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☆ Supreme Court medication abortion case threatens ‘seismic shift’ in FDA drug approval process, experts warn
▼ + stars: | 2024-03-26 | by ( Meg Tirrell | Tierney Sneed | ) edition.cnn.com time to read: +7 min

If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. “Nevertheless, drug developers invest in new medicines because, if their investments succeed, FDA’s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. “And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.”Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. “It is both my hope and my ‘bet’ that the court doesn’t uphold the 5th Circuit on the standing argument,” Cohen wrote. “But I have learned the Supreme Court is hard to predict much of the time.”

Persons: thalidomide, mifepristone that’s, ”, Daniel Grossman, ” Grossman, ” PhRMA, Glenn Cohen, Dr, Sanjay Gupta, Cohen, ” Cohen Organizations: CNN, Food and Drug, Federal Food, FDA, US, University of California San, Reproductive, Guttmacher Institute, Circuit, Appeals, Pharmaceutical Research, Manufacturers of America, Harvard Law School, CNN Health Locations: Massengill, University of California San Francisco, Texas

CANBERRA, Australia (AP) — Survivors of the harmful morning sickness drug thalidomide were in the public gallery Wednesday when Australia’s Parliament made a national apology to them on the 62nd anniversary of the drug being withdrawn from sale in the country. “Today, on behalf of the people of Australia, our government and this Parliament offers a full unreserved and overdue apology to all thalidomide survivors, their families, loved ones, and carers,” Albanese said. The apology was recommended in 2019 by a Senate inquiry into the support that was available to aging thalidomide survivors. The government will fulfill another recommendation Thursday by opening a memorial in Canberra in recognition of thalidomide survivors and their families. Australia established a support program in 2020 that is providing lifelong assistance to 148 survivors, and Albanese said his government was reopening the program to survivors who had yet to register.

Persons: thalidomide, Anthony Albanese’s, “, ” Albanese, Trish Jackson, ” Jackson, Albanese, Jackson, “ It’s Organizations: —, Australian Broadcasting Corp, Diageo Scotland Ltd Locations: CANBERRA, Australia, Canberra, Zealand, British

☆ Australia to apologise half a century after 'Thalidomide tragedy'
▼ + stars: | 2023-11-13 | by ( Renju Jose | ) www.reuters.com time to read: +2 min

Thalidomide was the active ingredient in a sedative widely distributed to many mothers in Australia and around the world in the early 1960s. "The thalidomide tragedy is a dark chapter in the history of our nation and the world," Albanese said in a statement. An Australian woman, who was born without arms and legs after her mother took Thalidomide, in 2012 won a multi-million dollar settlement from Diageo Plc, the local distributor. In 2010, Diageo agreed to make an A$50 million ($32 million) payment to 45 victims in Australia and New Zealand. There are 146 Thalidomide survivors registered with the government, though the exact number of affected is unknown.

Persons: Anthony Albanese, Joe Biden, Leah Millis, Thalidomide, " Albanese, Gruenenthal, Albanese, Renju Jose, Tom Hogue, Gerry Doyle Organizations: Australia’s, U.S, White, REUTERS, Rights, U.S . Food, Drug Administration, British, Diageo Plc, Diageo, New Zealand, Thomson Locations: Washington , U.S, Australia, U.S, United States, Australian, New, Sydney

☆ Lab models of human embryos raise hopes and concerns
▼ + stars: | 2023-10-26 | by ( Katie Hunt | ) edition.cnn.com time to read: +14 min

From the moment sperm fuses with an egg, human embryo development involves a string of complex and little understood processes. What happens during human embryo development, particularly in the crucial first month, remains largely unknown. However, 14 days is an important milestone because it is when permitted lab research on cultured human embryos routinely ends. He said, in the future, it might be possible to go as far as 40 days with human embryo models. Some in the field envision a “tipping point” wherein human embryo models might be afforded some protection like those surrounding human embryos, as scientific advances diminish the differences between the embryo models and their real-life counterparts.

Persons: CNN — It’s, ”, Jacob Hanna, demystify, they’ve, Hanna, “ It’s, ” Hanna, “, Peter Rugg, Gunn, it’s, …, Robin Lovell, Francis Crick, Naomi Moris, Francis Crick Institute’s, Moris, we’ve, ” Moris, It’s, Bobbie Farsides, ” Farsides Organizations: CNN, Weizmann Institute of Science, Weizmann Institute, Israel, Weizmann, Babraham Institute, International Society for Stem Cell Research, Stem Cell, Francis, Francis Crick Institute, Genetics, Development, ”, Sussex Medical School Locations: Israel, London, Brighton

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