Categoría: Geovanny Vicente

ATLANTA, Aug. 7, 2020 /PRNewswire/ — The Council of State and Territorial Epidemiologists (CSTE) has announced the approval of a second interim position statement revising the established standardized case definition and classification for COVID-19. Updates clarify clinical, laboratory, epidemiologic linkage and vital records criteria necessary for surveillance based on rapid advancement in the science of COVID-19 disease and SARS-CoV-2 infection. The revised case definition was developed by CSTE members in close collaboration with representatives of the Association of Public Health Laboratories (APHL) and experts at the Centers for Disease Control and Prevention (CDC). It has been broadly vetted among State Epidemiologists, CDC Response Incident Management and Office of Infectious Diseases leadership. View the interim position statement here.

«As the COVID-19 pandemic continues to evolve and we learn more about the disease, so too does the case definition and disease surveillance strategies,» said CSTE Executive Director Janet Hamilton, MPH. «Public health knows more about COVID-19 now, including optimal practices in identifying and classifying cases. I’d like to commend our members and partners who collaborated on this update, while tirelessly responding to this immense public health crisis.»

CSTE position statements are developed by CSTE members, in close partnership with CDC, and reflect membership consensus opinion on policy issues or surveillance strategies, including case definitions for diseases and conditions across the full spectrum of epidemiologic domains. Position statements are proposed, discussed, and ratified or rejected by the «Council,» which is a voting body comprised of State Epidemiologists from all U.S. states and territories. Case definition position statements establish more consistent disease surveillance across the nation improving national health monitoring and interactions between health care providers and public health disease investigators. As was done earlier this spring for COVID-19, position statements may also recommend that a disease or condition be placed under national public health surveillance, thus added to the list of Nationally Notifiable Conditions (NNC).  

For more information on the CSTE position statement process, please visit https://www.cste.org/page/PSLanding.  

About CSTE
Founded in 1951, the Council of State and Territorial Epidemiologists (CSTE) represents the interests of State Epidemiologists from all 50 U.S. states and territories, comprising the Council. CSTE is also the professional home to over 2000 practicing applied epidemiologists working at the state, local, tribal and territorial levels. For more information, visit www.cste.org.

Media Contact: Jeremy Arieh, Director of Communications, 770-458-3811, email: jarieh@cste.org

View original content:http://www.prnewswire.com/news-releases/cste-updates-interim-position-statement-on-covid-19-301108521.html

SOURCE Council of State and Territorial Epidemiologists

CHICAGO, Aug. 7, 2020 /PRNewswire/ — Always Growing, Auburn Gresham has been awarded the first ever Chicago Prize, a $10 million grant competition of the Pritzker Traubert Foundation that sought to invest in collaborative initiatives using physical development to spur economic activity, strengthen civic infrastructure, and improve the safety, well-being, and economic mobility of residents in the city’s South and/or West sides.

Also, the Foundation announced an additional commitment of $2.5 million in development funds accessible to the other finalist teams from Austin, Englewood, Little Village North Lawndale and South Chicago. This brings its total investment in the Chicago Prize teams to more than $13 million since the competition launched in April 2019.

Always Growing, Auburn Gresham is a collaborative of the Greater Auburn Gresham Development Corporation, Urban Growers Collective and Green Era Partners, led by Carlos Nelson, Erika Allen and Jason Feldman, respectively. Their initiative was selected for the Chicago Prize because of its unique combination of proposed projects that have the potential to create long-term economic opportunity, including the creation of 300 construction and 300 permanent professional jobs, and a greenhouse space expected to grow 14,000 – 26,000 pounds of food per year, while also meeting the immediate needs of residents.

«Our team has worked incredibly hard since the inception of this project to make this dream a reality for the Auburn Gresham community,» said Nelson, who has led the Greater Auburn Gresham Development Corporation since 2003. «The time and effort we have put into this project reflects the love we have for our community and the people who live here.»

The Always Growing, Auburn Gresham project involves two physical sites:  a 1920s-era, terracotta building that will be converted into a Healthy Lifestyle Hub that will serve nearly 11,000 unique patients annually and feature many amenities; and a vacant brownfield, being developed into a renewable energy and urban farm campus, a for-profit enterprise.

«Auburn Gresham’s submission is indicative of the innovative ideas and remarkable talent Chicago leaders have to offer and it represents the ideals of the Chicago Prize– strong and dedicated local leadership, a plan with deep roots in the community, projects that respond to the needs of residents and set the stage for additional investment,» said Bryan Traubert, co-founder and trustee of the foundation.  «Perhaps most exciting of all, the Auburn Gresham team has a unique initiative structure, which gives the Greater Auburn Gresham Development Corporation a financial stake in the digestor enterprise and allows for a share of its profits to be distributed back to the Auburn Gresham neighborhood.»

The Chicago Prize represents the single-largest investment in the project’s total development budget of $52.8 million. In July, the City of Chicago committed $4 million of funding from the federal C.A.R.E.S. Act to the Healthy Hub as part of the City’s Invest South/West initiative.

«Today is incredibly exciting, for me, for our city and for Auburn Gresham,» said Penny Pritzker, co-founder and trustee of the Pritzker Traubert Foundation.  «When we created the Chicago Prize, it was designed to provide flexible, private capital for neighborhoods whose potential has been restrained as a result of historic and present-day disinvestment. Over the past year, I’ve learned about many projects that are ready for investment and being led by dynamic teams. This project tops the list, and the spotlight we’re shining on it today is well-earned. We’re excited that our investment in Always Growing, Auburn Gresham will leverage public investments and has the potential to unlock additional private dollars for other important projects.»

«Always Growing, Auburn Gresham is the kind of bold, innovative work, rooted in deep community partnerships that is needed to make our city more equitable and vibrant.» said Penny Pritzker. «Chicago is our home and we are deeply committed to doing all we can to help strengthen the economic future for more of our residents, so that all our communities thrive.  We look forward to continuing to work with both public and private partners to support South and West side leaders whose bold ideas will positively impact their communities and uplift the quality of life for everyone in Chicago.»

The Chicago Prize was developed by the Pritzker Traubert Foundation with support from Lever for Change, a new affiliate of the John D. and Catherine T. MacArthur Foundation. Other Chicago Prize advisors include: BCG’s Center for Illinois’ Future; Urban Institute; SB Friedman; DLA Piper; Mt Auburn Associates; IFF;  Bridgespan Group; Michael Fassnacht and FCB; Commissioner Maurice Cox and the Invest South/West team of the Chicago Dept. of Planning and Development.

Chicago Prize launched in April 2019. Twenty entrants received top recognition by a review panel of subject-matter experts. Of those, 14 teams received a $10,000 award to recognize their collaborative work and six were named Chicago Prize finalists and each given $100,000 grants to support their ongoing project planning and preparation of final proposals for the selection committee.

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View original content:http://www.prnewswire.com/news-releases/pritzker-traubert-foundation-announces-recipient-of-the-chicago-prize-301108497.html

SOURCE Pritzker Traubert Foundation

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.

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SOURCE PTC Therapeutics, Inc.