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Saturday, January 5, 2019

Sage to Present at J.P. Morgan Healthcare Conference on Tuesday, January 8


Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the Company will present at the J.P. Morgan 2019 Healthcare Conference in San Francisco, Calif. on Tuesday, January 8, 2019 at 3:30 p.m. PST (6:30 p.m. EST), followed by a Q&A session.
A live webcast of the presentation can be accessed on the investor page of Sage’s website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage’s website following the conference.

Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering CNS disorders. Sage’s lead product candidate, ZULRESSO™ (brexanolone) injection, has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the U.S. Food and Drug Administration. Sage is developing a portfolio of novel product candidates targeting critical CNS receptor systems, including SAGE-217, which is in Phase 3 development in major depressive disorder and postpartum depression. For more information, please visit www.sagerx.com.

New rule could help small business employees afford health insurance


The Trump administration recently proposed a new ruleOpens a New Window. that could make health insurance more affordable, and stands to impact 10 million American workers by 2028.
It’s sorely needed. Many firms are dropping coverage because the premiums are just too expensive. They may want to help their workers with the cost of health insurance. But federal law effectively gives them two choices: offer expensive, comprehensive benefits that adhere to Obamacare’s cost-inflating mandates, or do nothing.
The new rule would provide a third option. It would permit employers to give their employees monthly tax-free cash allowances to help them pay for coverage in the individual market.

Your health insurance dollars

The rule could prove revolutionary. In the short term, it will help millions gain coverage. But in the long run, it could give individuals, rather than employers, control over health insurance dollars. Such a change would spur competition in the insurance market — and ultimately lead to higher quality, greater choice, and lower costs.
Sponsoring health insurance is becoming cost-prohibitive for many employers. The average premium for a family plan at firms with between three and 199 workers has nearly tripled since the turn of the century — from $6,500 in 2000 to $19,000 today.
Some firms have responded by dropping coverage. In 2000, nearly all firms with 50 to 99 employees offered insurance. Now, 89 percent provide coverage.
Even if employees at small and medium-sized companies receive health benefits, they’re unlikely to have a wide range of plans to choose from. Among companies with fewer than 200 employees that provide coverage, eight in ten offer just one plan.
The new rule would help reverse this trend by easing regulations on “health reimbursement arrangements.” HRAs allow employers to set aside a fixed amount of money tax-free each month to reimburse employees for healthcare expenses.
The Obama administration severely restricted the use of HRAs. Companies were barred from using HRAs to reimburse workers for health plans they had purchased on their own in the individual market.
The new rule will get rid of that restriction. The Treasury Department estimates that by 2028, 800,000 employers will take advantage of expanded HRA options — and thereby help more than 10 million workers pay for individual-market insurance.

More competition = more options

The increase in the number of customers in the individual market could result in more competition and a wider variety of insurance options.
Consider a pizza analogy. Right now, some businesses are catering pizza — health insurance — for their employees. The employer chooses the size and the toppings. If workers want pepperoni but the employer only offers cheese, they’re out of luck. And some firms can’t afford to provide pizza at all. So employees have to pay for it out of pocket, if they want it.
Soon, businesses will have the option of giving workers cash to help them cover the cost of whatever pizza they’d like to order. Budding restaurateurs will surely launch new pizzerias and types of pizza to compete for the dollars of this new stream of customers — inexpensive pies, pies with all sorts of toppings, and more.
This is exactly what will happen in the individual health insurance market. Sending millions of new people into the individual market will encourage insurers to find ways to provide better, more individually tailored health plans at lower cost. And it will build on the Trump administration’s other recent reforms, which have made a wider range of coverage options available to consumers — such as Association Health Plans and Short-Term Limited Duration plans — who don’t like or can’t afford what’s available on Obamacare’s exchanges.
The administration’s proposed rule would give businesses a new way to offer health benefits and make it easier for millions of workers to purchase coverage that suits their needs and budget. It’s time to finalize it.

Trump says drug makers ‘not living up’ to commitments on pricing


In a tweet, President Donald Trump said that, “Drug makers and companies are not living up to their commitments on pricing. Not being fair to the consumer, or to our Country!” Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
https://thefly.com/landingPageNews.php?id=2844115

Otsuka funds prescription therapy app for depression


Otsuka is once again betting on digital as a new avenue for depression treatment by collaborating with Click Therapeutics to develop and commercialise a ‘prescription digital therapeutic’ for major depressive disorder (MDD).
Otsuka will commit capital to fully fund development of Click’s mobile app ‘CT-152’ for MDD, and to commercialise it worldwide upon achievement of regulatory approvals. Otsuka will pay Click up to $10 million in upfront and regulatory milestone payments, along with an estimated $20 million in development funding. An additional $272 million in commercial milestone payments is contingent upon regulatory approvals.
In addition, Click will receive tiered, double-digit royalties on global sales of the software and the digital therapeutic applications that result.
The companies said that CT-152 will leverage evidence-based cognitive therapy principles and Click’s patient engagement platform to treat patients either independently or in conjunction with prescribed pharmacotherapies.
The intent is that the app will be classified as Software as a Medical Device (SaMD) and will fall under the FDA regulatory framework that supports innovation and commercialisation of digital tools while protecting patient health.
“Our goal is to deliver evidence-based cognitive therapies to a broader population of patients with MDD than is currently feasible, due to the challenges of a shortage of mental health professionals and limited time for them to conduct cognitive therapy,” commented Kabir Nath, president and CEO, Otsuka North America Pharmaceutical Business Division.
This is not Otsuka’s first foray into combining digital tech with mental health treatment: in November 2017 Abilify MyCite – a combination of the company’s drug aripiprazole, which treats schizophrenia, bipolar disorder and depression, with an ingestible sensor produced by Proteus Health – became the first ever ‘digital pill’ approved by the FDA.
The sensor records when the pill has been taken and sends a message to a wearable patch. This is then transmitted to a mobile phone app, allowing patients to track their own compliance and share this data with caregivers and doctors.
Digital therapies for mental health are an area of increasing interest for the pharma industry as a whole – Takeda has developed an Apple Watch app with Cognition Kit for monitoring depression, which has impressed in early studies, while in September last year digital health firm Akili struck a deal with the University of California for exclusive rights to a therapeutic video game that could improve cognitive function in psychological and neurological disorders like MDD.

Persistent Cough May Mean See Your Doctor


After suffering through a cold, many people still have a persistent cough — but why?
According to Dr. Jonathan Parsons, director of the Asthma Center at Ohio State University Wexner Medical Center, here are some reasons for a continuing cough:
  • Coughing is protective. It removes irritants from the lungs and protects the airway.
  • The cough might be due to an upper respiratory tract infection. Even after the infection is gone, you may still have some inflammation in the lungs.
  • Coughing can be worse at night. “For some patients, their cough is so severe that it disrupts their sleep to the point where they aren’t getting any sleep at all, which impacts their ability to function during the day. In that situation, you might consider taking a cough suppressant with codeine to blunt the cough reflex and assist with sleep,” Parsons said in a center news release.
A cough that lasts more than three weeks may be a chronic condition. If you’re still coughing and feeling sick after three weeks, then you should see a doctor.
Causes of a chronic cough include:
  • Uncontrolled allergies,
  • Uncontrolled asthma,
  • Side effects of medicine,
  • Acid reflux.
Persistent cough might be a symptom of a serious illness.
“If you’re coughing up blood, spiking fevers or have significant shortness of breath associated with the cough, you need to be evaluated quickly. You could have walking pneumonia. If you’re a smoker, it could be cancer. A doctor will examine you to determine the cause of the cough and establish a treatment plan,” Parsons said.
More information
Harvard University Medical School offers more on the causes and cures for a persistent cough.
SOURCE: Ohio State University Wexner Medical Center, news release, Dec. 28, 2018

Vericel Publishes Data From 954 Burn Patients Treated With Epicel


Vericel Corporation (Nasdaq:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the publication of outcomes data for 954 burn patients treated with Epicel (cultured epidermal autografts) in the Journal of Burn Care and Research. The results demonstrated an increased survival rate for patients treated with Epicel when compared to results reported for patients in the National Burn Repository with comparable burns.
Epicel is a permanent skin replacement produced from patients own cells and indicated for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area (TBSA) greater than or equal to 30%. The probable benefit of Epicel, mainly related to survival, has been previously demonstrated in two Epicel databases and one physician-sponsored study.
The publication summarized outcomes for the largest cohort of patients treated with Epicel published to date. The data set was compared to the National Burn Repository annual report which is the largest resource on epidemiology of thermal injury for patients admitted to burn centers and contains outcome data for 177,498 burn patients.
The overall mortality rate by burn size was lower for Epicel-treated patients than that reported in the National Burn Repository 2016 Report. The mean TBSA of burns in patients from the Epicel cohort was 67.5%, with an overall survival at discharge rate of 84.4% (804/953). According to the data set reported in the 2016 American Burn Association National Burn Repository, burns greater than 65 to 70% TBSA are associated with a 50% case mortality rate.1This comparative advantage in survival outcome was found to be consistent in both pediatric and adult patients treated with Epicel.
This new dataset demonstrating increased survival rates for patients treated with Epicel over a period of 25 years supports the strong clinical benefit achieved with Epicel in large full thickness burns, said Jon Hopper, Vericels chief medical officer. These data are important to patients and physicians since Epicel is the only FDA-approved permanent skin replacement for adult and pediatric patients with full-thickness burns.
The publication is entitled Twenty-five Years Experience and Beyond with Cultured Epidermal Autografts (CEA) for Coverage of Large Burn Wounds in Adult and Pediatric Patients, 1989-2015 and the full abstract is available on pubmed:

13 early signs of Parkinson’s


The hallmark symptoms of Parkinson’s disease are tremors and slow, rigid movements. Small changes in a person’s movements and behavior can signal the onset of Parkinson’s disease before diagnosis.
Parkinson’s disease is a nervous system disorder that affects around 1 percent of people aged 65 years and older. Symptoms usually develop slowly over several years. They may be subtle at first, so early signs are easy to miss.
If someone notices symptoms of Parkinson’s disease, they should consider contacting their doctor for more information. Early treatment can improve the condition’s long-term outcome.
In this article, we cover 13 early signs of Parkinson’s disease.

1. Tremors

Many healthcare professionals consider tremors to be a key characteristic sign of Parkinson’s disease. Tremors involve a persistent twitching or shaking of the hands, legs, or chin.
Tremors associated with Parkinson’s disease are called “rest tremors.” This means that the tremors stop when a person uses the affected body part.
Tremors are very subtle when they first appear. At this stage, the person experiencing the tremors is usually the only one who notices them. Tremors will gradually worsen as the disease progresses.
Tremors typically appear on one side of the body and then spread to other parts of the body later on.

2. Difficulty walking

Subtle changes in a person’s walking pattern could be an early sign of Parkinson’s disease.
Someone who has Parkinson’s disease might walk slowly or drag their feet as they walk. Many refer to this as a “shuffling gait.”
The person might walk at an irregular pace, suddenly walking faster or slower or changing the length of their stride.

3. Cramped or small handwriting

Micrographia is a disorder that involves abnormally small or cramped handwriting.
Doctors associate micrographia with medical conditions that affect the nervous system, or neurodegenerative disorders, such as Parkinson’s disease.

4. Loss of smell

Hyposmia occurs when someone loses their ability to smell. This is also called olfactory dysfunction. A loss of smell is a relatively common symptom, affecting 70–90 percent of people with Parkinson’s disease.
Loss of smell is one of the most noticeable symptoms of Parkinson’s disease that is not related to movement. It can appear several years before the disease affects a person’s movement.
People who have hyposmia as a symptom of Parkinson’s disease might experience:
  • a dulled sense of smell
  • difficulty detecting odors
  • difficulty identifying odors
  • difficulty telling the difference between odors
Doctors use smell identification tests to diagnose hyposmia, but the accuracy of these tests varies widely.
Having hyposmia does not always mean that someone has Parkinson’s disease. A person’s sense of smell can change for many reasons, such as age, smoking, or exposure to harsh chemicals. Hyposmia is also a symptom of other medical conditions, including Alzheimer’s disease and Huntington’s disease.

5. Sleep problems

Parkinson’s disease can severely affect a person’s ability to sleep. People who have Parkinson’s disease may experience a wide range of sleep-related symptoms, including:

6. Poor balance

Parkinson’s disease specifically targets nerve cells called basal ganglia, which reside deep within the brain. Basal ganglia nerves control balance and flexibility, so any damage to these nerves can impair a person’s balance.
Doctors use a test called the pull test to assess a person’s balance. The pull test involves a healthcare professional gently pulling a person’s shoulders backward until they lose their balance and recording how long it takes them to regain it.
Healthy individuals recover after one or two steps, while people with Parkinson’s disease may take a higher number of smaller steps to fully balance themselves.

7. Bradykinesia

Bradykinesia is a term that means slowness or absence of movement.
Bradykinesia causes a variety of symptoms, such as stiffness of the limbs and slow movements. A person who has bradykinesia might walk slower or have difficult starting a movement.
Some people who have this symptom might misinterpret it as muscle weakness. However, this symptom does not affect muscle strength.

8. Facial masking

Facial expressions involve many subtle, complex muscle movements. People with Parkinson’s disease often have a reduced ability to make facial expressions. This is called facial masking.
Facial masking is related to bradykinesia. The facial muscles move more slowly or rigidly than usual. People who have facial masking may appear blank or emotionless, though their ability to feel emotions is not impaired. Facial masking can also cause someone to blink their eyes slower.
A person with facial masking might have difficulty communicating with others because changes in their facial expressions are less noticeable than usual.

9. Vocal changes

Changes in the volume and quality of a person’s voice is another early sign of Parkinson’s disease.
Vocal changes may involve speaking in a softer tone, or starting to speak at a usual volume and then the voice becomes softer or fades away.
In other cases, a person might lose the usual variation in the volume and tone of their voice, so that the voice appears monotonous.

10. Stooping or hunched posture

People who have Parkinson’s disease may notice changes in their posture due to other symptoms of the disease, such as muscle rigidity.
People naturally stand so that their weight is evenly distributed over their feet. However, people who have Parkinson’s disease may start bending forward, making them appear hunched or stooped over.

11. Constipation

Constipation is a common problem that can have a wide range of causes. Constipation is one of the most common non-motor symptoms associated with Parkinson’s disease. Nearly 25 percent of people with the condition experience constipation before they develop motor symptoms.

12. Psychological symptoms

Parkinson’s disease can severely affect a person’s psychological well-being. The disease lowers the body’s natural levels of dopamine, which can cause changes in mood and behavior.
Some psychological symptoms associated with Parkinson’s disease include:

13. Weight loss

People with Parkinson’s disease might experience mild to moderate weight loss for several reasons.
Tremors and other motor symptoms associated with Parkinson’s may increase the body’s natural energy requirements. Non-motor symptoms, such as loss of smell, depression, or digestive issues, might cause people to eat less, which may result in weight loss.

Summary

Parkinson’s disease is difficult to diagnose, especially in the earlier stages. This is because the symptoms are subtler and more sporadic. However, knowing what symptoms to look for may encourage people to seek medical attention before they progress.
Early symptoms of Parkinson’s disease include:
  • tremors
  • difficulty walking
  • cramped or small handwriting
  • loss of smell
  • sleep problems
  • poor balance
  • bradykinesia
  • facial masking
  • voice changes
  • stooping or hunched posture
  • constipation
  • psychological symptoms
  • weight loss
Having these symptoms does not always mean that a person has Parkinson’s disease. People over the age of 60 should consider speaking with their healthcare provider if they experience any of the symptoms listed above.
Early diagnosis leads to earlier treatment, which can improve a person’s overall quality of life.