Mes: agosto 2020

WOODS HOLE, Mass., Aug. 7, 2020 /PRNewswire/ — A key component of the Gulf Stream has markedly slowed over the past century–that’s the conclusion of a new research paper in Nature Communications published on August 7. The study develops a method of tracking the strength of near-shore ocean currents using measurements made at the coast, offering the potential to reduce one of the biggest uncertainties related to observations of climate change over the past century.

«In the ocean, almost everything is connected,» said Christopher Piecuch, an assistant scientist in the Physical Oceanography Department at the Woods Hole Oceanographic Institution (WHOI) and author of the study. «We can use those connections to look at things in the past or far from shore, giving us a more complete view of the ocean and how it changes across space and time.»

Piecuch, who specializes in coastal and regional sea level change, used a connection between coastal sea level and the strength of near-shore currents to trace the evolution of the Florida Current, which forms the beginning of the Gulf Stream. The Gulf Stream flows north along the Southeast Atlantic Coast of the United States and eventually east into the North Atlantic Ocean, carrying heat, salt, momentum, and other properties that influence Earth’s climate. Because nearly continuous records of sea level stretch back more than a century along Florida’s Atlantic Coast and in some parts of the Caribbean, he was able to use mathematical models and simple physics to extend the reach of direct measurements of the Gulf Stream to conclude that it has weakened steadily and is weaker now than at any other point in the past 110 years.

One of the biggest uncertainties in climate models is the behavior of ocean currents either leading to or responding to changes in Earth’s climate. Of these, one of the most important is the Atlantic Meridional Overturning Circulation, or AMOC, which is a large system or «conveyor belt» of ocean currents in the Atlantic that includes the Gulf Stream and that helps regulate global climate. Piecuch’s analysis agrees with relationships seen in models between the deeper branches of the AMOC and the Gulf Stream, and it corroborates studies suggesting that the deeper branches of AMOC have slowed in recent years. His method also offers the potential to monitor ocean currents like the Gulf Stream from the coast, complementing existing but difficult-to-maintain moored instruments and expensive research cruises.

«If we can monitor something over the horizon by making measurements from shore, then that’s a win for science and potentially for society,» said Piecuch.

The Woods Hole Oceanographic Institution is a private, non-profit organization on Cape Cod, Mass., dedicated to marine research, engineering, and higher education. Established in 1930 on a recommendation from the National Academy of Sciences, its primary mission is to understand the ocean and its interaction with the Earth as a whole, and to communicate a basic understanding of the ocean’s role in the changing global environment. For more information, please visit www.whoi.edu.

Key Takeaways

• The Florida Current, which forms the start of the Gulf Stream, has slowed over the past century and is the slowest it has been at any point in the past 110 years.
• Historical analysis of the current was made using sea level records from Florida and the Caribbean.
• Slowing of the Florida Current relates to the strength of the Gulf Stream and the much broader system of currents known as the Atlantic Meridional Overturning Circulation (AMOC) that helps regulate global climate.
• Understanding past changes in ocean currents helps reduce one of the biggest uncertainties in observations of climate change over the past century.

Provided by Newswise, online resource for knowledge-based news at www.newswise.com

Media Contacts: Erin Koenig
Media Relations Manager
ekoenig@whoi.edu
Phone: 508-289-2270
Mobile: 508-566-0989

View original content:http://www.prnewswire.com/news-releases/florida-current-is-weaker-now-than-at-any-point-in-the-past-century-301108465.html

SOURCE Woods Hole Oceanographic Institution

SOUTH PLAINFIELD, N.J., Aug. 7, 2020 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Evrysdi™ (risdiplam), the first at-home, orally administered treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older. Evrysdi showed clinically meaningful improvements in motor function and obtainment of developmental milestones across two trials in patients age two months and above and across all levels of disease severity, including types 1, 2, and 3 SMA. Infants achieved key motor milestones not normally seen in the natural course of the disease, such as the ability to sit without support. Evrysdi also preserved vital functions and improved survival at 12 months. In particular, Evrysdi improved survival without permanent ventilation compared to natural history when measured at 12 and 23 months.

«Today marks an incredibly important moment for the broader SMA patient community that had been in dire need of safe and effective treatment options,» said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. «We are appreciative of the patients, physicians and others involved with its development, and our partners at the SMA Foundation and Roche. We are proud that the first oral treatment for spinal muscular atrophy patients was discovered through our splicing platform. I believe that this is one of the most innovative products in the pharmaceutical industry and we are gratified to have played a key role in its discovery and development.»

Evrysdi has been studied in a robust clinical trial program in SMA with more than 450 patients and subjects. The program includes infants aged 2 months to adults aged 60 with a range of symptoms and motor function including patients with scoliosis or joint contractures. Patients previously treated for SMA with other medications were also included. The approval is based on results from two clinical studies designed to represent a broad spectrum of patients living with SMA: FIREFISH in symptomatic infants aged 2 to 7 months; and SUNFISH, in children and adults aged 2 to 25 years. SUNFISH is the first and only placebo-controlled trial to include adults with types 2 and 3 SMA. 

«We started looking for treatments for SMA more than a decade ago,» said Loren Eng, President of the SMA Foundation. «PTC was one of the companies that embraced and remained committed to the idea of developing a truly innovative therapeutic for this disease. We are proud to be part of the collaboration that brought the first oral SMA treatment for patients.»

In FIREFISH, 41% (7/17) of infants treated with the therapeutic dose achieved the ability to sit without support for at least 5 seconds as measured by the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Additionally, 90% (19/21) of infants were alive without permanent ventilation at 12 months of treatment and reached 15 months of age or older. As described in the natural history of untreated infantile-onset SMA, infants would not be expected to be able to sit independently and only 25 percent of infants would be expected to survive without permanent ventilation beyond 14 months of age. In SUNFISH, children and adults treated with Evrysdi experienced a statistically significant and clinically meaningful improvement in motor function at 12 months (1.55 point mean difference; p = 0.0156) compared to placebo, as measured by a change in baseline on the Motor Function Measure-32 (MFM-32) scale.

Evrysdi demonstrated a favorable efficacy and safety profile, with the safety profile established across the FIREFISH and SUNFISH trials. The most common adverse reactions were fever, diarrhea, and rash in later-onset SMA. In infantile-onset SMA, the most common adverse events were similar and also included upper respiratory tract infection, pneumonia, constipation, and vomiting. There were no treatment-related safety findings leading to withdrawal from any study. Ophthalmological monitoring is not required.

Evrysdi will be available in the United States within two weeks for direct delivery to patients’ homes through Accredo Health Group Inc., an Express Scripts specialty pharmacy.

Evrysdi will be marketed in the United States by Genentech, a member of the Roche Group, and received an orphan drug designation from FDA in 2017. Outside the United States, Roche holds global commercialization rights to risdiplam, and the European Medicines Agency (EMA) previously granted PRIME (Priority Medicines) designation to risdiplam in 2018 for the treatment of people with SMA and an orphan drug designation in 2019. The submission of a marketing authorization application (MAA) to EMA for risdiplam is pending. At this time, Roche has submitted applications for approval in Brazil, Chile, China, Indonesia, Russia, South Korea and Taiwan.

Evrysdi is a product of the SMA collaboration between PTC, the SMA Foundation, and Roche.

About Evrysdi™ (risdiplam)

Evrysdi is a survival motor neuron 2 (SMN2)-directed RNA splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is designed to distribute evenly to all parts of the body, including the central nervous system (CNS). Evrysdi is administered daily at home in liquid form by mouth or feeding tube.

About the Clinical Studies

FIREFISH (NCT02913482)

FIREFISH, an open-label, two-part pivotal study, was designed to assess Evrysdi safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) in patients aged 1 to 7 months with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2. In Part 1, after 12 months of Evrysdi treatment:

• 41% (7/17) of infants treated with the therapeutic dose achieved the ability to sit without support for at least 5 seconds as measured by the BSID-III gross motor scale.
• 90% (19/21) of all infants were alive without permanent ventilation* and reached 15 months of age or older.
• 81% (17/21) of all patients were alive without permanent ventilation* after a minimum of 23 months of treatment and reached an age of 28 months or older (median 32 months; range 28-45 months)

*Permanent ventilation defined as tracheostomy or ≥16 hours of non-invasive ventilation per day or intubation for ≥21 consecutive days in the absence of, or following the resolution of, an acute reversible event.

SUNFISH (NCT02908685)

SUNFISH, a two-part, placebo-controlled, multicenter pivotal trial, was designed to assess Evrysdi safety, tolerability, efficacy, PK and PD in people with type 2 or 3 SMA aged 2 to 25, including those with scoliosis (67% in Part 2) and joint contractures at baseline. In Part 2, after 12 months, Evrysdi treatment led to:

• A clinically meaningful and statistically significant improvement in motor function among children and adults, as measured by a change in baseline in the MFM-32 total score (1.55 point mean difference; p = 0.0156), at 12 months as compared to placebo (1.36 points [risdiplam treatment arm -95% CI: 0.61, 2.11]; [placebo treatment arm: -0.19 points 95% CI: 1.22, 0.84]). MFM-32 assesses 32 different motor functions across a wide range of people with SMA.
• Improved upper limb motor function compared to baseline, as measured by the Revised Upper Limb Module (RULM), a secondary independent motor function endpoint of the study (1.59 point difference; p=0.0028).

Clinical Trial Safety Data

The safety profile of Evrysdi was established across FIREFISH and SUNFISH pivotal trials. The most common adverse reactions in later-onset SMA (incidence of at least 10% of patients treated with Evrysdi and more frequently than control) were fever, diarrhea, and rash. The most common adverse reactions in infantile-onset SMA were similar to those observed in later-onset SMA patients. Additionally, the most common adverse reactions (incidence of at least 10%) were upper respiratory tract infection, pneumonia, constipation, and vomiting. 

About the Evrysdi Clinical Trial Program

In addition to FIREFISH and SUNFISH, Evrysdi is being evaluated in a broad range of people with SMA, including in:

• JEWELFISH (NCT03032172): an open-label exploratory trial designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in people with SMA aged 6 months to 60 years who received other investigational or approved SMA therapies for at least 90 days prior to receiving Evrysdi. Recruitment for this study is complete with 174 people enrolled.
• RAINBOWFISH (NCT03779334): an open-label, single-arm, multicenter study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of Evrysdi in infants (~n=25), from birth to six weeks of age (at first dose) with genetically diagnosed SMA who are not yet presenting with symptoms. The study is currently recruiting.

About Spinal Muscular Atrophy (SMA)

Spinal muscular atrophy (SMA) is a severe, inherited, progressive neuromuscular disease that causes devastating muscle atrophy and disease-related complications. It is the most common genetic cause of infant mortality and one of the most common rare diseases, affecting approximately one in 11,000 babies¹. SMA leads to the progressive loss of nerve cells in the spinal cord that control muscle movement. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.

SMA is caused by a mutation in the survival motor neuron 1 (SMN1) gene that results in a deficiency of SMN protein. SMN protein is found throughout the body and increasing evidence suggests SMA is a multi-system disorder and the loss of SMN protein may affect many tissues and cells, which can stop the body from functioning.

About PTC Therapeutics, Inc.

PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, on Twitter at @PTCBio, and on LinkedIn.

For More Information:
Investors:
Alex Kane
+1 (908) 912-9643
akane@ptcbio.com

Media: 
Jane Baj
+1 (908) 912-9167 
jbaj@ptcbio.com 

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this release, other than statements of historical fact, are forward-looking statements, including statements regarding: the future expectations, plans and prospects for PTC; the timing of commercial availability and potential methods of distribution for Evrysdi; advancement of PTC’s joint collaboration program in SMA, including any potential regulatory submissions, regulatory approvals or commercial prospects;  PTC’s strategy, future operations, future financial position, future revenues and, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words «guidance», «plan,» «anticipate,» «believe,» «estimate,» «expect,» «intend,» «may,» «target,» «potential,» «will,» «would,» «could,» «should,» «continue,» and similar expressions.

PTC’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC’s products or product candidates that PTC commercializes or may commercialize in the future, including Evrysdi; the enrollment, conduct, and results of studies under the SMA collaboration and events during, or as a result of, the studies that could delay or prevent further development under the program, including any potential regulatory submissions and potential commercialization with regards to Evrysdi; the eligible patient base and commercial potential of Evrysdi or any of PTC’s other product candidates; and the factors discussed in the «Risk Factors» section of PTC’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC’s other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product or product candidate will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including Evrysdi.

The forward-looking statements contained herein represent PTC’s views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

View original content:http://www.prnewswire.com/news-releases/ptc-therapeutics-announces-fda-approval-of-evrysdi-risdiplam-for-the-treatment-of-spinal-muscular-atrophy-in-adults-and-children-2-months-and-older-301108489.html

SOURCE PTC Therapeutics, Inc.

PEAPACK and GLADSTONE, N.J., Aug. 7, 2020 /PRNewswire-PRWeb/ — Pendry Residences Natirar, a new luxury offering by Montage, today announced a collaboration with Delos™, the world’s leading wellness and real estate technology company, to integrate Delos’ leading home wellness intelligence network designed exclusively for luxury homes into the luxury residences coming to the rolling hills of Somerset County, New Jersey, an hour outside of New York City. The limited collection of fully serviced private Farm Villa residences will feature DARWIN Premier, Delos’ most exclusive offering that combines products, features, technologies, and services to create and maintain indoor environmental conditions that are designed to enhance health, well-being, and performance. The inclusion of the DARWIN system will apply best practices in design and construction with evidence-based health and wellness interventions, becoming the first residential community in the Northeastern United States to incorporate it as a base package.

The strategic collaboration between Pendry Residences Natirar and Delos delivers an innovative and unique comprehensive health and wellness living lifestyle into the residential experience. The DARWIN Premier technology optimizes well-being by:

• Monitoring air quality and temperature, mitigating environmental concerns within the home environment by reducing indoor contaminants that negatively affect respiratory, cardiovascular, immune and cognitive health.
• Ensuring cleaner, better tasting water through the DARWIN Water Filtration System.
• Providing circadian lighting that mimics the patterns of the sun to restore residents’ natural circadian rhythms.
• Creating spaces that help reduce stress, regulate energy levels, promote mindful living and improve sleep quality.

«By working with Delos to integrate DARWIN Premier, Pendry Residences Natirar are furthering our commitment to exceptional residential experiences, especially within the wellness space,» says Tina Necrason, executive vice president, residential, Montage International. «We are truly offering residents the most optimal connection to outdoor living and wellness management with modern design spaces and residential amenities that inspire the ultimate indoor-outdoor experience. In the current climate, it’s never been more important to create a home that benefits owners mental health and well-being and we foresee this being a necessity for buyers more now than ever.»

«From years of experience and extensive research, we know that our indoor environments can impact physical, emotional and cognitive health outcomes,» said Delos Founder and CEO Paul Scialla. «Through the integration of DARWIN Premier, Pendry Residences Natirar have demonstrated a commitment to the health, well-being and safety of their residents.»

Situated on 90 acres of pastoral grounds and featuring a sustainable 12-acre farm, Pendry Natirar, opening in early 2022, will redesign and reinvigorate the historic Tudor-style Natirar mansion estate to create a modern-day manor that will feature 66 guestrooms and suites, along with a limited collection of 24-fully serviced private Estate and Farm Villa residences ranging in size from 2,900 square feet to more than 3,600 square feet.

Thoughtfully designed into the landscape, the private residences celebrate contemporary style in a sophisticated atmosphere with intentionally curated materials and details that frame the seasonal beauty surrounding the property. Set within a private enclave named Abby Road, The Estate Villa Residences will offer a semi-custom home building experience with abundant living spaces, expansive views, and options to personalize selections and home configurations. The Farm Villa Residences encompass a true, private Agrihood—including a working farm as the backdrop – providing owners with the ability to immerse themselves in a community focused on sustainable living, wellness and connection to nature; all accompanied by the personalized services and amenities of Pendry Natirar.

Homeowners will have access to a full-service Spa Pendry including an extensive health and wellness programming, fitness center, swimming pool and tennis courts, and a variety of classic and unique outdoor activities to be discovered throughout the property.

«Pendry Natirar will be set among scenic trails and pathways groomed for hiking, biking and horseback riding surrounded by 400 acres of protected land along the north branch of the Raritan River,» says Robert Wojtowicz, founder, Natirar. «By blending this unparalleled setting with the Delos technology and all that Pendry Natirar has to offer – we are truly affording the ultimate amenities and experience in luxury and wellness real estate.»

The highly-anticipated Pendry Residences Natirar construction commenced in May 2020 with expected completion of the first phase of residences by the end of this year. Now pre-selling select Residences from the low $2 millions.

Montage International has plans to expand its partnership with Delos; announcement and more details to follow.

For more information about Pendry Residences Natirar, please visit http://www.pendryresidencesnatirar.com/. For more information about Delos, please visit http://www.delos.com.

About Pendry Residences
Pendry Residences is a bespoke collection of private, whole ownership residential offerings at select Pendry Hotels & Resorts, a new luxury hospitality brand from Montage International. Pendry combines inspired design with a celebration of culture and authentic service. Created for discerning homeowners, each residential offering infuses a unique perspective on contemporary style that blends with the arts and local community. The Pendry Residences portfolio under development includes: West Hollywood, California; Natirar, New Jersey; La Quinta, California; and Park City, Utah. For additional information on residential opportunities, please visit http://www.pendry.com/residences and http://www.distinctlivinghome.com.

About Pendry Hotels & Resorts
Pendry Hotels & Resorts is a new luxury hospitality brand from Montage International. Pendry combines inspired design with a celebration of culture and authentic service tailored to today’s cultured world traveler. Founders Alan J. Fuerstman and Michael Fuerstman’s well-seasoned experience in the hospitality industry serves as the foundation for the brand. Each property is injected with a unique perspective on contemporary style, and an emphasis on the arts and local community in the city it calls home. The portfolio of hotels includes Pendry San Diego and Sagamore Pendry Baltimore. Opening in 2020 is Pendry West Hollywood, opening in 2021 is Pendry Manhattan West and Pendry Park City, opening in 2022 is Pendry La Quinta, Pendry Natirar, and Pendry Washington D.C. – The Wharf. Pendry Hotels & Resorts is a member of Preferred Hotels & Resorts. For more information on Pendry Hotels & Resorts, follow @pendryhotels or visit http://www.pendry.com.

About Natirar
Natirar is one of the country’s most idyllic country retreats, formerly owned by the King of Morocco, and set on a 500-acre estate in New Jersey’s Somerset Hills. It is a public private partnership between Somerset County and Robert Wojtowicz, Natirar’s founder. In 2017, a comprehensive renovation to the historic Natirar Mansion was completed, including restoration to the 1912 Tudor and the addition of a new Grand Ballroom, ideal for galas, weddings and exclusive meetings. Natirar already boasts one of the region’s most acclaimed restaurants, Ninety Acres, built in the estate’s restored carriage house, which includes a cooking school, a private club and a 12-acre farm. Secluded, yet easily accessible, the Natirar estate is less than an hour from New York City, 90 minutes from Philadelphia and 30 minutes from Newark Liberty International Airport.

 

SOURCE Pendry Residences

WASHINGTON, Aug. 7, 2020 /PRNewswire/ — Alfredo Ortiz, President and CEO of the Job Creators Network, released the following statement regarding an executive order suspending the payroll tax:

«A payroll tax deferral would give a lifeline to the self-employed and small businesses and would go a long way to helping Main Street. It would especially help the 26 million Americans who are self-employed and responsible for paying both the employer and employee portions of the payroll tax (like Uber drivers and other gig employees). This action would put more money in people’s paychecks, help small businesses, and accelerate the economic recovery. Job Creators Network encourages President Trump to use an executive order to bypass those in the House of Representatives playing politics with people’s livelihoods and refusing to compromise.»

Visit JobCreatorsNetwork.com for more information.

View original content:http://www.prnewswire.com/news-releases/job-creators-network-supports-payroll-tax-deferral-via-executive-order-301108480.html

SOURCE Job Creators Network

NEW YORK, Aug. 7, 2020 /PRNewswire-PRWeb/ — Global law firm Greenberg Traurig, LLP released Episode 2 of the Legal Environmental Insights Podcast, «EPA Finalizes Rule Limiting States’ Energy Veto Authority,» as part of its «Empire Environmental» mini-series focused on environmental and energy issues impacting the State of New York.

In episode two, Shareholders Zackary D. Knaub and Steven C. Russo explore states’ authority to issue, deny or attach conditions to «water quality certification,» under the Clean Water Act, and the recent EPA rule aimed at reducing the states’ ability to use this authority to block controversial interstate infrastructure projects, such as fossil fuel pipelines.
Episode 2 is available on the Greenberg Traurig website, as well as on Apple Podcasts, Stitcher, and Spotify.

The firm’s Legal Environmental Insights podcast launched on the 50th Anniversary of Earth Day, April 22, 2020. The podcast’s mission is to offer comprehensive summaries and concrete takeaways on the latest developments and trends in environmental law. It is designed to help business leaders, in-house counsel, and entrepreneurs stay current on environmental laws that impact their businesses.

Listen to prior episodes:

• National Environmental Policy Act’s (NEPA) Upcoming Changes

About Greenberg Traurig’s Environmental Practice
Greenberg Traurig’s New York Environmental Practice brings together legal, legislative, and industry professionals to represent clients in permitting matters and associated environmental review, Brownfields, transactions, regulatory enforcement, administrative proceedings, and litigation. They represent clients on large mixed-use and residential development projects, transportation, energy, waste management, sewage treatment and drinking water, and all laws and regulations applicable thereto, including all major federal environmental statues as well as local zoning laws and ordinances. Greenberg Traurig received a first-tier ranking in the «Environmental Law» and «Litigation — Environmental» categories in the U.S. News – Best Lawyers 2019 «Best Law Firms» report.

About Greenberg Traurig, LLP
Greenberg Traurig, LLP (GT) has approximately 2,200 attorneys in 41 locations in the United States, Latin America, Europe, Asia, and the Middle East. GT has been recognized for its philanthropic giving, diversity, and innovation, and is consistently among the largest firms in the U.S. on the Law360 400 and among the Top 20 on the Am Law Global 100. Web: http://www.gtlaw.com Twitter: @GT_Law.

 

SOURCE Greenberg Traurig, LLP