Target to $45 from $41
Friday, March 4, 2022
Iowa Bans Male-Born Athletes From Participating In Female Sports At Schools
by Katabella Roberts via The Epoch Times,
Iowa Gov. Kim Reynolds on Thursday signed a bill barring male-born athletes from competing in female sports programs at school and college.
Under the bill, known as HF 2416, public and private K-12 schools and community colleges, as well as colleges and universities affiliated with the National Collegiate Athletic Association (NCAA) and National Association of Intercollegiate Athletics (NAIA), are required to designate sporting events as male, female, or co-ed.
According to the governor, the bill “protects girls’ sports programs at all school levels, including high school and collegiate levels in Iowa,” and allows students to participate in sports programs based on the biological sex listed on their birth certificate.
The measure means that only students who are female according to their birth certificate will be eligible to compete in girls’ sports and transgender women and girls will no longer be able to participate in the sports, effective immediately.
Reynolds signed the bill just one day after the state Senate passed the measure in a party-line 31–17 vote. Iowa Democrats opposed the legislation but lacked the votes to stop it from advancing in the Republican-controlled legislature.
“This is a victory for girls’ sports in Iowa. No amount of talent, training, or effort can make up for the natural physical advantages males have over females. It’s simply a reality of human biology,” said Reynolds.
“Forcing females to compete against males is the opposite of inclusivity and it’s absolutely unfair.”
Iowa is the latest state in the United States to pass such a measure, after Idaho, Tennessee, West Virginia, and Texas, among others, passed similar laws banning trans females from participating in women’s sports. Some of these states are now facing lawsuits over the measure.
Supporters of such a measure believe that it will create a level playing field and fairness for female athletes in schools because transgender athletes have an unfair advantage over cisgender students.
One Iowa Action board chair Angus Raymond condemned the signing of the new legislation by Reynolds, saying the move would cause harm to some students in schools.
“Despite overwhelming opposition, and a plethora of medical and mental health experts giving testimony to how this will cause harm, Gov. Reynolds is telling Iowa’s transgender children and youth that they are less-than, and unimportant to her state in blatant disregard for Title IX,” said Raymond.
“We are profoundly disappointed in the legislature and the governor’s office.”
The Epoch Times has contacted a spokesperson for Gov. Kim Reynolds for comment.
https://www.zerohedge.com/political/iowa-bans-male-born-athletes-participating-female-sports-schools
Recursion Provides Updated Guidance on Clinical Trial Starts
Recursion's leadership team has decided that conducting a dose optimization study in a sheep efficacy model of Tay-Sachs disease is prudent and in the best interest of patients before enrolling infants in a Phase 2 trial of REC-3599 in the ultra-rare indication infantile GM2 gangliosidosis. This decision will delay the GM2 Phase 2 trial start by approximately 2 years.
Recursion's Phase 2 trial of REC-994 in Cerebral Cavernous Malformation is on track and we expect to enroll the first patient in the coming weeks.
The Phase 2 portion of Recursion's adaptive Phase 2/3 trial of REC-2282 in Neurofibromatosis Type 2 is on track to enroll in Q2.
Recursion's Phase 2 trial of REC-4881 in Familial Adenomatous Polyposis is expected to enroll the first patient in either Q2 or potentially Q3, 2022 due to challenges with site opening presented by the Covid-19 Omicron variant.
Preparations for Recursion's Phase 1 study of REC-3964 in recurrent C. difficile colitis are on track, and we expect to begin enrollment in the second half of 2022.
Atreca updates on Phase 1b tumor therapy trial
Partial response (PR) observed in ATRC-101 monotherapy cohort as well as a confirmed complete response (CR) observed in pembrolizumab combination cohort in Phase 1b clinical trial
Clinical activity observed in multiple tumor types and significantly associated with ATRC-101 target expression; target diagnostic validated and planning for participant selection based on target expression
ATRC-101 has been well-tolerated with no dose-limiting toxicities observed
Conference call and webcast with accompanying slides scheduled for today at 4:30 p.m. EST
Conference Call and Webcast Details
Atreca will host a live conference call and webcast today at 4:30 p.m. EST. To access the conference call by telephone, please dial (800) 373-6606 (Domestic) or 409-937-8918 (International). The conference ID number is 5089907.
The live audio webcast and accompanying slide presentation can be accessed via the Events section of the Company’s investor relations website at https://ir.atreca.com/news-and-events/event-calendar. An archived replay of the webcast will be available on the Company's website for 90 days following the live event.
https://finance.yahoo.com/news/atreca-reports-fourth-quarter-full-210100465.html
Biogen, Eisai submit lecanemab application in Japan
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401). The lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) is ongoing.
The PMDA's process, known as "prior assessment consultation," is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter. Eisai plans to obtain the primary endpoint data from the Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan during Eisai's fiscal year 2022.
In September 2021, Eisai initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the beginning of Eisai's fiscal year 2022. Based on the results of the Clarity AD study as the confirmatory study, Eisai plans to submit for full approval of lecanemab to the U.S. FDA during fiscal year 2022. Eisai and Biogen are committed to providing innovative treatments to persons living with early AD, their families and healthcare professionals who are waiting for new treatment options, as early as possible.
Coherus: Positive Results from Phase 3 Esophageal Cancer Study
Toripalimab plus chemotherapy demonstrates improvement in co-primary endpoints of PFS and OS in patients with advanced ESCC -
- PFS and OS benefits were observed across all PD-L1 expression subgroups, including in patients with low PD-L1 expression -
https://finance.yahoo.com/news/coherus-junshi-biosciences-announce-positive-130000417.html
FDA declines pediatric EUA for Ocugen's COVID vaccine Covaxin
Ocugen Inc said on Friday U.S. regulators have declined to issue an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use in individuals aged 2 to 18 years.
Shares of Ocugen slumped 30% premarket on the news.
Ocugen said it intends to continue working with the U.S. Food and Drug Administration to evaluate the process for getting an EUA for pediatric use of Covaxin.
Ocugen had entered into a deal with vaccine maker Bharat Biotech in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market. (https://reut.rs/35nVA1P)
Covaxin, which is not cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and also has an emergency use listing from the World Health Organization
https://finance.yahoo.com/news/1-fda-declines-pediatric-eua-123725116.html
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