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Jun
21
Sandeep Singh Dhillon
How much is pain costing Singapore’s economy? EDGE Market Report Singapore
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SINGAPORE (June 20): Pain conditions are costing Southeast Asian economies about US$44.6 billion ($61.9 billion) in productivity losses on an annual basis – out of which Singapore’s estimated productivity losses make up about US$6.2 billion per year, according to the 2017 Global Pain Index commissioned by GlaxoSmithKline’s (GSK) healthcare division.

This year’s edition of the index features survey responses from 19,000 adults across 32 countries including Singapore, and its findings revealed that Southeast Asian countries rank among the highest in the world for sufferers living with everyday pain, says GSK Consumer Healthcare in a press release on Tuesday.

Through the index’s results, it was found that 85% of Singaporeans interviewed have suffered from head and body pain, with 42% reporting to suffer from body pain on a weekly basis.

Despite this, 61% and 46% of the men and women surveyed, respectively, say they suffer in silence – while a third of Singaporeans interviewed say they would delay seeking relief for their pain by weeks, or perhaps even longer.

This comes as a cost to the city state’s economy of about 2% of the nation’s gross domestic product (GDP) every year due to missed work day and reduced workplace productivity, says GSK.

The healthcare company also finds it surprising that Singaporeans claim to have some of the lowest levels of knowledge of the medicines available to treat their pain as compared to their global peers. This includes a lack of understanding in the subjects of dosings (24%), potential risks (15%), side effects (15%), ingredients (11%), and interactions with other medicines (10%).

The study’s findings show that pain inevitably impacts relationships as well, ranging from “fading into the background” while being out with friends (57%), to having less patience with their children as a result (77%).

“While headaches, body aches and migraines might not seem to have serious consequences, the 2017 GSK Global Pain Index shows that if not managed effectively, pain can have a cumulative impact,” says Yeo Sow Nam, director of The Pain Specialist, Mouth Elizabeth Hospital and Mouth Elizabeth Novena Hospital.

“Despite the availability of many suitable and effective options for treating pain, it is concerning that Singaporeans tend to suffer in silence for longer than they should, causing a huge burden both at a national and individual level especially for those who suffer from pain weekly. It is important that people take effective steps to address their pain.”

Jun
1
Sandeep Singh Dhillon
WHO commends Malaysia’s medical research work – MIMS Malaysia
Drug Discovery, Pharma News, Pharma Notables
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Newly-elected WHO director-general, Dr Tedros Adhanom Ghebreyesus has expressed interest in harnessing Malaysia’s medical expertise. The Health Ministry said the World Health Organisation (WHO) is truly impressed with the country’s medical research work and the accessible and affordable healthcare available here.

“WHO is looking into harnessing our expertise based on this unique model of the research ecosystem in Malaysia to bring down the cost of medicine. We highlighted crucial issues close to the heart of many in developing countries such as cost and access to diagnostics and medicine, where we are convinced that this new partnership model can close the gap of equitable access to medicine,” said Datuk Dr Noor Hisham Abdullah, the Health director-general.

He also took to social media to relay Ghebreyesus’s fascination with this country’s work on Hepatitis C treatment. This programme is in partnership with the global non-profit organisation, Drugs for Neglected Diseases Initiative.

Medical research a valuable field

Despite progression in research, the country still faces some barriers to producing high quality data. A healthcare professional weighed in on this issue recently and described that a basic skill set to conduct good research is required and should be identified in potential researchers.

The medical expert also explained that a large chunk of studies published comes from high-income countries with a Caucasian population. Thus, data from these places might not suit our population entirely and local research would prove beneficial. Another barrier faced here would be low number of cases per hospital and thus, effective research sample sizes are reduced and the study’s significance might be questionable.

Health minister advocates for zero hunger and good health

Health Minister Datuk Seri Dr S. Subramaniam said courageous steps are required as advocators to address the co-benefit of innovative public policy for health. Speaking at the 70th World Health Assembly (WHA) last week, he stated that a better, sustainable health system can be built when our view of the system goes beyond healthcare.

Subramaniam also said at the WHA in Geneva, Switzerland that pollution and climate change are not merely environmental issues once it changes the pattern of communicable disease. This is because Arbovirus infections such as dengue can spread beyond its usual temporal and geographical boundaries.

“A hungry world, a polluted world or a world where women do not stand equally cannot be defined or considered as a healthy world. Achieving zero hunger and good health goes hand in hand. In our passionate search for new vaccine and medical technology, we must remember that no vaccine can prevent the detrimental effect of famine and no medicine can replace the damaging effects of stunted growth,” he added. MIMS

May
29
Sandeep Singh Dhillon
Blood-Based Breast Cancer Detection Test May Help Avoid Biopsy – Forbes
Analytical Discussion, Pharma News, Pharmaceutical & Drug Delivery Journals
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By John Nosta

Early detection of cancer is one of the most powerful tools in the management of this disease. And while imaging modalities have advanced the ability to detect early disease, challenges still exist for both clinician and patient. Yet one point remains clear and is a driving principle—early detection saves lives. And the earlier, the better.

A study published in Clinical Breast Cancer examined the utility of blood markers to detect breast cancer. The test that was evaluated is called Videssa Breast and evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies. It was studied in women under 50 who had abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4).

Here’s the overall takeaway: The negative predictive value—the likelihood of a patient having no cancer—was 99%. In other words, clinicians may have a powerful tool to identify patients who are highly unlikely to have breast cancer, in instances where the mammogram is abnormal. Overall, imaging resulted in 341 participants receiving follow-up procedures to detect 30 cancers (90.6% FP rate). Videssa Breast would have recommended 111 participants for follow-up, a 67% reduction in false positives. The authors conclude:

Videssa Breast can effectively detect breast cancer when used in conjunction with imaging and can substantially reduce unnecessary medical procedures, as well as provide assurance to women that they likely do not have breast cancer.

While the results are impressive, the clinical path itself can be difficult. Primary care physicians, radiologists and surgeons all play a role in patient management. And the decision for invasive procedures such as a biopsy involves these stakeholders—and the patient. I presented the study to three of these decision-makers for their perspective on a blood-based test used in association with mammography.

The primary care physician:

I see these diagnostic uncertainties after breast cancer screening almost daily. When a mammogram comes back abnormal, I can tell my patient that it appears benign. But with Videssa Breast, I can give her much more powerful reassurance that it is not cancer. Having used the test for some time, my goal is to educate other providers about it, because I’ve seen it serve as a valuable decision-making tool that helps spare women potentially unnecessary biopsy. Most women who get that abnormal imaging result do not have cancer. With the simplicity of a blood test, I can send more of them home with peace of mind.

—Wendell Phillips, D.O., primary care physician with HonorHealth Medical Group in Phoenix, Ariz.

The radiologist:

As a radiologist, images don’t always give us a clear view of a patient’s cancer status. A blood test that offers clinicians the confidence to rule out cancer can help us better select the patients who truly need closer monitoring or that next intervention. In the case of breast biopsy, the test is a powerful avenue for reducing the use of an invasive procedure and still get to best outcomes for women.

—Josie R. Alpers MD, radiologist and study co-author

The surgeon:

Clearly this type of liquid biopsy test is the direction we are going with many cancers. As mammography technology has improved, we are finding many things that we have to act on, but may be clinically insignificant. I can see that increasing with the adoption of this technology—at least until we have gotten over our learning curve. However, there is no question that patients who have a BIRADS 3 mammogram and high anxiety about six-month follow up may be relieved by a negative Videssa test.

—Deanna Attai, M.D., past president, the American Society of Breast Surgeons

For solid tumors, the combination of an anatomic view and biological view may hold the promise to more sophisticated detection and management. Further, we may also gain new insights into other pathology such as atypical hyperplasia and how to best manage these conditions. But beyond the deeply scientific aspect of cancer detection lie deep personal and emotional aspects of this disease. The burden is tremendous and the ambiguities of diagnosis can add to the difficulties. A new test, particularly one with a high negative predictive value, can be a potent source of comfort that offers, in and of itself, a level of therapeutic value. And as more data become available, the potential for expanded use of Videssa Breast as a screening tool could be a game-changer in the diagnosis and management of breast cancer.

May
19
Sandeep Singh Dhillon
Jeff Bezos’s Amazon Wants a Slice of the Multi billion-Dollar Pharmacy Market – INC.com
Pharma News, Pharma Notables
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Jeff Bezos’s company is reportedly looking to expand its portfolio to the multibillion-dollar pharmacy market.

Over the past few years, Amazon has held “at least one annual meeting” to evaluate whether it should jump into the pharmacy space, according to CNBC citing sources familiar with the matter. Two weeks ago, Amazon posted a new job looking for a “PHC [Primary Home Care] Licensing Program Manager” to support its “Professional Healthcare Program.” Responsibilities include submitting state license applications and maintaining “documents and databases for state board of pharmacy licensing requirements,” according to the job description. The company didn’t immediately respond to a request for comment.

Amazon also recently announced its plans to hire 5,000 home-based workers to join its customer service teams. The majority of those jobs will come with benefits like health insurance, sick and vacation time, and tuition.

Jeff Bezos’s Amazon empire has expanded into food retail (Amazon Fresh), video streaming services (Amazon Prime), web hosting (Amazon Web Services). It’s also jumped into the rocket ship race with Blue Origins. Last month, Amazon announced its plan to roll out operations in Australia, where online sales are expected to account for more than a third of the country’s retailers’ sales. At last count, the company has invested or acquired more than 128 companies in the last few years.

May
19
Sandeep Singh Dhillon
The world’s largest drugmaker thinks it has 11 billion-dollar drugs in the pipeline : here’s what they treat – Business Insider
Drug Discovery, Pharma News, Pharmaceutical & Drug Delivery Journals
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Johnson & Johnson just listed out the drugs it plans to file for approval over the next few years that could be “blockbusters.”

These are drugs that haven’t been approved yet, but by 2021, they could be making more than $1 billion in annual sales each.

Right now, the world’s largest drugmaker is known for its immunology drugs like Remicade, which made $4.8 billion in sales in 2016 and Stelara, as well as the bloodthinner Xarelto, which made $2.2 billion in sales in 2016.

Here’s the list of drugs J&J plans to file for approval over the next four years that could hit that blockbuster threshold, including cancer and depression treatments:

guselkumab – psoriasis (Filed for approval in 2016)
sirukumab – rheumatoid arthritis (Filed for approval in 2016)
apalutamide – pre-metastatic prostate cancer
esketamine – treatment-resistant depression
talacotuzumab – acute myeloid leukemia, a type of blood cancer
erdafitinib – solid tumors
niraparib – prostate cancer
imetelstat – myelofibrosis, a bone marrow disorder
pimodivir – influenza A
lumicitabine – respiratory syncytial virus (RSV) infection
JNJ-7922 – adjunctive treatment for major depressive disorder

May
11
Sandeep Singh Dhillon
A giant drug maker just set the strictest price increase caps of the industry – Business Insider
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Drug manufacturers have been feeling the heat over the price increases they make on prescription drugs.

Sanofi, which makes drugs to treat diabetes, along with vaccines and heart medications, has been criticized in the past for the price of its insulin Lantus.

To counter that, the French drug giant has decided to make some of the strictest drug pricing commitments in the industry.

Among Sanofi’s new pricing promises,

The company committed not to increase the list price of existing drugs in the US by more than the rate of health inflation, as measured by the Centers for Medicare and Medicaid Services’ National Health Expenditure. In 2015, the NHE rate is expected to be 5.4%, and it’s expected to increase on average 5.6% through 2025 years.
Sanofi also plans to launch new drugs with a lot of rationale around how it set the price.
The company also decided to release its average list and net price increases going forward. It’s something other companies have been doing as well.
The approach is a bit of a departure from other players in the pharma industry. In September, Allergan committed to only single-digit drug price increases (a line it closely hugged for some drugs). Novo Nordisk, another diabetes drugmaker, also committed to capping increases to single digits.

Cybele Bjorklund, Sanofi’s head of global policy, said the company decided to use the NHE as a benchmark because it’s independent and has some level of predictability. “Single digit is somewhat arbitrary,” she said.

And if that inflation rate were to go down? “We’re willing to live with wherever it goes,” she said.

As far as the rationale goes for new launch prices, Sanofi will have to show why its drug is better than what’s currently available. Bjorklund gave the example of Dupixent, a drug to treat atopic dermatitis. When the drug launched in March, Sanofi and its partner Regeneron made headlines for setting a price that was lower than expected

As part of the new price policy, Sanofi began disclosing its average list price increases. On the whole, Sanofi’s list price increased 4% in 2016, but after factoring in discounts and rebates paid to pharma middlemen, the net price decreased by 2.1%.

In part, that’s because of its long-acting insulin Lantus, which hasn’t increased in list price since 2014, but has been facing pressures from pharma middlemen.

May
11
Sandeep Singh Dhillon
Pfizer : FDA Grants BAVENCIO Approval For Common Type Of Advanced Bladder Cancer
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(RTTNews.com) – EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. ( PFE ) said that the US Food and Drug Administration has approved BAVENCIO (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

In December 2015, Merck KGaA, Darmstadt, Germany and Pfizer announced the initiation of a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. This trial is currently enrolling patients.

May
9
Sandeep Singh Dhillon
Abbott announces CE Mark and first use of the world’s first smartphone compatible insertable cardiac monitor
Intellectual Property Rights, Pharma News
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ABBOTT PARK, Ill., May 8, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm Rx™ Insertable Cardiac Monitor (ICM), the world’s first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. The Confirm Rx ICM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlin™ mobile app, allowing physicians to follow their patients remotely and accurately diagnose arrhythmias.

With the launch of the Confirm Rx ICM in European CE Mark countries, Abbott has established a new paradigm in the connectivity of cardiac devices by incorporating wireless technology, which allows the ICM to communicate directly and securely to the app downloaded onto a patient’s smartphone. Traditional remote monitoring has required bulky handheld or bedside transmitters, which limit patient mobility. The new interactive myMerlin mobile app replaces these passive transmitters and empowers patients to participate in their own care.

In addition to patient convenience, the device is slimmer than currently available ICMs. The Confirm Rx ICM also offers intuitive one-touch indication-based programming, and remote monitoring via the Merlin.net™ Patient Care Network, making the technology convenient for clinicians involved in procedure and follow up.

“The Confirm Rx ICM device will be an important tool for diagnosing patients with suspected arrhythmias, such as those who have experienced fainting or palpitations,” said Georg Nölker, M.D., head of electrophysiology at the Herz-und Diabeteszentrum NRW, Ruhr-University of Bad Oeynhausen, Germany. Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark. “The simple insertion procedure and small device size make this technology convenient for both patients and providers. Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator.”

Christopher Piorkowski, M.D., head of the Department of Electrophysiology at the University of Dresden Heart Center in Dresden, Germany, and one of the first implanters, added: “The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.”

The myMerlin mobile app, available in over 35 languages, makes it easy for patients to stay connected to their physicians. Patients can record their symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate. Patients can also confirm their data was transmitted to their physician and get automatic alerts when they have missed a scheduled transmission, saving the clinic from having to follow up with the patient. The device also offers secure transmission of patient data. Recently, Abbott’s Merlin.net Patient Care Network received one of the medical device industry’s first Service Organization Control certifications (SOC2 certification), further confirming the safety and security of the company’s remote monitoring network.

“Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance,” said Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses. “The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.”

Currently the Confirm Rx ICM is available in select countries in Europe, with full European release expected during the second quarter of 2017. The device is currently under review by the U.S. Food and Drug Administration. The estimated 2017 worldwide insertable cardiac monitor market is approximately $800 million and is growing by more than $100 million a year.

About Abbott:
At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Apr
23
Sandeep Singh Dhillon
Albertsons produces first pharmacy tech in nation to administer immunization
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BOISE, Idaho — An Albertsons pharmacy technician has become the first in the nation to administer an immunization to a patient. The new ability for the technician is the product of new law in Idaho brought about by a partnership between Albertsons and Washington State University College of Pharmacy, who worked together to develop the first pilot program to train pharmacy technicians to provide immunizations with permission from the Idaho board of pharmacy.

The pilot, which began in December 2016, saw WSU working with the Accreditation Council for Pharmacy Education and the Idaho Board of Pharmacy. Albertsons got involved and provided a grant to develop and deliver the four-hour professional education to pharmacists in Boise, Idaho and Spokane, Wash.

“Pharmacy technicians are integral to our business,” Alberstons SVP pharmacy, health and wellness Mark Panzer said. “We are proud to embrace the changing role of pharmacy technicians and partner with WSU to expand access to health services in Idaho. We couldn’t be prouder than when our very own Samantha Thompson, a Safeway Pharmacy Technician in Coeur d’Alene, Idaho, became the first pharmacy technician in the country to administer an immunization.”

In March, Idaho passed the first law in the United States allowing pharmacy technicians to undergo the pharmacy board-approved training for administering immunizations to pharmacy patients.

“WSU faculty colleagues Kyle Frazier, Linda Garrelts-MacLean, and I trained 25 Albertsons and Safeway technicians and are collecting data on how many immunizations they give between December 2016 and May 2017,” said Kimberly McKeirnan, Clinical Assistant Professor, WSU College of Pharmacy. “The data collected will be used to show how expanding the number of health professionals trained to immunize patients can increase immunization rates, better utilize the skills of pharmacy technicians, and ease the time burden on pharmacists.”

Albertsons said more training is currently planned for other technicians in Idaho interested in pursuing the new responsibility.

Apr
21
Sandeep Singh Dhillon
Sun Pharma share price falls 3% after Dadra unit gets 11 observations from USFDA
Pharma Extra, Pharma News
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Sun Pharmaceutical Industries share price fell nearly 3 percent intraday Friday after CNBC-TV18 reports quoting agencies that the company has received 11 observations from the US health regulator for its Dadra unit.

While inspecting the plant, the US Food & Drug Administration found incomplete lab records at the pharma major’s Dadra plant.

These observations include failure to produce appropriate master or control record for each batch of drugs and failure to properly investigate batches that don’t meet specifications.

CNBC-TV18, quoting sources, had reported this news of Sun Pharma getting 11 observations on April 14.

Inspection of the plant by USFDA was concluded in the first week of this month.

Dadra site is the biggest unit for the company after Halol plant, for supplying drug in the United States.

Analysts say with these observations, the problem for the company may aggravate as its Halol plant has already been under import alert, which contributed 40 percent to US sales in FY16.

Meanwhile, in the first week of current month, the US Food & Drug Administration had said it would lift the import alert imposed on Mohali (Punjab) manufacturing facility and would also remove the facility from official action initiated (OAI) status.

Mohali, which had been under import alert since September 2013, is an oral solids plant and capacity-wise is understood to be as big as Ranbaxy’s Ohm Labs facility in the US.

At 09:38 hours IST, the stock was quoting at Rs 643.35, down Rs 12.50, or 1.91 percent on the BSE.