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Reuters Health News Summary

Following is a summary of current health news briefs.

US FDA staff raises concerns over OTC use of Perrigo’s birth control pill

The U.S. health regulator’s reviewers on Friday raised concerns around allowing Perrigo Co’s birth control drug over the counter, saying switching to non-prescription sale could lead to inappropriate usage by consumers. Perrigo’s Opill, which is currently approved for prescription use, would be the first OTC non-estrogen contraceptive pill in the United States if approved.

UNICEF: More than 1 million polio vaccines destroyed in Sudan

More than 1 million polio vaccines intended for cost of generic clomid no prescription children have been destroyed as a result of looting in Sudan during the upsurge in violence since April, the U.N. children’s agency UNICEF told Reuters on Friday. “A number of cold chain facilities have been looted, damaged and destroyed, including over a million polio vaccines in South Darfur,” Hazel De Wet, deputy director of the Office of Emergency Programmes, UNICEF told Reuters in an email.

US CDC chief Rochelle Walensky stepping down in June

U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky, a top health official who oversaw the agency’s contentious response where to buy generic clomid the COVID-19 pandemic, is leaving the institution at the end of June, the CDC said on Friday. Walensky led the institution for two years while the pandemic was at its height. Her agency was pivotal in ushering in the adoption of vaccine recommendations that slowed the spread of a virus that has killed more than a million Americans and is still killing more than a thousand a week.

CDC to scale back data collection as US ends COVID health emergency

The U.S. Centers for Disease Control and Prevention (CDC) said on Friday it would stop reporting or monitoring COVID-19 case data and transmission rates after the government ends the pandemic’s public health emergency designation next week. The agency will stop using its color-coded COVID-19 Community Levels (CCL) system, which relies on those metrics to track the spread of the virus and will instead primarily rely on hospital admission data.

Cigna’s health insurance strength drives profit forecast raise

Cigna Group on Friday raised its annual profit forecast after lower medical costs at the company’s health insurance business helped it beat estimates in the first quarter, lifting shares 7.5% in morning trade. The health insurer also cut the midpoint of its 2023 medical cost ratio – or spending on claims as a percentage of premiums – by 10 basis points to between 81.5% and 82.3%.

WHO declares end to COVID global health emergency

The World Health Organization ended the global emergency status for COVID-19 on Friday more than three years after its original declaration, and said countries should now manage the virus that killed more than 6.9 million people along with other infectious diseases. The global health agency’s Emergency Committee met on Thursday and where can i buy generic clomid recommended the UN organization declare an end to the coronavirus crisis as a “public health emergency of international concern” – its highest level of alert – which has been in place since Jan. 30, 2020.

North Carolina’s Republican-led legislature passes 12-week abortion ban

North Carolina’s Republican-controlled legislature passed a bill on Thursday that limits the window for most abortions to 12 weeks, down from 20, which could sharply reduce access to the procedure for millions of women across the U.S. south. The measure now heads to Democratic Governor Roy Cooper, who has vowed to veto it, clomid generic following the Senate’s 29-20 approval along party lines, a day after the state House of Representatives passed it in a similar party-line vote.

EU needs tiered drug pricing to improve patient access, Bayer exec says

The European Union should put mechanisms in place to allow drugmakers to charge higher prices in wealthy European countries and lower prices in poorer nations to assure more equitable patient access to life saving medicines, Bayer’s global pharmaceuticals head said in an interview. That might be accomplished in part by restricting drug importation within the EU, Stefan Oelrich, head of Bayer’s pharmaceuticals unit, told Reuters on Thursday.

FibroGen’s anemia drug fails to meet main goal in late-stage trial

FibroGen Inc said on Friday its anemia drug had failed to meet the main goal in a late-stage trial, sending its shares tumbling nearly 12% before the bell. The miss is the latest setback for the company whose application seeking approval for the drug to treat anemia in kidney disease patients was rejected by the U.S. Food and Drug Administration in 2021 seeking additional data.

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FDA may approve birth control pill WITHOUT prescription by summer

Come this summer, women could have access how to get cheap clomid birth control pills without a prescription for the first time in US history.

The Food and Drug Administration is weighing the merits of approving a type of over-the-counter birth control in use since the 1970s called Opill, a progestin-only pill that prevents unwanted pregnancies in about 94 percent of cases.

HRA Pharma presented real-world evidence Tuesday that showed the vast majority of eligible people took its pill correctly without negative consequences and followed the instructions without the help of a medical professional, a concern that FDA officers had about making it OTC.

The manufacturer of the FDA-approved prescription drug also reported that teenagers and people with less understanding of their health and the healthcare system were able to stick to their daily medication regimen, a strong sign that the populations most vulnerable to unplanned pregnancies would be well protected.

The debate about prescription-free birth control has been brewing for years but hit a boiling point last year following the groundbreaking decision by the Supreme Court to rescind the federal guarantee to abortion established 50 years ago.

HRA Pharma, the now owned by Perrigo approval for the first-ever birth control pill that women could buy without a prescription. The request from a French drugmaker sets up a high-stakes decision for the Food and Drug Administration amid the political fallout from the Supreme Court’s recent decision overturning Roe v Wade

Access to mifepristone, one of two pills in a medication abortion regimen, has become a fixture of the culture wars dictated by far-right conservative ideology.

While birth control is entirely and completely different from mifepristone, it has been swept up in the fight over abortion since Supreme Court Justice wrote that the court ‘should reconsider’ several precedents that concern the right to privacy—including the legality of contraception.

Approving Opill for use over the counter would widen birth control options for more than 19 million women living in areas of the US without reasonable access to a health center that offers the full range of contraceptive methods.

Roughly three dozen medical organizations including the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been calling for a non-prescription birth control pill option for years.

Opill, also called the mini-pill, has been safely in use for about five decades, but the US is an outlier when it comes to making the pills available without a doctor’s order.

Opill contains progestin only, unlike many oral contraceptives that contain both progestin and estrogen.

This is the appeal of the mini-pill. Because it does not contain estrogen, which increases the risk of blood clotting by several-fold, the progestin-only pills is seen as lower-risk.

Its modus operandi is how to get cheap clomid thicken mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.

Progestin-only pills do not prevent ovulation as well as combination birth control pills. Therefore, their effectiveness is slightly lower.

The FDA’s Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee had two primary concerns about designating Opill for over the counter use.

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Japan’s Takeda sells $670 mln of Europe OTC assets to pare debt

TOKYO, April 24 (Reuters) – Japan’s Takeda Pharmaceutical Co Ltd said it would sell up to $670 million of over-the-counter drug operations in Europe to pare debt ahead of its full-year earnings announcement.

Takeda, Japan’s biggest pharma company, has pledged to sell $10 billion in non-core assets to reduce leverage following its $59 billion purchase of Shire Plc, completed in January 2019. The company is due to release full-year earnings on May 13.

Takeda said on Friday it would sell selected OTC and prescription products that are sold in Europe to Denmark-based Orifarm Group. The sale, cheap clomid without rx which includes two manufacturing sites in Denmark and Poland, would amount to about $670 million subject to customary legal and regulatory closing conditions.

The announcement followed a report by Nikkei Business that Takeda was seeking to sell its Japan-based consumer health unit for around 400 billion yen ($3.72 billion).

Possible buyers of Takeda Consumer Healthcare Co include Taisho Pharmaceutical Co. and large investment funds, Nikkei reported. Takeda and Taisho declined to comment.

“The Japanese consumer healthcare business is not one of the company’s core businesses and has little to no overlap with them, so this divestiture does not surprise me,” said Morningstar analyst Jay Lee.

Takeda Chief Executive Christophe Weber had said last year that a sale of the Japan-focused consumer unit, known for its Alinamin line of energy drinks, was unlikely.

Takeda completed $7 billion of divestments in calendar 2019, including assets in the Middle East and Africa and a dry-eye drug sold for $5.3 billion to Novartis, Refinitiv data showed. It announced last month the sale of non-core products in Latin America to Hypera Pharma for $825 million.

Takeda’s shares rose 2.2% in Tokyo trading versus a 0.9% drop in the broader market. Takeda shares are still down 14% so far this year.

($1 = 107.6500 yen) (Reporting by Rocky Swift; Editing by Muralikumar Anantharaman and cost of generic clomid no prescription David Evans)

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