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FDA presses pause on trial for OTC version of anti-impotence drug…

By Tassilo Hummel and Natalie Grover

PARIS/LONDON, May 30 (Reuters) – The U.S. health regulator has put on hold a trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment, French drugmaker Sanofi said on Monday.

The pause is related to concerns about how the trial protocol has been designed, the company said, adding that no patients had so far been recruited for the study.

Cialis, known chemically as tadalafil, was first approved by the European Medicines Agency in 2002 and then by the U.S. Food and Drug Administration (FDA) in 2003 as a prescription-only therapy.

The treatment – which made developer U.S. drugmaker Eli Lilly billions before generic competition eroded sales – has differentiated itself from competition because it has a time-release formula that allows men to take it anywhere up to 36 hours before they use it.

In 2014, Sanofi won the license to sell Cialis as a non-prescription drug in the United States, Europe, Canada and Australia, once regulatory approvals have been secured in each region.

This OTC version cost of generic clomid Cialis is expected to be a key contributor to achieving above-market growth from 2024 in Sanofi’s consumer health division, a company executive said last year.

Any delays here are clearly unhelpful, Bernstein analyst Wimal Kapadia told Reuters, adding that it was unclear what the delay would mean for that 2024 timeline.

Sanofi’s stock was down more than 3% by late morning on Monday.

When determining whether to allow prescription drugs to be sold over the counter, the FDA weighs whether patients are able to understand complex aspects cost of generic clomid their condition and exactly when to take the drug to ensure safe use.

Like rival anti-impotence drugs, such as Viagra, Cialis can cause a dangerous fall in blood pressure if taken with nitrates, a class of heart drugs that include nitroglycerine.

The global erectile dysfunction treatment market was estimated to be worth roughly $3.7 billion last year, and is expected to grow to about $5.9 billion by 2028, according to market intelligence firm Coherant Market Insights, though it was unclear what slice cost of generic clomid the market was expected to be taken by OTC drugs. (Reporting by Tassilo Hummel in Paris and Natalie Grover in London; additional reporting by Juliette Portala in Gdansk; Editing by Bradley Perrett and David Holmes)

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People taking blood thinners may risk danger by mixing with OTC meds

By Reuters Staff

(Reuters Health) – People taking blood-thinning medications often use over-the-counter (OTC) medicines with the potential to cause dangerous internal bleeding, a recent study suggests.

The study focused on 791 patients prescribed apixaban, one of several newer blood thinners known as NOACs (non-vitamin K antagonist oral anticoagulants) that are recommended to prevent stroke in people with atrial fibrillation, a heart rhythm disorder.

Almost all of these patients used over-the-counter medicines, and 33% of them took at least one nonprescription drug daily or most days of the week with the potential to cause dangerous side effects when combined with apixaban. And almost 7% of them regularly took two or more over-the-counter medicines that could be a dangerous mix with apixaban.

“New OTC products are constantly being adopted by patients,” Dr. Derjung Tarn of the David Geffen School of Medicine at UCLA and colleagues write in the Journal of the American Geriatrics Society. “This study demonstrates that patients have limited knowledge about potential serious interactions between OTC products and apixaban.”

In atrial fibrillation, electrical impulses in the upper chambers of the heart are chaotic, causing the heart muscle to quiver rather than contracting normally. As a result, blood doesn’t flow smoothly through the heart. This can i get cheap clomid lead to the formation of clots that can i get cheap clomid then travel through the arteries to the brain.

NOACs are the drug of choice for stroke prevention in patients with atrial fibrillation, which occurs most frequently in older patients. Apixaban is one of the most frequently prescribed. Others include dabigatran, rivaroxaban, and edoxaban.

Unlike the older blood-thinner warfarin, which required regular blood tests to prevent side effects, most people prescribed apixaban or other NOACs are not followed in specialized anticoagulation clinics or monthly by health care professionals, the study team writes. As a result, they may not be aware of potential drug interactions.

In the current study, researchers surveyed patients prescribed apixaban in 2018. They asked patients how often they took over-the-counter remedies like aspirin, ibuprofen, naproxen, and acetaminophen. They also asked about common dietary supplements, including Chinese herbs, various fish oils, ginger and herbal teas.

Aspirin was the most commonly used nonprescription treatment in the study, and almost two-thirds of people on aspirin also took at least one other over-the-counter medicine with the potential to increase the risk of bleeding when mixed with apixaban.

The study didn’t look at whether mixing over-the-counter medicines or supplements with blood thinners actually caused bleeding or other dangerous side effects in these patients.

One limitation of the analysis is that researchers relied on patients to accurately recall and report on what over-the-counter medicines and supplements they used.

It’s also not clear from the study whether people started using any of these nonprescription remedies before or after they were prescribed apixaban.

“Patients who have taken OTC medications or dietary supplements without any problems prior to starting apixaban may not consider potential interactions, particularly if they ingest the supplements as part of their diet,” the study team writes.

“For example, certain ethnic groups may regularly incorporate dietary supplements, such as turmeric and Chinese herbs, in their meals,” the study team notes. “Unless providers ask them, patients may not realize these are important to disclose.”

SOURCE: website Journal of the American Geriatrics Society, online October 28, 2019.

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US FDA to seek public opinion before deciding on disallowing…

Sept 14 (Reuters) – The U.S. Food and Drug Administration said on Thursday that it would seek public opinion before finalizing its decision how to get cheap clomid remove an ingredient widely used in cough syrups from the agency’s list of ingredients for over-the-counter (OTC) use.

The FDA’s clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, an ingredient widely used in cold and cough syrups. (Reporting by Leroy Leo in Bengaluru; Editing by Shailesh Kuber)

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LME to commission independent review of nickel market chaos

April 4 (Reuters) – The London Metal Exchange said on Monday it would commission an independent review into the events that led to chaos in the nickel market last month, and said it had introduced daily price limits for all its metals.

The LME, the world’s oldest and largest market for industrial metals, last month brought in 15% upper and lower daily price limits for all of its physically delivered metals plus cash-settled cobalt.

The exchange suspended nickel trading on March 8 after prices spiked by more than 50% to hit $100,000 a tonne. Activity resumed on March 16 when it launched daily price limits and the provision of OTC nickel trading data for the first time.

The price surge was blamed on short-covering by one of the world’s top nickel producers, China’s Tsingshan Holding Group. The LME has said the large short positions originated primarily from the over-the-counter (OTC) market.

The exchange also said it wanted to introduce OTC trade reporting across the board and that a first step was to extend provision of OTC daily position reporting, as is now implemented for nickel, to other metals.

The LME said it welcomed an announcement by British financial regulators who said on Monday that they would review the way the exchange handled the halt in nickel trading last month.

It added that it would also commission an independent review of events leading up where to get cheap clomid the trading suspension in an attempt to prevent a repeat of such a situation. (Reporting by Swati Verma in Bengaluru; Editing by David Goodman,Pravin Char and David Evans)

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Hong Kong regulator sharpening scrutiny of derivatives after…

By Selena Li

HONG KONG, June 28 (Reuters) – Hong Kong’s financial watchdog is tightening oversight on derivatives markets after the collapse of Archegos Capital Management, a senior official at the city’s Securities and Futures Commission (SFC) said on Tuesday.

Archegos, a U.S.-based family office of investor cost of generic clomid no prescription Bill Hwang which had $36 billion in assets, blew up last year when it was caught short on highly leveraged trades and where can i get clomid no prescription left global banks with $10 billion in losses.

A majority of Hwang’s exposure was built via a type of equity derivative traded over the counter, written by his bank counterparties, which helped him to circumvent rules requiring reporting positions to U.S. regulators.

“The collapse of Archegos prompted us to take a fresh look at the surveillance tools we use to detect concentrated positions in the over-the-counter (OTC) market,” said SFC Deputy Chief Executive Officer Julia Leung.

Prime brokers operating in the OTC derivatives markets have faced “tough challenges” and it was “evident from the Archegos saga last year,” said Leung, who is also SFC’s executive director for intermediaries.

The regulator is also conducting a thematic review of OTC derivatives activities in Hong Kong to assess prevailing market practices, she said, and the scope of the review will probe firms’ risk management, assessment and escalation practices.

Fragmented global practice and regulation in the opaque OTC derivatives market compounds the regulatory challenges, Leung said, adding gaps in oversight would remain unless “risk governance structures” are integrated.

The SFC will also soon launch a review on block trading, or large sales of shares, in Hong Kong with an aim to potentially introduce standards for how to conduct such business activities.

“We are looking into how market participants communicate information with potential investors prior to the announcement of a (block trade) transaction, commonly known as market sounding,” she added. (Editing by Jacqueline Wong)

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Perrigo unit asks FDA to approve first ever OTC birth control pill

July 11 (Reuters) – Perrigo Company said on Monday its unit HRA Pharma has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control cheap clomid pill for over-the-counter (OTC) sale, cost clomid the first such request for this type of contraception.

The application from the HRA comes on the back of the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.

The contraceptive is currently a prescription drug sold under brand Opill.

HRA Pharma expects the regulator to hold an advisory committee meeting and where can i buy generic clomid approve the application in the first half of 2023, a period of about 10 months is typical for such approval requests, said Frederique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.

“The timing is a bit coincidental. We have been working on that application for the last seven years,” Welgryn said.

The FDA declined to comment on the submission.

Meanwhile, Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, said the submission was a positive.

“We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons,” Hoskins said, but added that the pill could still help more people to “control their own reproductive futures”.

Currently, the only contraception drugs available for women without a prescription are emergency oral pills that can be taken within three days after having unprotected sex.

Abortion rights activists have stepped up calls to make mifepristone, which in combination with misoprostol induces an abortion up to 10 weeks into a pregnancy, available OTC.

The non-estrogen Opill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills, generic clomid for sale such as Opill, are effective at preventing pregnancy and safe for most women to use. (Reporting by Leroy Leo in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini Ganguli)

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FDA presses pause on trial for OTC version of anti-impotence drug…

By Tassilo Hummel and Natalie Grover

PARIS/LONDON, May 30 (Reuters) – The U.S. health regulator has put on hold a trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment, French drugmaker Sanofi said on Monday.

The pause is related to concerns about how the trial protocol has been designed, clomid without insurance the company said, adding that no patients had so far been recruited for the study.

Cialis, known chemically as tadalafil, was first approved by the European Medicines Agency in 2002 and then by the U.S. Food and Drug Administration (FDA) in 2003 as a prescription-only therapy.

The treatment – which made developer U.S. drugmaker Eli Lilly billions before generic clomid without dr prescription competition eroded sales – has differentiated itself from competition because it has a time-release formula that allows men to take it anywhere up to 36 hours before they use it.

In 2014, Sanofi won the license to sell Cialis as a non-prescription drug in the United States, Europe, Canada and Australia, once regulatory approvals have been secured in each region.

This OTC version of Cialis is expected to be a key contributor to achieving above-market growth from 2024 in Sanofi’s consumer health division, a company executive said last year.

Any delays here are clearly unhelpful, Bernstein analyst Wimal Kapadia told Reuters, adding that it was unclear what the delay would mean for that 2024 timeline.

Sanofi’s stock was down more than 3% by late morning on Monday.

When determining whether to allow prescription drugs to be sold over the counter, the FDA weighs whether patients are able to understand complex aspects of their condition and exactly when to take the drug to ensure safe use.

Like rival anti-impotence drugs, such as Viagra, Cialis can cause a dangerous fall in blood pressure if taken with nitrates, a class of heart drugs that include nitroglycerine.

The global erectile dysfunction treatment market was estimated to be worth roughly $3.7 billion last year, and where can i get generic clomid is expected to grow to about $5.9 billion by 2028, according to market intelligence firm Coherant Market Insights, though it was unclear what slice of the market was expected to be taken by OTC drugs. (Reporting by Tassilo Hummel in Paris and Natalie Grover in London; additional reporting by Juliette Portala in Gdansk; Editing by Bradley Perrett and David Holmes)

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US Supreme Court appears wary in case targeting consumer financial…

By John Kruzel and Andrew Chung

WASHINGTON, Oct 3 (Reuters) – U.S. Supreme Court justices on Tuesday appeared skeptical of the payday lending industry’s challenge to the Consumer Financial Protection Bureau’s funding structure in a case that President Joe Biden’s administration has said imperils an agency set up to curb predatory lending after the 2008 global financial crisis.

The justices heard arguments in the administration’s appeal of a lower court’s ruling that the CFPB’s funding mechanism, established when Congress passed Democratic-backed legislation in 2010 creating the agency, violated a constitutional provision giving lawmakers the power of the purse. The agency, which enforces consumer financial laws, draws money each year from the U.S. Federal Reserve rather than budgets passed by Congress.

It was the first of several cases the justices are tackling during their new nine-month term, which began on Monday, that could curb the power of federal agencies.

Questions posed by the court’s three liberal justices and at least two of the six conservative justices – Brett Kavanaugh and Amy Coney Barrett – signaled doubt over the argument by the challengers that the CFPB’s funding design violates the U.S. Constitution’s “appropriations clause,” which vests spending authority in Congress.

Kavanaugh pushed back against the assertion that the structure unlawfully lets the agency determine its own funding without a meaningful limit set by Congress.

“Congress could change it tomorrow. And there’s nothing perpetual or permanent or about this,” Kavanaugh said.

Barrett expressed reservations about how the challengers – two payday lending trade groups – would rectify the funding issue.

“I think we’re all struggling to figure out, then, what’s the standard that you would use,” Barrett told Noel Francisco, who argued for the challengers, adding: “How do you decide how much is too much or how specific is specific enough?”

U.S. Solicitor General Elizabeth Prelogar, arguing for Biden’s administration, called the funding mechanism lawful and said Congress has used a “materially identical” structure for other financial regulators including the Federal Reserve Board, Office of the Comptroller of the Currency and Federal Deposit Insurance Corporation.

‘EXACTING CONTROL’

The court’s conservative majority has rolled back the power of U.S. agencies including the Environmental Protection Agency in recent years. Some of the conservative justices on Tuesday echoed the industry concerns about the CFPB.

Conservative Justice Clarence Thomas asked whether the agency’s setup “eviscerates the kind of exacting control that Congress usually exercises in the appropriations process.”

Conservative Chief Justice John Roberts called Prelogar’s view of congressional appropriations power “aggressive,” and said such a stance could undermine the constitutional separation of powers between the legislative and executive branches of government when both are controlled by the same party.

“In that situation, you can see Congress empowering the president in a way that might seem unusual to the framers” of the Constitution, Roberts added.

The liberal justices pressed the challengers on the repercussions of deeming the CFPB’s funding structure unconstitutional.

“It sure seems that on your view, the Federal Reserve would also be unconstitutional,” liberal Justice Elena Kagan said.

Payday loans are short-term and high-interest loans typically due on the borrower’s next payday after the loan is made, with the annual percentage rate usually steep – 390% or more, according to the U.S. Federal Trade Commission.

The CFPB was established by legislation signed by Democratic former President Barack Obama to curb the type of predatory lending that contributed to the financial crisis. The agency has delivered $16 billion of relief to consumers as a result of its 300-plus enforcement actions from 2012-22 including a $3.7 billion settlement last year with Wells Fargo.

The New Orleans-based 5th U.S. Circuit Court of Appeals last year ruled that the CFPB’s funding structure violated the appropriations clause. The 5th Circuit also invalidated a CFPB regulation opposed by payday lenders that stops them from trying to charge a borrower’s bank account after two unsuccessful attempts due to insufficient funds.

Many conservatives and their Republican allies see the CFPB as part of an unwieldy “administrative state,” the network of agencies responsible for the array of federal regulations affecting businesses and individuals.

Its supporters have urged the justices to uphold the CFPB’s funding mechanism, saying that a ruling against the agency would leave consumers vulnerable to deceptive and abusive practices, and could place its existing rules on shaky legal ground.

A ruling is expected by the end of June.

(Reporting by John Kruzel and Andrew Chung; Editing by Will Dunham)

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LME launches reporting of OTC positions after nickel chaos

By Pratima Desai

LONDON, June 17 (Reuters) – The London Metal Exchange (LME) approved rules on Friday for members to report all over the counter (OTC) positions, a move taken after off-exchange trading was partly blamed for a wild spike in nickel prices in March.

“This … will improve the ability of the LME to oversee activity holistically through increased visibility, ensuring future market stability,” the exchange said in a statement.

The exchange, owned by Hong Kong Exchanges and Clearing Ltd , was forced how to get cheap clomid suspend nickel trading and cancel all deals on March 8 because of disorderly activity caused partly by a large OTC short nickel position.

The new rules, due to take effect in one month, require OTC positions reported on a weekly basis in all physically-delivered metals including aluminium, copper and nickel.

The LME has withdrawn an existing requirement for members to report daily their OTC nickel positions.

The LME, the world’s oldest and largest market for industrial metals, will also require holders of large OTC positions to tell the exchange the rationale for holding them.

The LME received 27 submissions during its two-week consultation period, with a majority opposed to introducing the OTC rules before probes were completed into what caused chaotic nickel trading in March.

Benchmark nickel on the LME doubled how to get cheap clomid a record above $100,000 a tonne on March 8 on expectations China’s Tsingshan Holding Group and others would have how to get cheap clomid buy back their short positions, which bets on prices falling.

British financial regulators in April launched a sweeping probe into how to get cheap clomid the LME suspended nickel trading and the LME also commissioned its own independent review.

“While any relevant findings from the independent review will also be considered and factored into the LME´s plans in due course, the LME will not delay taking appropriate actions,” it said.

U.S. hedge fund Elliott Associates and Jane Street Global Trading are suing the LME for $456 million and $15.3 million respectively for cancelled nickel trades. (Additional reporting by Eric Onstad; Editing by Edmund Blair)

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U.S. FDA to review Perrigo’s birth control pill for OTC use in…

Sept 12 (Reuters) – Perrigo Co Plc said on Monday that the U.S. Food and Drug Administration had scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.

The drugmaker’s unit, HRA Pharma, in July submitted an application to the health regulator seeking to make its prescription contraceptive drug, Opill, an over-the-counter where buy cheap clomid pill.

Since the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide, the spotlight has been on contraception access.

Abortion rights activists have stepped up calls to make mifepristone, where to buy clomid which, in combination with misoprostol, induces an abortion up to 10 weeks into a pregnancy, can i buy clomid no prescription available without a prescription.

Opill, a non-estrogen contraceptive, has been used with prescription since its approval in 1973. If the FDA approves HRA Pharma’s application, Opill would become the first daily OTC birth-control pill in the United States.

HRA said in July it was expecting a decision from the FDA in the first half of 2023.

(Reporting by Bhanvi Satija in Bengaluru; Editing by Anil D’Silva)

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