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Saturday, January 5, 2019

Solid Biosciences to Present at J.P. Morgan


Solid Biosciences Inc. (NASDAQ: SLDB) today announced that Ilan Ganot, Co-Founder, Chief Executive Officer and President of Solid Biosciences will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9th at 7:30 am PT. Members of the management team will participate in a question and answer session following the presentation at 8:00 am PT.
A live webcast of the presentation and question and answer session can be found under the investor relations section of Solid Biosciences’ website at www.solidbio.com and will be archived there following the presentation for 30 days.
Solid Biosciences is a life science company focused solely on finding meaningful therapies for Duchenne muscular dystrophy (DMD). Founded by those touched by the disease, Solid is a center of excellence for DMD, bringing together experts in science, technology and care to drive forward a portfolio of candidates that have life-changing potential. Solid is progressing programs across four scientific platforms: Corrective Therapies, Disease-Modifying Therapies, Disease Understanding and Assistive Devices. For more information, please visit www.solidbio.com.

FDA clears Bruin Biometrics’ wireless device to detect bedsore risk


(Bruin Biometrics)

Swiss biotech Oculis raises cash, nabs Novartis eye drug in extended series B


Hoping to push on with its work on next-gen eye treatments, Oculis has raised an extra CHF 15 million ($15.2 million) as it looks to fellow native Swiss biopharma Novartis for its next project.
First up, its cash haul: Its extended series B bumps its total to around $35 million for the round, a healthy start for a European biotech, with funds coming from the likes of Tekla Capital Management and included Nan Fung Life Sciences as new investors.
And it’s putting this cash boost to work straight away, wrapping up a deal with Novartis that sees it nab a license to the Big Pharma’s unwanted topical anti-TNF alpha antibody.

As is often the case in these types of deals, no financials were disclosed but the compound, named LME636, is based on a “single-chain antibody fragment technology specifically designed for topical delivery,” according to the company.
The drug has undergone early testing in three clinical trials, which the biotech says shows a “promising profile for treating inflammatory conditions of the anterior segment of the eye, including dry eye disease,” which has few treatments.
This comes as Novartis is looking to draw back from work on ophthalmology, with a planned spinoff for its Alcon eye unit slated in the coming months. This itself comes on the heels of Novartis CEO Vas Narasimhan’s strategy to focus the company on innovative meds, such as its work in CAR-T cancer therapies.

Oculis hopes that LME636, now to be renamed OCS-02, will get through the testing phase and be the “first topical anti-TNF alpha therapy for ophthalmic indications.”
Dr. Riad Sherif, CEO of Oculis, said: “This agreement [with Novartis] is part of our ongoing strategy to access multiple sources of technologies and compounds that bolster our portfolio of innovative products to treat eye diseases. We are looking forward to working with the ophthalmology community on the rapid development of this promising therapy.”

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.