Related: By Mary Catherine Collet April 30, 2021 Reprints Tags advocacydrug developmentgovernment agencies I’ve tried to do the right things since losing my mom: read, study, be informed. Talk to people who know processes and systems and can influence change. Think creatively. Go to meetings. Speak out. Find like-minded individuals and move the system in new directions.Decades into the struggle for effective therapies, I’ve found myself among an incredibly talented and thoughtful group of people living with ALS and their caregivers who want to facilitate smart, practical, and needed change in how therapies for this devastating disease are developed and approved.advertisement We thought we were close over the past couple years — close to more humane trials and faster approvals for ALS therapies, and to better access to investigational therapies for those dying from ALS.In the past few weeks, though, we’ve learned we’re anything but close. @alsadvocacy Matt Scozzari holds his girlfriend Sabrina Parker’s hand during a friendship ceremony in Jacksonville, N.C., in November 2010 to pledge their commitment to each other. Sabrina passed away days later from ALS, which also killed her mother and grandmother. Gerry Broome/AP FDA wants more data on promising ALS drug, frustrating patients seeking faster access About the Author Reprints It appears to me and to others that FDA officials wanted Amylyx’s study to knock the agency’s socks off. But in all those encouraging FDA meetings, agency officials forgot to tell ALS families and advocates that, in addition to the trial hitting its endpoints, knocking socks off was also going to be required, and the socks clause certainly wasn’t included in the agency’s ALS guidance for industry.In addition to faster, better paths to drug approval, people with ALS, their caregivers, and other advocates have been working to improve access to investigational therapies for people dying from ALS who can’t get into clinical trials. The FDA’s expanded access pathway was designed for a deadly disease like ALS — at least that’s the theory. Family members, physicians, and advocates talk and talk with sponsors over hours of meetings. Sponsors’ representatives nod — just like the FDA does — when asked about smart implementation of expanded access programs as part of their clinical research efforts.Families and advocates do their homework. We know the rules about expanded access better than some sponsors do, and patiently counter concerns about cost or trial disruption. Sponsors’ representatives nod some more and schedule more Zoom meetings, but then don’t deliver expanded access in meaningful ways for people with ALS. A friend of mine with ALS put it this way: If they are just humoring dying people with no intention of changing anything, then I have better ways to spend my last months.Think of an ALS clock: The day before being diagnosed with ALS, a 35-year-old has a life expectancy of around 40 years. On the day of diagnosis, that suddenly compresses to three or four years. This temporal shift should cause a sense of urgency, but it doesn’t, at least not for drug sponsors or the FDA, who I fear are using it to their advantage: The disruptors with ALS today will soon be dead, and the people who are nodding affirmatively but not acting may be just waiting them out.The ALS community is tired of being played. Physicians, researchers, regulators, those in the pharmaceutical and biotech industries, and others need to show a fraction of the courage people with ALS display every day. It’s time to step up and deliver.We’ve caught on to those polite nods. We won’t be played again.Mary Catherine Collet is an advocate for better clinical research and public policy for those dealing with ALS. She volunteers for several organizations and blogs about ALS at ALS Advocacy. First OpinionALS groups to the FDA and drug sponsors: ‘We won’t be played again’ Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease) has been like a cruel version of 1950s game show “Beat the Clock,” in which grassroots advocates like me and many others manage to do everything that today’s version of Bud Collyer asks, even those last-minute wrinkles that seem impossible. We jump through hoops and figure out solutions and do it all according to the rules as the clock ticks down. We’ve heard applause from the audience. But we’ve never been given the prize.We’ve been played.I’ve been an advocate for better public policies and clinical research for ALS since my mom died from this beast in 1997. It was outrageous that her prognosis then was largely the same that Lou Gehrig faced in 1939, and is all the more outrageous today. ALS is still cruel, difficult, quickly fatal, and has no cure.advertisement Clinical trial and regulatory processes are broken. When it’s time to translate theories about faster approvals into practice, nothing happens. The ALS community is in the same position today that Lou and Eleanor Gehrig faced in 1939 and my family faced in 1997. What’s more, there is a frustrating shroud of secrecy about what is really holding up approvals or access to investigational therapies that gives cover to the parties involved — physicians, researchers, regulators, industry, and sometimes even ALS advocacy organizations.People with ALS and their caregivers want humane trials that get to the scientific truth more quickly, and have worked hard to get the Food and Drug Administration’s guidance for industry for developing ALS therapies to set out a plan to do just that.A Phase 2/3 trial from Amylyx recently hit its endpoints. But what should have been “Hallelujah!” was actually just “Ha!” because the FDA indicated it wanted another trial.Where is the FDA that nodded politely while we testified at its ALS hearing about urgency and flexibility? Americans dying of ALS now have to wait while the company has moved on to Canada and Europe for faster approval possibilities.All of the meetings ALS families and advocates have had with the FDA and all of the encouragement its regulators offered ring hollow when the agency offers no information to the people most affected by its decision, and sponsors are hesitant to share it for fear of annoying the FDA, meaning we get only rumors and the occasional informative news report. Related: Mary Catherine Collet Biogen to expand access to its ALS drug, but move may come too late for some patients
SHARE Entire border patrol unit in North Hamgyong Province placed into quarantine following “paratyphoid” outbreak Facebook Twitter News RELATED ARTICLESMORE FROM AUTHOR By Daily NK – 2006.07.14 1:38pm Daily NKQuestions or comments about this article? Contact us at [email protected] Rome Conference: Promoting Human Rights in North Korea There are signs that North Korea is running into serious difficulties with its corn harvest Rome, Italy — On the 12th (local time) “The 4th International Conference, Promoting Human Rights in North Korea” commenced in Rome, Italy.The conference was jointly sponsored by the Italian partyTransnational Radical Party and the U.S. human rights organization Freedom House in order to discern methods to resolve issues of public execution and freedom of religion in North Korea. News North Korea tries to accelerate building of walls and fences along border with China News News
U.S. President Biden Approves Disaster Declaration for Poarch Band of Creek Indians The White HouseToday, President Joseph R. Biden, Jr. declared that a major disaster exists for the Poarch Band of Creek Indians and ordered federal aid to supplement the Tribe’s efforts in the areas affected by the Coronavirus Disease 2019 (COVID-19) pandemic beginning on January 20, 2020, and continuing.The President’s action makes federal funding available for Crisis Counseling for the Poarch Band of Creek Indians.Federal funding is also available to the Poarch Band of Creek Indians and certain private nonprofit organizations for emergency protective measures, including direct federal assistance, for the entire Tribe impacted by COVID-19.Robert J. Fenton, Senior Official Performing the Duties of the Administrator, Federal Emergency Management Agency (FEMA), Department of Homeland Security, named Gracia B. Szczech as the Federal Coordinating Officer for federal recovery operations in the affected areas.Additional designations may be made at a later date if requested by the Tribe and warranted by the results of further assessments. /Public Release. This material comes from the originating organization and may be of a point-in-time nature, edited for clarity, style and length. View in full here. Why?Well, unlike many news organisations, we have no sponsors, no corporate or ideological interests. We don’t put up a paywall – we believe in free access to information of public interest. Media ownership in Australia is one of the most concentrated in the world (Learn more). Since the trend of consolidation is and has historically been upward, fewer and fewer individuals or organizations control increasing shares of the mass media in our country. According to independent assessment, about 98% of the media sector is held by three conglomerates. This tendency is not only totally unacceptable, but also to a degree frightening). Learn more hereWe endeavour to provide the community with real-time access to true unfiltered news firsthand from primary sources. It is a bumpy road with all sorties of difficulties. We can only achieve this goal together. Our website is open to any citizen journalists and organizations who want to contribute, publish high-quality insights or send media releases to improve public access to impartial information. You and we have the right to know, learn, read, hear what and how we deem appropriate.Your support is greatly appreciated. All donations are kept completely private and confidential.Thank you in advance!Tags:coronavirus, counseling, covid-19, crisis, disaster, disease, Emergency, Emergency Management, Federal, Government, India, pandemic, President, security, United States, White House
RelatedPS Emphasises Urgency of Investing in Greener Future RelatedPS Emphasises Urgency of Investing in Greener Future RelatedPS Emphasises Urgency of Investing in Greener Future Advertisements FacebookTwitterWhatsAppEmail Permanent Secretary in the Ministry of Industry, Investment and Commerce, Reginald Budhan, emphasised today (July 22), that investing in a greener future has assumed added significance and urgency, given the emergence of climate change and its ill effects on global weather systems.The Permanent Secretary noted that one area that offers significant opportunity for investment in the future, which would assist in the green process, is renewable energy, especially in the area of electricity generation from solar energy.“This must be the primary source of energy for the future. Shortly fossil fuel will not be our source of primary energy for the future,” he pointed out.Permanent Secretary, Ministry of Industry, Investment and Commerce, Reginald Budhan (centre), exchanges pleasantries with (from left), President, Jamaica Promotions Corporation (JAMPRO), Sancia Bennett Templer and Professor of Caribbean Sustainable Development, University of the West Indies, Professor Anthony Clayton, at the launch of the 20th edition of the United Nations World Investment Report 2010, under the theme: ‘Investing in a greener future’, at a press briefing, held at JAMPRO, in New Kingston, today (July 22).Mr. Budhan was speaking at the launch of the 20th edition of the United Nations World Investment Report 2010, under the theme: ‘Investing in a Greener Future’, at Jamaica Promotions Corporation (JAMPRO), in New Kingston.Some of the strategies to develop a greener future for Jamaica include: utilising higher levels of capital to increase the use of cleaner technologies; integrating environmental considerations into all functional management areas; addressing waste emissions, water and energy through integrated sustainable planning for the productive sectors; promoting green jobs and industries; and encouraging the adoption of environmental management systems by productive enterprises.“The long term strategy is ultimately to see more Jamaican companies adopting eco-efficiency in order to increase profits, gain competitive advantages and boost market share. Our objective is to integrate environmental considerations into all functional management areas, such as research and development, strategic planning and marketing,” Mr. Budhan said.“I am happy that this year’s world report focuses on the mitigation of climate change; and in particular, the role of transnational corporations in achieving this through the reduction of greenhouse gas emissions, and a shift towards low carbon production,” the Permanent Secretary said.In her remarks, President of JAMPRO, Sancia Bennett Templer, explained that green investments were activities that focus on the establishment of companies or projects that are committed to the conservation of natural resources, the production and discovery of natural resources and the implantation of environmentally conscious business practices.She cited some important areas for green investment, including solar and wind energy, geothermal, bio fuels, agriculture/organic food, reforestation, recycling and water technologies.Recognised as the global authoritative source of investment information, the World Investment Report presents the latest data on foreign direct investment from around the world.It also puts a special focus on climate change mitigation and the emerging Trans National Corporation (TNC) development paradigm. The publication presents a study of the changing operations of TNCs and how these practices affect development, while also examining how developing countries can promote foreign direct investments in low carbon sectors and benefit from it. PS Emphasises Urgency of Investing in Greener Future CommerceJuly 23, 2010
RelatedParents Need to Listen to their Children – Crawford Parents Need to Listen to their Children – Crawford CultureNovember 9, 2012 RelatedParents Need to Listen to their Children – Crawford RelatedParents Need to Listen to their Children – Crawford Advertisements FacebookTwitterWhatsAppEmail Co-ordinator of the Coalition for Better Parenting, Doret Crawford, has stressed the need for parents to listen more to their children. Listening effectively, she said, nurtures trust and confidence between parent and child and builds stronger parent-child relationships. “Listening is one of the fundamental skills that parents need to learn. A listening parent is an informed parent. By listening to children, you can gather information about what they know, how they feel about something, the things they like, the things they fear and what they think about you as a parent,” Ms. Crawford said. She was addressing a Think Tank Thursday (November 8) at the Jamaica Information Service’s (JIS) head office on Half-Way-Tree Road. Ms. Crawford informed that the Coalition has been working with the Ministry of Education and non-governmental organisations (NGO) to train parents, guardians and caregivers in better parenting and listening skills. The aim, she said, is “to move away from authoritarian childrearing attitudes to a more flexible approach to parenting”. These initiatives, she said, will continue during November, which is being observed as Parent Month, through a series of workshops in the Ministry of Education’s six regions, geared towards parents, caregivers and guardians. Parenting exhibitions will also be held across the regions. “Many parents will need help in adopting this concept of listening,” Ms. Crawford said. Parent Month is being observed under the theme: ‘Parent the Right Way: Start Listening to Your Child Today’, and activities getunderway with a national church service on Sunday (Nov.11) at the Ocho Rios Baptist Church on Milford Road, starting at 9:00 a.m. Activities for the month will culminate with a Parenting Award Ceremony schedule for Friday, November 30 at the RIU hotel in Montego Bay starting at 10:00 a.m.
HomeBriefsFairview Library – Franklin Haynes Marionettes “The Princess and the Pirate” Show Jul. 08, 2019 at 4:40 amBriefsEducationEntertainmentEventsNewsFairview Library – Franklin Haynes Marionettes “The Princess and the Pirate” Shownews2 years agofairview branch libraryfairview librarysanta monica public librarysummer reading programThe Princess and the Pirate The Summer Reading program is in full swing at the Fairview Branch Library, 2101 Ocean Park Blvd, with a line-up of fun shows for kids, including Franklin Haynes Marionette’s “The Princess and the Pirate” Show on Friday, July 26, 2019 at 2:30 pm. Don’t miss this delightful pirate adventure for families with children ages 4-11. The free, 45 minute show will be held in the library’s Community Room. To see all the Summer Reading shows at the Santa Monica Public Library please go to our online calendar at smpl.org.The Fairview Library is wheelchair-accessible. For special disabled services, call (310) 458-8681 at least one week prior to event. The Fairview Library is served by Big Blue Bus routes 8, 16 and 44. Ride your bike. Bicycle parking racks are available at the library.Submitted by Christa Muscatine, Youth Services LibrarianTags :fairview branch libraryfairview librarysanta monica public librarysummer reading programThe Princess and the Pirateshare on Facebookshare on Twitteradd a commentFairview Library – Mad Science: What Do You Know About H2O?Fairview Library – Georgette Baker’s Silly Songs and Goofy StoriesYou Might Also LikeFeaturedNewsBobadilla rejects Santa Monica City Manager positionMatthew Hall8 hours agoBriefsLos Angeles Sheriff’s deputy accused of destroying evidence of 2019 assaultAssociated Press11 hours agoBriefsCalifornia State Treasurer Fiona Ma to Speak at Online Santa Monica College Commencement Ceremony June 25Guest Author11 hours agoEntertainmentLifeNoteworthyTales of Two DaughtersCharles Andrews13 hours agoNewsCouncil picks new City ManagerBrennon Dixson18 hours agoFeaturedNewsProtesting parents and Snapchat remain in disagreement over child protection policiesClara Harter18 hours ago
NEW DELHI – Just like last year, SSP Chawrasia leads the Indian Open after a flawless third-round 68 on Saturday. The 37-year-old, who won the 2008 Indian Masters over the same tree-lined layout, has a two-shot lead over Terry Pilkadaris (73) of Australia. Chawrasia went four under for the first eight holes. There were no birdies afterward but Chawrasia scrambled from extremely difficult positions to register 10 straight pars from the ninth to the 18th. ”I want to win it because I have finished second over here four times,” said Chawrasia, who is 14 under overall. Chawrasia holed a 10-footer at the first, almost chipped in from the bunker on the third, and then reeled off three birdies from Nos. 6 to 8, including a 20-foot putt on the seventh. He had to hole difficult par putts on the 10th and 17th, including a chip-in from a grassy hollow after being stuck in thorny bushes on the par-3 12th. Chawrasia has been here before. In 2015 he led by two over Siddikur Rahman of Bangladesh, before Anirban Lahiri took the title in a playoff against Chawrasia. Pilkadaris, winless since 2005, is at 12 under, while defending champion Lahiri (67) and Rashid Khan (69) are two shots behind the Australian. ”If I get a fast start and am only three or so behind, I could have a shot,” said Lahiri. Rahil Gangjee (66), Jeunghun Wang (66), Sebastien Gros (68) and Adilson Da Silva (69) are at nine under. The 42-year-old Pilkadaris had birdies on the first and fourth but missed clutch putts for par on Nos. 2 and 3. A wayward drive into trees down the ninth led to another dropped shot.
Journey home will be easier – Paul Hegarty Pinterest Donegal hoteliers enjoy morale boost as bookings increase WhatsApp Facebook Google+ Over 30 people waiting for a bed at Letterkenny University Hospital Disruption to cancer service will increase mortality – Oncologist RELATED ARTICLESMORE FROM AUTHOR Pinterest Twitter There were 32 people waiting for a bed at Letterkenny University Hospital this morning according to the INMO.19 people were on trolleys in its Emergency Department while a further 13 were waiting on wards.Yesterday saw 35 people waiting for a bed at the hospital which resulted in the full capacity protocol implemented.University Hospital Limerick was the most overcrowded with 49 people waiting there.Nationally, there were 562 people waiting at hospitals across the country today. Google+ 45 new social homes to be built in Dungloe By News Highland – December 19, 2017 Facebook Twitter Hospitalisations rise as Donnelly suggests masks will stay ’til autumn WhatsApp Previous articleConcern over Donegal nightclub’s decision to open on Christmas nightNext articleContract signed to address poverty & social inclusion in Donegal News Highland Consultation launched on proposal to limit HGV traffic in Clady Homepage BannerNews
Share via Shortlink TagsBrown Harris StevensHalsteadTerra Holdings Share on FacebookShare on TwitterShare on LinkedinShare via Email Share via Shortlink Brown Harris Stevens’ Bess Freedman and Halstead’s Diane RamirezTwo of the biggest names in New York City residential brokerage are joining forces.Sister companies Brown Harris Stevens and Halstead will merge under the BHS banner, owner Terra Holdings said Thursday. The combined firm will have 2,500 agents. Last year the brokerages’ sales totaled $9 billion, according to data from Real Trends.The fusion of two mainstay brands — each with a distinctive company culture — comes amid consolidation in the industry and as residential firms look to dig themselves out of a hole deepend by coronavirus. Even before the pandemic, a slowdown in the luxury market squeezed already-thin brokerage margins.In a statement, Terra COO Alan Kersner said the restructuring will expand Brown Harris Stevens’ footprint and resources as the housing market recovers.According to Kersner, the transition will occur in phases, starting in New York. Brown Harris Stevens CEO Bess Freedman will be chief executive of the unified brokerage. Halstead CEO Diane Ramirez, who co-founded the firm in 1987, will stay on as a senior executive. So will BHS president Hall Willkie, Halstead president Richard Grossman and Terra Development Marketing president Stephen Kliegerman.Kersner said BHS will keep its headquarters at 445 Park Avenue, but Terra didn’t disclose plans for Halstead’s flagship, a 17,000-square-foot space at 499 Park Avenue. The combined company will have 54 other offices in New York City and the Hamptons, Connecticut, New Jersey, Palm Beach and Miami.Kersner, responding to questions via text message, said Terra’s goal is to retain as many employees as possible. The company also aims to keep legacy offices open, “as long as it makes sense financially.”Although Terra will be able to shave off “procedural redundancies,” Kersner said the company will double down on technology and marketing.“It’s no secret that the real estate industry has changed, especially with all of the aggregators and iBuyers now competing for business,” he said. “In order to stay competitive, brokerages have to adapt. This restructuring was not a spur of the moment decision, but the pandemic certainly forced us to act quickly.”Arthur Zeckendorf, William Lie Zeckendorf, David Burris, Kent Swig, and Eric HadarTerra — owned by Arthur Zeckendorf, William Lie Zeckendorf, Kent Swig, David Burris and Eric Hadar — has owned BHS and Halstead since 1995 and 2001, respectively.Despite their common ownership, the firms have cornered different parts of the residential market. Established in 1873, BHS is a dominant player in the luxury market and has been for decades. The blue-blooded firm represented Jeff Bezos when the Amazon chief paid a record $80 million last year for a spread at 212 Fifth Avenue.More than a century younger, Halstead has 32 offices, a strong rental division and is known for being more of a volume player on the sales side. By acquiring regional brokerages over the years, it has built a strong presence in the outer boroughs, Connecticut and New Jersey. Last year, Halstead closed $362.3 million sell-side deals in Brooklyn and $179.1 million in Queens, according to an analysis by The Real Deal.Read moreBHS chief of tech, comms out amid shakeup Corcoran, Citi Habitats to merge BHS names Bess Freedman CEO Both BHS and Halstead — and their competitors — had to make strategic cuts during the pandemic. In April, Terra slashed executive pay and furloughed employees across the organization.Executives say by joining forces, the combined organization will emerge stronger from an unprecedented few months in which brokerage was nearly shut down.“As the real estate industry begins to reopen around the country, we are growing a company with a purposeful culture and incredible depth and breadth for the future,” Freedman said in a statement.The deal gives the combined firm more muscle — more than 1,600 agents and $3.25 billion in sales — at the top of New York’s cutthroat brokerage business. Market-leader Douglas Elliman, with 2,460 agents, closed $7.96 billion sell-side deals in the metro area in 2019, according to TRD’s analysis. The Corcoran Group came next with $7.84 billion in sell-side sales, followed by Compass with $4.85 billion.Pre-pandemic, the leaderboard saw a wave of consolidation. Last year, SoftBank-backed Compass acquired Stribling & Associates, one of the city’s last independent firms. And in January, Realogy’s Corcoran Group and Citi Habitats said they would formally merge after operating as “sister” companies for nearly two decades.Smaller firms have also joined forces to retain profitability in a tight market, including Bond New York (which bought Caliber), Living New York (which merged with Mdrn. Residential) and Keller Williams Midtown (which was acquired and then merged with KW Tribeca).Write to E.B. Solomont at [email protected]