Europe's drug regulator said on Wednesday it had assessed nine cases of an auto-immune blood condition following vaccination with Moderna Inc's (MRNA.O) COVID-19 shot, but no "clear causal relationship" could be established between the two.
The European Medicines Agency (EMA) said its safety committee would continue to monitor for cases of immune thrombocytopenia, an auto-immune condition with low blood platelet levels that can lead to bruising and bleeding, with Moderna's vaccine, Spikevax.
The U.S. Food and Drug Administration could potentially have done more to avoid the current controversies around its accelerated approval of Biogen Inc's (BIIB.O) Alzheimer's drug, Aduhelm, FDA acting Commissioner Janet Woodcock said during a Wednesday summit hosted by Stat.
The FDA last week called for an independent federal probe into its representatives' interactions with Biogen ahead of the regulator's approval of Aduhelm last month. read more
"The accelerated approval was based on very solid grounds," Woodcock said during Stat's Breakthrough Science Summit.
However, she said, "It is possible the process could have been handled in a way that would have decreased the amount of controversy involved."
Aduhelm was approved by the FDA on June 7 despite strong objection from its expert advisory panel, resulting in the resignation of three of its 11 members.
"There continue to be concerns raised ... regarding contacts between representatives from Biogen and FDA during the review process," Woodcock said in a letter posted on Twitter last week.
During her interview with Stat, Woodcock also said COVID-19 booster shots are not needed in the United States at this time. She added that the FDA is still reviewing data to determine if boosters will be necessary in the future.
Woodcock said the FDA will not be able to sustain the speed at which it authorized COVID-19 medicines after the virus was first detected in the United States last year.
Woodcock said she is very engaged in reviewing e-cigarette regulatory submissions and hopes that the FDA will be able to provide more information on its reviews soon.
The FDA is working on new guidelines to reduce Americans' exposure to addictive opioid-based painkillers, she said, adding that recent federal funding for telehealth services could be important in combating addiction.
TransMedics Group Inc. shares have had trading halted on the Nasdaq ahead of a regulatory meeting that will review one of the company's products.
The Food and Drug Administration's panel for gastroenterology and urology devices will meet at 9 a.m. ET to discuss TransMedic's liver system, a portable device designed to preserve a donated liver prior to transplant.
AstraZeneca's closure of its Alexion acquisition is expected to prompt an upgrade to EPS guidance, likely when the company reports results on July 29, UBS says. The acquisition is expected to add about $0.40 to the pharma company's standalone EPS guidance this year, which now stands in a range of between $4.75 and $5, says UBS. Confidence in AstraZeneca's research-and-development productivity is seen returning as a result of the acquisition and after the unhelpful Covid-19 vaccine dynamics that the company has been going through, UBS says. This should in turn boost confidence in AstraZeneca's growth profile, according to the Swiss bank.
Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Qualigen's QN-165 with an initial target indication for the treatment of COVID-19 in hospitalized patients. QN-165, a DNA aptamer, is a broad-based antiviral drug candidate that has exhibited antiviral activity in multiple in vitro assays against different viruses.
“We are excited to have reached this important milestone of submitting our first IND application to the FDA on our most advanced therapeutics program. This submission of the IND application for Phase 1b/2a clinical trials for QN-165 represents another step in our evolution from a globally patented and commercially successful diagnostics company to a clinical-stage therapeutics company with multiple programs,” stated Michael Poirier, Chairman and Chief Executive Officer at Qualigen Therapeutics.
Poirier added, “QN-165 is a unique drug candidate that has a completely different approach to attacking a virus, which we think will enable it to work against all virus strains and variants. QN-165 is a piece of synthetic DNA that does not attack the coronavirus directly. Instead, it targets and binds to the nucleolin protein and can enter cells that overexpress nucleolin. Viruses such as SARS-CoV-2 exploit nucleolin to gain access to a cell and manipulate it for its own viral replication purposes. We believe that QN-165, by tying up nucleolin, blocks that mechanism and prevents the virus replication process. Therefore, even if the virus mutates, we do not expect this to decrease the effectiveness of QN-165. The reason is that QN-165 targets nucleolin instead of the virus itself. We believe that this approach will set QN-165 apart and has the potential for QN-165 to be proven effective against a multitude of viral mutations, including all of the strains and variants of the novel coronavirus.”
New York Gov. Andrew Cuomo’s administration has continued publicizing a much lower state COVID-19 death toll count than the numbers being presented to and displayed by the federal government, a new report revealed.
The state and federal coronavirus death toll differential has even widened this year to a current reported gap of 11,000 — despite numerous investigations into the Cuomo administration for lowballing the number of nursing home COVID-19 deaths, according to a review by the Associated Press.
News of New York’s undercount comes months after Florida Gov. Ron Desantis was erroneously accused of doing the same thing.
As of this week, New York publicized a COVID-19 death toll of roughly 43,000, compared to the Centers for Disease Control public tally of about 54,000.
The total, higher federal count, includes people who have died with coronavirus as a cause or contributing factor listed on their death certificate, the report said.
Cuomo has refused to include “probable” coronavirus fatalities in the state’s reporting, but New York City has done so since April 2020.
Many other states including Florida have taken approaches in line with the CDC, which includes in fatality counts all cases where COVID-19 is an associated or contributing factor.
A March Yahoo report, citing research published in the American Public Health Association, had suggested The Sunshine State’s skewed their COVID-19 numbers, basing the assessment off a discrepancy in the state’s excess-death count.
But an analysis by The Washington Post debunked allegations of undercounting in Florida.
In New York, this year, CDC data shows 3,200 more COVID-19 deaths than the state’s own numbers.
“New York State reports every single COVID-19 death publicly – every confirmed death reported by hospitals, nursing homes and adult care facilities in the state tracker and all preliminary death certificate data, including unconfirmed cases and home deaths, to the federal government which in turn reports that data online, allowing the public full access to all of this detailed data on a daily basis,” a spokesperson for New York’s Department of Health told The Post.
News of New York’s latest “undercounting” has angered critics.
“The overall undercounting of COVID deaths is the nursing home scandal all over again,” said Bill Hammond, senior fellow at the Empire Center Center for Public Policy.
Hammond and the Empire Center filed a Freedom of Information Act lawsuit against Cuomo after the state refused to release the total number of nursing home residents who died from the coronavirus.
A judge ruled the Cuomo administration violated the law and ordered them to release the complete data to the Empire Center.
A separate stinging report by state Attorney General Letitia James found that the state was undercounting COVID-19 nursing home resident deaths by 50 percent.
“After what’s happened, Cuomo doesn’t deserve the benefit of the doubt. You have to suspect the motives,” said Hammond.
“We knew they were violating the law on nursing homes. That was a political decision on their part to save face,” he added.
https://nypost.com/2021/07/13/new-york-publicizing-lower-covid-death-count-than-fed-figures/
