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☆ Legal Actions Seek Guarantee of Abortion Access for Patients in Medical Emergencies
▼ + stars: | 2023-09-12 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

Early in her pregnancy, Jaci Statton was in her kitchen when she felt like she was going to pass out and saw that her jeans had become soaked with blood. Doctors told her the pregnancy was not viable and that it could threaten her life if an abortion was not performed soon, she said. But Ms. Statton lives in Oklahoma, a state that bans most abortions. At the third, “they said, ‘We can’t touch you unless you’re like crashing in front of us,’” Ms. Statton, 26, said in an interview. Her case is part of several legal challenges filed Tuesday involving patients and doctors in three states — Idaho, Tennessee and Oklahoma — who claim that those states’ abortion bans are preventing women with serious pregnancy complications from getting abortions, even in cases where the medical need is clear.

Persons: Jaci Statton, Doctors, Statton, “, ’ Organizations: U.S . Department of Health, Human Services, Oklahoma Children’s Hospital Locations: Oklahoma, — Idaho , Tennessee

☆ A Stroke Stole Her Ability to Speak at 30. A.I. Is Helping to Restore It Years Later.
▼ + stars: | 2023-08-23 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

At Ann Johnson’s wedding reception 20 years ago, her gift for speech was vividly evident. In a milestone of neuroscience and artificial intelligence, implanted electrodes decoded Mrs. Johnson’s brain signals as she silently tried to say sentences. Technology converted her brain signals into written and vocalized language, and enabled an avatar on a computer screen to speak the words and display smiles, pursed lips and other expressions. The research, published in the journal Nature, demonstrates the first time spoken words and facial expressions have been directly synthesized from brain signals, experts say. Mrs. Johnson chose the avatar, a face resembling hers, and researchers used her wedding toast to develop the avatar’s voice.

Persons: Ann Johnson’s, ”, Johnson —, —, Johnson Organizations: Technology

☆ Appeals Court Upholds Abortion Pill Restrictions
▼ + stars: | 2023-08-16 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: 1 min

A federal appeals court panel said Wednesday that it would impose restrictions on the abortion pill mifepristone that would prevent the drug from being prescribed by telemedicine or dispensed through the mail. But the decision — the latest development in a closely watched lawsuit filed by abortion opponents seeking to block access to abortion pills — will not take effect until the Supreme Court ultimately decides the case. In a ruling this spring, the high court said mifepristone should remain available under the current rules until the appeals process concludes. In its ruling, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit upheld part of a decision issued in April by a federal judge in Texas. That decision, by Judge Matthew J. Kacsmaryk, had nullified the Food and Drug Administration’s approval of the pill 23 years ago.

Persons: mifepristone, Judge Matthew J, Kacsmaryk Organizations: U.S ., Appeals, Fifth Locations: Texas

☆ For the First Time, There’s a Pill for Postpartum Depression
▼ + stars: | 2023-08-04 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Friday approved the first pill for postpartum depression, a milestone considered likely to increase recognition and treatment of a debilitating condition that afflicts about a half-million women in the United States every year. Clinical trial data show the pill works quickly, beginning to ease depression in as little as three days, significantly faster than general antidepressants, which can take two weeks or longer to have an effect. That — along with the fact that it is taken for just two weeks, not for months — may encourage more patients to accept treatment, maternal mental health experts said. The most significant aspect of the approval may not be the features of the drug, but that it is explicitly designated for postpartum depression. The hope is that it will encourage more women to seek help and prompt more obstetricians and family doctors to screen for symptoms and suggest counseling or treatment.

Organizations: Drug Administration Locations: United States

☆ Treating Alzheimer’s Very Early Offers Better Hope of Slowing Decline, Study Finds
▼ + stars: | 2023-07-17 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

Treating Alzheimer’s patients as early as possible — when symptoms and brain pathology are mildest — provides a better chance of slowing cognitive decline, a large study of an experimental Alzheimer’s drug presented Monday suggests. The study of 1,736 patients reported that the drug, donanemab, made by Eli Lilly, can modestly slow the progression of memory and thinking problems in early stages of Alzheimer’s, and that the slowing was greatest for early-stage patients when they had less of a protein that creates tangles in the brain. For people at that earlier stage, donanemab appeared to slow decline in memory and thinking by about four and a half to seven and a half months over an 18-month period compared with those taking a placebo, according to the study, published in the journal JAMA. Among people with less of the protein, called tau, slowing was most pronounced in those younger than 75 and those who did not yet have Alzheimer’s but had a pre-Alzheimer’s condition called mild cognitive impairment, according to data presented Monday at the Alzheimer’s Association International Conference in Amsterdam. “The earlier you can get in there, the more you can impact it before they’ve already declined and they’re on this fast slope,” Dr. Daniel Skovronsky, Eli Lilly’s chief medical and scientific officer, said in an interview.

Persons: Eli Lilly, donanemab, “, they’ve, Dr, Daniel Skovronsky, Eli Lilly’s Organizations: Alzheimer’s Association International Locations: Amsterdam

☆ F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill
▼ + stars: | 2023-07-13 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a step that could significantly expand access to contraception. The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription. The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024. The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.

Persons: Opill, Ms, Welgryn Organizations: Drug Administration, Perrigo Locations: United States, Dublin

☆ New Federal Decisions Make Alzheimer’s Drug Leqembi Widely Accessible
▼ + stars: | 2023-07-06 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, and Medicare said it would cover much of its high cost, laying the foundation for widespread use of a medication that can modestly slow cognitive decline in the early stages of the disease but also carries significant safety risks. The F.D.A.’s decision marks the first time in two decades that a drug for Alzheimer’s has received full approval, meaning that the agency concluded there is solid evidence of potential benefit. But data from a large clinical trial suggests that the drug — administered every two weeks as an intravenous infusion — may slow decline by about five months over about 18 months for people with mild symptoms. Still, some Alzheimer’s experts have said it is unclear from the medical evidence whether Leqembi’s ability to delay erosion of memory and cognition would be enough to be noticeable or meaningful for patients and their families. And while most cases of brain swelling and bleeding have been mild or moderate and have resolved, there have been some serious cases.

Persons: Alzheimer’s Organizations: Drug Administration, Medicare

☆ What to Know if You’re Considering the Alzheimer’s Drug Leqembi
▼ + stars: | 2023-07-06 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

On Thursday, the Food and Drug Administration gave full approval to the drug Leqembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the cost of the $26,500-per-year medication. The decisions by the two federal agencies will vastly increase access to the drug but also present a dilemma for patients and their families. Leqembi is not a cure for Alzheimer’s, and the drug doesn’t improve patients’ memories or cognitive abilities. What Leqembi can do is modestly slow down cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested that the drug may slow decline by about five months over a period of 18 months for those patients.

Persons: ” Organizations: Food and Drug Administration, Medicare

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