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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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Health Canada says more heartburn medicines being recalled after…

Sept 25 (Reuters) – Health Canada said on Wednesday four companies were recalling popular heartburn drug ranitidine, known by its brand generic clomid for sale name Zantac, after presence of a probable cancer-causing impurity was found in some of the drugs.

The companies recalling the drugs include Apotex Inc, Pro Doc Limitée, Sanis Health Inc and Sivem Pharmaceuticals ULC, along with Novartis AG’s recall, which was announced last week.

Branded versions of the drug such as Sanofi SA’s Zantac are available for can i get generic clomid over-the-counter (OTC) sale in Canada, while can i order generic clomid price versions are available for sale both OTC and with prescription. (Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta)

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Japan’s Takeda to sell some Asia-focused drugs to Celltrion for…

June 11 (Reuters) – Takeda Pharmaceutical Co Ltd has agreed to sell cheap clomid without a prescription portfolio of over-the-counter and cheap clomid without a prescription drugs marketed in the Asia Pacific region to South Korea’s Celltrion Inc for $278 million, it said on Thursday

Takeda, Japan’s biggest drugmaker, will get $266 million upfront in cash and up to an additional $12 million in potential milestone payments, the company said.

The portfolio to be sold to Celltrion includes OTC and pharmaceutical products marketed mainly in Australia, Hong Kong, South Korea, and elsewhere in Asia, it said.

Takeda will continue to manufacture the products and supply them to Celltrion.

The Japanese company pledged to dispose of $10 billion in non-core assets following its $59 billion purchase of Shire Plc completed last year, which left it saddled with debt.

Prior to Thursday’s announcement it had divested $7.7 billion in non-core assets so far, with the latest deal being the sale of OTC and cheap clomid without a prescription products to Denmark-based Orifarm Group for about $670 million.

Nikkei Business reported last month that Takeda is looking to sell its Japanese OTC business for around 400 billion yen ($3.72 billion).

After Takeda reported full-year earnings on May 13, Chief Executive Christophe Weber said “we are not an OTC company.” (Reporting By Mrinalika Roy in Bengaluru, Rocky Swift in Tokyo; Editing by Shounak Dasgupta and how to get cheap clomid Jan Harvey)

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Emergent aims to price over-the-counter Narcan at about $50

April 20 (Reuters) – Contract drugmaker Emergent BioSolutions Inc said on Thursday it is aiming to price the over-the-counter (OTC) version of its opioid overdose reversal drug Narcan at around $50 per carton.

The OTC version will become available at U.S. stores and online retailers later this summer, while the currently available prescription nasal spray carries a wholesale price tag of $125 per carton.

Emergent’s statement comes nearly a month after the U.S. Food and Drug Administration allowed Narcan to be sold over-the-counter, allowing for easier availability of the life-saving medication.

The approval paved the way for expanded access to the drug in areas that have concentrated overdose problems and a few pharmacies, but uncertainty remains around Narcan’s final price and whether insurers will offer coverage.

Emergent has not disclosed the final price for order generic clomid OTC Narcan yet.

“A goal for the out-of-pocket retailer price is to be consistent with our public interest pricing for one carton of two 4 milligram doses,” the company said in its statement, adding that current price for cheap clomid without a prescription public interest groups averages less than $50.

Customers will pay the out-of-pocket retailer price, which is set by individual retailers for Narcan once it becomes available in the United States.

generic clomid without dr prescription Narcan is currently covered under commercial- and government-backed insurance plans, which allows people to get the drug for free from the pharmacy or for a nominal co-pay.

Government-backed Medicare health insurance plans do not cover OTC products, but have previously made exceptions such as in the case of COVID-19 tests.

Naloxone-based Narcan rapidly reverses or blocks the effects of opioids, restoring normal respiration, especially when given within minutes of the first signs of an overdose.

(Reporting by Bhanvi Satija in Bengaluru; Editing by Devika Syamnath)

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LME WEEK-LME looking at fee structure to address cheaper OTC…

LONDON, Oct 9 (Reuters) – The London Metal Exchange (LME) is looking at its fee structure to address the fact that over-the-counter (OTC) trading is cheaper than trading on the exchange, clomid without rx the LME’s chief executive said on Monday.

The 146-year-old LME was forced to halt nickel trading and cancel all deals in March last year after a wild spike in prices caused partly by large OTC short nickel positions.

Since then the exchange, the world’s oldest and largest market for industrial metals, has imposed measures requiring members to report all OTC positions.

The LME has said that the market would benefit from more trading migrating to its electronic platform rather than to telephone-based trading or OTC markets.

During a panel discussion on Monday on the future of the LME nickel contract, which saw trading volumes tumble after last year’s crisis, LME CEO Matthew Chamberlain noted that people sometimes ask him why OTC trading is cheaper than on the LME.

“That’s one area we’re looking at,” Chamberlain said, giving no details.

The LME requires institutions that book OTC trades that use LME prices as a benchmark to pay a fee to the LME of $1.14 per equivalent LME lot, which compares to all-in fees of $2.70 per lot paid for exchange trading.

The LME is owned by Hong Kong Exchanges and Clearing Ltd. (Reporting by Eric Onstad; Editing by Sharon Singleton)

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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, can i get cheap clomid which is currently approved for clomid without 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 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 clomid without prescription 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 to 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 generic clomid prices 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, 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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DOMINIC LAWSON: Stolen car part is a sad indictment of policing

This may be farewell, old friend. I refer to my 15-year-old Lexus RX petrol hybrid. It has over 123,000 miles on the clock, but I still enjoy the way it unfailingly starts in all conditions and the silent, vibration-free comfort of every journey.

Or at least I did until ten days ago, when I turned on the engine and it made a noise like a tractor. I turned it off and started it again. Same monstrous roar.

This was in the car park of Stonegate station in East Sussex — about a quarter of an hour’s drive from our home. Rather longer, on this occasion, as it struggled to get up the hills en route, the engine’s noise becoming deafening. At times, I thought it wouldn’t make it.

My guess was that something terrible had happened to the exhaust — though I couldn’t think how that could have been the case, when it had driven perfectly on the way to the station two days earlier, and been parked there since then.

The truth was revealed as soon as our wonderful local garage mechanic, Matt, clomid cost came round. He emerged from under the car and said: ‘It’s what I thought. Your catalytic converter has been stolen, and they’ve torn through the exhaust to remove it.’

The catalytic converter of Dominic Lawson’s Lexus RX petrol hybrid was stolen and the thieves tore through the exhausts to remove it (File image)

Gangsters

Add me to the spiralling statistic of car owners facing what could be thousands of pounds in costs, and possibly the write-off of their vehicle, as a result of the gangs who have been stealing catalytic converters in every part of the country — and with very little chance of being caught, let alone prosecuted.

The reason for all these thefts is the precious metals in the catalytic converters. The platinum, palladium and rhodium inside them are key to their ability to limit the emissions of noxious elements from the exhaust.

But these precious metals are, well, precious: and they can you get generic clomid be sold for use in various other ways. The most valuable of all, rhodium, can go for thousands of pounds an ounce.

As I have now learned, my car would have been top on the hit list for these gangsters. According to the motoring website Parkers: ‘The UK’s most targeted models are petrol hybrid cars, particularly Toyota and Lexus.’ Apparently, the rhodium, palladium and platinum inside their catalytic converters ‘are usually preserved a lot better than on other types of vehicles’.

Matt said he thought the cost of repairing the car and getting the new parts would be at least £2,000 — which is probably not much less than the vehicle’s trade-in value.

When my wife rang the insurance company, they suggested that we would lose our no-claims bonus if she asked them to cover the costs — on the grounds that ‘we don’t have someone to claim against’.

Well, no, the gangsters weren’t going to give us their details. But after my wife protested (forcibly), the insurance company relented: we would keep our no-claims bonus.

The theft took place in a railway station car park that was ‘festooned’ with CCTV cameras. File photo 

But our main concern was to get the police on the case. Apart from our own loss, it seemed more than likely that other cars had been vandalised in the same way, at the same time, and at the same place.

The chap sent from the insurance company to pick up our vehicle said he had recently been involved in a case where 16 cars had had their catalytic converters stolen all in the same incident in a supermarket car park (which is extraordinary, given that would probably have been in broad daylight).

So I phoned Sussex Police, giving them all the details, and added that I would be getting in touch with the people responsible for the station car park, to get them to look through CCTV footage (the place is festooned with these cameras).

The policewoman answering my call was charming but, on this point, dismissive, in a world-weary way: ‘They probably won’t agree to go through days of film.’

Well, I said, we’re still going to ask them.

It turned out we could not do this directly, but the request had to come via our insurance company, to Southeastern Railway Customer Services. That, I hope, is what will now happen.

Busy

In one respect, the police have been very swift to act. Barely a week after I reported the incident, I received a letter from Chief Superintendent Jo Banks of Sussex Police. Its second paragraph read: ‘Having carefully considered the available information, we are unfortunately unable to investigate further on this occasion. This now means that your report is considered closed.’

The letter went on to inform me that ‘people who have been victims of crime sometimes find it helpful to have support dealing with their experience. On the reverse of this letter you will find advice that you may find helpful’.

Barely a week after I reported the incident, Dominic Lawson received a letter from Chief Superintendent Jo Banks of Sussex Police which said it had ‘closed’ the case 

This was, of course, a bog-standard pro forma letter, which only appeared to be personal to me and this incident. I don’t believe for a minute that Sussex Police had ‘carefully considered’ the information I gave them, or that there was the slightest possibility they would have pursued the matter.

My interpretation of the real meaning of ‘we are unfortunately unable to investigate further on this occasion’ is: ‘We don’t accord any priority to incidents like this; frankly, we’re too busy with other stuff to spend any time worrying about the gang who did this to your car.’

To be fair, the letter appearing to come from Superintendent Banks did say: ‘Your report has been officially recorded and will remain as a permanent record which we can reopen if new information or evidence comes to light.’

Which, in theory, would include any CCTV footage which may emerge — if Southeastern Railway Customer Services, contrary to the resigned view of the person who spoke to me from Sussex Police, actually take the trouble to go through it. But what are the chances?

This is not a particular criticism of my local police. Six months ago, following Freedom of Information requests to police forces by the Liberal Democrat party, it emerged that, of the more than 50,000 thefts of catalytic converters reported between 2017 and 2021, fewer than 550 of these incidents resulted in anyone being charged — a rate of just 1 per cent.

Some of the biggest forces, such as West Midlands and Greater Manchester, did not even bother to respond fully to the Freedom of Information request; but of those that did, there were a number who recorded no charges at all (including Hertfordshire and South Yorkshire).

Insult

I am not arguing that things are getting much worse, clomid pills in terms of police dealing with thefts. It has been terrible for a long time. When I called my sister Nigella to moan about this, she replied: ‘You sound like John.’ She was referring to her late husband, John Diamond, who in 1993 had his beloved vintage Harley Davidson stolen from outside their London home, the villains having cut through a wrought iron railing to remove his pride and joy.

Nigella Lawson with her late husband John Diamond, who in 1993 had his beloved vintage Harley Davidson stolen

John had an eyewitness account of the theft (from a neighbour) and also gave the name of ‘the owner of a dodgy bike shop in South London who knew I owned the bike, knew where I lived, and who had, I knew, associates in those countries to which stolen Harleys are usually shipped’.

John got the usual ‘case closed’ letter, saying the crime had been ‘investigated’. But he then established that the police had not spoken to the eyewitness and had made no attempt even to contact the ‘dodgy bike shop’ whose details he had given them.

As John wrote at the time: ‘To be told that the case had been investigated, which was a patent lie, added insult to injury’.

My own case has none of my late brother-in-law’s pathos. With any luck I will get my trusty old car back, repaired.

But, to judge by the lack of any challenge from the police to the lucrative business model of the catalytic converter-stealing gangs, I’d be a fool ever to leave it overnight again at the railway station.

Petrol

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CVS Health raises forecast as insurance business, OTC COVID tests…

Aug 3 (Reuters) – CVS Health Corp on Wednesday raised its full-year profit forecast after strength in its insurance business and where to buy generic clomid sales of COVID-19 over-the-counter test kits helped the company report a 6% jump in second-quarter earnings.

The largest U.S. pharmacy chain’s retail and long-term care segment revenue rose 6.3%, helped by the sale of OTC test kits and the impact of the flu season, which helped offset lower COVID-19 vaccinations and diagnostic testing.

Its insurance business reported an 11% growth in revenue as well as a decrease in medical benefit ratio, which is the costs it incurs as a percentage of premiums.

CVS raised its adjusted profit outlook to $8.40-$8.60 per share from $8.20-$8.40 per share forecast earlier.

Net income for the quarter ended June 30 rose to $2.96 billion, or where buy clomid $2.23 per share, from $2.79 billion, or buying cheap clomid $2.10 per share a year earlier. (By Leroy Leo and Bhanvi Satija in Bengaluru; Editing by Vinay Dwivedi)

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LME WEEK-LME looking at fee structure to address cheaper OTC…

LONDON, Oct 9 (Reuters) – The London Metal Exchange (LME) is looking at its fee structure to address the fact that over-the-counter (OTC) trading is cheaper than trading on the exchange, the LME’s chief executive said on Monday.

The 146-year-old LME was forced to halt nickel trading and cancel all deals in March last year after a wild spike in prices caused partly by large OTC short nickel positions.

Since then the exchange, the world’s oldest and largest market for industrial metals, generic clomid without a prescription has imposed measures requiring members to report all OTC positions.

The LME has said that the market would benefit from more trading migrating to its electronic platform rather than to telephone-based trading or OTC markets.

During a panel discussion on Monday on the future cost of cheap clomid the LME nickel contract, which saw trading volumes tumble after last year’s crisis, LME CEO Matthew Chamberlain noted that people sometimes ask him why OTC trading is cheaper than on the LME.

“That’s one area we’re looking at,” Chamberlain said, giving no details.

The LME requires institutions that book OTC trades that use LME prices as a benchmark to pay a fee to the LME cost of cheap clomid $1.14 per equivalent LME lot, which compares to all-in fees cost of cheap clomid $2.70 per lot paid for exchange trading.

The LME is owned by Hong Kong Exchanges and Clearing Ltd. (Reporting by Eric Onstad; Editing by Sharon Singleton)

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CVS Health raises forecast as insurance business, OTC COVID tests…

Aug 3 (Reuters) – CVS Health Corp on Wednesday raised its full-year profit forecast after strength in its insurance business and sales of COVID-19 over-the-counter test kits helped the company report a 6% jump in second-quarter earnings.

The largest U.S. pharmacy chain’s retail and long-term care segment revenue rose 6.3%, helped by the sale of OTC test kits and the impact of the flu season, which helped offset lower COVID-19 vaccinations and diagnostic testing.

Its insurance business reported an 11% growth in revenue as well as a decrease in medical benefit ratio, which is the costs it incurs as a percentage of premiums.

CVS raised its adjusted profit outlook to $8.40-$8.60 per share from $8.20-$8.40 per share forecast earlier.

Net income for buying generic clomid no prescription the quarter ended June 30 rose to $2.96 billion, or $2.23 per share, from $2.79 billion, clomid for sale or $2.10 per share a year earlier. (By Leroy Leo and Bhanvi Satija in Bengaluru; Editing by Vinay Dwivedi)

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