 73,000 new cases, nearly 1,000 deathsThere were 73,240 new cases of COVID-19 identified in the United States on Tuesday, according to a real-time count kept by Johns Hopkins University.The latest daily tally is nearly 6,500 more than the previous day but still less than the country’s all-time high of 83,757 new cases set on Friday.An additional 985 fatalities from COVID-19 were also registered nationwide Tuesday, more than double the previous day’s count but still down from a peak of 2,666 new deaths in mid-April.A total of 8,779,653 people in the United States have been diagnosed with COVID-19 since the pandemic began, and at least 226,723 of them have died, according to Johns Hopkins. The cases include people from all 50 U.S. states, Washington, D.C. and other U.S. territories as well as repatriated citizens.By May 20, all U.S. states had begun lifting stay-at-home orders and other restrictions put in place to curb the spread of the novel coronavirus. The day-to-day increase in the country’s cases then hovered around 20,000 for a couple of weeks before shooting back up and crossing 80,000 for the first time on Oct. 23.An internal memo from the U.S. Department of Health and Human Services that was obtained by ABC News on Tuesday night shows the number of new COVID-19 cases recorded across the nation has increased substantially in week-over-week comparisons, as has the number of new deaths from the disease.Copyright © 2020, ABC Audio. All rights reserved.last_img read more

1 Mar

Mutations drive malignant melanoma

first_imgTwo mutations that collectively occur in 71 percent of malignant melanoma tumors have been discovered in what scientists call the “dark matter” of the cancer genome, where cancer-related mutations haven’t been previously found.Reporting their findings in the Jan. 24 issue of Science Express, Harvard Medical School (HMS) researchers at the Dana-Farber Cancer Institute and researchers at the Broad Institute said the highly “recurrent” mutations — occurring in the tumors of many people — may be the most common mutations in melanoma cells found to date.The researchers said these cancer-associated mutations are the first to be discovered in the vast regions of DNA in cancer cells that do not contain genetic instructions for making proteins. The mutations are located in non-protein-coding DNA that regulates the activity of genes.This non-coding DNA, much of which was previously dismissed as “junk,” accounts for 99 percent of a cell’s genome. A large number of oncogenic mutations in cancer have been identified in the past several decades, but all have been found within the actual genetic blueprints for proteins.“This new finding represents an initial foray into the ‘dark matter’ of the cancer genome,” said Levi Garraway, HMS associate professor of medicine and the article’s senior author.A human melanoma cell line growing in tissue culture is pictured. The study of cancer cell lines such as this one allows scientists to investigate cancer cell biological processes and ways to modify them in order to design and test new treatments. Image by Dlumen/iStock“In addition, this represents the discovery of two of the most prevalent melanoma gene mutations. Considered as a whole, these two TERT promoter mutations are even more common than BRAF mutations in melanoma. Altogether, this discovery could cause us to think more creatively about the possible benefits of targeting TERT in cancer treatment or prevention,” Garraway said.The mutations affect a promoter region — a stretch of DNA code that regulates the expression of a gene — adjacent to the TERT gene. TERT contains the recipe for making telomerase reverse transcriptase, an enzyme that can make cells virtually immortal, and is often found overexpressed in cancer cells. A promoter region of DNA controls the rate of a gene’s transcription — the copying of its DNA recipe into a message used by the cell to manufacture a protein.“We think these mutations in the promoter region are potentially one way the TERT gene can be activated,” said Franklin Huang, an HMS clinical fellow in medicine and co-first author of the report along with Harvard M.D.-Ph.D. student Eran Hodis.To investigate the mutation’s effect, the researchers hooked the mutant TERT promoter to a gene that makes luciferase, a light-emitting protein. They observed that the mutant promoter increased the production of luciferase in laboratory cell lines. In the same way, the scientists presume, the mutant promoter in human pigmented skin cells can send the TERT gene into overdrive, potentially contributing to the development of melanoma.The mutations were discovered when the scientists sifted through data from whole-genome sequencing of malignant melanoma tumors. Unlike “whole-exome” searches that examine only the protein-coding DNA of a cell’s genome, whole-genome searches scan all the DNA, including the non-coding regions.In analyzing whole-genome data, the investigators discovered the two somatic, or not-inherited, mutations in 17 of 19 (89 percent) of the tumors. Next, they sequenced a larger number of melanoma tumors and found that the two mutations were present in 71 percent of tumors in total.The researchers said the same mutations are present in cell lines from some other malignancies, and that preliminary evidence showed they might be unusually common in bladder and liver cancers. They also noted that the discovery of these important mutations in DNA previously not linked to cancer-causing alterations highlights the value of whole-genome searches of tumor DNA.Other authors include Mary Jue Xu, a student at Harvard Medical School; Gregory V. Kryukov of the Broad; and Lynda Chin of MD Anderson Cancer Center.The research was supported in part by the National Institutes of Health, the Mittelman Family Fellowship, the American Cancer Society, the Novartis Institutes for Biomedical Research, the Melanoma Research Alliance, and the Starr Cancer Consortium.This article was adapted from a Dana-Farber Cancer Institute news release.last_img read more

19 Dec

Rules panel votes to protect juveniles waiving right to counsel

first_imgRules panel votes to protect juveniles waiving right to counsel Rules panel votes to protect juveniles waiving right to counsel Associate EditorTestimony from researchers came as a shock to members of The Florida Bar Commission on the Legal Needs of Children: Juveniles entitled to representation in delinquency cases often waive that right, without really understanding what they are giving up, even as they are sent to adult court for prosecution.Many of the judges and lawyers on the commission wondered: How can that happen?Something had to be done, and the commission drafted a proposed amendment to Rule 8.165 that spells out waiver of counsel by a juvenile can only occur after the child has had a meaningful opportunity to confer with counsel.Armed with the commission’s report and support from the Nancy Daniels, president of the Florida Public Defender Association, Gerard Glynn, chair of the Public Interest Law Section, and Carlos Martinez, chair of the commission’s representation subcommittee, persuaded the Juvenile Rules Committee to amend Rule 8.165.The 25-5 vote took place at the Bar Midyear Meeting in Miami in January, and the matter next goes to the Bar Board of Governors and then to the Florida Supreme Court.“This is a big step. It was our third try. The most persuasive thing Gerry said is that there are 33 opinions in Florida where the cases were reversed where the judges did not do an appropriate job in explaining to the juvenile defendants what waiving their right to counsel meant,” said Martinez, an assistant public defender in the 11th Judicial Circuit.Glynn, a law professor at Barry University School of Law Clinical Programs, said PILS made a commitment to carry forward recommendations of the Bar’s Commission on the Legal Needs of Children, which completed its final report in June after three years of study (available on the Bar Web site at www.FLABAR.org).“One of the problems in previous discussions with the Juvenile Rules Committee is it was submitted without backup documentation and without explanation,” Glynn said. “This time, I could show that the commission spent a significant amount of time studying the issue.”University of Florida researchers Lonn Lanza-Kaduce, at the Center of Studies in Criminology and Law, and Jodi Lane, an assistant professor of criminology and sociology, shared with the commission their preliminary findings on juveniles transferred to adult court who have no lawyer because they waived their constitutional right to counsel.“About 5 percent of the transfers (to adult court) and about 23 percent of juvenile detainees with relatively serious offenses had no counsel of record,” Lanza-Kaduce said.“The preliminary results show that among the transfer to adult court who didn’t have counsel, 70 percent re-offended. And 44 percent of the juvenile justice retainees re-offended when they didn’t have counsel. In both instances, this is the highest instance of re-offense. Failure to have counsel or legal representation is linked, at least at this basic analysis, to higher rates of recidivism.”Children in juvenile court giving up their right to counsel is a national phenomenon, Glynn said, also documented by the American Bar Association Juvenile Justice Center, funded by the U.S. Department of Justice.As Glynn said, many juvenile defendants are foster children who have no parents and plead away their rights without discussing options with a caring adult.Even children appearing in court with their parents can be led astray.“Especially if it is their first time in the system, neither they nor their parent have any idea what the process is,” Daniels said. “With some parents, there is a lot of pressure on kids and they are mad at them for doing something wrong. Parents want them to fess up and take their licks.”But, as Glynn and Daniels agree, there is a way for children to own up to their wrongdoing, receive an appropriate punishment, and be helped at the same time.Another hurdle in getting this changed in the past, Glynn said, has been on “ongoing battle in the rules committee about the role of the rules committee” – whether it’s a substantive right the legislature should address or whether it’s a procedural issue for the rules committee and the Supreme Court.“My belief is right to counsel is not a substantive right, it’s a procedural right, it’s constitutional due process,” Glynn said. “My position is this is not only something the rules committee can do, but it is the exclusive jurisdiction of the Supreme Court, and the court has delegated the rules committee to give advice on this issue.”Daniels said she is “dismayed it had not been approved originally” and the board of the Florida Public Defender Association has supported it unanimously.In her letter to Judge John Alexander, chair of the Juvenile Rules Committee, Daniels wrote: “Even if our caseloads would increase, we believe the rule is sound as a matter of juvenile justice policy.. . . We respectfully recommend that your committee consider and support proposed Rule 8.165. By doing so, you will take a step toward improving the administration of justice for the children of our state.”How widespread is the problem of children waiving their right to counsel?“It’s strictly anecdotal, but in the experience we’ve had with various juvenile judges, it varies wildly,” Daniels said.“Some, in a heavy proportion of cases, are appointing the public defender. Other judges start out with taking pleas without counsel and think they can control their dockets that way. We tried to resist that and say, ‘No, judge, it’s very important that we represent these children and talk to them.’“It’s hard enough for an adult defendant to understand that if you enter a plea, you are giving up your right to a trial and an appeal and all of those things. Those are fairly formidable, abstract principles. And to expect someone under 18 to grasp that in a very frenetic court appearance is just not realistic.“Especially in these times when juvenile sanctions have been bumped up and their records stay with them if they re-offend,” Daniels said. “All that adds to our feeling that this is hyper-important.” February 15, 2003 Jan Pudlow Associate Editor Regular Newslast_img read more