Monthly Archives: June 2020

How to launch a drug in a pandemic? Here’s how 4 drugmakers are using digital tools and fast footwork to do just that – FiercePharma

Posted: June 18, 2020 at 7:50 pm

Launching a new drug is an arduous task even in the best of times. Drugmakers build their commercial teams from scratch, spending months of effort and huge sums of money to ensure their med reaches as many physicians, patients and payers as possible.

Add a global pandemic to that challenging situation, and companies are faced with one of two options: Adapt or fail.

In the early months of COVID-19, drugmakers Esperion, Horizon, Eisai and Clarus, among others, faced thatunexpected hurdle to bringing their drugs to market after years of planning and millions of dollars invested.

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For two, Esperion and Horizon, the pandemic was the backdropand often thedriverfor unexpected success for their novel therapies.In the case of Eisai and Clarus, the pandemic hit like a hammer, leaving both drugmakers scrambling for answers to the new challenge.

These talesof hardship, adaptation and sometimessuccess underscore the pharmaceutical industry's needtoquickly pivot to new ways of communicating during extraordinary circumstances. They also may reveal a new path forward for drugmakers in the uncertain future of global pandemics and, potentially, rolling waves of lockdowns.

Here are their stories.

After nabbing back-to-back FDA approvals for their lipid-lowering game-changers Nexletol and Nexlizet in February, Michigan-based drugmaker Esperion planned an aggressivelaunchto takethe fight right to its pricey PCSK9 class rivals.

Esperion's plan was simple: The drugmaker wouldlaunch Nexletol (bempedoic acid)on March 30 to set the stage for combo therapy Nexlizet (bempedoic acid and ezetimibe, also known as Zetia) to hit the market in July. The company would rely on its 300-strong sales team to reach as many physicians as possible and greasethe wheels for the more effective combo's launch.

Then, COVID-19 struck with only weeks to go before Nexletol took the stage. Facing a full-scale commercial pivot to digital, the only option off the table was delaying the drug'sMarch 30 launch date, CEO Tim Mayleben said.

"There was never a question about whether we were going to launch at that time," Mayleben said."The question internally was 'how do we adapt?'"

RELATED:Esperion scores FDA nod for cholesterol-buster Nexletol

Luckily, Esperion had adopteddigital outreach tactics before the pandemic. The companytasked its field managers with migrating the company'spromotional materials online and leaning into virtual meeting platforms like Zoom and Veeva Engage to replace face-to-face interactions with physicians.

That shift didn't happen overnight, Mayleben said. In fact, it took nearlyamonth post-launch to roll out all the digital tools needed to reach out to physicians effectively. That meant painstakingly building an outreach effort:The company went from a few hundred live engagements each week with physicians early on to a few thousand now, Mayleben said.

But one portion of that arduous effort came with an unexpected result. Esperion launched a virtual speaker series in the last week of April that gave doctors an opportunity to hear more about Nexlizet's pending launch. Not expecting a huge turnout, Esperion was shocked to see enormous attendance numbers for those sessionsfive times the number other drugmakers were getting for similar events, Mayleben saidunderscoring an immense interest in Nexlizet's clinical efficacy.

"We have been absolutely stunned at how successful that has been," Mayleben said.

RELATED:Esperion notches 2nd FDA approval with cholesterol-lowering combo Nexlizet

With doctor feedback pouring in from the series, Esperion accelerated its launch plans for Nexlizet, taking the drug to market in early Junea month ahead of schedule. The decision wasn't an easy one, but after Esperion confirmed doctors' interest and the ability of its supply chain to keep pace, the drugmaker ultimately decided Nexlizet was "the right drug at the right time for physicians and patients."

With lockdowns easing across the board, Esperion's sales team is beginning to return to normalor as close to normal as possiblebut the company's pivot to digital outreach likely won't be going anywhere, Mayleben said.

Having a "nimble" corps of territory managers who are well-versedin virtual outreach tools and equipped with digital promotional materials will remain a high priority in a blended commercial future, Mayleben argued.

"This is our make-or-break moment so we have to be inventive, and that inventiveness makes us more patient-focused," Mayleben said.

Horizon Therapeutics, once a company known for the unsavory practiceofbuying older meds and dramatically raising their prices to turn a profit, has trumpeted aplan in recent years to pin its future on a small stable of successful rare disease drugs.

One of the centerpieces of that plan is Tepezza, a bulging eye drug with blockbuster aspirations approved by the FDA in January.

Tepezza launched immediately after that approval, scoringa six-week head start on the pandemic before its commercial team of 100 was sidelined. For CEO Tim Walbert, that meant making an immediate shift to virtual outreach and helping existing patients find access to clinical sites to receive their Tepezza infusions, even as cities and states were locking down.

"Everything you do is fundamentally changed," Walbert said."The question you face is'have you built the right relationships?'If you haven't, having thatdialogue about your drug's benefits [to] patientsyoure going to be chasing without a lot of success."

RELATED:Horizon notches blockbuster FDA approval for rare eye disease med Tepezza

Despite facing a huge hurdle that early into Tepezza's launch, Walbert acknowledged that just six weeks on the market up front helped in getting initial patients on the drug. Unexpected, however, was how popular Tepezza would be so early into its launch.

Once projecting between $30 million and $40 million in Tepezza sales in 2020, Horizon has now upped its forecast to around $200 million in sales in the first year alone. Even that eye-popping increase is only a fraction of what Horizon believes it could have achieved if COVID-19 hadn't happened.

"We were still able to drive an amazing launchwithout COVID-19, we may have been able to do $500 million in first-year sales," Walbert said.

Having digitalpromotional materials ready to go beforethe pandemic gave Horizon reps the ability to quickly pivot to virtual outreach, but existing relationships with doctors and enthusiasm for the drug's results also paved the way for a successful first six months, Walbert said.

Now, with itsreps beginning to venture back out in the field, Horizon is leaning on those same physician relationships to chart the best path forward.

"Were having to redefine and work with each individual physician and ask, 'what is the best way to communicate?' Walbert said. "Were going and having our reps build a plan for each of our physicians to figure out how we can best serve them."

Eisai had its work cut out for it in marketing its recently approvedinsomnia med Dayvigo, a DEA-scheduled drug launching in a market full of generic competitors.

Dayvigo notched its FDA approval in December but was forced to hold back its launch untilDEA scheduling came through inearlyAprilright in the heart of the COVID-19 pandemic. Unlike other drugmakers that stuck to their launch dates, Eisai decided to postpone the rolloutuntil June 1.

That drastic decision effectively sidelined Eisai's 250-strong commercial team and put the drugmaker nearly two months behind schedule on its physician and consumer outreach, and education campaigns. According to Ivan Cheung, CEO and president of Eisai's global neurology business, the decision was all about "sensitivity" tophysicians'role in fighting COVID-19.

"From our commercial launch preparation, weve been ready for a late March launch for a long, long time," Cheung said. "Its nothing to do with readiness;its really about sensitivityduring the COVID-19 pandemic. We have to bea responsible corporate citizen."

RELATED:Eisai preps for launch with insomnia med Dayvigo after buying out Purdue

However, Eisai said it began to hear from physicians who felt the pandemic madeadequate sleep even more important as lockdowns added pressure to patients' daily schedules.

Reason enough, Eisai thought, to move ahead with the Dayvigo launch. Now,it's working with physicians to establish communication moving forwardand doctors were fine with the high-tech approach.

"What we found is that, given the impact on sleep health, theres a lot of enthusiasm," said Tushar Patel, Eisai's executive director and global lead of sleep-wake disorders in the neurology business group. "The majority of physicians weve spoken to are not only interested in learning about the new medicine, but theyre very open to receiving information digitally."

Eisai has also leaned into its digital outreach to consumers for Dayvigo, hoping to establish a place in an insomnia market jam-packed with generic competitors andMerck & Co.'sBelsomra brand, which hit the scene in 2014.

That outreach plan includes Eisai's "Dayvigo Together" online campaign to connect patients with live nurse educators to help them understand their insomnia symptoms and assess whether Dayvigo could be an effective treatment for them.

Being a huge, global drugmaker comes with some obvious benefits during a pandemic, including the sheer resources to weather the storm. But size isn't everything in times of crisis, a lesson that Clarus Therapeutics learned well in the early months of COVID-19.

Clarus, the maker of oral testosterone replacement tabletJatenzo, had a long road to market: The drug'sFDA approval in April 2019 capped off an arduous, years-long clinical development program, CEO Bob Dudley, Ph.D.,said. And then it had to gear up for launch.

With those past challenges in mind, Jatenzo's February rollout plans represented a big milestone not only for Clarus, but also forDudley, who developed AndroGel's topical formula as CEO at Unimedand is now a big believerin Jatenzo's place in the testosterone replacement field.But just as the launchgotunderway, COVID-19 struckhard.

"[Launching a new drug] isa challenging task, and it turned out to be a lot more challenging than I thought," Dudley said.

RELATED:As COVID-19 social media fatigue sets in, pharma begins to restart other health conversations

Clarus' commercial team of 55 was immediately tasked with unlearning their training in face-to-face physician meetings and pivoting to virtual. For any company, that's a tall task, butClarusmade that shift with remarkable speed, Dudley said.

In the space of a single weekend, Clarus' team came up with a game plan to amp up its digital outreach and get back in front of physicianshungry for new options in testosterone replacement therapies.

"We had all of these well-trained, motivated people with a great message to deliver tohealthcareprofessionals," Dudley said. "It necessitated pivoting on a dime and figuringout how we were going to maintain some semblance of a normal launch."

Speaking to doctors virtually wasn't as easy as showing up at their offices,Dudley said, and often requirednot only educating Clarus' team to use virtual meeting technology but also doctors themselves.

"In some cases, they didnt know how to do it," Dudley said of physicians using meeting technology."We found ourselves not only communicating the message of Jatenzo, but we also had to become experts in that side of it as well.

"The flip side of that was physicians, when they embraced the technology, then we found that they were keenly interested in learning about something new."

Now, after the storm of those early months, Clarus is making the shift back to face-to-face conversations, and Dudley said his team has moved with the same sense of purpose and "nimbleness" that allowed it to succeed during the lockdowns.

What will happen in an uncertain future is still unknown, but Dudley said the lessons learned during the lockdown helped his team preparefor a "blended" commercial future.

"In this environment, you have to be nimble," he said."This is why I think weve been able to maintain forward momentum when it could have justcrashed and burned."

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How to launch a drug in a pandemic? Here's how 4 drugmakers are using digital tools and fast footwork to do just that - FiercePharma

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Impact of COVID-19 on Testosterone Replacement Therapy Market 2020 Key Players, Opportunities, Challenges, Trend and Forecast by 2027 | Endo…

Posted: June 18, 2020 at 7:50 pm

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The report offers a systematic presentation of the existing trends, growth opportunities, market dynamics that are expected to shape the growth of the Testosterone Replacement Therapy market. The various research methods and tools were involved in the market analysis, to uncover crucial information about the market such as current & future trends, opportunities, business strategies and more, which in turn will aid the business decision-makers to make the right decision in future.

This Report Covers Leading Companies Associated in Worldwide Testosterone Replacement Therapy Market: AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.

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The report begins with a brief introduction and market overview of the Testosterone Replacement Therapy industry followed by its market scope and size. Next, the report provides an overview of market segmentation such as type, application, and region. The drivers, limitations, and opportunities for the market are also listed along with current trends and policies in the industry.

The key players profiled in this report include: AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.

Regions included:

o North America (United States, Canada, and Mexico)

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Impact of COVID-19 on Testosterone Replacement Therapy Market 2020 Key Players, Opportunities, Challenges, Trend and Forecast by 2027 | Endo...

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Why the ketogenic diet can help with diabetes and how to tell if it’s right for you – Insider – INSIDER

Posted: June 18, 2020 at 7:49 pm

The keto diet is a high-fat, low-carb eating plan. On the keto diet, you're usually eating around 80% fewer carbs than what national guidelines typically advise.

Research shows that the diet's approach to limiting carbs may help people with type 2 diabetes manage their condition. Here's a closer look at how the keto diet works and what people with type 2 diabetes should know before giving it a try.

Type 2 diabetes means that the body doesn't respond to insulin like it should. The hormone insulin helps your body utilize blood sugar, or glucose, for energy. For patients with insulin resistance or type 2 diabetes, insulin is still produced but it may be in insufficient amounts or the body doesn't use insulin properly. This causes blood sugar levels to increase. If not treated, chronically high blood sugar levels can lead to heart disease, kidney damage, nerve damage, eye damage, sleep apnea, and more.

To keep diabetes under control, you want to keep your blood sugar levels as close to normal as possible, says Osama Hamdy, MD, an associate professor at Harvard Medical School and senior staff physician at the Joslin Diabetes Center in Boston.

"Glucose in blood comes predominantly from carbohydrates, so eating more carbohydrates increases blood glucose and reducing carbohydrates reduces blood glucose."

That's why the carb-cutting keto diet might be helpful for people with type 2 diabetes.

As far as research goes, Hamdy says that there haven't been long-term studies on whether the keto diet can actually prevent type 2 diabetes. But there is some research on the diet's effect on those who already have the condition. Although many of the studies have been done on small groups of participants, the results seem promising.

For example, in a small study published in Nutrition & Metabolism in 2005, overweight adults (mostly men) with type 2 diabetes followed a keto diet, where they aimed to keep carbs at or below 20 grams per day for four months. At the end of the study, participants were able to reduce or completely stop taking their diabetes medications. Moreover, they also experienced a 16% reduction in their A1c levels, which is the average amount of glucose in the blood in the last 3-months.

"Reduction in A1C indicates improvement in diabetes control, which in turn reduces the chances of diabetes complications on eyes, kidneys, nerves and the cardiovascular system," says Handy

Another study, published in Nutrition & Metabolism in 2008, looked at how overweight adults with type 2 diabetes fared following a keto diet versus a low-cal-low-glycemic diet for 6 months. (Low-glycemic refers to foods with a low glycemic index that are less likely to spike blood sugar levels.) The study found that while both groups did well, results for the keto group were better in certain areas, including the reduction of A1C levels. Plus: 95% of those on a keto diet were able to cut or lower their medication use, compared to 62% in the low-calorie-low glycemic group.

A study published in Nutrition & Diabetes in 2017, found that after a year, overweight adults with prediabetes or type 2 diabetes who adhered to a keto diet saw a reduction in their A1C levels and also reduced medication more than those who ate a moderate carb and low-calorie/low-fat diet. Plus, the keto dieters had an average weight loss of 8.3% compared with 3.8% in the low-calorie group. Weight loss can also help keep blood sugar levels in check.

Generally, if you're following the keto diet, you're eating less than 50 grams of carbs per day. Some versions of the diet call for an even smaller amount around 20 or 30 grams of carbs per day, says Hamdy. For comparison, the Dietary Guidelines for Americans puts the recommended daily carb intake at somewhere between 225 and 325 grams per day.

The Academy of Nutrition and Dietetics describes how the diet works like this: With carbs pretty much out of the picture, the body needs another way to fuel itself. So, it uses fat, which is broken down into ketones and these ketones become the body's primary energy source. Once that happens, your body enters ketosis. "Ketosis indicates that the body switched its fuel source to stored fat," says Hamdy.

The good news for diabetes? Since blood glucose levels are lower when carb intake is less and ketones don't increase blood glucose levels, diabetes is better kept in control, says Hamdy.

The fact that ketones don't increase blood glucose levels, combined with eating a low-carb diet that also helps keep glucose levels lower, could help explain why research points to the positive effect of the keto diet on type 2 diabetes.

But if you do have type 2 diabetes, your doctor should be monitoring you while you're on the keto diet. That's in part because ketone levels that are too high can be dangerous changing the degree of blood acidity, and possibly leading to conditions like cardiac arrhythmia, says Hamdy.

Hamdy says the keto diet isn't harmful for the majority of type 2 diabetes patients. However he also says that "replacing carbohydrates in the diet with any type of fat, like meat or bacon, can result in a significant increase in bad cholesterol." That's why substituting the carbs you're cutting from your diet with healthier proteins and fats, like olive oil, avocados, and nuts, is better than gorging on bacon, steak, and barbecue.

The keto diet also comes with a series of side effects sometimes referred to as the keto flu like headache, constipation, and bad breath. Other risks include eventually developing conditions like kidney stones and vitamin deficiencies, according to the Academy of Nutrition and Dietetics. The academy also advises against the diet for people with certain conditions, like eating disorders or those with pancreatic disease, because of the detrimental effect on the pancreas from the high intake of fat.

For his part, Hamdy recommends a modified version of the keto diet for overweight or obese type 2 diabetes patients one where carb intake is specific to the individual, unhealthy fats like saturated fat in red meat is limited, and protein intake, particularly plant-based protein like beans, is higher.

"What most people don't know is that with the keto diet, you are not only losing fat but also losing muscle mass, which is dangerous. The capacity to regain muscle mass again is limited," Hamdy says. "So, replacing carbohydrates with protein instead of fat is a better idea, especially in conjunction with strength training."

In his clinic, Hamdy says that type 2 diabetes patients have had success with weight loss and diabetes control by cutting carbs to 40% of their diet, stick with low-glycemic index carbohydrates, and increased protein.

"For example, Joslin's Why WAIT program, which implements this structured nutrition plan along with exercise and behavioral changes, helped participating patients with diabetes to maintain a 6.9% weight loss for 10 years. They also cut their medications significantly, and many had partial or complete remission from type 2 diabetes," he says.

If you're suffering from prediabetes or type 2 diabetes, the keto diet may be worth considering. Consult with a doctor before trying any type of extreme diet.

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Why the ketogenic diet can help with diabetes and how to tell if it's right for you - Insider - INSIDER

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Assessment of Clinical Inertia in People With Diabetes Within Primary Care – DocWire News

Posted: June 18, 2020 at 7:49 pm

Rationale, aims and objectives:Clinical inertia, defined as a delay in treatment intensification, is prevalent in people with diabetes. Treatment intensification rates are as low as 37.1% in people with haemoglobin A1c (HbA1c) values >7%. Intensification by addition of medication therapy may take 1.6 to more than 7 years. Clinical inertia increases the risk of cardiovascular events. The primary objective was to evaluate rates of clinical inertia in people whose diabetes is managed by both pharmacists and primary care providers (PCPs). Secondary objectives included characterizing types of treatment intensification, HbA1c reduction, and time between treatment intensifications.

Method:Retrospective chart review of persons with diabetes managed by pharmacists at an academic, safety-net institution. Eligible subjects were referred to a pharmacist-managed cardiovascular risk reduction clinic while continuing to see their PCP between October 1, 2016 and June 30, 2018. All progress notes were evaluated for treatment intensification, HbA1c value, and type of medication intensification.

Results:Three hundred sixty-three eligible patients were identified; baseline HbA1c 9.6% (7.9, 11.6) (median interquartile range [IQR]). One thousand one hundred ninety-two pharmacist and 1739 PCP visits were included in data analysis. Therapy was intensified at 60.5% (n = 721) pharmacist visits and 39.3% (n = 684) PCP visits (P < .001). The median (IQR) time between interventions was 49 (28, 92) days for pharmacists and 105 (38, 182) days for PCPs (P < .001). Pharmacists more frequently intensified treatment with glucagon-like peptide-1 agonists and sodium glucose cotransporter-2 inhibitors.

Conclusion:Pharmacist involvement in diabetes management may reduce the clinical inertia patients may otherwise experience in the primary care setting.

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Assessment of Clinical Inertia in People With Diabetes Within Primary Care - DocWire News

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Erectile dysfunction and diabetes: take control today | Health | gmtoday.com – Greater Milwaukee Today

Posted: June 18, 2020 at 7:49 pm

Learn strategies to prevent or treat a common and frustrating potential complication of diabetes.

Erectile dysfunction is a common problem for men who have diabetes but its not inevitable. Consider prevention strategies, treatment options and more.

Erectile dysfunction the inability to get or maintain an erection firm enough for sex is common in men who have diabetes, especially those with type 2 diabetes. It can stem from damage to nerves and blood vessels caused by poor long-term blood sugar control.

Erectile dysfunction can also be linked to other conditions common in men with diabetes, such as high blood pressure and heart disease. Erectile dysfunction might occur earlier in men with diabetes than in men without the disease. Difficulty maintaining an erection might even precede the diabetes diagnosis.

Having erectile dysfunction can be a real challenge. It can leave you and your partner feeling frustrated and discouraged. Take steps to cope with erectile dysfunction and get your sex life back on track.

Talk to an expert

Many men are reluctant to discuss erectile dysfunction with their doctors. But dont let embarrassment keep you from getting help. One small conversation can make a big difference. Heres what to do:

Tell your health care provider whats going on. Your health care provider will consider underlying causes of your erectile dysfunction and can give you information about medication and other erectile dysfunction treatments. Find out your options.

Ask if theres anything you can do to better manage your diabetes. Improving your blood sugar levels can help prevent nerve and blood vessel damage that can lead to erectile dysfunction. Youll also feel better overall and improve your quality of life. Ask your doctor if youre taking the right steps to manage your diabetes.

Ask about other health problems. Its common for men with diabetes to have other chronic conditions that can cause or worsen erectile dysfunction. Work with your doctor to make sure youre addressing any other health problems.

Check your medications. Ask your doctor if youre taking any medications that might be worsening your erectile problems, such as drugs used to treat depression or high blood pressure. Making a change to your medications might help.

Seek counseling. Anxiety and stress can make erectile dysfunction worse. Erectile dysfunction can also have a negative impact on your relationship with your intimate partner. A psychologist, counselor or other mental health specialist can help you and your partner find ways to cope.

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Erectile dysfunction and diabetes: take control today | Health | gmtoday.com - Greater Milwaukee Today

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Dario Health to Host Key Opinion Leader Call on Digital Therapeutics for the Management of Diabetes and Other Chronic Conditions – PRNewswire

Posted: June 18, 2020 at 7:49 pm

NEW YORK, June 18, 2020 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO), a pioneer in the global digital therapeutics market, today announced that it will host a key opinion leader (KOL) call on digital therapeutics for the management of diabetes and other chronic conditions on Tuesday, June 23, 2020 at 10:30 a.m. Eastern Time.

The call will feature a presentation by KOL David Simmons, MD, who will discuss the importance of digital therapeutics as a complement to the current standard of care for the long term management and treatment of patients with diabetes and other chronic diseases. Dr. Simmons will be available to answer questions at the conclusion of the event.

The DarioHealth management team will also discuss its state-of-the-art software as a service (SaaS) technology platform that has been clinically demonstrated to improve long-term health outcomes while lowering costs. Dario offers a holistic, integrated service that combines a proprietary medical device, mobile app, and digital and human coaching that enables real-time data capture and drives therapeutic interventions.

Tuesday, June 23rd @ 10:30amETWebcast: Click Here to Register for the Webcast

David A. Simmons, MD, a highly regarded diabetologist with more than 40 years of diverse experience in the areas of diabetes, metabolism and cardiovascular disease as a researcher, professor, corporate executive and board member. He currently serves as Principal of Metabolic Management Consultants, LLC. Previously, Dr. Simmons served as Vice President, Chief Medical Officer and Board Member at Ascensia Diabetes Care where he provided senior leadership during the transition of the company from a division of Bayer into a stand-alone medical solutions company. His responsibility included Medical Affairs, Clinical Affairs, Regulatory Affairs and Quality Assurance. Before Ascensia, he served as Vice President and Chief Medical Officer of Bayer Diabetes Care from 2007 to 2015. Earlier in his corporate career, Dr. Simmons also directed clinical research teams at Pfizer, Inc. that were involved in the development of atorvastatin (Lipitor) and Exubera, as well as other components of Pfizer's cardiometabolic portfolio. From 1983 until 1999, Dr. Simmons served as Fellow, Assistant Professor and Associate Professor at the University of Pennsylvania School of Medicine. Dr Simmons is an associate of the American Diabetes Association and a past fellow of the College of Physicians of Philadelphia. His research has been published in many peer-reviewed journals, including Science, Diabetologia, Journal of Clinical Investigation, Diabetes Care, Diabetes Technology and Therapeutics, and Journal of Diabetes Science and Technology. He serves on the editorial review boards of Diabetes Technology and Therapeutics and Journal of Diabetes Science and Technology. He was the recipient of the Outstanding Achievement in Diabetes Service award from the Pennsylvania affiliate of the American Diabetes Association in 1995.Dr. Simmons received his medical degree from the University of Pennsylvania School of Medicine. He completed his internship and residency in internal medicine at Baylor Medical College in Houston and his fellowship in the Diabetes Division at the George S. Cox Research Institute, UPenn School of Medicine.

About DarioHealth Corp.

DarioHealth Corp. (Nasdaq: DRIO) is a leading, global digital therapeutics company revolutionizing the way people with chronic conditions manage their health. By delivering evidence-based interventions that are driven by data, high-quality software and coaching, we empower individuals to make healthy adjustments to their daily lifestyle choices to improve their overall health. Our cross-functional team operates at the intersection of life sciences, behavioral science and software technology to deliver highly engaging therapeutic interventions. Dario is one of the highest-rated diabetes solutions in the market, and its user-centric MyDario mobile app is loved by tens of thousands of consumers around the globe. DarioHealth is rapidly moving into new chronic conditions and geographic markets, using a performance-based approach to improve the health of users managing chronic disease. To learn more about DarioHealth and its digital health solutions, for more information, visit http://dariohealth.com

Cautionary Note Regarding Forward-Looking Statements

This news release and the statements of representatives and partners of DarioHealth Corp. (the "Company") related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. For example, the Company is using forward-looking statements in this press release when it states that its SaaS technology platform that has been clinically demonstrated to improve long-term health outcomes while lowering costs. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company's commercial and regulatory plans for Dario as described herein) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

DarioHealth Corporate Contact: Claudia Levi Content & Communications Manager[emailprotected] +1-347-767-4220

Media Inquiries:Investor Relations Contact:Matthew Picciano[emailprotected]+1-646-889-1200

SOURCE DarioHealth Corp.

http://dariohealth.com/

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Dario Health to Host Key Opinion Leader Call on Digital Therapeutics for the Management of Diabetes and Other Chronic Conditions - PRNewswire

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Glyscend Therapeutics raises $20.5M Series A to advance a new way of treating Type 2 diabetes – Technical.ly

Posted: June 18, 2020 at 7:49 pm

Baltimore-based biopharmaceutical company Glyscend Therapeutics closed a $20.5 million financing round that will help to advance its treatment for Type 2 diabetes toward clinical trials next year.

The round was led by healthcare-focused investors Brandon Capital Partners and Sant Ventures. In 2019, the company also previously received seed funding from Breakout Labs, which is a fund in the Thiel Foundation of Paypal cofounder and investor Peter Thiel.

Glyscend will use the funding for product development, scaling up manufacturing, and proof-of-concept clinical trials that are slated to begin in Australia in 2021.

The company is developing an oral therapy that is designed to offer specific benefits of surgery, without the need for invasive procedures.

The technology we are developing was inspired by the remarkable efficacy of gastric bypass surgery in correcting the metabolic disorder associated with type 2 diabetes, said Dr. Ashish Nimgaonkar, CEO of Glyscend, in a statement. Our goal is to develop an oral medication that works locally in the gastrointestinal tract to provide the benefits of gastric bypass surgery while greatly reducing the potential risks and complications.

Founded in 2104, the company evolved from research that originated at the Johns Hopkins Center for Bioengineering Innovation and Design, which has served as a launch point for multiple startups, via collaboration between the labs of Nimgaonkar and Dr. Jay Pasricha. In this research, scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation following certain types of weight loss surgery, Nimgaonkar said. In seeking to create non-absorbable drugs, the team tapped the expertise of medicinal polymer chemist Dr. Thomas Jozefiak, who is chief scientific officer.

It licensed technology from the university, and is now based at the FastForward 1812 innovation hub near Johns Hopkins Hospital in East Baltimore, which has become a biotech hub through offering access to coveted wet lab space in the city and proximity to other young companies.

Being located close to John Hopkins University has been vital for us grow by tapping into the deep scientific expertise roots, Nimgaonkar said. It also offers access to the wealth of knowledge from one of the countrys leading healthcare universities.

Additional materials science research and development is also conducted at a Lowell, Massachusetts, location of JLABS, which is Johnson & Johnsonsstartup incubator.

Along with the funding, entrepreneur and executive Dr. Karen Talmadge, who cofounded Medtronic-acquired medical device company Kyphonand is a 25-year member of the American Diabetes Association, joined the companys board.

Type 2 diabetes is a terrible disease whose personal and societal impact is both under-appreciated and deeply misunderstood, Talmadge said in a statement. I am honored to join Glyscends board to help fulfill the companys mission of providing life-changing benefits to patients with diabetes by reducing or eliminating the burden of disease.

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Type 2 diabetes: Using this oil when cooking could help lower your blood sugar levels – Express

Posted: June 18, 2020 at 7:49 pm

Type 2 diabetes, like many health conditions, can be life-threatening if not correctly managed. The threat comes in the form of having high blood sugar levels which is worsened by the wrong types of food, drink and even cooking oils. What is the best cooking oil to use to help lower your blood sugar?

Diabetes.co.uksaid: Extra virgin olive oil reduces blood sugar and cholesterol more than other kinds of fats.

In a study conducted at Sapienza University in Romen, the health benefits associated with a traditional Mediterranean diet for people with diabetes was investigated.

The findings of the study were consistent with previous studies, which have linked extra virgin olive oil to higher levels of insulin, making it beneficial to people with type 2 diabetes.

More surprising were the reduced levels of low-density lipoprotein (LDL) or bad cholesterol, associated with the extra virgin olive oil meal.

In study with the US National Library of Medicine National Institutes of Health, the effect of daily consumption of extra virgin olive oil on blood glucose among diabetic patients was analysed.

The study noted: Saudi Arabia has the highest prevalence of type 2 diabetes mellitus among the modern nation states in the world.

In addition, the majority of Saudi diabetic patients do not have their blood glucose controlled.

Data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and glycated haemoglobin.

Olive oil has been associated with weight reduction as well as improvements in lipid profile.

In another study with the US National Library of Medicine National Institutes of Health, olive oil use in the prevention and management of type 2 diabetes mellitus was analysed.

The study noted: Olive oil as food is composed mainly of fatty acids and bioactive compounds depending on the extraction method.

We conducted a meta-analysis to illustrate the impact of this food on type 2 diabetes by investigating the association between olive oil and risk of type 2 diabetes and the effect the oil intake has on the management of type 2 diabetes.

The study concluded that evidence from the intake of olive oil could be beneficial for the prevention and management of type 2 diabetes.

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Can CAR-T Cells Be Used to Treat Diseases like Diabetes and Fibrosis? – BioSpace

Posted: June 18, 2020 at 7:49 pm

An immunotherapy, chimeric antigen receptor T-cell (CAR-T), has revolutionized certain types of cancer treatments. The two approved CAR-T therapies are Novartis Kymriah (tisagenlecleucel) and Gilead Sciences Yescarta (Axicabtagene ciloleucel). They are essentially living therapies. They are drawn from a patient, engineered in a lab to focus more closely on the specific cancer, and reinfused into the patient where the cells grow and attack the cancer cells.

New research out of the Memorial Sloan Kettering Cancer Center suggests the genetically engineered immune cells can be used to treat diseases of senescence, which could include fibrotic liver disease, atherosclerosis, and diabetes.

Cellular senescence is a kind of zombie state related to aging, where cells stop dividing and growing, but dont actually die. It is particularly associated with diseases of aging.

Senescence is a double-edge sword, said Scott Lowe, chair of the Cancer Biology and Genetics Program at the Sloan Kettering Institute and co-responding author on the study. Cells in this state play an important role in wound healing and cancer deterrence. But if they linger for too long, they can cause chronic inflammation, which itself is a cause of many diseases. Finding a way to safely eliminate these cells would be a major therapeutic breakthrough in the treatment of these diseases.

The research was published in the June 17 issue of the journal Nature.

The research team compared molecules on the surface of senescent cells to other types of cells. They identified a molecule called urokinase plasminogen activator receptor (uPAR) that was enriched on the senescent cells, but largely absent on other cells. They then designed CAR-T cells that recognized uPAR.

Evaluating these newly engineered cells on mouse models of senescence-related diseases, such as cancer and liver fibrosis, they found that CAR-T cells successfully eliminated senescent cells from two different mouse models of liver fibrosis. The CAR-T cells also improved survival in lung cancer mouse models when dosed with drugs that induced senescence in this type of cancer.

The researchers plan to continue studying uPAR-directed CAR-T cells in other senescence-associated diseases, such as atherosclerosis, diabetes, and osteoarthritis, with hopes of developing them for clinical use in humans.

This study demonstrates that T-cell engineering and CAR therapy can be effective beyond cancer immunotherapy, said Michel Sadelain, director of the Center for Cell Engineering at Sloan Kettering.

Lowe added, We think this approach has the potential to tackle a number of senescence-related diseases for which new treatments are badly needed.

Senescence has been a growing field in the last few years. South San Francisco-based Unity Biotechnology focuses on senescence to halt, slow or reverse age-associated diseases. The companys pipeline includes UBX0101, which is in Phase II trials for osteoarthritis and UBX1967 and UBX1325 for age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Other programs are studying idiopathic pulmonary fibrosis, liver and kidney diseases, and neurodegenerative and cognitive disorders.

On March 31, the company announced that it had completed enrollment in its UNITY Phase II trial of UBX0101 in moderate-to-severe osteoarthritis of the knee. It was evaluating 183 patients and expects to report results in the second half of 2020

Research that came out of Rockefeller University last year found that, unexpectedly, the neurons affected by Parkinsons disease may actually be senescent and that these undead neurons release molecules that shut down neighboring brain cells that lead to common Parkinsons symptoms.

Senescent cells occur throughout the body, but it is not usually seen in nerve cells in the brain. Neurons halt division once fully formed. But the research group found that dopamine neurons that regulate motivation, memory and movement by producing dopamine can become senescent.

Similarly, in 2018, researchers at the University of Texas Health Science Center at San Antonio found cellular senescence was linked to tau protein tangles associated with end-stage Alzheimers disease. Cellular senescence can be a survival strategy for cells under stress, but it can also cause cells to behave abnormally and secrete toxins that kill surrounding cells.

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Millimeter Wave Diabetes Treatment Devices Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By…

Posted: June 18, 2020 at 7:49 pm

The global Millimeter Wave Diabetes Treatment Devices market is segregated on the basis of Type as Under 50 GHz and Above 50 GHz. Based on Application the global Millimeter Wave Diabetes Treatment Devices market is segmented in Type 1 Diabetes and Type 2 Diabetes.

FYI, You will get latest updated report as per the COVID-19 Impact on this industry. Our updated reports will now feature detailed analysis that will help you make critical decisions.

The global Millimeter Wave Diabetes Treatment Devices market report scope includes detailed study covering underlying factors influencing the industry trends.

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The global Millimeter Wave Diabetes Treatment Devices market report provides geographic analysis covering regions, such as North America, Europe, Asia-Pacific, and Rest of the World. The Millimeter Wave Diabetes Treatment Devices market for each region is further segmented for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.

Competitive Rivalry

Zimmer MedizinSysteme, Smiths Group, Domer Laser, Hubei YJT Technology and others are among the major players in the global Millimeter Wave Diabetes Treatment Devices market. The companies are involved in several growth and expansion strategies to gain a competitive advantage. Industry participants also follow value chain integration with business operations in multiple stages of the value chain.

The Millimeter Wave Diabetes Treatment Devices Market has been segmented as below:

Millimeter Wave Diabetes Treatment Devices Market, By Type

Millimeter Wave Diabetes Treatment Devices Market, By Application

Millimeter Wave Diabetes Treatment Devices Market, By Region

Millimeter Wave Diabetes Treatment Devices Market, By Company

The report covers:

Report Scope:

The report covers analysis on regional and country level market dynamics. The scope also covers competitive overview providing company market shares along with company profiles for major revenue contributing companies.

The report scope includes detailed competitive outlook covering market shares and profiles key participants in the global Millimeter Wave Diabetes Treatment Devices market share. Major industry players with significant revenue share include Zimmer MedizinSysteme, Smiths Group, Domer Laser, Hubei YJT Technology, Application C10, Application B10, Application B8, Application B9, Application B10, Application C10, and others.

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