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Perrigo unit submits approval application to FDA for OTC birth…

July 11 (Reuters) – Perrigo Company said on Monday its unit has submitted an application to the U.S. Food and Drug Administration (FDA) cheap clomid for sale approval of an over-the-counter (OTC) birth control pill.

The application from the Paris-based HRA Pharma 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.

If approved, the contraceptive, which is currently a prescription drug under the brand Opill, would be the first daily birth control pill available without a prescription in the U.S., the company said.

The non-estrogen pill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills like Opill are effective at preventing pregnancy and cheap clomid without insurance safe cheap clomid for sale most women to use.

The conservative-leaning U.S. Supreme Court’s decision last month curbing the right to an abortion has shifted the focus to alternatives.

Abortion rights activists have stepped up calls to make mifepristone, which in combination with a second drug called misoprostol induces an abortion up to 10 weeks into a pregnancy, available OTC. (Reporting by Leroy Leo in Bengaluru; Editing by Krishna Chandra Eluri)

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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 Bill Hwang which had $36 billion in assets, blew up last year when it was caught short on highly leveraged trades and 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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U.S. FDA panel to discuss Perrigo’s daily OTC birth-control pill in…

March 28 (Reuters) – The U.S. Food and Drug Administration plans to hold an advisory panel meeting to discuss Perrigo Company Plc’s over-the-counter (OTC) birth control pill in May, the drugmaker said on Tuesday.

The panel will decide on recommending the non-estrogen contraceptive as a daily OTC birth control pill on May 9 and can i order generic clomid price 10. The drug, Opill, is expected to be the first such pill in the United States if approved.

Opill, which has been used with a cost of clomid without prescription since its approval in 1973, was due for review in November last year, but the FDA delayed that meeting to review additional information.

Contraceptives have been in focus since abortion rights were curtailed in 2022 when the U.S. Supreme Court overturned the constitutional right to terminate pregnancies as it scrapped a landmark ruling in the 1973 Roe vs. Wade case.

(Reporting by Pratik Jain; Editing by Shinjini Ganguli)

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As FDA rules some cold drugs don’t work, docs say what to take instead

It turns out Grandma may have been right all along: Chicken soup is the perfect remedy for a cold and flu.

Last month, the US Food and Drug Administration (FDA) announced a key ingredient in some of the most common cold medications doesn’t actually work, leaving millions of Americans without reliable cold and flu remedies. 

An FDA panel said after a two-day review that phenylephrine, an oral decongestant, ‘is not effective’ at standard or even high doses compared to a placebo and stores began pulling products containing the substance from their shelves, including Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night.

Dr Stuart Fischer, an internal medicine doctor in New York City, told DailyMail.com there were several over-the-counter alternatives – and natural remedies – that work better.

Dr Fisher’s alternatives to  Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night

CVS will begin pulling popular oral cough and cold products with phenylephrine as the only active ingredient from its store shelves. Pictured: Empty CVS shelves in New York City

The pharmacy chain is removing the products voluntarily after a panel of advisers to the FDA last month refused to back the effectiveness of oral over-the-counter medicines made with the ingredient

Dr Fischer said he was pleased to hear the news and said there are plenty cost of cheap clomid alternatives that work better than the over-the-counter products, including the age-old recommendation of chicken soup.

Dr Fischer said: ‘I’m not very big on over medicating the signs and symptoms of a winter cold. 

‘I see this as our bodies utilizing the immune system and over medicating ourselves so that we feel “normal” – it’s not going to help you.

‘You cannot achieve normal feelings in the midst of a winter virus. It’s going to take time and it’s going to run its course. 

‘The idea that someone can totally erase the signs and symptoms of a winter virus – I don’t think that’s necessary and I frankly very rarely recommend [these medications] and I never take them myself.’ 

In lieu of the products with phenylephrine in them, Dr Fischer recommended other ways to help a person feel better. 

When it comes to pharmaceutical options, the physician said taking the regular version cost of cheap clomid Benadryl that only contains diphenhydramine and not phenylephrine can help people suffering from sinusitis, the swelling of tissue lining the sinuses that causes facial pain and nasal congestion, by drying out of the mucous membranes in the nose. 

It can also help ‘dry up’ a wet cough.  

The internist also recommended a cough syrup like Robitussin, adding the medication ‘is essentially harmless.’

Dr Fischer said N-acetyl csyteine (NAC), an antioxidant that comes from the amino acid L-cysteine, could help people feeling under the weather. 

NAC is thought to possibly play a role in preventing cancer and is used to treat acetaminophen poisoning.

People also commonly use it for a cough and other lung conditions, as well as the flu and dry eye. There aren’t many studies on NAC and its impact on the immune system, but current research suggests it may help improve immune function. 

Phenylephrine is everywhere, so much so that nearly every nasal decongestant on pharmacy shelves contains it

One study found people who took 600 mg of the substance twice a day had fewer flu symptoms than those who took placebo. 

A remedy that has been recommended for decades, chicken soup, is one of the best things to alleviate the symptoms cost of cheap clomid a cold or the flu, Dr Fischer said, and he was even taught it during his medical training. 

There are three things in chicken soup that are vital to alleviating an illness: the broth, salt and chicken fat. 

When people are sick, taking in fluids is essential to stay hydrated, and the broth in soup can help do that. 

Secondly, people sick with fevers may be sweating and losing water, but the salt in chicken soup draws water into the body’s cells, rehydrating them. 

Lastly, the chicken fat in the soup is a good surfactant, a fat soluble molecule that opens and closes air sacs deep in the lungs, helping people take deep breathes in and breath out more fully. 

When it comes to actually preventing illness, one of the best things you can take, according to Dr Fischer, is probiotics. 

He said: ‘My own particular way of preventing colds is probiotics. I don’t think anyone can get too many probiotics. I take 25 billion units of probiotics every morning. 

‘And this to me is what people mean when they say they have a good immune system. It’s not something inherent in their chemistry, but its live good bacteria overwhelming the bad negative bacteria.’

Probiotics are considered ‘good bacteria’ in the digestive system and can help fight off harmful bacteria that can lead to illnesses.

They can be found in foods like yogurt, cottage cheese and kimchi. Supplements containing different strains are also sold over the counter.

Probiotics have been shown to help boost immune health by balancing the gut’s good bacteria.

Along with the alternative remedies, Dr Fischer stressed people who are sick should rest and take in fluids with electrolytes to replace the fluid they are losing through sweating, which can happen when someone has a fever. 

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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 where to buy clomid 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 where to buy clomid 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 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 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.

Prescription Narcan is currently covered under commercial- and government-backed insurance plans, which allows people where to buy clomid 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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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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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, 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 cost of clomid without prescription 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 cost of clomid without prescription the Japan-focused consumer unit, known for its Alinamin line of energy drinks, was unlikely.

Takeda completed $7 billion cost of clomid without prescription 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 cost of clomid without prescription 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 David Evans)

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RAY MASSEY: Lexus joins the big boys with its hybrid RX SUV

Amazing to think it’s 30 years since upmarket car brand Lexus was launched by the Japanese car giant Toyota. 

Big in Japan and the U.S., Lexus remains a niche player in the UK, targeting discerning drivers who want something a little different.

It’s sold about 200,000 cars here since 1990 and this year is looking at a record 16,000 sales.

Well-padded: The new Lexus RX SUV blends petrol and electric for greater fuel efficiency

So to help celebrate its three decades on the road I’ve been for a spin in the new 5th generation Lexus RX SUV. 

Launched in 1998, it has sold 3 million worldwide since then. It’s been a while since I’ve driven a Lexus so I was taken aback by the huge size of the RX.

But it’s taking on big-boned rivals such as the Audi Q7 and Volvo XC90, so size does matter. 

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The five-seater RX F-Sport Ray drove on 20-inch multi-spoke wheels accelerated from rest to 62mph in 7.7 seconds with a top speed of 124 mph — the seven seater is a little slower

There are three main trim levels from launch: RX with premium pack, F Sport and top range Takumi. It’s initially available as a flexible five-seater or as a slightly longer seven seater.

From early next year, customers will also be able to specify six stand-alone ‘captain’s chairs’ —two in each row. Prices range from £52,705 up to £62,605.

The RX certainly looks sharp. Loads of room inside, a commanding driving position and a premium dashboard. 

Now into its fifth generation, the first RX SUV was launched in 1998 and has sold 3 million worldwide since then

In a big nod to road safety, the top-cost of clomid without prescription-the-range Takumi trim has a new BladeScan Adaptive High Beam system that gives 24m of extra vision at night to help spot potential hazards, but without blinding other drivers.

Plenty of power too from the RX 450h’s self-charging hybrid system, comprising a 259bhp 3.5 litre direct injection V6 petrol engine working in conjunction with two electric motors — front and back — which create total pulling power of 308 bhp, about the same as three Ford Fiestas.

The five-seater RX F-Sport I drove on 20-inch multi-spoke wheels accelerated from rest to 62mph in 7.7 seconds with a top speed cost of clomid without prescription 124 mph — the seven seater is a little slower.

There are three main trim levels from launch: RX with premium pack, F Sport and top range Takumi. It’s initially available as a flexible five-seater or as a slightly longer seven seater

Like me, this well-padded SUV is built for comfort not for sporty performance. The sinews tighten up in Sport and Sport-plus modes which give it more engagement, especially on corners, but it’s no sports car.

It will do up to 35.7mpg under the new ‘real-world’ tests with low CO2 emissions of 172g/km.

Lexus reckon that under average driving, around a third of the journey will be in electric-only zero-emissions mode.

However, if you press the EV button to drive exclusively in electric-only mode, don’t expect more than a couple cost of clomid without prescription miles.

 Volvo launches its first electric car

‘Do you want a car with a plug?’ Volvo customers will be asked this from now on as the Swedish giant launches its first electric car, with a pledge to make zero-emissions battery-powered vehicles its priority over petrol for all future sales.

The new XC40 Recharge unveiled in Los Angeles is based on the award-winning XC40 small SUV, and marks the first in a family of fully electric Volvos.

Volvo’s radical electric push: From next year, dealers by default will assume customers want electric models when available. Buyers will need to specify if they want a petrol or hybrid

On sale in the UK next year, expect a price of about £50,000 — with a £3,500 taxpayer-funded subsidy for zero-emissions cars.

Volvo wants all-electric cars to account for half its global sales by 2025, with the rest as petrol-electric hybrids.

It wants plug-in petrol-electric hybrid cars to make up 20 per cent of total sales next year (2020).

A spokesman said: ‘Future customers will need to answer a fundamental question: do you want a new Volvo with a plug or without?’ 

Bentley makes a splash in Monaco

If I could ‘break the bank’ at Monte Carlo — with a win on roulette at the famous casino in Monaco — I’d be tempted to splash out on arguably the finest modern Bentley ever made.

 Powerful and luxurious: The new Flying Spur is arguably the finest modern Bentley ever made

I was one of the first to spend a day behind the wheel of the flagship Bentley Flying Spur after the Monaco launch. 

First deliveries to customers are due in February. Base prices start at £168,300, but the car — built in Crewe — I drove had £37,125 cost of clomid without prescription extras, totalling a hefty £205,425.

Powered by a 6-litre twin-turbocharged W12 TSI petrol engine developing 635hp, the Flying Spur accelerates its 2.5 tonne mass from rest to 60mph in just 3.8 seconds.

Powerful and luxurious, it’s perfect for the Cary Grant and Grace Kelly de jour.

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US FDA approves over-the-counter sale of overdose reversal drug Narcan

By Bhanvi Satija

March 29 (Reuters) – The U.S. Food and Drug Administration on Wednesday approved over-the-counter (OTC) sales of Emergent BioSolutions Inc’s Narcan, allowing for easier availability of the life-saving medication used to reverse opioid overdoses.

The formal decision makes Narcan the first naloxone-based drug available clomid without dr prescription a prescription.

Emergent said it will make Narcan available on U.S. store shelves and online retailers by late summer.

“I think it’s a big win. The question now remains about the cost,” said Noa Krawczyk, assistant professor at the NYU Grossman School of Medicine.

The contract drugmaker declined to share details on the price of its OTC version of Narcan.

Currently, a 4-milligram, two-dose pack of the nasal spray has a wholesale price of about $120, according to 46Brooklyn, a drug pricing non-profit.

“For people who need it most, it needs to be at a lower price point than what it is currently available,” said Maryann Mason, associate professor of emergency medicine at Northwestern University.

The approval could allow for access to the drug in areas that have concentrated overdose problems and few pharmacies, she said.

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

The Biden administration has been pushing for action, as U.S. drug-related overdose deaths surpassed 100,000 in 2021, according to government estimates. The OTC approval helps align the federal government’s stance with states that already offer the nasal spray clomid without dr prescription clomid without dr prescription at pharmacies.

The FDA approval followed a unanimous recommendation from its independent panel of advisers backing OTC use of Narcan, while suggesting changes to the drug’s packaging.

Shares of Maryland-based Emergent rose as much as 20.2% to $10.70 in early trading. They were up more than 5% at $9.37 later on Wednesday.

The approval puts Emergent ahead in the OTC product race.

While Benchmark analyst Robert Wasserman, ahead of the FDA green light, noted that Narcan sales had been declining, he added, “I do think there’ll be a big demand for the product and I don’t think it’s going to be too price sensitive right away either.”

Emergent reported a 14% fall in 2022 for its nasal naloxone products, compared with a 40% increase in 2021. In late 2021, FDA approved the first generic version of Narcan, sold by Israeli drugmaker Teva Pharmaceuticals.

The company will have to compete on the price once Narcan begins to face additional OTC competition later this year, said TD Cowen analyst Boris Peaker.

Non-profit Harm Reduction Therapeutics’ application for its OTC naloxone nasal spray is currently under FDA review with a decision expected in July 2023.

(Reporting by Bhanvi Satija and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli and Bill Berkrot)

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