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Category Archives: News

Brexit: Shockwaves to AstraZeneca, Novartis, GlaxoSmithKline

Business Finance News believes It is too early to comment on the effects of Brexit on the pharmaceutical arena in European Union and the UK

The astonishing verdict by the UK people to cut ties with the European Union (EU) has put pharmaceutical companies such as AstraZeneca plc (NYSE:AZN), Novartis, and GlaxoSmithKline in a rollercoaster as the European Medicines Agency (EMA) has to be relocated from London to other cities in Europe. EMA plays a distinct role in the regulation of the clinical trials and approval of drugs for the EU members. The association of Germany’s pharmaceuticals industry said that the relocation of the EMA will bring multiple administrative problems for the pharmaceutical industry.

With Brexit’s voting results, manufactures will be in hot water as they will face a long-lasting impact for the approval of the drug and multiple hurdles in initiating the clinical studies. Pharmaceuticals and medical devices contribute a major chunk in the UK exports to the EU. According to the UK Trade and Investment board, the life sciences sector generates revenue of $80 billion annually.

GlaxoSmithKline plc (NYSE:GSK) representative said: “Although the EU Referendum result creates uncertainty and potentially complexity for us in the future, we do not currently anticipate a material adverse impact on the business, Group’s results or financial position. We will continue to operate as usual and will engage in the process ahead. We look forward to working closely with all relevant stakeholders. Our priority continues to be ensuring patient access to our medicines, vaccines and consumer products across the world.”

In addition, GSK expects that Brexit’s impact on the global market will be not so unfathomable, but it will definitely put its slight impression on the UK pharmaceutical industry in terms of investment, research, and jobs opportunities.

AstraZeneca’s spokesman said it is completely UK’s choice, but we think enduring with EU will be more beneficial for the patients and industry. The spokesman added that the company respects the decision of the referendum.

Alexion Pharmaceuticals, BioMarin, and Amgen have shown a dip of 9%, 8%, and 4%, respectively due to their major exposure to the European market.

For the last four decades, the pharmaceutical companies in Europe were working in a systematic manner and have an integrated portfolio beginning from the research and development and finales at commercialization of the drug in the therapeutic market. After the announcement of the results, GlaxoSithKline and AstraZeneca are still uncertain whether to shift their head offices from the UK.

EMA will have the major impact of Brexit as it has a fulltime staff of 600. Since 1995, the agency has been involved in the approvals of multiple drugs, which will be marketed in EU member countries. According to the EMA spokeswoman: “It is too early to foresee the implications of this decision and at this stage, we are waiting for further guidance from the European Commission (EC).”

Despite EMA officials are waiting for further progress from the EC, multiple countries such as Sweden, Denmark, Italy, and Germany have shown their keen interest in establishing the EMA head office in their territories.

EMA has 33 members of national associations and 40 leading pharmaceutical companies. In addition, it exemplifies 1,900 EU companies involved in the research, development, and manufacturing of novel molecules for the management and treatment of multiple therapeutic areas.

Despite the transfer of the EMA head office to other location, UK does not face any critical problem, as it has regulatory agency by the name of Medicines and Healthcare products Regulatory Agency (MHRA).

In the UK, National Institute for Health and Care Excellence (NICE) plays a vital role in conserving the drug price factor. The agency is interlinked with European network for Health Technology Assessment (EUnetHTA), who is responsible for the data influx regarding the price factor in the EU. With the implementation of the voting that might take more than two years, NICE will not be able to get the data influx from EUnetHTA and will be in hot water in order to testify the drugs’ price factor in the UK.

Currency Impact

The impact of the currency will be limited as expected, because majority of the pharmaceutical companies are established in the US and Asia. GlaxoSmithKline has a positive scenario after Brexit result and is of an opinion that it will not affect its business, but on the other hand, it will give benefit due to the volatile pound sterling in the days to come. Other companies such AstraZeneca will not be affected by the referendum decision as they are dealing in US dollar. Approximately, 70,000 people are involved in the pharmaceutical sector in the UK, which encompasses 25% of the total research and development in the country.

New Drugs Approval

After the exit, the UK drugmakers have to become the European Economic Area in order to get the fastest drug approval as Norway, Liechtenstein, and Iceland are implicating. With the membership, UK will have an access to the EMA for single marketing authorization to launch the drugs throughout Europe, but they will not be entitled for the operational entities of EMA.

On the other hand, if the UK does not adopt the aforementioned process, it will be difficult for the pharma industry to get authorization of the drugs in a simple fashion.

Drug Pricing Factor

In the UK, drug pricing is a type of voluntary agreement between the pharmaceutical industry and the government. Both the entities mutually set the drug’s price for five years. The UK pricing mainly depends on the external reference price of other EU countries and then finalize the price keeping in view EU’s situation.

The UK is also a member of EU Joint Procurement Agreement, which gives the liberty to the countries for the procurement of drugs in the case of a cross-border health emergency.

Leaving the EU will put immense pressure on the UK pharmaceuticals as the majority of clinical trials and launch of new drugs in the UK will become cumbersome. The majority of the pharmaceutical companies are of the opinion that Britain will have to remain in the EU chapter.

According to the pharmaceutical industry, Britain has been involved in approximately 40% of rare disease trials covering the whole EU segment. After the decision, the region will lose some of the clinical trials.

On the other hand, officer bearers of the National Eczema Society also elaborated that they were intimated by the two US companies that their eczema drug trial will not be initiated in the UK due to Brexit decision.

Despite all the drawbacks, UK pharma segment will be freed from the EU and EMA. British government has an excellent opportunity to implement its own strategic policy for the research and development of drugs. According to the GlobalData, it will be a tough time for Britain to maintain the same level of excellence in the research and development of its participation in external programs such as Horizon 2020.

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WHY HAS MY ONLINE PHARMACY STOPPED TAKING CREDIT CARD PAYMENTS?

WHY HAS MY ONLINE PHARMACY STOPPED TAKING CREDIT CARD PAYMENTS?

Have you had trouble using a credit card to purchase medications from an international online pharmacy lately? You’re not alone. Unfortunately, this problem won’t be going away any time soon. Companies like Visa and Mastercard have joined the Center for Safe Internet Pharmacies (CSIP), an alliance of organizations that aims to protect people from rogue and unsafe online pharmacies. Unfortunately, CSIP’s definition of a “safe online pharmacy” takes a broad-based approach and rejects any based outside the United States.

We agree that consumer protections are critical. Consumers should be wary when ordering medications online because there are rogue entities out there selling counterfeit medicine. But safe and legitimate international online pharmacies also exist. More importantly, they offer dramatic savings (50-80 percent) to American patients struggling to afford their needed medicines. Because what good is a medicine if you can’t afford it?

LegitScript is steering the course of CSIP. This private company certifies online pharmacies for safety and they have an FDA contract for $5.2 million to provide “Internet monitoring of illegal online pharmacies.” Their mission is: “promoting safety and transparency for online pharmacies and health products.” But their guidelines require that a pharmacy be located in the United States and that drugs are FDA approved if selling into the U.S.

Canada and other international pharmacies often sell the exact same drugs that get at home with the only difference being the packaging. And of course, these meds are not “FDA approved” because each country has its own system for regulating pharmaceuticals (some arguably safer than our own).

The good news is that international online pharmacies are offering customers the ability to pay for their medications by check. Of course, this may mean that payments take longer to process and medication shipments are delayed, which is never good for patients. Please keep this in mind when planning your next order.

Remember, we have tips for finding a safe international online pharmacy on our website.

reference : www.rxrights.org

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Study shows ‘brain doping’ is common in amateur sport

brain-doping razidrug

What is brain enhancement?

So called “smart” drugs that can improve mental function have become popular in recent years. A number of substances have been developed that can improve concentration, attention, memory and cognition.

Methylphenidate: Known by the brand names Ritalin and Concerta among others. It is a psychostimulant used to treat attention deficit hyperactivity disorder (ADHD). Prescriptions for these drugs increased by 50% in the six years from 2007.

Modafinil: This medicine is used to treat the sleep disorder narcolepsy. The drug helps people stay awake and improves alertness and the ability to concentrate.

Aking substances to enhance the brain is more popular among amateur athletes than taking drugs to boost the body.

Researchers in Germany found that 15% of recreational triathletes admitted to brain doping, using prescription medicines that increase attention.

Some 13% of competitors reported using physical enhancers like steroids or human growth hormone.

Brain doping is more popular say the scientists, because many of the substances aren’t banned.

 

The research has been published in the journal Plos One.

Previous studies have shown that, among amateur competitors, the use of performance-enhancing substances is widespread.

This new work used the responses of almost 3,000 triathletes taking part in events in Germany, to analyse the broader picture of physical and cognitive doping.

Researchers believe that many so-called “smart drugs” are being widely used to enhance mental functions outside the patients groups they have been designed to help.

They are also concerned that competitors in a variety of sports may be using these substances to gain an edge.

 

Previous studies have shown that, among amateur competitors, the use of performance-enhancing substances is widespread.

This new work used the responses of almost 3,000 triathletes taking part in events in Germany, to analyse the broader picture of physical and cognitive doping.

Researchers believe that many so-called “smart drugs” are being widely used to enhance mental functions outside the patients groups they have been designed to help.

They are also concerned that competitors in a variety of sports may be using these substances to gain an edge.

 

“There is some searching for additional help, we found a strong connection between those taking legal cognitive enhancers and those taking illicit ones,” said Prof Simon.

“There seems to be a certain proportion of our society that is willing to take a bit more of a risk to gain an advantage.”

 

The authors believe that the sporting status of cognitive enhancement may be affecting the attitudes of some of these amateur sports participants.

Athletes are aware that physical doping is forbidden and drug testing is common in triathlon competitions, including amateur ones.

However the use of cognitive substances is not associated with sanctions and therefore abusing them may seem a lesser infringement.

The researchers believe this reflects attitudes in society where the taking of ADHD medicine doesn’t carry the same stigma as using steroids.

The authors say their research leaves many unanswered questions about brain doping.

Prof Simon said: “On the cognitive level, we don’t know enough about these substances. Is there is a hyper performance effect?”

“What we know is that if you are a patient you are going to perform better than before, but if you are already a high-level performer we don’t know if there is an effect. That’s the big question.”

The researchers warn that, regardless of the enhancement, abusing brain doping substances can have damaging impacts in the long run.

 

A question of substance

The authors accept that getting to a precise definition of what constitutes doping is difficult. They tried to be as clear as possible in their questions on the different types of enhancement.

Physical doping: Have you used substances which can only be prescribed by a doctor, are available in a pharmacy, or can be bought on the black market (such as anabolic steroids, erythropoietin, stimulants, growth hormones) to enhance your physical performance during the last 12 months?

Cognitive doping: Have you used substances which can only be prescribed by a doctor, are available in a pharmacy, or can be bought on the black market (such as caffeine tablets, stimulants, cocaine, methylphenidate, modafinil, beta-blockers) to enhance your cognitive performance during the last 12 months?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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What Ingredient Is in Fake Cocaine?

ketamine cocaine razidrug

They usually mix : a local anesthetic (lidocaine )

+  An inhalation anesthetic (ketamin) + amphetamines (methylphenidate )+ fillers (caffeine..)

to be continue  …..

The most widely used stimulants are

  • caffeine (in coffee, tea, and cola beverages)
  • nicotine (in cigarettes)
  • amphetamines
  • cocaine

Local Anesthetics

These chemical relatives of cocaine act by blocking the voltage-gated Na+ channels of sensory neurons preventing them from generating action potentials. [Discussion] They are injected or applied topically and block transmission not only in pain-conducting neurons but in others as well (causing general numbness).

Examples:

  • lidocaine
  • procaine

Inhaled Anesthetics

Most of these are volatile hydrocarbons or ethers. Diethyl ether and chloroform are seldom used today, having been replaced by safer alternatives such as isofluorane, a fluorinated ether.

Some, like isofluorane, bind to inhibitory GABA receptors) in the brain hyperpolarizing, and thus decreasing the sensitivity of, postsynaptic neurons.

Others, like ketamine, block the activity of excitatory glutamate receptors.

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Female Viagra not covered on most insurance plans …

insurance viagra razidrug

(CNN)

Michelle Weber says that when her boyfriend wanted to take Viagra, his insurance paid for it, no questions asked.

So when she wanted to take the new “female Viagra” for her sexual problems, she figured that would go smoothly, as well.

But it didn’t.

Her insurance company refused to pay for the drug, called Addyi, saying she’d have to see a psychiatrist first.

“They don’t tell men who want Viagra that they have to see a psychiatrist,” said Weber, 38, who asked that her real name not be used, in order to protect her and her boyfriend’s privacy.

Indeed, they don’t, say doctors who treat sexual dysfunction.

And these doctors say the psychiatrist requirement is just one of many “barriers” that insurance companies have put in place for women, but not men, who are seeking drugs to treat sexual problems.

“It’s a huge double standard,” said Weber’s gynecologist, Dr. Tami Rowen, an assistant professor of obstetrics and gynecology at the University of California-San Francisco.

 

Dr. Irwin Goldstein, a sexual health specialist in San Diego for both men and women, said insurance companies have routinely rejected his prescriptions for Addyi, but that’s never been the case for Viagra.

“It’s startling. It’s so sexist,” said Goldstein, the president of the International Society for the Study of Women’s Sexual Health, who has been a paid consultant to the pharmaceutical companies that make both Addyi and Viagra.

In addition to the psychiatrist requirement, Weber’s insurance company, Blue Shield of California, refuses to pay for Addyi unless a woman first tries another, less expensive drug, according to the company’s prescribing guidelines.

That less expensive drug isn’t approved to treat sexual problems and can have devastating side effects.

Blue Shield gave Weber a third reason it wouldn’t pay for Addyi, according to a letter it wrote her. The company said it wouldn’t pay because her low libido appeared to be a side effect of a medication she’s taking.

Weber said Blue Shield must have been referring to the only drug she takes: a type of antidepressant known to have sexual side effects for both men and women.

 

But she said she suffered from low libido even when she wasn’t on an antidepressant.

“And I’d love to know, do they tell men they can’t have Viagra because they’re on antidepressants?” she asked.

CNN sent Clinton McGue, a Blue Shield of California spokesman, an email with this question. He responded that “without knowledge of the member’s detailed history or the case,” he could not provide more of a response.

When asked about the Addyi denials, a spokeswoman for the insurance industry responded that some studies have shown Addyi isn’t very effective and can have side effects.

“If there’s a question mark around a coverage decision, that usually means there’s a question mark around the efficacy,” said Clare Krusing, a spokeswoman for America’s Health Insurance Plans. “This drug failed two FDA reviews prior to being approved, and the reason it got approved the third time is because of a broad PR campaign by the company that makes it.”

That explanation doesn’t sit well with doctors who treat sexual dysfunction. They say the FDA ruled last year that Addyi, which is taken every day, is safe and effective. The doctors add that the drug doesn’t work for all women, but it certainly works for some.

“I think women in general should be alarmed. Insurance companies are covering things for men that they’re not covering for women,” said Dr. Alyse Kelly-Jones, a gynecologist in North Carolina.

Doctors said the “double standard” they see for women with sexual problems manifests in other ways, too.

They said insurance typically pays for their older male patients to take testosterone to boost their sagging sex lives. But when older women want treatments for vaginal dryness and atrophy, insurance companies usually balk.

Krusing disagreed, saying major insurance companies do cover such treatments.

 

But gynecologists cite denial after denial for such drugs.

Dr. Laura Hirshbein, associate professor of psychiatry at the University of Michigan, said she’s dismayed but not surprised that insurance companies are often refusing to pay to treat women with sexual problems.

Hirshbein, who studies issues of gender, sex and psychiatry, said men with erectile dysfunction get a multitude of treatment options, which are often celebrated in giant advertising campaigns.

“Men get told they can expect to function sexually and can expect to easily get whatever they need in order to do that,” Hirshbein said.

But she said that historically, women have been told that if they have sexual problems, they must be mentally ill.

“Women are told it’s all in their head,” she added.

In March, when Weber received her Addyi prescription from her gynecologist, she unsuspectingly headed to the pharmacy to fill it.

The pharmacist came back with the news: Her insurance company wouldn’t pay for it. She could pay for it herself — to the tune of $1,000 a month.

No, thank you, Weber said, and walked out empty-handed.

Blue Shield’s McGue said in a statement that “a committee of external pharmacists and physicians, including psychiatrists, review the medical evidence for prescription medication to determine Blue Shield’s coverage policy,” he wrote. “The committee determined that Hypoactive sexual desire disorder is best diagnosed after a psychiatric evaluation.”

 

But doctors said other specialists, such as gynecologists and sexual health experts, have the training and experience to identify and treat sexual problems, not psychiatrists.

“I’m a sexual health expert. This is my niche,” said Rowen, Weber’s gynecologist. “And they’re telling me I can’t diagnose a sexual disorder? That’s crazy.”

Hirshbein, the psychiatrist at the University of Michigan, agreed. She said that when her patients suffer from sexual dysfunction, she sends them to doctors who have more experience in that area.

“I’m a psychiatrist. I wouldn’t write a prescription for [Addyi], in the same way I wouldn’t write a prescription for Viagra,” she said.

In his statement, McGue also mentioned “the serious safety concerns associated with Addyi [which] include adverse effects of the central nervous system.”

Addyi has a “black box warning” highlighting the increased risk of low blood pressure and fainting when combined with certain other drugs or with alcohol.

The less expensive drug that Blue Shield requires women try before taking Addyi has a black box warning of its own.

Bupropion, also known as Wellbutrin, has a warning highlighting the risk of developing “serious neuropsychiatric symptoms,” including suicidal thoughts.

“That makes no sense,” said Kelly-Jones, the gynecologist in North Carolina. “For Wellbutrin to be considered first-line therapy for something it’s not FDA-approved to treat, that’s concerning.”

Since getting the rejection from Blue Shield in March, Weber has been on a mission.

She did get a prescription from a psychiatrist and marched it into the pharmacy a few weeks ago.

The pharmacist came back with more news: Blue Shield had rejected it again, saying she needed more documentation from the psychiatrist.

Weber calls the whole situation ironic.

Her boyfriend doesn’t need Viagra, she says. He can have sex without it. He wants it so he can have longer-lasting erections, hoping that might make her happier.

“I’m the one with the actual disorder. I’m the one with no sex drive at all. But he’s the one who walks out of the doctor’s office with a prescription that he can actually fill,” she said.

As she tries to increase her libido — she sees a certified sexologist for help — she hopes her relationship will survive.

 

She explains to her boyfriend that she doesn’t know why she has a low libido, but she knows it has nothing to do with him or his sexual performance.

Even with the reassurances, she’s not sure their relationship will survive her lack of interest in sex.

“We’re thinking about getting married. It’s really serious. But a big piece of it isn’t working, and that’s hard for both of us,” she said.

 

CNN

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Baby needs Viagra to live !!!

A  ten MONTH-OLD baby girl has to take Viagra

Best known for treating erectile dysfunction, so that her heart can function properly, Kosmo! reported.

Nur Aafiyah Amanda Norhisham, who has suffered from heart and liver complications since birth, has to take four pills every month, which are divided into small doses and transferred into her body via a tube.

Her mother Raja Karipah Raja Hamzah, 46, said the youngest of her six children was prescribed Viagra by a specialist doctor.

She said she bought the Viagra pills at RM38 each at the pharmacy.

Viagra is the trade name for sildenafil citrate, the first oral treatment for erectile dysfunction. It was green-lit for use by the US Food and Drug Administration in 1998.

Raja Karipah said her daughter’s health issues began after she was delivered at Segamat District Hos­pital via Caesarean section when she was just 34 weeks old on Sept 29, 2015.

“The doctor advised me to give Nur Aafiyah the Viagra pills to help overcome her hole in the heart condition,” she said.

Raja Karipah added that she and her self-employed husband spent RM1,100 every month to treat Nur Aafiyah, besides receiving a RM300 monthly aid from the welfare department.

> Putting an end to speculation over their relationship, popular TV stars Amar Baharin, 31, and Amyra Rosli, 25, have announced that they were getting married on Nov 11, reported Sinar Harian.

Amar, when met at a function in Sunway Montana Clubhouse, said they had their reasons for keeping a lid on the relationship so far.

“I did not want to lie to the reporters when they pursued the issue earlier.

“I, myself, do not like sharing sensational stories before the matter is confirmed,” said Amar, adding that he became attracted to Amyra after they worked together in the drama Suamiku Encik Sotong.

“We became close and got along well afterwards, but we never declared that we were lovebirds.”

Amyra, whose full name is Nur Amira Izzati Rosli, said she was comfortable with Amar because he was mature and smart.

“Yes, Amar fulfils the features of my dream man and he is serious about taking our relationship to the next level.”

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