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Search resuls for: "Liz Essley Whyte"


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☆ House Republicans Investigate Covid-19 Aid to Hospitals
  + stars: | 2023-04-11 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
This copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit www.djreprints.com. https://www.wsj.com/articles/house-republicans-investigate-covid-19-aid-to-hospitals-29b6b3da
☆ What the Texas Court’s Abortion-Pill Ruling Means for FDA
  + stars: | 2023-04-08 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
A federal judge’s ruling against the Food and Drug Administration’s approval of the abortion pill could weaken the agency, opening its science-based decisions to court reviews, said lawyers specializing in the matters. The decision, if it is appealed to the Supreme Court, could also give conservative justices an opportunity to trim the power of federal agencies generally, lawyers said.
☆ Abortion-Pill Approval Suspended by Federal Judge in Texas
  + stars: | 2023-04-07 | by ( Laura Kusisto | Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
A federal judge on Friday suspended approval of the abortion pill, in a preliminary ruling against the Food and Drug Administration that could limit women’s access to the most common method for ending a pregnancy. U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, said in a 67-page ruling that the FDA made a series of legal errors in approving the pill for sale in the U.S. The judge suspended approval of the pill but delayed the impact of his decision for a week to give the Biden administration a chance to appeal.
☆ FDA Forces the Only Drug for Preterm Births to Leave Market
  + stars: | 2023-04-06 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The FDA typically nudges manufacturers to withdraw drugs voluntarily; it is rare for the agency to force a drug withdrawal. The only drug on the market to help prevent preterm births must stop being sold immediately, a move that comes after scientists at the Food and Drug Administration earlier determined it was ineffective. The FDA said Thursday it is withdrawing its approval for the drug Makena and its generics because the drugs no longer are shown to be effective and the benefits don’t outweigh the risks. Makena, as well as its generics, can no longer be lawfully distributed in interstate commerce.
☆ Federal Judge to Hear Abortion Pill Arguments in Texas Case
  + stars: | 2023-03-15 | by ( Laura Kusisto | Liz Essley Whyte | Adolfo Flores | ) www.wsj.com   time to read: 1 min
AMARILLO, Texas—A federal judge is set to hear arguments Wednesday on whether to block sales of a medication used in more than half of the abortions in the U.S., the first public hearing in a case that has drawn national attention. Antiabortion medical groups and individual physicians filed a lawsuit in November, arguing that the Food and Drug Administration exceeded its authority when it approved the sale of the abortion-inducing pill known as mifepristone under a process meant for treatments of serious or life-threatening illnesses. The judge is now weighing whether to issue a preliminary injunction blocking sales of the pill while litigation continues.
☆ NIH Top Job Still Empty as Candidates Back Out
  + stars: | 2023-03-13 | by ( Liz Essley Whyte | Stephanie Armour | ) www.wsj.com   time to read: 1 min
Photo: Shuran Huang for The Wall Street JournalDiscoveries by National Institutes of Health scientists and grant recipients have been awarded more than 100 Nobel Prizes. The top job at the National Institutes of Health, a prestigious role that has attracted a Nobel Prize winner and other leading scientists, is going unfilled as candidates back out. At least two potential choices for the job have walked away, and the White House has struggled finding qualified candidates willing to fill a job that would probably force them to take a substantial pay cut and face popular attacks on scientists, people familiar with the search said.
☆ Drug to Prevent Preterm Births to Be Pulled From Market
  + stars: | 2023-03-07 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
Photo: Eric Lee for The Wall Street JournalMakena was the only drug approved by the FDA to reduce the risk of preterm birth in women with a history of early deliveries. Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled. Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.
☆ Drug-Prices Investigation Focused on Middlemen Opens in Congress
  + stars: | 2023-03-01 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
House Republicans have launched an investigation into the companies that manage drug benefits, dialing up the scrutiny of the middlemen who play an important role in how much medicines cost. The House Oversight and Accountability Committee said Wednesday that it has sent letters to CVS Health Corp.’s CVS Caremark, Cigna Group ’s Express Scripts and UnitedHealth Group Inc.’s OptumRx—the largest pharmacy-benefit managers—seeking documents about the drug-price rebates they negotiate and fees they charge.
☆ Congress Investigates How Pharma Middlemen Affect Drug Prices
  + stars: | 2023-03-01 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
House Republicans have launched an investigation into the companies that manage drug benefits, dialing up the scrutiny of the middlemen who play an important role in how much medicines cost. The House Oversight and Accountability Committee said Wednesday that it has sent letters to CVS Health Corp.’s CVS Caremark, Cigna Group ’s Express Scripts and UnitedHealth Group Inc.’s OptumRx—the largest pharmacy-benefit managers—seeking documents about the drug-price rebates they negotiate and fees they charge.
☆ Adderall, OxyContin Prescriptions to Require In-Person Doctor Visit Under Biden Plan
  + stars: | 2023-02-24 | by ( Liz Essley Whyte | Rolfe Winkler | ) www.wsj.com   time to read: 1 min
The ban on first-time online prescriptions for drugs such as Adderall was influenced by improper prescribing during the pandemic, the DEA said. The Biden administration proposed tighter rules for the online prescription of drugs including Adderall and buprenorphine, shrinking the scope of telehealth services that expanded dramatically during the pandemic. The Drug Enforcement Administration on Friday said the telehealth restrictions would take effect after the Covid-19 public-health emergency ends on May 11. The proposed changes affect prescriptions for drugs classified as controlled substances because of their potential for abuse.
☆ Novavax to Sell 1.5 Million More Covid Vaccines to U.S. Government
  + stars: | 2023-02-13 | by ( Liz Essley Whyte | Stephanie Armour | ) www.wsj.com   time to read: 1 min
The U.S. government has agreed to buy 1.5 million more doses of Novavax Inc.’s Covid-19 vaccine, the company said, part of efforts preparing for the end of government purchases and the start of a commercial market for the shots. Novavax wouldn’t provide the monetary value of the deal or the price that the federal government would pay per dose.
☆ House Republicans Probe Covid-19 Origins, Government Response
  + stars: | 2023-02-01 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
Some Republicans questioned whether federal officials were too quick to disparage theories that Covid-19 escaped from a lab. House Republicans kicked off hearings exploring the origins of the Covid-19 pandemic and scrutinizing the federal government’s response. The hearings on Wednesday, by the House Oversight and Accountability committee and an Energy and Commerce subcommittee, were the first in what is expected to be a series by Republican lawmakers who had been airing concerns about the Biden administration’s handling of the public-health crisis and are now in charge of the chamber.
☆ Risky Virus Research Needs Tougher Review, Government Advisers Say
  + stars: | 2023-01-28 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
An advisory board at the Bethesda, Md.-based National Institutes of Health unanimously backed research-oversight proposals. Virus experts advising the federal government backed proposals to bolster oversight of research that could make pathogens more dangerous or contagious. The experts, members of the National Institutes of Health’s biosecurity advisory board, voted unanimously on Friday in favor of the proposals. The NIH helps to administer the board, which gives advice to the entire U.S. government.
☆ FDA Advisers Back Annual Covid-19 Boosters With Reservations About Rollout
  + stars: | 2023-01-27 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
Advisers to the Food and Drug Administration welcomed the idea of annual, updated Covid-19 vaccines but said scientists should conduct more studies to determine the specifics of the plan. The 21 advisers also voted unanimously on Wednesday that people getting the vaccine for the first time should get an updated version that targets both the original strain and the Omicron variant, rather than earlier formulations that targeted only the original strain.
☆ Abortion-Pill Restrictions in Two States Challenged in Lawsuits
  + stars: | 2023-01-25 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
This copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit www.djreprints.com. https://www.wsj.com/articles/abortion-pill-restrictions-in-two-states-challenged-in-lawsuits-11674656653
☆ FDA Proposes Annual Covid-19 Vaccinations
  + stars: | 2023-01-23 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
Most people would get one Covid-19 shot annually—as they do with the flu shot—under Food and Drug Administration proposals for simplifying the nation’s Covid-19 vaccine procedures. The drug regulator also proposed that people getting vaccinated for the first time receive vaccines that target both Omicron and the original strain of the coronavirus.
☆ Abbott Under Federal Criminal Investigation Over Baby Formula
  + stars: | 2023-01-21 | by ( Liz Essley Whyte | Dave Michaels | Jesse Newman | ) www.wsj.com   time to read: 1 min
The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Mich., that led to its shutdown last year and worsened a nationwide formula shortage, people familiar with the matter said. Attorneys with the Justice Department’s consumer-protection branch are conducting the criminal investigation, the people said.
☆ NIH Advisers Propose Strengthening Oversight of Virus Research
  + stars: | 2023-01-20 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
National Institutes of Health advisers proposed measures to enhance security of pathogen research, as House Republicans prepared to investigate the agency’s funding of virus experiments and handling of the Covid-19 pandemic. The NIH group recommended on Friday that federal officials expand their reviews of risky research to include any experiments altering a virus in a way that could make it so transmissible or virulent that it would pose a threat to public health or national security.
☆ NIH Faces GOP Scrutiny Over Handling of Covid-19 Pandemic
  + stars: | 2023-01-20 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
House Republicans plan to put the National Institutes of Health under the microscope, conducting investigations into its funding of research on viruses and handling of the Covid-19 pandemic. The lawmakers, now in charge of the House, said they aim to probe the NIH’s oversight of research that involves modifying viruses to identify potential threats to humans and develop ways to fight them. The Republicans also want to probe the agency’s links to an institute in Wuhan, China, that conducts the pathogen research.
☆ Nursing Homes’ Use of Schizophrenia Drugs to Be Audited by U.S. Government
  + stars: | 2023-01-19 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Centers for Medicare and Medicaid Services said it would factor in use of antipsychotic medicines in nursing-home ratings. Federal health officials said they would take steps to increase oversight of nursing homes that prescribe powerful antipsychotic drugs, and prevent abuse of the medicines. The Centers for Medicare and Medicaid Services said Wednesday it would begin auditing nursing homes to see if they are accurately diagnosing their residents as schizophrenic, and would factor in use of antipsychotic medicines in nursing-home ratings.
☆ FDA Commissioner Denies Wrongdoing in Approval Process for Biogen Alzheimer’s Drug Aduhelm
  + stars: | 2023-01-11 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: +1 min
FDA Commissioner Robert Califf says a high level of interaction between agency officials and drug companies helps cut down on applications for drugs that don’t work. U.S. Food and Drug Administration Commissioner Robert Califf defended his agency’s decision to approve the Alzheimer’s drug Aduhelm, after an investigation by House Democrats found close cooperation between the drug’s sponsor and regulators. Findings released late last year from the then-Democratic-led Oversight and Reform Committee and the Energy and Commerce Committee faulted the FDA for holding an unusual number of meetings with Biogen Inc. while it weighed approval of Biogen’s Alzheimer’s treatment, Aduhelm, as well as for co-authoring with the company a briefing document presented to outside advisers. The FDA granted preliminary approval to Aduhelm in 2021, but Medicare officials refused to cover it routinely, dooming the company’s plans for profits.
☆ FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs
  + stars: | 2023-01-10 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies. The agency, which must sign off before companies can begin testing an experimental drug in people, has long used its authority to place holds on studies due to safety concerns. As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a Wall Street Journal review of FDA data on clinical holds, some of which was obtained through a Freedom of Information Act request.
☆ Walgreens Becomes First U.S. Pharmacy Chain to Say It Will Sell Abortion Pill
  + stars: | 2023-01-05 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
Packages of Mifepristone, a drug that blocks a hormone needed for pregnancy and is FDA-approved for use up to 10 weeks in pregnancy. Walgreens Boots Alliance Inc. is the first major national pharmacy chain to say it plans to dispense the abortion pill under new rules laid out by the Food and Drug Administration. The new rules, issued Tuesday, allow any pharmacy to become certified to dispense mifepristone, the drug that blocks a hormone needed for pregnancy and is FDA-approved for use up to 10 weeks in pregnancy. Until the changes, the agency had allowed only a handful of mail-order pharmacies and certified doctors to hand out the drug.
☆ Abortion Pills to Be Available More Widely Under New FDA Rules
  + stars: | 2023-01-04 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration expanded access to a drug that induces abortion, allowing bricks-and-mortar pharmacies to dispense the pills for the first time. Under changes to the rules outlined Tuesday by makers of abortion pills, any pharmacy can complete and sign a short form to become certified to provide the so-called abortion pill, not just the handful of mail-order pharmacies that were permitted to ship prescriptions during the pandemic.
☆ FDA Faulted for Working Improperly With Biogen Before Clearing Alzheimer’s Drug
  + stars: | 2022-12-29 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The U.S. Food and Drug Administration “inappropriately” collaborated with Biogen Inc. before approving its Alzheimer’s treatment Aduhelm in 2021, a new report from House Democrats concluded, as the agency prepares to issue decisions on similar drugs. Biogen internal documents obtained through a congressional investigation also showed that the company expected pushback from patients and payers but priced its drug at $56,000 to maximize profit, the report says.
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