Margaret Brennan interviews Ohio Gov. John Kasich and Rep. Will Hurd of Texas. Plus, we'll kick off our 2018 CBS News midterm election Battleground Tracker, which explains where things stand in the race to control Congress this fall.
Reported by CBS News 1 hour ago.
6/3: Jung Pak, Amb. Robert Gallucci, Anthony Salvanto
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Supreme Court refuses appeal from condemned San Antonio man
HOUSTON (AP) — The U.S. Supreme Court has refused an appeal from a San Antonio man on Texas death row for the gang rape and fatal stabbing of a 15-year-old girl in 1996. The high court decision upholds a 5th U.S. Circuit Court of Appeals ruling that rejected arguments from condemned prisoner Carlos Trevino that […]
Reported by Seattle Times 2 hours ago.
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Dallas-area church targets ‘dangerous isms’ like Judaism
RICHARDSON, Texas (AP) — A Dallas-area church has distributed fliers advertising a series of weekly seminars it plans to host condemning “dangerous isms” like Judaism, Islamism and liberalism. Greenville Avenue Church of Christ in Richardson says in the fliers that the Wednesday seminars will “provide a proper response for the Christian.” Pulpit minister Shelton Gibbs […]
Reported by Seattle Times 2 hours ago.
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American Airlines plane makes emergency landing in Texas after hail damages windshield
Reported by DallasNews 2 hours ago.
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Senator denied entry into migrant detention facility, claims he saw kids caged in another
Jeff Merkley live-streamed the incident outside a Texas detention facility
Reported by CBS News 2 hours ago.
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Gwen Stefani & Blake Shelton All Loved Up at a Texas Wedding
Reported by Extra 2 hours ago.
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Rep. Will Hurd: ‘Absolutely’ Would Support Requiring Trump to Get Congressional Approval Before Imposing Tariffs
Rep. Will Hurd (R-Texas), who sits on the House Intelligence and Homeland Security Committees, told CBS’s “Face the Nation” on Sunday that he would “absolutely” support requiring that President Donald Trump to get congressional approval before raising tariffs.
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DONATE Reported by CNSNews.com 1 hour ago.
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*Please support CNSNews today! (a 501c3 non-profit production of the Media Research Center)*
DONATE Reported by CNSNews.com 1 hour ago.
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Top cornerback Derek Stingley Jr. to announce college decision June 20
LSU, Florida and Texas are Stingley's finalists.
Reported by nola.com 2 hours ago.
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First Liberty Celebrates Supreme Court Decision Protecting Free Exercise Rights of Business Owners
Victory for Free Exercise should protect other business owners like First Liberty Institute clients Aaron and Melissa Klein
PLANO, Texas, June 04, 2018 (GLOBE NEWSWIRE) -- First Liberty Institute today issued a statement regarding the United States Supreme Court decision in Masterpiece Cakeshop v. Colorado Civil Rights Commission. In a 7-2 decision, the justices upheld the free exercise rights of Jack Phillips, a cakebaker in Colorado, to operate his business according to his beliefs. “The Supreme Court today determined once again that the First Amendment prohibits the government from forcing Americans to violate their religious beliefs,” said Kelly Shackelford, President and CEO for First Liberty Institute. “No one in America should be forced by the government to choose between their faith and their livelihood. But that’s exactly what happened to our clients, bakers Aaron and Melissa Klein. The Kleins deserve the same protection from a hostile government given Jack Phillips.”
In 2013, the State of Oregon issued a crippling $135,000 damages award against the Kleins—who have since been forced to close their family business because of the state’s action against them—because they declined to design and create a custom wedding cake for a same-sex wedding, which violates the Kleins’ sincerely religious convictions. In December the Oregon Court of Appeals rejected the Klein’s appeal. First Liberty Institute appealed that decision to the Supreme Court of Oregon in March.
Adam Gustafson of Boyden Gray & Associates, who with First Liberty filed the appeal on behalf of the Kleins added, “The Oregon Bureau of Labor and Industries (BOLI) decision against the Kleins was tainted by the same anti-religious bias that caused the U.S. Supreme Court to rule for Masterpiece Cakeshop on Free Exercise grounds. This anti-religious bias is evident in Commissioner Avakian’s Facebook post about the Kleins’ religious beliefs, the Commissioner’s decision to award damages for Aaron Klein’s quotation of Scripture, and the outrageous magnitude of the $135,000 damage award.
“The U.S. Supreme Court did not reach the free-speech claim in Masterpiece because of uncertainty about whether the proprietor of Masterpiece Cakeshop declined to sell a custom cake or a pre-made cake. ‘If a baker refused to design a special cake with words or images celebrating the marriage . . . that might be different from a refusal to sell any cake at all.’ There is no dispute that the Kleins only sold custom cakes, so their case squarely presents the free-speech question that the Court avoided in Masterpiece.”
*About First Liberty Institute *
First Liberty Institute is the largest legal organization in the nation dedicated exclusively to defending religious freedom for all Americans.
To arrange an interview, contact Lacey McNiel at media@firstliberty.org or by calling 972-941-4453.
*Contact:* Lacey McNiel, media@firstliberty.org
Direct: 972-941-4453
Reported by GlobeNewswire 3 hours ago.
PLANO, Texas, June 04, 2018 (GLOBE NEWSWIRE) -- First Liberty Institute today issued a statement regarding the United States Supreme Court decision in Masterpiece Cakeshop v. Colorado Civil Rights Commission. In a 7-2 decision, the justices upheld the free exercise rights of Jack Phillips, a cakebaker in Colorado, to operate his business according to his beliefs. “The Supreme Court today determined once again that the First Amendment prohibits the government from forcing Americans to violate their religious beliefs,” said Kelly Shackelford, President and CEO for First Liberty Institute. “No one in America should be forced by the government to choose between their faith and their livelihood. But that’s exactly what happened to our clients, bakers Aaron and Melissa Klein. The Kleins deserve the same protection from a hostile government given Jack Phillips.”
In 2013, the State of Oregon issued a crippling $135,000 damages award against the Kleins—who have since been forced to close their family business because of the state’s action against them—because they declined to design and create a custom wedding cake for a same-sex wedding, which violates the Kleins’ sincerely religious convictions. In December the Oregon Court of Appeals rejected the Klein’s appeal. First Liberty Institute appealed that decision to the Supreme Court of Oregon in March.
Adam Gustafson of Boyden Gray & Associates, who with First Liberty filed the appeal on behalf of the Kleins added, “The Oregon Bureau of Labor and Industries (BOLI) decision against the Kleins was tainted by the same anti-religious bias that caused the U.S. Supreme Court to rule for Masterpiece Cakeshop on Free Exercise grounds. This anti-religious bias is evident in Commissioner Avakian’s Facebook post about the Kleins’ religious beliefs, the Commissioner’s decision to award damages for Aaron Klein’s quotation of Scripture, and the outrageous magnitude of the $135,000 damage award.
“The U.S. Supreme Court did not reach the free-speech claim in Masterpiece because of uncertainty about whether the proprietor of Masterpiece Cakeshop declined to sell a custom cake or a pre-made cake. ‘If a baker refused to design a special cake with words or images celebrating the marriage . . . that might be different from a refusal to sell any cake at all.’ There is no dispute that the Kleins only sold custom cakes, so their case squarely presents the free-speech question that the Court avoided in Masterpiece.”
*About First Liberty Institute *
First Liberty Institute is the largest legal organization in the nation dedicated exclusively to defending religious freedom for all Americans.
To arrange an interview, contact Lacey McNiel at media@firstliberty.org or by calling 972-941-4453.
*Contact:* Lacey McNiel, media@firstliberty.org
Direct: 972-941-4453
Reported by GlobeNewswire 3 hours ago.
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Three residential brokerages — two San Antonio-based, one Austin-based — merging
Local residential brokerage company Better Homes and Gardens Real Estate Bradfield Properties plans to merge with Austin-based HomeCity Real Estate and San Antonio-based Ultimate Realty as it continues to expand across South and Central Texas. Better Homes and Gardens Bradfield Properties said the merger will help the company provide a wider array of services, including the implementation of the (RE)gen technology platform developed by HomeCity Real Estate. (RE)gen is a platform for managing transactions…
Reported by bizjournals 3 hours ago.
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George P. Bush Tells Premier High School Grads to Stay Committed
AUSTIN, Texas, June 04, 2018 (GLOBE NEWSWIRE) -- Texas Land Commissioner George P. Bush delivered a rousing commencement speech to the high school graduates from Premier High School - Austin South and Premier High School - American YouthWorks. Both campuses joined for a dual-graduation ceremony in the Lady Bird Johnson Auditorium at the LBJ Library and Museum on June 2 at 1:30 p.m.
“He spoke of staying committed to your goals and serving others even if it means going against the grain,” said Premier High School Regional Director Jennifer Kasapi. “This was a message these kids really needed to hear as they prepare for the next stage of their lives.”
Thirteen seniors earned diplomas from the American YouthWorks campus and another 35 from the Austin South campus. Each graduate received a handshake and personal congratulations from Mr. Bush.
Commissioner Bush is the grandson of President George H.W. Bush, the son of former Florida Governor Jeb Bush and the nephew of President George W. Bush. Prior to becoming Texas land commissioner, Bush worked as a public-school teacher after graduating from Rice University and serving in Operation Enduring Freedom in Afghanistan as an officer in the U.S. Naval Reserve.
Founded in 1999, ResponsiveEd operates 35 Premier High School campuses across Texas. With the motto ‘Don’t Wait. Graduate.’ the Premier High School model helps students recover high school credits and work toward early graduation.
ResponsiveEd® is a non-profit corporation that operates more than 75 tuition-free public schools throughout Texas and Arkansas, including Premier High Schools℠, ResponsiveEd Classical Academies, Founders Classical Academies®, Quest Academies, iSchool High®, and iSchool Virtual Academy. ResponsiveEd’s mission is to provide hope to students through innovative, character-based, personalized learning environments. To learn more, visit www.ResponsiveEd.com.
*Stay Connected:*
Facebook: www.facebook.com/responsiveed
Twitter: www.twitter.com/responsiveed
LinkedIn: www.linkedin.com/responsiveed
Instagram: www.instagram.com/responsiveeducation
*Attachments*
· Premier_Color
· Bush shaking hands
CONTACT: Billy Rudolph
Responsive Education Solutions
972-316-3663 x379
brudolph@responsiveed.com Reported by GlobeNewswire 3 hours ago.
“He spoke of staying committed to your goals and serving others even if it means going against the grain,” said Premier High School Regional Director Jennifer Kasapi. “This was a message these kids really needed to hear as they prepare for the next stage of their lives.”
Thirteen seniors earned diplomas from the American YouthWorks campus and another 35 from the Austin South campus. Each graduate received a handshake and personal congratulations from Mr. Bush.
Commissioner Bush is the grandson of President George H.W. Bush, the son of former Florida Governor Jeb Bush and the nephew of President George W. Bush. Prior to becoming Texas land commissioner, Bush worked as a public-school teacher after graduating from Rice University and serving in Operation Enduring Freedom in Afghanistan as an officer in the U.S. Naval Reserve.
Founded in 1999, ResponsiveEd operates 35 Premier High School campuses across Texas. With the motto ‘Don’t Wait. Graduate.’ the Premier High School model helps students recover high school credits and work toward early graduation.
ResponsiveEd® is a non-profit corporation that operates more than 75 tuition-free public schools throughout Texas and Arkansas, including Premier High Schools℠, ResponsiveEd Classical Academies, Founders Classical Academies®, Quest Academies, iSchool High®, and iSchool Virtual Academy. ResponsiveEd’s mission is to provide hope to students through innovative, character-based, personalized learning environments. To learn more, visit www.ResponsiveEd.com.
*Stay Connected:*
Facebook: www.facebook.com/responsiveed
Twitter: www.twitter.com/responsiveed
LinkedIn: www.linkedin.com/responsiveed
Instagram: www.instagram.com/responsiveeducation
*Attachments*
· Premier_Color
· Bush shaking hands
CONTACT: Billy Rudolph
Responsive Education Solutions
972-316-3663 x379
brudolph@responsiveed.com Reported by GlobeNewswire 3 hours ago.
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Houston Wire & Cable Company Elects Robert Reymond to Board of Directors
HOUSTON, June 04, 2018 (GLOBE NEWSWIRE) -- Houston Wire & Cable Company (NASDAQ:HWCC) announces the election of Robert Reymond to its Board of Directors. Mr. Reymond will also serve as a member of the Audit Committee.Mr. Reymond, age 52, is currently the President of the Oil, Gas and Chemical Division and a member of the board of directors of Burns & McDonnell, a privately held full-service engineering, architecture, construction, environmental and consulting solutions firm, a role he has held since 2015. Prior to his current role, Mr. Reymond was the Senior Vice President and Manager of the Projects, Process & Industrial Division of Burns & McDonnell from 2012 to 2014. Prior to 2012, Mr. Reymond held various management level roles since joining Burns & McDonnell in 2002. Mr. Reymond is a United States Navy veteran.
"We are very excited to welcome Robert to our Board of Directors. Robert’s extensive experience in engineering and construction make him a great addition to our Board," commented James Pokluda, President & CEO of Houston Wire & Cable Company.
About the Company
With 43 years’ experience in the industry, Houston Wire & Cable Company, an industrial distributor, is a large provider of products in the U.S market. Headquartered in Houston, Texas, the Company has sales and distribution facilities strategically located throughout the United States.
Standard stock items available for immediate delivery include continuous and interlocked armor cable; instrumentation cable; medium voltage cable; high temperature wire; portable cord; power cable; primary and secondary aluminum distribution cable; private branded products, including LifeGuard™, a low-smoke, zero-halogen cable; mechanical wire and cable and related hardware, including wire rope, lifting products and synthetic rope and slings; corrosion resistant fasteners, hose clamps, and rivets.
Comprehensive value-added services include same-day shipping, knowledgeable sales staff, inventory management programs, just-in-time delivery, logistics support, customized online ordering capabilities and 24/7/365 service.
CONTACT: CONTACT:
Kayla Draper
Investor Relations Coordinator & Assistant to the CEO
Direct: 713.609.2227
Fax: 713.609.2168
kdraper@houwire.com Reported by GlobeNewswire 2 hours ago.
"We are very excited to welcome Robert to our Board of Directors. Robert’s extensive experience in engineering and construction make him a great addition to our Board," commented James Pokluda, President & CEO of Houston Wire & Cable Company.
About the Company
With 43 years’ experience in the industry, Houston Wire & Cable Company, an industrial distributor, is a large provider of products in the U.S market. Headquartered in Houston, Texas, the Company has sales and distribution facilities strategically located throughout the United States.
Standard stock items available for immediate delivery include continuous and interlocked armor cable; instrumentation cable; medium voltage cable; high temperature wire; portable cord; power cable; primary and secondary aluminum distribution cable; private branded products, including LifeGuard™, a low-smoke, zero-halogen cable; mechanical wire and cable and related hardware, including wire rope, lifting products and synthetic rope and slings; corrosion resistant fasteners, hose clamps, and rivets.
Comprehensive value-added services include same-day shipping, knowledgeable sales staff, inventory management programs, just-in-time delivery, logistics support, customized online ordering capabilities and 24/7/365 service.
CONTACT: CONTACT:
Kayla Draper
Investor Relations Coordinator & Assistant to the CEO
Direct: 713.609.2227
Fax: 713.609.2168
kdraper@houwire.com Reported by GlobeNewswire 2 hours ago.
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San Francisco's out-of-control housing prices are causing residents to consider leaving the city in droves — here's where they're headed
· *A Bay Area Council survey reports that 46% of San Francisco Bay Area residents plan to leave the area soon.*· *San Franciscans cite the Bay Area's high housing costs as the largest reason for wanting to move.*
· *According to a new report from Redfin, Seattle, Washington, is the top out-of-state destination for Bay Area residents. Others include Sacramento, California; Austin, Texas; Portland, Oregon; and Las Vegas, Nevada.*
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Fed up with the Bay Area's high housing costs, 46% of residents say they plan to move elsewhere soon — up from 40% last year and 34% in 2016. That's according to the 2018 Bay Area Council survey, which suggests that the Bay Area exodus is getting even more dire.
When asked why they want to leave, 42% of residents said rising housing prices (a big jump from 28% last year). Eighteen percent cited traffic and congestion, 14% said poverty and homelessness, and 12% said living costs. Census data shows that net migration to the Bay Area peaked in 2014 and has been declining every year since.
As Business Insider's Melia Robinson has reported, researchers have been concerned about a mass departure from the Bay Area for some time. Earlier in 2018, the real-estate site Redfin found that San Francisco lost more residents than any other US city in the last quarter of 2017.
A new report from the same team may suggest where Bay Area residents could be moving. Redfin analyzed searches from more than 1 million users looking for homes across 75 metro areas from January to March 2018.
According to the study, the highest share of users (20.7%) searching for homes elsewhere came from Bay Area IP addresses. The top-searched destination for these users was Sacramento, California, and the top out-of-state destination was Seattle, Washington. San Franciscans also considered Austin, Texas; Portland, Oregon; and Las Vegas, Nevada.
All five of these metro areas generally have lower housing costs than the Bay Area, where the median price of a home recently hit a record high of $820,000. In Las Vegas, meanwhile, residents could find a home for just $252,000.
Seattle — home to Microsoft and Amazon — is a slightly less expensive city than San Francisco, and has seen an influx of tech workers in the past decade. Seattle is not immune to high housing costs, however. From 2005 to 2015, Seattle's median rent went from $1,008 to $1,286, an increase nearly three times the national median.
Recent data also shows Seattle's median home price hit $777,000 in February — $20,000 more than the previous all-time high set a month prior. According to Redfin, Seattle residents looking to leave mostly searched for homes in areas that are more affordable and less competitive, like Phoenix, Arizona, and Chicago, Illinois.
The Bay Area, considered the nation's tech capital, could also lose top tech workers if they can't afford to live there — even on six-figure salaries.
*SEE ALSO: Striking maps reveal the huge wealth gap between San Francisco and the rest of the country*
Join the conversation about this story »
NOW WATCH: Here's why coating our streets white could help lower temperatures in the summer Reported by Business Insider 2 hours ago.
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Texas mosque welcomes church damaged by car crash
VICTORIA, Texas (AP) — A Texas mosque that was destroyed by a fire early last year is opening its doors to church members who lost their place of worship after a car crashed into the facility. The Victoria Advocate reports that the Victoria Islamic Center offered its worship space Sunday to a group of about […]
Reported by Seattle Times 30 minutes ago.
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Texas A&M's Jacob Green on 2019 College Football Hall of Fame ballot
Former Texas A&M All-American Jacob Green is among 75 players and six coaches on the College Football Hall of Fame’s 2019 ballot.
Reported by Harrison Daily 1 hour ago.
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Cracked Windshield Leads to American Airlines Emergency Landing
A cracked windshield forced an American Airlines jetliner headed to Phoenix to make an emergency landing in El Paso, Texas, Sunday night, officials said.
Reported by Newsmax 2 hours ago.
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Dallas-area church targets 'dangerous isms,' such as Judaism
RICHARDSON, Texas (AP) — A Dallas-area church has distributed flyers advertising a series of weekly seminars it plans to host condemning "dangerous isms," such as Judaism, Islamism and liberalism.Greenville Avenue Church of Christ...
Reported by New Zealand Herald 2 hours ago.
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Chuy’s Holdings, Inc. to Participate at Three Upcoming Investor Conferences in June
AUSTIN, Texas, June 04, 2018 (GLOBE NEWSWIRE) -- Chuy’s Holdings, Inc. (NASDAQ:CHUY) today announced that the Company will participate at three investor conferences in June.On Wednesday, June 6, 2018, the Company will participate in a fireside chat discussion at the Baird 2018 Global Consumer, Technology & Services Conferences at the Intercontinental Barclay Hotel in New York City. Chuy’s discussion will begin at 4:20 PM Eastern Time.
On Tuesday, June 12, 2018, the Company will host investor meetings in conjunction with the Stifel 2018 Cross Sector Insight Conferences in Boston.
On Tuesday, June 19, 2018, the Company will participate in a fireside chat discussion at the Jefferies 2018 Global Consumer Conference at the White Elephant Hotel in Nantucket. Chuy’s discussion will begin at 3:00 PM Eastern Time.
These discussions will be webcast live and archived on the Chuy’s website. To access the webcast and recent copy of the Company’s presentation, please visit www.chuys.com under the “Investors” tab.
*About Chuy’s*
Founded in Austin, Texas in 1982, Chuy’s owns and operates 95 full-service restaurants across 19 states serving a distinct menu of authentic, made from scratch Tex-Mex inspired dishes. Chuy’s highly flavorful and freshly prepared fare is served in a fun, eclectic and irreverent atmosphere, while each location offers a unique, “unchained” look and feel, as expressed by the concept’s motto “If you’ve seen one Chuy’s, you’ve seen one Chuy’s!”. For further information about Chuy’s, including the nearest location, visit the Chuy’s website at www.chuys.com.
Investor Relations Contact:
Fitzhugh Taylor
203-682-8261
investors@chuys.com Reported by GlobeNewswire 1 hour ago.
On Tuesday, June 12, 2018, the Company will host investor meetings in conjunction with the Stifel 2018 Cross Sector Insight Conferences in Boston.
On Tuesday, June 19, 2018, the Company will participate in a fireside chat discussion at the Jefferies 2018 Global Consumer Conference at the White Elephant Hotel in Nantucket. Chuy’s discussion will begin at 3:00 PM Eastern Time.
These discussions will be webcast live and archived on the Chuy’s website. To access the webcast and recent copy of the Company’s presentation, please visit www.chuys.com under the “Investors” tab.
*About Chuy’s*
Founded in Austin, Texas in 1982, Chuy’s owns and operates 95 full-service restaurants across 19 states serving a distinct menu of authentic, made from scratch Tex-Mex inspired dishes. Chuy’s highly flavorful and freshly prepared fare is served in a fun, eclectic and irreverent atmosphere, while each location offers a unique, “unchained” look and feel, as expressed by the concept’s motto “If you’ve seen one Chuy’s, you’ve seen one Chuy’s!”. For further information about Chuy’s, including the nearest location, visit the Chuy’s website at www.chuys.com.
Investor Relations Contact:
Fitzhugh Taylor
203-682-8261
investors@chuys.com Reported by GlobeNewswire 1 hour ago.
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Texas mosque welcomes members of church damaged by car crash
VICTORIA, Texas (AP) — A Texas mosque that was destroyed by a fire last year is opening its doors to congregants who lost their place of worship after a car crashed into their church.The Victoria Advocate reports that the Victoria...
Reported by New Zealand Herald 1 hour ago.
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Sanofi: New England Journal of Medicine publishes pivotal cemiplimab trials showing positive results in advanced cutaneous squamous cell carcinoma
* * *Press Release*
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
* *
*New England Journal of Medicine publishes pivotal cemiplimab trials showing positive results in advanced cutaneous squamous cell carcinoma *
Patients treated with cemiplimab experienced robust anti-tumor effects Data also presented today at the 2018 ASCO Annual Meeting Cemiplimab applications under review by regulatory authorities in the U.S. and the EU; if approved, would be the third anti-PD-1 available
*Paris and Tarrytown, NY - June 4, 2018 *- The New England Journal of Medicine (NEJM) today published pivotal data from two trials evaluating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC). The results were also presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. Advanced CSCC, the deadliest nonmelanoma skin cancer, encompasses both patients with metastatic CSCC and those with locally advanced CSCC who are not candidates for surgery; there is currently no approved treatment for these patients. Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).
"The strong results seen with cemiplimab are noteworthy given that advanced CSCC is a very serious condition that currently has no approved treatments once surgery is no longer an option," said Michael R. Migden, M.D., co-lead author and Associate Professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center. "Advanced CSCC tumors were shown to be responsive to cemiplimab in both metastatic and locally advanced patients, with the results being clinically meaningful and consistent between the Phase 1 and Phase 2 trials."
*Pivotal CSCC trials represent largest prospective data set in this advanced cancer*
Data published in NEJM and/or presented at ASCO, and confirmed by independent central review, include:
Phase 2 EMPOWER-CSCC-1 trial: Cemiplimab-treated patients had a 47.5 percent response rate (28 of 59 patients, including 4 complete responses and 24 partial responses [PRs]) with a median observed time to response of 2 months as of the data cut-off date. The durable disease control rate (DCR) was 61 percent (36 of 59 patients) and was defined as the proportion of patients without progressive disease for at least 105 days. The median duration of response (DOR), median progression free survival, and median overall survival have not been reached as of the data cut-off date (median follow-up for all patients: 8 months). Of the responding patients, 82 percent remained in response and continued on cemiplimab. The estimated progression-free probability at 12 months was 52.5 percent, and the estimated probability of survival at 12 months was 81 percent.
The most common treatment-emergent adverse events were diarrhea (27 percent), fatigue (24 percent), nausea (17 percent), constipation and rash (each 15 percent). Grade 3 or higher adverse events regardless of attribution were reported in 25 patients (42 percent), of whom seven (12 percent) were considered related to treatment. Three patients (5 percent) had adverse events with the outcome of death; however, none were considered related to treatment. Data are from 59 metastatic CSCC patients who received cemiplimab (3 mg/kg every 2 weeks) for up to 96 weeks.
CSCC expansion cohorts of Phase 1 trial: Cemiplimab-treated patients had a response rate of 50 percent (13 of 26 patients, all of which were PRs) with a median observed time to response of 2 months as of the data cut-off date. The durable DCR was 65 percent (17 of 26 patients). The median DOR has not been reached as of the data cut-off date (median follow-up for all patients: 11 months).The most common treatment-emergent adverse events of any grade were fatigue (27 percent), constipation, decreased appetite, diarrhea, hypercalcemia, hypophosphatemia, nausea and urinary tract infection (each 15 percent). Grade 3 or higher adverse events regardless of attribution were reported in 12 patients (46 percent), of which five (19 percent) were considered related to treatment. Two patients (8 percent) had adverse events related to treatment that led to treatment discontinuation. Data are from 26 advanced CSCC patients who participated in two Phase 1 expansion cohorts and received cemiplimab (3 mg/kg every 2 weeks) for up 48 weeks. Patients either had metastatic CSCC or locally advanced CSCC who were not candidates for surgery.
These findings formed part of the data set used for regulatory applications for cemiplimab as a potential treatment for advanced CSCC. These applications were accepted earlier this year for priority review by the U.S. Food and Drug Administration (FDA) and review by the European Medicines Agency (EMA). The FDA target action date is October 28, 2018, and the EMA review process is expected to be complete by the first half of 2019. Regulatory applications in additional countries are also being considered for submission later in 2018. There are currently no FDA- or EMA-approved treatments for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.
Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In addition to CSCC, cemiplimab is also being investigated in potentially pivotal/pivotal trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer alongside exploratory trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.
Cemiplimab is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
*About CSCC*
CSCC is the second most common type of skin cancer in the U.S., accounting for approximately 20 percent of all skin cancers and with the number of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer. While estimates vary, sources suggest that between 4,000 to 8,000 people in the U.S. die annually of advanced CSCC.
*About Sanofi*
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
* *
*About Regeneron Pharmaceuticals, Inc.*
* *
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite^® technologies, such as VelocImmune^® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
* *
*Sanofi Media Relations Contact
*Ashleigh Koss
Tel.: +33 (0)1 53 77 46 46
mr@sanofi.com
*Regeneron Media Relations Contact*
Daren Kwok
Tel: +1 (914) 847-1328
daren.kwok@regeneron.com
* *
*Sanofi Investor Relations Contact
*George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
*Regeneron Investor Relations Contact*
Manisha Narasimhan, Ph.D.
Tel: +1 914-847-5126
Manisha.narasimhan@regeneron.com
*Sanofi Forward-Looking Statements *
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the potential marketing approvals for the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", "will be" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, including future clinical data relating to the product ,decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, , risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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*Regeneron Forward-Looking Statements and Use of Digital Media*
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate,""expect,""intend,""plan,""believe,""seek,""estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation cemiplimab for the treatment of patients with advanced cutaneous squamous cell carcinoma ("CSCC"), non-small cell lung cancer ("NSCLC"), basal cell carcinoma, cervical cancer, squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, Non-Hodgkin lymphoma, or other potential indications; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, such as cemiplimab for the treatment of patients with advanced CSCC, NSCLC, basal cell carcinoma, cervical cancer, squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, Non-Hodgkin lymphoma, or other potential indications; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials, such as cemiplimab; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates, such as cemiplimab; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in later studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labelling, distribution, and other steps related to Regeneron's products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer HealthCare LLC, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to Praluent® (alirocumab) Injection, the ultimate outcome of any such litigation proceedings, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2017 and its Form 10-Q for the quarterly period ended March 31, 2018. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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*Attachment*
· Press release (PDF).pdf Reported by GlobeNewswire 1 hour ago.
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
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*New England Journal of Medicine publishes pivotal cemiplimab trials showing positive results in advanced cutaneous squamous cell carcinoma *
Patients treated with cemiplimab experienced robust anti-tumor effects Data also presented today at the 2018 ASCO Annual Meeting Cemiplimab applications under review by regulatory authorities in the U.S. and the EU; if approved, would be the third anti-PD-1 available
*Paris and Tarrytown, NY - June 4, 2018 *- The New England Journal of Medicine (NEJM) today published pivotal data from two trials evaluating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC). The results were also presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. Advanced CSCC, the deadliest nonmelanoma skin cancer, encompasses both patients with metastatic CSCC and those with locally advanced CSCC who are not candidates for surgery; there is currently no approved treatment for these patients. Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).
"The strong results seen with cemiplimab are noteworthy given that advanced CSCC is a very serious condition that currently has no approved treatments once surgery is no longer an option," said Michael R. Migden, M.D., co-lead author and Associate Professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center. "Advanced CSCC tumors were shown to be responsive to cemiplimab in both metastatic and locally advanced patients, with the results being clinically meaningful and consistent between the Phase 1 and Phase 2 trials."
*Pivotal CSCC trials represent largest prospective data set in this advanced cancer*
Data published in NEJM and/or presented at ASCO, and confirmed by independent central review, include:
Phase 2 EMPOWER-CSCC-1 trial: Cemiplimab-treated patients had a 47.5 percent response rate (28 of 59 patients, including 4 complete responses and 24 partial responses [PRs]) with a median observed time to response of 2 months as of the data cut-off date. The durable disease control rate (DCR) was 61 percent (36 of 59 patients) and was defined as the proportion of patients without progressive disease for at least 105 days. The median duration of response (DOR), median progression free survival, and median overall survival have not been reached as of the data cut-off date (median follow-up for all patients: 8 months). Of the responding patients, 82 percent remained in response and continued on cemiplimab. The estimated progression-free probability at 12 months was 52.5 percent, and the estimated probability of survival at 12 months was 81 percent.
The most common treatment-emergent adverse events were diarrhea (27 percent), fatigue (24 percent), nausea (17 percent), constipation and rash (each 15 percent). Grade 3 or higher adverse events regardless of attribution were reported in 25 patients (42 percent), of whom seven (12 percent) were considered related to treatment. Three patients (5 percent) had adverse events with the outcome of death; however, none were considered related to treatment. Data are from 59 metastatic CSCC patients who received cemiplimab (3 mg/kg every 2 weeks) for up to 96 weeks.
CSCC expansion cohorts of Phase 1 trial: Cemiplimab-treated patients had a response rate of 50 percent (13 of 26 patients, all of which were PRs) with a median observed time to response of 2 months as of the data cut-off date. The durable DCR was 65 percent (17 of 26 patients). The median DOR has not been reached as of the data cut-off date (median follow-up for all patients: 11 months).The most common treatment-emergent adverse events of any grade were fatigue (27 percent), constipation, decreased appetite, diarrhea, hypercalcemia, hypophosphatemia, nausea and urinary tract infection (each 15 percent). Grade 3 or higher adverse events regardless of attribution were reported in 12 patients (46 percent), of which five (19 percent) were considered related to treatment. Two patients (8 percent) had adverse events related to treatment that led to treatment discontinuation. Data are from 26 advanced CSCC patients who participated in two Phase 1 expansion cohorts and received cemiplimab (3 mg/kg every 2 weeks) for up 48 weeks. Patients either had metastatic CSCC or locally advanced CSCC who were not candidates for surgery.
These findings formed part of the data set used for regulatory applications for cemiplimab as a potential treatment for advanced CSCC. These applications were accepted earlier this year for priority review by the U.S. Food and Drug Administration (FDA) and review by the European Medicines Agency (EMA). The FDA target action date is October 28, 2018, and the EMA review process is expected to be complete by the first half of 2019. Regulatory applications in additional countries are also being considered for submission later in 2018. There are currently no FDA- or EMA-approved treatments for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.
Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In addition to CSCC, cemiplimab is also being investigated in potentially pivotal/pivotal trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer alongside exploratory trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.
Cemiplimab is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
*About CSCC*
CSCC is the second most common type of skin cancer in the U.S., accounting for approximately 20 percent of all skin cancers and with the number of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer. While estimates vary, sources suggest that between 4,000 to 8,000 people in the U.S. die annually of advanced CSCC.
*About Sanofi*
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
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*About Regeneron Pharmaceuticals, Inc.*
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Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite^® technologies, such as VelocImmune^® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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*Sanofi Media Relations Contact
*Ashleigh Koss
Tel.: +33 (0)1 53 77 46 46
mr@sanofi.com
*Regeneron Media Relations Contact*
Daren Kwok
Tel: +1 (914) 847-1328
daren.kwok@regeneron.com
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*Sanofi Investor Relations Contact
*George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
*Regeneron Investor Relations Contact*
Manisha Narasimhan, Ph.D.
Tel: +1 914-847-5126
Manisha.narasimhan@regeneron.com
*Sanofi Forward-Looking Statements *
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the potential marketing approvals for the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", "will be" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, including future clinical data relating to the product ,decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, , risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
* *
*Regeneron Forward-Looking Statements and Use of Digital Media*
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate,""expect,""intend,""plan,""believe,""seek,""estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation cemiplimab for the treatment of patients with advanced cutaneous squamous cell carcinoma ("CSCC"), non-small cell lung cancer ("NSCLC"), basal cell carcinoma, cervical cancer, squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, Non-Hodgkin lymphoma, or other potential indications; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, such as cemiplimab for the treatment of patients with advanced CSCC, NSCLC, basal cell carcinoma, cervical cancer, squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, Non-Hodgkin lymphoma, or other potential indications; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials, such as cemiplimab; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates, such as cemiplimab; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in later studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labelling, distribution, and other steps related to Regeneron's products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer HealthCare LLC, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to Praluent® (alirocumab) Injection, the ultimate outcome of any such litigation proceedings, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2017 and its Form 10-Q for the quarterly period ended March 31, 2018. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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*Attachment*
· Press release (PDF).pdf Reported by GlobeNewswire 1 hour ago.
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