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Opill - 3 Roe - 2 Wade - 2 — Opill - 1 I’ve - 1 George W - 1 Bush - 1 Biden - 1
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Search resuls for: "HRA Pharma"


11 mentions found


☆ Over-the-Counter Birth Control Pills Are Coming. What Next? - The New York Times
  + stars: | 2023-07-19 | by ( Daniel Grossman | ) www.nytimes.com   time to read: +2 min
Like many of my colleagues, I’ve been holding my breath for the last year, since HRA Pharma, which manufactures Opill, submitted its application to the F.D.A. We now have hope that other advances could be coming to help offset restrictions on minors’ access to contraception and state-level abortion bans. under President George W. Bush approved Plan B for over-the-counter sale, but only for people 18 or older. Because of the age restriction, the product was shunted behind the pharmacy counter, where the consumer’s age could be confirmed. asked Plan B’s sponsor for additional data on people 17 and younger to show the product could be used safely and effectively by adolescents.
Persons: Roe, — Opill, I’ve, Opill, George W, Bush Organizations: Food and Drug Administration, HRA Pharma
☆ FDA approves Opill, the first over-the-counter birth control pill
  + stars: | 2023-07-13 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +3 min
HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent unintended pregnancies without a prescription. The daily pill, called Opill, was first approved by the FDA as a prescription in 1973. Medical organizations like the American College of Obstetricians and Gynecologists and women's health advocates have pushed for wider access. More than 50 members of Congress in March 2022 also called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay.
Persons: Biden, Wade, –, Welgryn, Robert Califf, Patrizia Cavazzoni, Opill Organizations: HRA Pharma, FDA, Drug Administration, American College of Obstetricians, FDA's Center, Drug, Research Locations: U.S, Paris, Dublin
☆ FDA approves first over-the-counter birth control pill in US
  + stars: | 2023-07-13 | by ( Manas Mishra Sriparna Roy | Manas Mishra | Sriparna Roy | ) www.reuters.com   time to read: +3 min
July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru
☆ EQT to take UK's Dechra Pharma private in about $6 bln deal
  + stars: | 2023-06-02 | by ( ) www.reuters.com   time to read: 1 min
June 2 (Reuters) - Swedish investment firm EQT will take Dechra Pharmaceuticals (DPH.L) private in a deal with an enterprise value of 4.88 billion pounds ($6.16 billion), the British veterinary drugmaker said on Friday. ($1 = 0.7923 pounds)Reporting by Eva Mathews in Bengaluru; Editing by Dhanya Ann ThoppilOur Standards: The Thomson Reuters Trust Principles.
Persons: EQT, drugmaker, Eva Mathews, Dhanya Ann Thoppil Organizations: Dechra Pharmaceuticals, Thomson Locations: Bengaluru
☆ Knocked-down EQT pet buyout will get over the line
  + stars: | 2023-06-02 | by ( ) www.reuters.com   time to read: +2 min
Private equity firm EQT (EQTAB.ST) on Friday announced a new deal that values the Cheshire-based company at 4.9 billion pounds ($6.1 billion) including debt. The offer took a 5% bite out of the original bid from April, mainly because Dechra subsequently released a poor trading update. Shares in the target, led by company veteran Ian Page, shot up on Friday but are 6% below the EQT takeout price. For starters, board directors have backed the deal and committed to tender their, admittedly small, slither of shares. Breakingviews calculated in April that the buyer would earn a so-so 17% gross return at the original price, even using very generous growth assumptions.
Persons: Dechra, Ian Page, Liam Proud, Aimee Donellan, Streisand Neto Organizations: Reuters, Dechra Pharmaceuticals, RBC, Twitter, Toyota, Thomson Locations: Cheshire, Saudi, East
☆ FTSE 100 edges higher as NatWest, StanChart shares rise
  + stars: | 2023-05-22 | by ( Johann M Cherian | ) www.reuters.com   time to read: +2 min
SummarySummary Companies Domestic house prices rise in MayUK lowers stake in NatWest, shares climbDechra Pharma down after profit warningUS debt ceiling talks to resume after impasseFTSE 100 0.3%, FTSE 250 flatMay 22 (Reuters) - UK's blue-chip index edged higher on Monday, with NatWest shares rising after it agreed to buy 1.3 billion pounds ($1.6 billion) worth of its shares back from the government, although lingering uncertainty over the U.S. debt ceiling impasse weighed on overall mood. The FTSE 100 (.FTSE) rose 0.3%, with bank stocks in the lead. Standard Chartered (STAN.L) rose 2.4% after Bank of America upgraded the stock to "buy" from "neutral". UK-listed stocks have traded in tight bands since late April as investors digested mixed corporate earnings, weakening outlook for commodity-linked stocks and standoff over the U.S. debt ceiling deal. ($1 = 0.7923 pounds)Reporting by Johann M Cherian in Bengaluru; Editing by Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.
☆ FDA advisors recommend sale of birth control pill without a prescription
  + stars: | 2023-05-10 | by ( Spencer Kimball | ) www.cnbc.com   time to read: +3 min
A panel of experts who advise the Food and Drug Administration unanimously recommended Wednesday that the agency for the first time allow women to obtain a birth control pill without a prescription. The panel had been asked whether the benefits of selling HRA Pharma's birth control pill Opill outweighed the risks of consumers improperly using the medication resulting in unintended pregnancy. Medical associations such as the American College of Obstetricians and Gynecologists for years have urged over-the-counter sales of birth control pills be allowedMore than 50 members of Congress in March 2022 called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system." Shrinking access to abortion across the U.S. in turn sparked renewed calls for expanded access to birth control to prevent unwanted pregnancies.
☆ A Birth Control Pill May Soon Be Available Over the Counter. Here’s What to Know.
  + stars: | 2023-05-10 | by ( Alisha Haridasani Gupta | ) www.nytimes.com   time to read: +1 min
Food and Drug Administration advisers concluded that the benefits outweighed the risks of making a hormonal contraceptive pill — sold under the brand name Opill and produced by the French company HRA Pharma — available without a prescription. follows the nonbinding recommendation of its advisers — and there is a chance the agency might not — Opill would become the first and only birth control pill to be available over the counter since oral contraceptives were introduced in the U.S. in 1960. A 2022 survey found that 77 percent of more than 5,000 female participants favored the idea of getting the birth control pill over the counter, with many saying it would be more convenient and efficient to get it without a prescription. Progestin-only pills have been widely used in the United States since the first one was approved in 1973. Like other oral contraceptives, they require a prescription from a health care provider or, in some states, a pharmacist.
☆ F.D.A. Advisers Say Benefits of Over-the-Counter Birth Control Pill Outweigh Risks
  + stars: | 2023-05-10 | by ( Pam Belluck | ) www.nytimes.com   time to read: +1 min
A panel of advisers to the Food and Drug Administration voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States. If the F.D.A. approves nonprescription sales of the medication, called Opill, this summer, it could significantly expand access to contraception, especially for young women and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor, reproductive health experts say. Approval is not a foregone conclusion, however. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.
☆ FDA may allow birth control pill without prescription this summer as experts weigh data
  + stars: | 2023-05-09 | by ( Spencer Kimball | ) www.cnbc.com   time to read: +2 min
The Food and Drug Administration could approve the sale of birth control medication without a prescription for the first time by this summer. The FDA approved prescription sales of HRA Pharma's birth control pill in 1973. Medical associations such as the American College of Obstetricians and Gynecologists for years have supported over-the-counter access to birth control without age restrictions. In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to review applications for over-the-counter sales of birth control without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system."
☆ F.D.A. Advisers Weigh Allowing First U.S. Over-the-Counter Birth Control Pill
  + stars: | 2023-05-09 | by ( Pam Belluck | ) www.nytimes.com   time to read: +1 min
It was like a tale of two birth control pills. At a hearing Tuesday to consider whether the Food and Drug Administration should authorize the country’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency was left to reckon with two contradictory analyses of the medication called Opill. During the eight-hour session, the manufacturer of the pill, HRA Pharma, which is owned by Perrigo, and representatives of many medical organizations and reproductive health specialists said that data strongly supported approval. scientists questioned the reliability of company data that was intended to show that consumers would take the pill at roughly the same time every day and comply with directions to abstain from sex or temporarily use other birth control if they missed a dose. “I’m just really quite confused by the level of discrepancy,” one member of the advisory panel, Pamela Shaw, a senior investigator with Kaiser Permanente Washington, said after both sides had made presentations.
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