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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 cost of generic clomid no prescription 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 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 cost of generic clomid no prescription 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 David Evans)

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U.S. FDA to review Emergent’s OTC opioid overdose drug on priority

Dec 6 (Reuters) – Contract drugmaker Emergent Biosolutions said on Tuesday its over-the-counter nasal spray as generic clomid without a prescription treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator.

Emergent is seeking the U.S. Food and Drug Administration’s approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country.

The agency will make its decision by March 29 and its priority review status puts Narcan on track to become the first naloxone-based drug to be sold over the counter, Benchmark analyst Robert Wasserman said.

Emergent’s announcement comes generic clomid without a prescription few weeks after the FDA said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally.

There are legal barriers limiting access to naloxone in some states, and even in others the drug is not always available to those most at risk of an overdose.

The worsening opioid crisis has prompted U.S. President Joe Biden’s administration to develop newer strategies, including the use of naloxone.

If approved, Narcan could face competition from generic clomid without a prescription versions of the drug, pressuring margins for Emergent, Cowen analyst Boris Peaker said.

Rival Opiant Pharmaceuticals’ drug nalmafene is also under the FDA’s review and could pose additional risk to Narcan sales, as it provides better protection against an opioid overdose, Peaker added.

Government data estimates that there were more than 100,000 drug-related overdose deaths in the country during 2021, a near 15% increase from the year earlier.

The Maryland-based company said its application to the health regulator includes data that supports safe and effective use of Narcan based on usability and more than five years of post-marketing studies. (Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Anil D’Silva and Maju Samuel)

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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 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 where can i buy cheap clomid 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 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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Lucira’s home test for flu and COVID-19 gets U.S. FDA nod for OTC use

Feb 27 (Reuters) – Lucira Health said on Monday the U.S. Food and Drug Administration (FDA) had granted emergency use authorization for its combination diagnostic test for COVID-19 and the flu, making it the first to be available over-the-counter.

The test – called Lucira COVID-19 & Flu Home Test – is a single-use, at-home rapid test kit that provides results from self-collected nasal swab in about 30 minutes.

Shares of the medical test maker rose more than four-fold to 66 cents in premarket trade.

The FDA’s authorization, which came on Friday, allows the test to be purchased without a prescription and performed completely at home by individuals aged 14 years or older or collected by an adult for children two years or older.

The development comes days after Lucira filed for bankruptcy protection in the United States, and said it intended to pursue a sale of its business. “Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through,” said CEO Erik Engelson.

The company was hoping where to buy cheap clomid launch the test during autumn last year – in time for the 2022 flu season – but remains confident that the test will play a key role in upcoming periods of severe respiratory disease.

Lucira is also seeking a strategic or financial partner to resume the manufacturing and development of additional home diagnostic tests. (Reporting by Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Shailesh Kuber and Uttaresh Venkateshwaran)

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LME starts consultation to make OTC metals market more transparent

By Zandi Shabalala

LONDON, May 13 (Reuters) – The London Metal Exchange (LME) on Friday proposed measures that it said would improve transparency and stability in the over-the-counter (OTC) metals market, cheap clomid without rx including more frequent disclosures of all positions.

In March, the exchange was forced to halt trading cost of clomid nickel after short-covering by one of the world’s top producers, clomid without prescription China’s Tsingshan Holding Group, caused prices to skyrocket.

The LME, owned by Hong Kong Exchanges and Clearing Ltd , has said Tsingshan’s trades originated primarily in the OTC market.

“Recent events in the LME Nickel market have demonstrated the effects that OTC activity can have on the wider LME market,” the exchange said in a notice announcing a consultation with market participants on its proposals.

“The LME believes it is now essential to accelerate the introduction of regular OTC reporting.”

The OTC market is made up of banks and traders who do deals with one another outside of any exchange.

The LME proposed that its members report weekly to the exchange on all the OTC positions they hold in physically deliverable metals with no minimum position size threshold.

It also proposed that holders of large OTC positions should tell the exchange why they held them.

Previous attempts to introduce transparency to the OTC market were resisted by market participants, clomid for sale the LME said. It said a consultation on its proposals would run until May 27.

In the longer term, the LME said it was considering imposing real time reporting of OTC trades alongside reporting of OTC positions.

British financial regulators are probing the suspension of the LME’s nickel market.

(Reporting by Zandi Shabalala Editing by Mark Potter)

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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, buying generic clomid in July submitted an application to the health regulator seeking to make its prescription contraceptive drug, Opill, an over-the-counter 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, which, in combination with misoprostol, induces an abortion up to 10 weeks into a pregnancy, available without a prescription.

Opill, clomid otc 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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Takeda preparing to sell Japan consumer health unit to Blackstone…

TOKYO, Aug 19 (Reuters) – Japan’s Takeda Pharmaceutical Co Ltd is making final arrangements to sell its domestic over-the-counter (OTC) business to U.S. investment fund Blackstone Group Inc, Kyodo News reported on Wednesday.

Takeda, Japan’s largest pharma company, has been reducing its OTC assets worldwide as it seeks to refocus its business and reduce debt following its $59 billion acquisition of Shire.

Blackstone was among final bidders for the OTC unit, Reuters reported in June, along with Bain Capital, CVC Capital Partners and Taisho Pharmaceutical Holdings Co Ltd.

Takeda is looking to sell Takeda Consumer Healthcare, known for cheap clomid pills its Alinamin line of energy drinks, for more than 300 billion yen ($2.85 billion) by the end of the month, Kyodo reported.

A Takeda spokeswoman declined to comment to Reuters on the report beyond saying it had not come from the company. A Blackstone representative was not immediately available for comment.

The Shire acquisition, completed in January 2019, clomid generic expanded Takeda’s drug pipeline and diversified its global sales, but also left it heavily indebted. To reduce the debt, Takeda has pledged to dispose of $10 billion worth of non-core assets.

Takeda’s shares rose 1.1% in Tokyo versus a 0.2% gain for the broader market. ($1 = 105.2600 yen) (Reporting by Chris Gallagher, Rocky Swift and Junko Fujita in Tokyo; Editing by Shri Navaratnam and Christopher Cushing)

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China eases rules to help channel personal savings into government…

SHANGHAI, Aug 4 (Reuters) – China published draft rules on Friday how to get cheap clomid promote “over the-counter” (OTC) services for interbank bond trading, seeking how to get cheap clomid channel more personal savings into government bonds.

The People’s Bank of China (PBOC) also said restrictions will be eased for institutional investors to trade bonds via OTC services, which were launched in 2002 to facilitate treasury sales by individuals and companies.

China’s consumers and companies are tying up trillions of yuan in longer-dated deposits with banks, effectively taking a vast pool of money out of circulation at a time authorities are encouraging investment how to get cheap clomid aid a flagging economy.

The new rules will “promote OTC services, support the expansion of government bond market, enable residents how to get cheap clomid invest more effectively with their savings, and improve market liquidity”, the PBOC said in a statement.

The interbank OTC services has played a key role in channeling private funds into government bonds, but the business is small, while institutional participation has just taken root, the PBOC said.

The draft rules made clear that licensed financial institutions and asset managers can invest in interbank bonds via OTC services.

Meanwhile, the scope for investment for institutions through this channel has also been broadened, to include corporate bonds and policy bank bonds. (Reporting by Shanghai newsroom; editing by John Stonestreet, Robert Birsel)

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SMALL CAP IDEAS:Diaceutics offers new take on drug development process

Medical advances recently have forced a re-think of the ‘one-drug-fits-all’ approach to therapy.

Something that works for some patients might not work for others or even be dangerous.

Identifying an individual’s biological indicators or biomarkers, therefore, is critical in the precise diagnosis of a patient’s disease and treatment.

It’s known as precision or personalised medicine and helping pharmaceutical companies identify these key genetic traits is the skillset of recent AIM-listee Diaceutics.

Diaceutics is involved in precision medicine testing

In fact, its ticker symbol – DXRX – tells you all you need to know about the business.

DX is the industry abbreviation for testing and RX the shorthand for treatment, and bringing the two together is what the company is all about.

‘Some drugs only work in certain patient types and you find those patients through genetic testing,’ says Peter Keeling, Diaceutics’ chief executive.

To build a dataset, Diaceutics acquires anonymous patient data directly from testing in laboratories, which is then overlaid with information from insurance claims.

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No one dataset ever gives all the answers, says Keeling, and it this layering of information that is the key for its drug developer customers.

The group has been collecting information since it was set up in 2005 and has now amassed a ‘deep data lake’.

That includes 3.5million tests from more than 2,500 laboratories, a US database of 51million patient records, and results from over 53million ‘testing events’ outside the US.

This week, the company added to its database with the acquisition of 16million records for £1million, something it promised when it listed in March.

Data protection rules are strict in both the US and Europe, but the pharma industry itself has a zero tolerance for mistakes in data handling and Diaceutics is keenly aware of its need for security.

The ambition is to be the global market leader in patient test data for a variety of new types cost of generic clomid no prescription precision drugs.

Oncology/cancer testing is a core market for the company alongside multiple sclerosis and rheumatoid arthritis.

Today, precision medicine is all focused on the therapy, but the amount of value in improving patient testing is at least the equivalent to the introduction of a new drug, the company believes.

Industry estimates suggest it can cost of generic clomid no prescription between $1billion -$2billion to develop a new drug and Keeling wants to highlight the value ‘in the first half of the drug development equation’ ie. the testing beforehand.

That means demonstrating just how much money can be released into the healthcare system or to the pharma or clinical groups just by fixing the testing ecosystem. ‘Pharmaceutical groups are good at launching the drugs, but struggle to manage the testing,’ says Keeling.

Oncology/cancer testing is a core market for the company alongside multiple sclerosis and rheumatoid arthritis

It is a growing market. Big pharma already spends around $1billion a year on testing, but Keeling believes this total will double or more over the next 4-5 years. That makes a big target to go for and with the funds available from its listing Diaceutics plans to be in a position to take advantage.

The fact that it is one of only a handful cost of generic clomid no prescription companies to brave the Brexit uncertainty and float this year underlines its confidence. It has been well-rewarded for its endeavour with the share price rising handily since the float.

A placing that preceded the listing and raised £17million at 76p was also heavily over-subscribed. The cash raised was earmarked for patient data acquisitions and to put infrastructure on the ground for a push into Asia and Latin America.

A new software platform, Nexus, that does everything quicker and more efficiently is also under development. 

Revenues have grown 40-50 per cent annually over the past five years and brokers expect that the trend of good sales growth will continue helped by the investments made with the placing money.

Sales last year jumped to £10.4million from £7.4million, with profits rising 82 per cent on an underlying basis to £1.9million.

Keeling noted that the business has been profitable from day one, but the group’s listing indicates a step-up in ambition and scale.

The shares now trade at 85.5p each, which values the group at a shade under £60million.

That might look punchy on current yardsticks but if Keeling is right about the direction cost of generic clomid no prescription the pharma industry towards precision medicine testing this is a company that has a lot further to travel.

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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 of 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 of 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, how to buy clomid 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 buying generic clomid no prescription decades, chicken soup, is one of the best things to alleviate the symptoms of 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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