All posts by edc2sdtm

911 – Silence

Another year has passed and another year that the culprits of 911 are at large while the war on terror (aka the war on YOU) continues.

The only ones beneficiating from 911 war on terror are the same calling for more wars, more security at the airports (of course, they have the contracts for those machines causing cancers and the security agencies are all from the same group of people)

In order to keep the wars, they need more taxes.

He who has ears to hear, let him hear.

Follow the Money….before, during and after 911

A Conspiracy Theory that happened to be truth…

To Mossad from Dick Chenney – The Elephant in the room…

Methodical Deception

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Change – Amsterdam

At the end of 2008 and close to the holidays, a friend of mine from the States told me to visit this psychic lady from downtown (she was the one interested in having a palm reading). I don’t believe it much so I went along. After her reading, the lady asked me if I wanted a palm reading. I said, “why not.” Nothing to lose as I am already here.

Amsterdam

All I can remember her saying ”…soon you will meet someone and move…I see a lot of water surrounding this place…lots of water…” I said to myself. “That must be Panama.” We have the canal, rivers, lakes and two oceans…When her last words were “I see a trip to Europe”.

That was a day like today in 2009.

My life changed a day like today when I received an email that changed my life forever. A move to Europe [Amsterdam] that I never saw coming. Life has a lot of ups and downs. Like a roller coaster, I was up and many times down but it made me stronger than ever and open my life to the reality of love.

 

In front of the place I met my destiny – All is Change – Soulmate!

Life has a lot of twist and turns…

So what’s a soul mate? I was told that my past relationship was of a soul mate type.  Someone I spent at least one past life together. It sure felt more like a karmic relationship. I needed to pay a karmic debt.

One thing is clear to me. My soulmate must be in the same ‘vibrational path’ before we meet again. Whether in this life or the next (I hope not to be back to this planet… :-)…if there is no vibration, it will never happen.

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EMA and The Netherlands Biopharm Opportunities

The European Medicines Agency (EMA) is relocating from London to Amsterdam.

According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands.

On Friday, 13 April 2018, the Dutch Council of Ministers agreed to sign the document.

Amsterdam – EMA

Quantify research reported earlier this year that the shift of the EMA to Holland will be a welcome boon to that country, particularly due to some companies shuttering their Netherlands locations in favor of other European countries. The research report pointed to more than 1,500 job losses about eight years ago following Abbott and Merck Sharpe and Dohme closing facilities in that country. Between 2009 and 2014, Quantify said the Dutch market share in the European pharma industry plummeted from 3.3 percent in 2009 to 17 percent in 2014.

To help spur the resurgence of the Netherlands pharma industry, the Netherlands Foreign Investment Agency is hosting a landscape tour at the end of summer to showcase the country’s offerings. While the EMA is expected to become the core of the Netherlands biopharma industry, the NFIA said the country is home to facilities for more than 420 biopharmaceutical companies, such as AstraZenecaJanssen, MSD, Amgen and Teva, to name a few. The Netherlands Foreign Investment Agency pointed to the companies because they “rely on their Dutch operations for both R&D and distribution activities.”

But, it’s not just the large global pharma companies that have a home in Holland. The country is also home to a number of biopharmaceutical startups and scale-ups, like GalapagosGenmabPharming and uniQure.

Another company that will be relocating to the Netherlands is Gilead Sciences.  This new facility will be employing over 300 people. Other companies worth mentioning are GSK-Novartis, Merk and most well-known Clinical Research Organizations (CROs) have made the Netherlands their home.

For those interesting in working and living in Amsterdam, you should know that it is one of the countries with the highest taxes at a 52% income tax rate if you make over 55,000 euros per year (apparently they think this is good money). For a regular employee with benefits, your tax rate will be at a 42 %. Don’t expect to be making more than 55,000 euros a year unless you are a highly skilled employee or hold a managerial level position.

Tot Ziens!

Source:

Biospace

EMA

https://www.government.nl/latest/news/2018/04/23/the-european-medicines-agency-ema-and-the-netherlands-agree-on-seat-agreement

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Drug Information Update – New Drug Safety Communication on Invokana (canagliflozin) and Invokamet (canagliflozin and metformin)

Drug Information Update - New Drug Safety Communication on Invokana
(canagliflozin) and Invokamet (canagliflozin and metformin)
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.

------------------------------------------------------------------------

The U.S. Food and Drug Administration (FDA) has strengthened the warning
for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet)
related to the increased risk of bone fractures and added new
information about decreased bone mineral density. Bone mineral density
relates to the strength of a person’s bones. To address these safety
concerns, we added a new /Warning and Precaution/ and revised the
/Adverse Reactions/ section of the Invokana and Invokamet drug labels.

Health care professionals should consider factors that contribute to
fracture risk prior to starting patients on canagliflozin. Patients
should talk to their health care professionals about factors that may
increase their risk for bone fracture. Patients should not stop or
change their diabetes medicines without first talking to their health
care professional.

Canagliflozin is a prescription medicine used with diet and exercise to
lower blood sugar in adults with type 2 diabetes. It belongs to a class
of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Untreated, type 2 diabetes can lead to serious problems, including
blindness, nerve and kidney damage, and heart disease. Canagliflozin
lowers blood sugar by causing the kidneys to remove sugar from the body
through the urine. It is available as a single-ingredient product under
the brand name Invokana and also in combination with the diabetes
medicine metformin under the brand name Invokamet.

Information about the risk of bone fractures was already in the /Adverse
Reactions/ section of the drug label at the time of canagliflozin’s
approval. Based on updated information about bone fractures from several
clinical trials, we revised the drug label and added a new /Warning and
Precaution/. The additional data confirm the finding that fractures
occur more frequently with canagliflozin than placebo, which is an
inactive treatment. Fractures can occur as early as 12 weeks after
starting the drug. In the clinical trials, when trauma occurred prior to
a fracture, it was usually minor, such as falling from no more than
standing height.

In addition, we have added new information about the risk of decreased
bone mineral density to the canagliflozin label. A clinical trial that
we required the manufacturer of canagliflozin to conduct evaluated
changes to bone mineral density over two years in 714 elderly
individuals and showed that canagliflozin caused greater loss of bone
mineral density at the hip and lower spine than a placebo. This new
safety information has been added to the /Adverse Reactions/ section of
the drug label.

For more information, please visit: Canagliflozin
<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTEwLjQ4OTQ3NzMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkxMC40ODk0NzczMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg1NzUwJmVtYWlsaWQ9bWVtYmVyc2hpcEByYWVjbGluaWNhLmV1JnVzZXJpZD1tZW1iZXJzaGlwQHJhZWNsaW5pY2EuZXUmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>

FDA Approval: Promacta (eltrombopag)

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.

ITP is a disorder that results in an abnormally low number of platelets, the cells that help your blood clot. Without enough platelets, bleeding can occur under the skin, in mucous membranes (such as in the mouth) or in other parts of the body.

The most common side effects of treatment with Promacta in children ages one and older were infections of the upper respiratory tract or nose and throat (symptoms including fever, cough, nasal congestion, runny nose and sore throat), diarrhea, abdominal pain, rash and increase in liver enzymes.

The safety and efficacy of Promacta in pediatric patients younger than one year with ITP, or in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia, have not been established.

For more information, please visit: Promacta

FDA Approval: Repatha (evolocumab) injection

The U.S. Food and Drug Administration yesterday approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

The most common side effects of Repatha include nasopharyngitis, upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the injection is given. Allergic reactions, such as rash and hives, have been reported with the use of Repatha. Patients should stop using Repatha and get medical help if they experience symptoms of a serious allergic reaction.

For more information, please visit: Repatha

Allergan Issues Voluntary Nationwide Recall In The U.S.

Allergan plc, today announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH® Lacri-Lube® 3.5g and 7g for dry eye, REFRESH P.M.® 3.5g for dry eye, FML® (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Source: FDA.org

Benefits of Early Antiretroviral Therapy in HIV Infection

AIDS is caused by HIV, a retrovirus that attacks the immune system. The virus destroys CD4+ T cells, a type of white blood cell that’s vital to fighting off infection. The number of these cells, known as a CD4+ count, is a key measure of immune system health. After people get infected with HIV, their immune system becomes progressively weaker from the HIV infection, their CD4+ count drops, and eventually they develop AIDS.

AIDS is treated with antiretroviral drugs. These drugs suppress HIV but don’t completely eliminate the virus from the body. Guidelines for when to start treatment differ around the world because the evidence for using antiretroviral drugs when CD4+ counts are higher wasn’t definitive. Some experts felt it prudent to wait until the disease progressed to CD4+ levels at which there was a proven benefit.

The START (Strategic Timing of AntiRetroviral Treatment) study is a randomized, controlled clinical trial designed to more clearly define the optimal time for people with HIV to begin antiretroviral therapy. The study was funded in part by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and other NIH components.

Researchers in 215 clinics across 35 countries enrolled 4,685 HIV-positive men and women ages 18 and older. All participants had CD4+ counts in the normal range (above 500 cells/mm3) at the time of enrollment and had never taken antiretroviral therapy. They were randomly assigned to 2 groups. The early-treatment group began taking antiretrovirals immediately. The deferral group delayed treatment until their CD4+ counts dropped to 350 cells/mm3 or until they developed AIDS or another condition that required antiretroviral treatment.

The team tracked combinations of outcomes: serious AIDS events (such as AIDS-related cancers or death from AIDS) and serious non-AIDS events (such as cardiovascular disease, end-stage renal disease, liver disease, and non-AIDS-related death).

In May 2015, an independent panel reviewed interim results. They found that the benefits of early antiretroviral therapy far outweighed any risks. The findings were disseminated to study participants, and treatment was offered to everyone in the deferred group.

The research team reported additional findings online on July 20, 2015, in the New England Journal of Medicine. The scientists determined that the overall risk of developing serious AIDS-related events, serious non-AIDS events, or death was reduced by 57% among those in the early-treatment group compared to those in the deferred group. This reduction was seen regardless of age, sex, baseline CD4+ counts, geographic region, or country income level.

Early antiretroviral treatment lowered the risk of serious AIDS-related events by 72%. Early treatment also lessened the risk of serious non-AIDS events by 39%.

A limitation of the study, the researchers note, is that the participants were fairly young, with a median age of 36 years. In addition, they were only followed for 3 years, which is fairly short given that antiretroviral therapy is typically prescribed for a lifetime.

“This study conclusively shows that the benefits of early therapy far outweigh any adverse outcomes, and reinforces recommendations to offer immediate antiretroviral therapy to all HIV patients,” says NIAID Director Dr. Anthony S. Fauci.

Source: FDA.Gov

Designing Web Applications for Older Health Consumers

Designing Web Applications for Older Health Consumers – Easier Said Than Done

Consumers older than 65 may have difficulty using Web applications to identify providers that meet their needs, according to an AHRQ-funded study. Researchers created a Web application that enabled Rhode Island consumers to compare home health agencies based on information such as services offered and health outcomes. They conducted usability testing of the Web application using two focus groups, totaling 14 older consumers looking for information about home health agencies and six hospital case managers. Investigators noted that while Web applications are a cost-effective way to disseminate information, it is important to ensure that people with low literacy, low health literacy and low computer proficiency can access, understand and use these applications. Although the researchers based their initial design on best practices, user testing showed that they overestimated the extent to which older adults were familiar with using computer applications. Researchers subsequently adopted simpler navigation and additional user prompts. The study and abstract were published in the May 15 issue of the journal eGEMS (Generating Evidence & Methods to improve patient outcomes).

source: AHRQ.gov

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD)

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD) 3 milliliter (ml) and 5 ml syringes unless there is no suitable alternative available.

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.

If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the patient has been receiving a subpotent product, or adverse consequences could occur.

BD’s 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. The company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs.

FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only.  These syringes were not cleared for use as a closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established.  This issue may extend to other general use syringes made by other manufacturers that were not cleared for the purpose of closed-container storage usage.

FDA has received several reports of compounded and repackaged drugs, such as fentanyl, morphine, methadone and atropine, losing potency when stored in BD 3ml and 5ml general purpose syringes. It is possible that this chemical reaction may affect other compounded and repackaged drugs stored in syringes not FDA cleared for closed-container storage.

Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD 3ml and 5ml syringes.  These syringes are marked with the BD logo at the base of the syringe.

At this time, FDA does not have information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are filled.

This warning does not extend to products approved by FDA for marketing as pre-filled syringes, because as part of the approval process, FDA has determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product.

On July 30, 2015, the Institute for Safe Medication Practices (ISMP) issued a Special Alert regarding this problem.  See http://www.ismp.org/newsletters/acutecare/articles/loss-of-drug-potency.aspx

The FDA is continuing to investigate this issue and will provide more information when it is available.

FDA asks health care professionals and patients to report any adverse reactions to the FDA’s MedWatch program:

Source: FDA.gov