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☆ FDA panel recommends revoking the approval of controversial drug for preterm births
▼ + stars: | 2022-10-19 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The trial found that the drug failed to reduce the risk of preterm births or produce better health outcomes for newborns. When a 2019 trial showed that the drug produced no benefits, the same FDA advisory panel voted to revoke the drug's approval. What's more, "retaining Makena’s approval likely hinders study of more promising treatments for preterm birth," FDA scientists wrote. It also proposed a partial withdrawal of the drug, making the drug only available to women at the highest risk of preterm birth.

☆ About 17 Americans die waiting for transplants each day. Scientists are trying to make more organs in 5 creative ways.
▼ + stars: | 2022-10-18 | by ( Morgan Mcfall-Johnsen | ) www.businessinsider.com time to read: +11 min

Courtesy of Leilani GrahamIf pig organs turn out to be just as effective as human organs, she added, "That is more appealing to me than using marginal donors." If the technique works for human organs in the future, it could allow clinicians to preserve many more organs for donation after death. Changing organs' blood typeEnzymes are delivered to a lung inside a perfusion machine at Dr. Marcelo Cypel’s lab. Growing synthetic organs from stem cellsResearcher Stormy Chamberlain holds a tray of stem cells at the University of Connecticut's Stem Cell Institute. Hanna started a company called Renewal Bio to pursue the possibility of turning stem cells into organs for transplants.

Oct 14 (Reuters) - The U.S. Treasury Department is asking primary dealers of U.S. Treasuries whether the government should buy back some of its bonds to improve liquidity in the $24 trillion market. The Treasury is also querying whether reduced volatility in the issuance of Treasury bills as a result of buybacks made for cash and maturity management purposes could be a "meaningful benefit for Treasury or investors." But it let that exclusion expire and big banks had to resume holding an extra layer of loss-absorbing capital against Treasuries and central bank deposits. The Treasury Borrowing Advisory Committee, a group of banks and investors that advise the government on its funding, has said that Treasury buybacks could enhance market liquidity and dampen swings in Treasury bill issuance and cash balances. The Treasury is posing the questions as part of its regular survey of dealers before each of its quarterly refunding announcements.

☆ US Treasury asks major banks if it should buy back U.S. government bonds
▼ + stars: | 2022-10-14 | by ( ) www.reuters.com time to read: +2 min

Oct 14 (Reuters) - The U.S. Treasury Department is asking primary dealers of U.S. Treasuries whether the government should buy back some U.S. government bonds to improve liquidity in the $24 trillion market. Investors are worried about rising volatility in bonds as the Federal Reserve rapidly raises interest rates to bring down inflation. The Treasury is also querying whether reduced volatility in the issuance of Treasury bills as a result of buybacks made for cash and maturity management purposes could be a "meaningful benefit for Treasury or investors." The Treasury Borrowing Advisory Committee (TBAC), a group of banks and investors that advise the government on its funding, has said that Treasury buybacks could enhance market liquidity and dampen swings in Treasury bill issuance and cash balances. The Treasury is posing the questions as part of its regular survey of dealers before each of its quarterly refunding announcements.

☆ University of Florida students protest against Ben Sasse’s anti-LGBTQ past
▼ + stars: | 2022-10-12 | by ( Zachary Schermele | ) www.nbcnews.com time to read: +8 min

Hundreds of University of Florida students held protests this week criticizing the anticipated appointment of Sen. Ben Sasse, R-Neb., to lead the school. Sasse has said that as university president, he would do his best to represent the views of lesbian, gay, bisexual, transgender and queer students. But for some, his candidacy has called to mind the university’s anti-LGBTQ history and the extent to which many of them feel it continues to sideline their needs and experiences, four LGBTQ students told NBC News. The university’s LGBTQ+ Affairs office, for example, has a high staff turnover rate, he said. He said a “silver lining” of the protests was that many LGBTQ students made their concerns more widely known.

☆ FDA authorizes Covid omicron booster shots for kids as young as 5 years old
▼ + stars: | 2022-10-12 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Wednesday authorized Covid booster shots that target the omicron variant for preschoolers through elementary school students. Pfizer's new omicron boosters are now authorized for children ages 5 to 11 and Moderna's shots for kids ages 6 through 17. The new boosters target omicron BA.5 as well as the original strain of Covid that first emerged in Wuhan, China, in 2019. The first generation of Covid shots were developed in 2020 to target the original strain of Covid. More than 11 million Americans ages 12 and older have received the new booster shots so far, according to CDC data.

☆ After Fiona, climate experts urge Canada to fix flagship adaptation strategy
▼ + stars: | 2022-09-28 | by ( Nia Williams | ) www.reuters.com time to read: +3 min

Sept 28 (Reuters) - Canada's first national climate adaptation strategy needs to be improved to include near-term targets and specific solutions ahead of its November release to mitigate worsening global warming impacts, experts advising the government told Reuters in the wake of devastation caused by storm Fiona. The destruction comes weeks before Ottawa releases its first ever National Adaptation Strategy (NAS) in early November. A 2020 report from the Federation of Canadian Municipalities estimated Canada needs to spend C$5.3 billion a year to adapt to climate change but the country is at least a decade behind Europe in developing a national strategy, experts said. Britain released its first national adaptation program in 2013, with five-year targets, and is currently developing a third version. "Our first adaptation strategy needs to be a home run," said Ryan Ness, adaptation research director for the Canadian Climate Institute (CCI).

☆ A controversial ALS drug potentially worth $1 billion is on the cusp of FDA approval. It could change Amylyx's fortunes and be a much-needed treatment for the rare disease.
▼ + stars: | 2022-09-26 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

The FDA may soon approve a new treatment for ALS, also known as Lou Gehrig's disease. If approved, Amylyx Pharmaceuticals's drug, AMX0035, will be a new treatment option for patients. A new drug for amyotrophic lateral sclerosis, more commonly known as ALS or Lou Gehrig's disease, is on the cusp of approval from the US Food and Drug Administration. The association said that treatment has the support of the larger ALS community and urged the FDA to "swiftly approve" AMX0035. By comparison, there are around 30,000 ALS patients in the US, meaning reimbursing AMX0035 would pose a much lighter burden on the CMS.

☆ Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11
▼ + stars: | 2022-09-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Pfizer on Monday asked the Food and Drug Administration to authorize its new Covid booster shots that target the omicron BA.5 subvariant for children ages 5 to 11. The company, in a statement, said its request is based on human data from a similar vaccine that targets the omicron BA.1 subvariant and data from animal studies on the BA.5 shots. Pfizer's main competitor on Covid shots, Moderna, asked the FDA to authorize its omicron shots for kids ages 6 through 17 on Friday. Officials at the FDA and CDC expect the omicron BA.5 shots will provide significantly better protection against infection and disease this fall and winter. The new boosters target the dominant omicron BA.5 subvariant as well as the original strain of Covid that first emerged in Wuhan, China in 2019.

☆ 5 cutting-edge medical experiments could expand our organ supply, from gene-edited pigs to artificial embryos
▼ + stars: | 2022-09-24 | by ( Morgan Mcfall-Johnsen | ) www.businessinsider.com time to read: +10 min

Courtesy of Leilani GrahamIf pig organs turn out to be just as effective as human organs, she added, "That is more appealing to me than using marginal donors." While much of the shortage is driven by imperfect logistics and bureaucracy rather than supply, cutting-edge research could make organs — human, pig, or synthetic — more accessible in Graham's lifetime. If the technique works for human organs in the future, it could allow clinicians to preserve many more organs for donation after death. Changing organs' blood typeEnzymes are delivered to a lung inside a perfusion machine at Dr. Marcelo Cypel’s lab. Growing synthetic organs from stem cellsResearcher Stormy Chamberlain holds a tray of stem cells at the University of Connecticut's Stem Cell Institute.

☆ Moderna asks FDA to authorize omicron Covid boosters for children as young as 6 years old
▼ + stars: | 2022-09-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Moderna has asked the Food and Drug Administration to authorize its omicron booster shots for children, the company announced on Friday. The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to become eligible for the omicron boosters by mid-October pending authorization by the FDA. Pfizer told the CDC advisory committee earlier this month that it expects to ask the FDA to authorize omicron boosters for children ages 5 to 11 in early October. U.S. health regulators cleared Moderna's omicron boosters for adults earlier this month. There is also concern that the original shots' effectiveness at preventing hospitalization and severe illness is starting to decline.

☆ SEC Advisory Panel Recommends Oversight of U.S. Accounting Rule Maker
▼ + stars: | 2022-09-21 | by ( Mark Maurer | ) www.wsj.com time to read: +4 min

The SEC’s Investor Advisory Committee, a group of investors, academics and financial advisers, recommended setting up another advisory committee to ensure the Financial Accounting Standards Board remains politically independent. PREVIEWRoughly 260 accounting and tax experts in November 2021 asked federal lawmakers to not tie the then-proposed tax to income metrics reported to investors. The new advisory group would consider ways to strengthen financial reporting in areas such as intangible assets, for example internally developed software, the Investor Advisory Committee said. SEC staff attend the FASB’s advisory committee meetings as formal observers and provide insight to help with rule making but lack the voting power of full board members. The FASB should then factor those costs into the cost-benefit analysis it conducts when drawing up new accounting rules, the SEC Investor Advisory Committee said.

☆ Airline passengers with disabilities share their travel nightmares: Being forgotten on planes, receiving damaged wheelchairs, or facing life-threatening injuries
▼ + stars: | 2022-08-22 | by ( Lloyd Lee | ) www.businessinsider.com time to read: +13 min

Wheelchair users are caught in the chaos, risking lost or damaged wheelchairs or even life-threatening injuries. Similar incidents have occurred, in which wheelchair users developed serious infections from an injury sustained during or after a flight, Brown said. On July 26, the Department of Transportation released the Airline Passengers with Disabilities Bill of Rights, which outlines the ten fundamental rights of passengers with disabilities. Ansley added that it would also be ideal if wheelchair users could use their own wheelchair to fly. This could include carving a space at the beginning of the aircraft so that wheelchair users don't have to transfer to an aisle chair.

☆ UNDP Moldova: Procurement Associate - UNDP Moldova Country Office
▼ + stars: | 2021-06-29 | by ( Alte Articole | ) www.civic.md time to read: +13 min

BackgroundUnder the guidance and direct supervision of the Procurement Analyst/Head of Procurement Unit, the Procurement Associate provides leadership in execution of procurement services in CO ensuring their effectiveness, transparency and integrity. CO Procurement business processes mapping and elaboration of the content of internal Standard Operating Procedures (SOPs) in Procurement and Logistics, control of the workflows in the Procurement Unit. Organizes procurement processes for CO, NIM/DIM projects and at the request of other Agencies focusing on achievement of the following results:Preparation of procurement plans for the office and projects and their implementation monitoring. Review of procurement processes conducted by projects; submissions to the Contract, Asset and Procurement Committee (CAP) and Advisory Committee on Procurement (ACP). Ensures implementation of sourcing strategy and e-procurement tools focusing on achievement of the following results:Development and update of the rosters of suppliers, implementation of supplier selection and evaluation.

Persons: • Organizations: Procurement Unit, Unit, UNDP HQs, Organization, UN, UNDP, Logistics, Procurement, ., Procurement Committee, Management Systems, Business, Administration, United Nations Locations: Moldova, Republic of Moldova

☆ Water's edge: the crisis of rising sea levels
▼ + stars: | 2014-09-04 | by ( Reuters Graphic | ) www.reuters.com time to read: +20 min

But sea levels have been rising for 100 years in Baltimore.”ROCKET SCIENCEThe irony is evident at Wallops Flight Facility. Yet this bastion of climate research has been slow to apply the science of sea level rise to its own operations. Reviewers from state and federal agencies criticized the 348-page document for failing to adequately take rising sea levels into account in the project design and impact, or to temper future plans for expansion. Joshua Bundick, Wallops’s environmental planning manager, explained that he distilled the issues “down to only the highest points,” and sea level rise wasn’t among them. The cost to American taxpayers of repeated destruction of the parking lot and causeway from rising sea levels would only increase, Fish and Wildlife officials said.

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