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Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced Friday that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.
“We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism of action, to patients whose virus has become resistant to therapies in multiple classes and have limited treatment options for the long-term management of their condition,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. “The granting of Priority Review status is important since it confirms that, if approved, ibalizumab would represent a significant improvement in the treatment of this serious condition,” added Mr. Tanguay.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014.
The BLA, submitted on May 3, 2017, is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients who had high pre-existing levels of drug resistance and advanced clinical disease.
The ibalizumab Expanded Access Program (EAP), or study TMB-311, is ongoing and enrolling patients. For more information about TMB-311 (NCT02707861), please refer to the ClinicalTrials.gov website (www.clinicaltrials.gov[clinicaltrials.gov]) or the study website (www.ibalizumab-eap.com[ibalizumab-eap.com]).
As HIV multiplies in the body, the virus may mutate to produce drug-resistant strains. Viral mutations may mean that HIV medicines that previously controlled a person’s virus are no longer effective, causing treatment to fail. There are approximately 20,000 to 25,000 Americans with HIV-1 that are resistant to at least one drug out of the three different classes of antiretroviral therapies. Up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment.
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of MDR HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function.
Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.
Nearly half of Americans and 64% of those who identify as LGBT allies say they are more likely to spend money with brands that are LGBT inclusive, according to a new survey from Ogilvy.
The study found that the opposite was true as well — nearly half of Americans and a majority of allies said they would avoid purchasing products and services from companies they perceived as not supporting the LGBT community.
“We were happy with the findings,” said Bill Berman, Group director at Ogilvy and co-chair of Ogilvy PRIDE. “We were happy that the needle is moving in the right direction, but I think it’s a slow shift.”
More than one-third of respondents said they used advertising as an indicator that a brand was LGBT inclusive, citing social media and news outlets as the most common way to find information about a particular company’s stance.
While 72% of respondents said that an LGBT-inclusive business is an ally to the LGBT community, a similar number of participants reported that representative advertising isn’t enough. Sixty-eight percent of respondents believe brands need to deliver on plans and promises of support to the LGBT community to truly be allies.
“These consumers are demanding authenticity from brands,” Berman said. “They want brands to take action on some level. They want them to ‘walk the walk’ and follow through.”
Nearly 75% of Americans believe businesses need to employ a diverse team of people to best serve customers, according to the survey.
It’s not enough to just put out an ad during PRIDE month or target messages to LGBT spaces and publications. Brands need to hire and promote LGBT employees and support groups and organizations working against discrimination, Berman said of the survey findings.
He pointed to IKEA’s “Dream” commercial, which promotes the company’s products while asserting that all homes are created equal, as an example of good inclusive advertising.
https://youtube.com/watch?v=d-KqfiomvV8
“The reason I love that campaign is because it included an interracial same-sex couple, but it was less of a spotlight and more of an image of diversity overall,” he said.
But inclusive advertising is more than just a diversity campaign initiative. This survey shows that it affects the bottom line as well, and if it’s done right it can create a positive halo-effect for the entire business.
“I think the thing people respond to, like in the IKEA campaign, is that we’re part of the fabric of society,” Berman said. “We’re not just given this special treatment when you think it’s viable for you to do it.”
This year’s latest casualty in the ongoing war on transgender women is Josie Berrios, 28. She lived in Ithaca, New York, and was described by those who loved her as a proud transgender woman of color.
Berrios had what police say was a “personal relationship” with a man named Michael Davis, 45. Police have charged him with her murder as well as first-degree arson, apparently for setting fire to her body, reported WSTM-TV.
Detectives arrested Davis late Tuesday night and he was arraigned in Ithaca City Court, according to police. He’s incarcerated at the Tompkins County Jail and being held without bail, according to authorities. His next court date in Ithaca City Court is Monday, June 19th.
While prosecutors said Davis killed Berrios, they’re not saying how. The felony complaint alleges Davis brought a can of gasoline to the building under construction where Berrios was found dead, along with a lighter. Berrios’s body was found with apparent burns and that gas can was found at the scene, according to the court records.
Media reports indicate detectives searching Davis’s home found the lighter in a duffel bag, as well as a security company uniform Davis was seen wearing in surveillance video. A photograph of Davis taken Monday shows him with a similar duffel bag, wearing the uniform shirt in the very building where Berrios was found. Police reportedly also recovered work gloves, and that the strong odor of gasoline was evident on the uniform they found in the bag.
“The Ithaca Police Department would like to speak to anyone who may have seen someone walking or hitchhiking on Ellis Hollow Road, Turkey Hill Road, or Ellis Hollow Creek Road between 5:00 am to 6:00 am yesterday, June 13, 2017,” police said in a release Wednesday.
Josie Berrios
Berrios is the 13th transgender individual killed in 2017, the 12th trans woman and the 11th trans woman of color. The epidemic of violence against transgender Americans shows no sign of letting up, and advocates fear this year’s death toll may surpass 2016’s horrifying record of 27. The National Coalition of Anti-Violence Programs counts 23 homicides, because some of the victims were not a result of homicide or not related to hate violence.
Although initial reports by police misgendered Berrios based on her identification, police were swift to correct the record.
“We’re choosing to honor the victim’s choices in life and her beautiful life in honoring her self identification as that of a female,” Officer Jamie Williamson told reporters. “We ask that the community join us as well.”
Kat Von Riesling, an Ithaca woman, posted more information about Berrios on Facebook. She said Berrios was also known as Kimbella Rosé, and helped start the House of Merlot drag troupe.
Kimbella, also known as Kendra Adams or Josie to some, was one of our founding members of the House of Merlot before we were even official. She was usually full of energy, rarely on time, and always slayed her performances.
A proud trans woman of color, she always tried her best to make new performers feel comfortable in our spaces. She recognized the realness in all of us without question and made us feel beautiful. She was part of so many families here in Ithaca, that many are feeling stunned and lost following this news. Her presence is still felt, and will never be forgotten.
A Celebration of Life and Pride Show on June 22 at the Range will be dedicated to Rosé, and will include a moment of silence.
Below are the names of the other 12 transgender murder victims of 2017:
Alphonza Watson, 38
Chay Reed, 28
Kenneth Bostick, 59
In a community-created consensus statement released today, AIDS United provides critical guidance for clinical providers, funders and social service providers to strengthen their understanding of how best to engage and support transgender communities. The statement provides concrete and measurable steps organizations can take to improve their approach to HIV work in transgender communities and was drafted by 12 transgender leaders at a think tank convened by AIDS United and generously supported by Janssen Therapeutics, Division of Janssen Products, LP.
The transgender community is critically affected by HIV and faces unique challenges accessing HIV care. A landmark 2013 study estimates that 22 percent of transgender women in the United States are living with HIV. This makes transgender women the most heavily affected group in the United States, relative to their population size. This disproportionate risk is fueled by pervasive violence and discrimination faced by transgender and gender non-conforming individuals in areas such as housing, education and when accessing health care.
“Our recent survey shows 41 percent of the respondents reported lapses in health care for longer than six months. This speaks to the need to meaningfully involve trans people living with HIV in cultural competency training and program designs. Trans people are experts of their experiences and this consensus statement puts the expertise of trans people front and center,” said nationally recognized leader in civil rights and trans equality Cecilia Chung.
“Twelve trans leaders from across the country came together to create concrete recommendations so that funders, health care providers and social services organizations can serve our communities with the dignity and respect we deserve. There is power in this—and the best practices we outlined are critical for improving trans health and justice in this country,” said Chung.
Due to these factors, it is critical that clinics and support services are welcoming, inclusive and competent in serving transgender people. Additionally, funders must ensure that funding strategies and decisions are community informed to yield the greatest impact.
“We can no longer ignore the needs of the transgender and gender-nonbinary community. Our consciousness of their presence has been raised, but our services have not stepped up to meet their unique needs,” said AIDS United President & CEO Jesse Milan, Jr. “We cannot allow transgender people to be left out or left behind or we will not fully achieve our national goals.”
The Consensus Statement and the newly launched Transgender Leadership Initiative, also funded by Janssen Therapeutics, are programmatic efforts by AIDS United to better partner with transgender leaders to address the dire HIV epidemic in transgender communities, to improve transgender health outcomes and to solidify transgender power in our society. Proposals for support from the Transgender Leadership Initiative are due by Jun 14, 2017 at www.aidsunited.org.
“This statement is a foundational tool that every provider and HIV advocate can use. It is the newest tool in our toolbox for ending the HIV epidemic in this country and AIDS United is proud to release it to everyone,” said Milan.
College students who belong to sexual minority groups are more likely to seek help for mental health problems than their straight peers, but they still face many barriers to using on-campus mental health services, according to a new RAND Corporation study.
Researchers found that students who identify themselves as lesbian, gay, bisexual, queer or questioning were more likely to use off-campus mental health services than their heterosexual peers and were more likely to report being deterred by barriers such as concerns over confidentiality and uncertainty over eligibility for on-campus services.
The findings are from one of the largest surveys ever of college students about mental health issues. More than 33,000 students from 33 public four-year and two-year colleges in California were surveyed about mental health needs during 2013. The study was published online by the Journal of Adolescent Health.
“It’s encouraging that college students who identify as sexual minorities are more likely to utilize mental health services, but our findings suggest there is a need to develop campus-based mental health services tailored to this group and address barriers to using them,” said Michael S. Dunbar, lead author of the study and an associate behavioral scientist at RAND, a nonprofit research organization.
The study found that 7 percent — roughly 1 in 15 — of the students surveyed identified as being lesbian, gay, bisexual, queer or questioning.
Compared to heterosexual students, sexual minority students had higher rates of psychological distress (26 percent versus 18 percent), were more likely to report academic impairment related to mental health problems (17 percent versus 11 percent) and reported higher overall levels of stress over the past month (63 percent versus 55 percent).
Members of sexual minority groups were nearly twice as likely to have used some type of mental health services during their time in college (31 percent versus 18 percent). Among all students, most of those who reported serious psychological distress did not use mental health services.
Among students who needed services but didn’t get them on campus, sexual minority individuals were more likely than their heterosexual peers to report specific barriers to using on-campus mental health services. In particular, sexual minority students endorsed concerns over confidentiality, embarrassment over using services and uncertainty over whether they would be eligible for services as reasons they did not use on-campus services. They also were more likely to report seeking help off-campus.
“Our study underscores the need for additional actions to increase access to and use of mental health services among all students,” said Dr. Bradley D. Stein, co-author of the study and a physician scientist at RAND. “It also highlights the need for efforts to ensure that campuses’ mental health services are sensitive and responsive to the needs of sexual minority students, enabling all students to address their mental health needs and maximize their chances for success in college and beyond.”
Previous studies have estimated that 17 percent or more of college students suffer from serious psychological distress, with risks being higher for lesbian, gay, bisexual, queer or questioning students. If unaddressed, psychological problems among college students often persist, with consequences including greater levels of substance abuse, lower academic achievement, poor graduation rates, and lower workforce participation and income.
Few studies have examined ways that sexual minority college students differ from heterosexual students on factors such as mental health status and their use of mental health services.
The RAND study analyzed information from a survey about mental health completed by students from nine University of California campuses, nine California State University campuses and 15 California community colleges. The results were weighted to help reflect the state’s overall college student population.
Support for the study was provided by California Mental Health Services Authority (CalMHSA), an organization of county governments working to improve mental health outcomes for individuals, families and communities in California. Programs implemented by CalMHSA are funded by counties through Proposition 63, which provides the funding and framework needed to expand mental health prevention and early intervention services to previously underserved populations and all of California.
Other authors of the study are Lisa Sontag-Padilla, Rajeev Ramchand and Rachana Seelam.
Logo, the leading entertainment brand for the LGBTQ community, today released the second annual ‘Trailblazing Companies’ list, a ranking of companies and brands that have demonstrated a public commitment to LGBTQ people and issues through advertising, communications, and other public initiatives. The campaigns and marketing endeavors on the list showcase a range of personalities, stories and experiences within the LGBTQ community.
Hilton, Anheuser-Busch, Marriott, Google, and Apple were found to have the highest scores in categories that counted LGBTQ initiatives in the following objective, public-facing categories: LGBTQ-Inclusive Advertising, Digital Video & Social Media, Policy Support, Spokespersons & C-Suite Executives, Donations & Sponsorships, and Website Engagement. This year, examples of corporate support for the survivors, families and victims of the Orlando Pulse nightclub tragedy were also calculated in scoring.
According to Bob Witeck, President of Witeck Communications, LGBTQ consumers represent an estimated buying power of $971 billion. Previous Logo research also has found that 71 percent of LGBTQ consumers are more likely to support a brand after seeing an equality-themed ad, while 71 percent were more likely to purchase from a company that actively supports and contributes to LGBTQ charities/causes.
Logo’s ‘Trailblazing Companies’ list was created through extensive research conducted in partnership with Witeck Communications, a strategic communications firm with special expertise in LGBTQ communications. Logo started with a pool of close to 200 consumer-facing companies that earned 100% scores for their internal LGBTQ policies on the Human Rights Campaign’s Corporate Equality Index. Each company was then evaluated based on the seven objective categories that demonstrate each company’s support of the LGBT community in the public sphere. Companies were awarded points based on their performance in each of these areas.
“Each of these companies is delivering a message of inclusion, diversity and equality that is needed now more than ever,” said Pamela Post, SVP of Programming for Logo. “While we are incredibly proud to recognize these 25 trailblazing companies who are raising the bar higher than just their bottom line, the ultimate goal is to one day reach a time when a list like this is no longer necessary.”
Bob Witeck also adds that, “the resonance of LGBTQ attitudes in the marketplace has made a sea of change in how brands express their values, connect innovatively with diverse households, and grow market share. This new study is an encouraging roadmap of trends and opportunities for all brands aiming to step up their competition.”
Logo’s Top 25 Trailblazing Companies (in ranking order):
For more information on the rankings and each company’s score visit:
http://files.logotv.com/rules/logo-25-trailblazing-companies-2016.pdf
Look good, do good, and make a statement! #Bows4Pride is a fundraising campaign that was created in collaboration with the SF LGBT Center, SAGE, Free2Luv, and Bows-N-Ties. 100 percent of the sales from these bow ties will support LGBTQ rights. With your help we aim to sell 10,000 of these pride themed bow ties, raising a total of $250,000 for the LGBTQ community.
By purchasing one of these bow ties you will not only help raise money for three fantastic LGBTQ organizations, but by wearing this bow you will proudly display your support for basic human rights.
#Bows4Pride was created by four organizations. Designed, made, and donated by San Francisco based neckwear designers BOWS-N-TIES 100 percent of the sales from these bow ties will go toward the following LGBTQ organizations’ values and missions.
SAGE is the country’s largest and oldest organization dedicated to improving the lives of lesbian, gay, bisexual and transgender (LGBT) older adults. Founded in 1978 and headquartered in New York City, SAGE is a national organization that offers supportive services and consumer resources for LGBT older adults and their caregivers, advocates for public policy changes that address the needs of LGBT older people, and provides training for aging providers and LGBT organizations.
The SF LGBT CENTER connects the community to opportunities, resources and with each other to achieve a vision of a stronger, healthier and more equitable world for LGBT people.
Free2Luv® is a global, award-winning youth empowerment nonprofit passionate about embracing individuality, celebrating equality, spreading kindness and standing up to bullying through arts and entertainment. With Celebrity Ambassadors and Youth Advocates in over 27 states and 13 countries, Free2Luv is creating a kinder, braver, more loving world for ALL youth.
For more information or to buy a ‘Bow 4 Pride’ go here.
Gov. Kate Brown has signed a bill that will make it easier for transgender people in Oregon to shield any updates they make to their birth certificates, a process typically conducted through the court system without privacy from public view.
The measure, which takes effect next year, makes Oregon the second state after California to adopt laws specifically designed to help mitigate potential discrimination against transgender individuals from employers, landlords or anyone else who is otherwise able to dig up birth-record changes through public record.
The new law eliminates the requirement that changes to someone’s name or gender identity must be posted publicly by the courts. It also allows court cases involving gender identity changes on birth records to be sealed.
It’s a minor tweak to state law that could have a big impact on the local transgender community, says 59-year-old Stacey Rice, executive co-director of Q Center, a Portland community support center for LGBTQ individuals.
Rice is a transgender woman but still hasn’t been able to change her North Carolina birth records after 17 years because she hasn’t undergone a sex-change operation, which the state says must also be confirmed through a notarized letter from their doctor. The same requirements apply for driver’s licenses, although Rice got it done anyway thanks to the kindness of a North Carolina DMV employee years ago.
“I was going to have a driver’s license that has my female face on it, my female name, but it’s still going to say ‘M’ and let’s say I get pulled over for some reason and maybe a police officer looks at it and says ‘what’s going on here?’ that was terrifying,” Rice said.
HB 2673 passed the Democratic-controlled Oregon Legislature earlier this month with some Republican support at a time when, two years after the U.S. Supreme Court‘s legalization of same-sex marriage, the nation remains largely divided as to how to balance LGBTQ rights and religious freedoms.
This year about 30 states introduced roughly 130 anti-LGBTQ bills, about half last year’s figure, according to the D.C.-based Human Rights Campaign. Most of the measures have died, but legislatures in South Dakota, Alabama and Texas passed bills providing protections for faith-based adoption agencies that do not want to place children with gay or lesbian adoptive parents.
Opposite scenarios are playing out in other states like Nevada, where GOP Gov. Brian Sandoval signed a law earlier this month banning “conversion therapy” for LGBTQ youth. And this week, Republican Congressman Scott Taylor of Virginia agreed to co-sponsor the federal Equality Act, which would give that community civil rights protections.
Oregon wasn’t always a welcoming place for gay rights. Voters approved a measure banning same-sex measure in 2004. It was overturned a decade later.
For Oregon, Brown said in emotional remarks that the transgender equity bill carries broader significance in the aftermath of last week’s deadly stabbings of two men trying to defend two teenage girls from racial and religious slurs on a Portland light-rail train.
“Hate and discrimination have no place in our Oregon,” Brown said.
Brown, herself a bisexual, became the nation’s first openly-LGBTQ elected governor last November and Democrat Tina Kotek is the first openly lesbian House Speaker.
SeniorAdvice.com, one of the nation’s top senior housing referral services, has released an article on the challenges and progress of the aging transgender community. The company recognizes that the LGBT senior community is a very important part of the American population, and that the struggle for acceptance and safety among the transgender community has finally reached the national conversation.
There is generally less acceptance of the trans community among older generations, which can make it very difficult to find a supportive community within the senior demographic. According to a recent study by the Williams Institute at the UCLA Law School, 14% of those identifying as transgender are over the age of 65. The senior transgender community often faces many difficulties. SeniorAdvice.com has identified three of these challenges and has researched ways to combat these issues, including current public and private efforts to improve upon the lives of transgender seniors.
The three challenges of transgender seniors explored by SeniorAdvice.com are:
1) Isolation and a Negative Social Stigma
In addition to the rampant discrimination, loneliness, and violence that all transgender people often encounter, older individuals in this community can face particular challenges in dealing with long-standing familial roles. There can be difficulties when families and friends have to consider modifying deeply established roles and there may be a period of adjustment for all involved. There is also a lack of availability of social groups for seniors, particularly outside of large metropolitan areas, and this can worsen the isolation.
2) Senior Housing Issues
There is a serious lack of availability in LGBT-friendly senior housing and the problem is most severe for those who are transgender. Because there are no legal protections at the national level for transgender people, those seeking nursing home or assisted living care often face discrimination and lack of acceptable living conditions.
3) Health Concerns
Transgender people of all ages frequently lack access to properly-trained healthcare providers who understand their unique medical and psychological challenges. Many within the community even report facing harassment, ridicule, and rough treatment by medical professionals, or are refused treatment altogether. Individuals who are older often face additional complications due to requirements for longer-term and sometimes more intense hormone therapy that require a closer level of attention from their healthcare providers.
To further investigate these challenges, SeniorAdvice.com conducted an in-depth interview with a retired transgender woman. Cynthia, whose name was changed to protect her identity, is a parent, a decorated military veteran, and a Purple Heart recipient. She recently began her transition and is the happiest she’s ever been, though she has faced many obstacles along her journey.
“SeniorAdvice.com continues to be dedicated to the challenges and needs of elder people of all backgrounds. The transgender senior community is a particularly vulnerable group and has been largely ignored for far too long. It’s time to bring their story into the public conversation,” says Ryan Patterson, SeniorAdvice.com CEO and Founder.
To view the full article on “Transitioning After Retirement: The Struggles and Triumphs of Transgender Seniors” visit https://www.