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Wednesday, June 19, 2019

Seres’s investigational candidates unaffected by FDA alert

Seres Therapeutics (NASDAQ:MCRB) says its investigational therapeutic candidates — highly purified consortia of spore-based commensal bacteria — are fundamentally distinct from fecal microbiota transplantation and aren’t affected by a recent FDA alert.
On June 13, 2019, the FDA issued an alert regarding bloodstream infections with multi-drug resistant organisms transmitted through FMT; two immunocompromised adults who received FMT had developed invasive infections caused by extended-spectrum beta-lactamase-producing E. coli and one individual died.
Unapproved FMT is  widely used under an FDA Enforcement Discretion policy for the treatment of recurrent C. difficile infection not responsive to standard therapies; that policy doesn’t require safety monitoring and oversight that are standard requirements for investigational therapies under an IND.
The new FDA safety alert indicated that additional protections are needed for any investigational use of FMT including appropriate donor screening questions, testing of donor stool for MDROs and informing patients of the potential risk of infection and serious adverse reactions.
Seres remains supportive of continued patient access to FMT, particularly for those patients who may lack access to clinical trials. However, Seres believes that FMT use should be performed under an IND using pre-specified and mandatory safety reporting requirements appropriate for unapproved investigational therapies.

Bausch + Lomb ULTRA Multifocal for Astigmatism lenses now available in U.S.

Bausch + Lomb, a wholly owned subsidiary of Bausch Health Companies (NYSE:BHCannounces the U.S. launch of Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses, the first and only multifocal toric lens available as a standard offering in the eye care professional’s fit set.
The new monthly silicone hydrogel lens is designed for patients with both astigmatism and presbyopia.

Catalent to buy Bristol-Myers plant in Italy

Catalent’s (NYSE:CTLTpurchase of Bristol-Myers Squibb’s (NYSE:BMY) oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy, will complement its existing sterile fill/finish capabilities in Belgium and its drug substance, analytical, and fill/finish capabilities in North America.
Catalent will continue to manufacture products for Bristol-Myers Squibb’s current product portfolio at the site.
Meanwhile, Bristol-Myers will maintain a presence in Italy through ongoing development and commercialization of new medicines.
Terms of the deal weren’t disclosed; the companies expect the transaction to close by the end of 2019.

Biolase started at Speculative Buy by Benchmark

Target $2

KemPharm started at Buy by Wainwright

Target $3

Tuesday, June 18, 2019

Top 4 Virtual Reality (VR) Breakthroughs in Medicine

Virtual reality (VR) is becoming a prominent force in the healthcare industry. The VR market in medicine is expected to grow to $3.8 billion by 2020, according to a report by Global Industry Analysts. Another report by Grand View Research predicts this market to grow to a whopping $5.1 billion by 2025. This technology holds promise in revolutionizing the healthcare industry, with applications ranging from training medical professionals to diagnosing and treating different conditions. In this article, DocWire News has compiled the top four headlines in recent news regarding medical VR.

St. Joseph’s Children’s Hospital Using VR to Plan Surgeries

The St. Joseph’s Children’s Hospital in Tampa is using VR technology from flight simulations to create virtual models of a patient’s anatomy. These 360-degree models are generated using CT and MRI images and provide pediatric surgeons with a detailed planning tool.
The hospital is using the Surgical Theater Precision Virtual Reality technology to create these patient models, the same VR technology is utilized in F-16 fighter aircraft simulations. This VR is currently being used in the hospital’s neurology and cardiac surgery programs. Surgical Theater’s VR was recently used at the UCSF Benioff Children’s Hospitals to create similar patient models for neurosurgery as well.
BotCyberAniMax@cyberanimax
https://www.prnewswire.com/news-releases/st-josephs-childrens-hospital-first-childrens-hospital-in-southeast-to-use-virtual-reality-visualization-platform-300864944.html 
With virtual reality headsets, surgeons are able to guide a patient through a 360-degree model @cyberanimax

St. Joseph’s Children’s Hospital First Children’s Hospital in Southeast to Use Virtual Reality…

TAMPA, Fla., June 10, 2019 /PRNewswire/ — St. Joseph’s Children’s Hospital in Tampa is the first children’s hospital in Florida and the only pediatric…
prnewswire.com
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VR May Be the Best Way to Detect Early Alzheimer’s Disease

Recent work from the University of Cambridge has found that VR could be more effective in detecting early Alzheimer’s disease than traditional cognitive tests. With over 525,000 UK citizens living with the disease, the researchers’ work has great implications for the use of technology in diagnosing and monitoring the neurological disease. This research was recently published in the journal Brain.
The research builds on the 2014 work from Professor John O’Keefe of the University College London, which identified a mental “satnav” of one’s current and previous locations that aids in navigation. O’Keefe received the Nobel Prize in Physiology or Medicine for “discoveries of cells that constitute a positioning system in the brain’ for this research.
i newspaper
✔@theipaper
Cambridge University scientists developed and trialled a VR navigation test in patients at risk of developing dementia https://inews.co.uk/news/health/virtual-reality-better-at-spotting-alzheimers-than-gold-standard-test/ 

Virtual reality ‘better at spotting Alzheimer’s than gold standard test’

Virtual reality can identify early Alzheimer’s disease more accurately than “gold standard” cognitive tests currently in use, new research from the Cambridge University scientists developed and…
inews.co.uk
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Helping those with Parkinson’s Disease Walk Using VR

Recent work has found VR to be effective in building balance skills in patients with Parkinson’s disease. This system successfully improved patient’s obstacle negotiation and balance, as well as their confidence in moving around in their environment, according to their findings published in Experimental Biology.
Walking is a very challenging task for those living with Parkinson’s, due to damage in their dopamine-producing neurons. Muscle rigidity, tremors, and impaired speed of gait often lead to falls and injuries in patients with the disease, making balance therapy a common treatment.

How Osso VR is Reshaping the Surgical Training Process

osso vrPerforming an operation for the first time is a very daunting task for a surgeon. Training opportunities at this early career stage are limited. At best, first-time surgeons were able to perform the surgery on a cadaver once prior to the real procedure, after which point the safety of the live patient was fully in their hands. The need for improved surgical training procedures is evident, and one company that aims to potentially fill this void is Osso VR, previously covered on DocWire News, using VR to reshape the surgical training process by providing life-like simulations of many operations.

Sen. Alexander supports in-network guarantee to end surprise medical bills

The chair of the Senate health committee showed his support for the so-called “network matching” policy to end surprise medical bills, a proposal sharply opposed by specialty physician groups and the hospitals that employ them.
In a committee hearing on Tuesday, Sen. Lamar Alexander (R-Tenn.) said the policy, under which hospitals would have to guarantee to their patients that any doctor they see is in-network, is the one he “instinctively liked the best.”
“It seemed to me, if the problem was out-of-network doctors, the solution would be to have in-network doctors,” Alexander said. “That seemed to me the simplest solution to the problem. It also saves the most money.”
After the hearing, Alexander declined to confirm whether it’s the option that will end up in the final draft of the 165-page draft legislation, even as he announced that the committee will vote on the package next week.
“We’ll see,” he told reporters.
The debate over how Congress should end surprise bills is especially contentious in the Senate health committee, where two members have led a rival effort to pass a more provider-friendly arbitration model backed by specialty physician groups.
Sens. Bill Cassidy (R-La.), a physician, and Maggie Hassan (D-N.H.) both defended their own proposal, which triggers an arbitration process if out-of-network doctors or any other party aren’t happy settling on a median in-network payment rate.
The health committee also included an arbitration policy, but its stricter limits haven’t appeased specialty physicians who have been fighting hard for alternative proposals. Dr. Anthony Cirillo, who is lobbying on the issue for the specialty physician practice US Acute Care Solutions, characterized the panel’s model as “sham arbitration” in a media call ahead of the hearing.
Cirillo and other specialty physician groups are pushing for the Cassidy bill in the Senate and a separate proposal from Reps. Raul Ruiz (D-Calif.) and Phil Roe (R-Tenn.), both physicians, in the House.
In addition to arbitration, the Senate health committee has also offered a payment benchmark model similar to the measure debated last week in the House Energy and Commerce Committee, which hospitals and specialty physician groups oppose.
On Tuesday, the American Hospital Association Executive Vice President Tom Nickels argued that a benchmark amounted to rate-setting and would ultimately resemble a single-payer system like Medicare for All.
But few Republicans appeared to buy that argument, including Sen. Mitt Romney of Utah, who said that “at first blush” he was concerned about the complexity of arbitration, adding that he believed a benchmark based on Medicare rates would be a simpler solution.
Sen. Mike Braun (R-Ind.) was also skeptical of Nickels’ argument and said the industry needed to “wake up” or “Medicare for All will be the only alternative.”
Senators spent less time on a provision that many insurers don’t like, which would establish an all-payer claims database nationwide, although witnesses talked about how employers and states have been able to save millions of dollars once they knew how to get a handle on costs.
Sen. Tina Smith (D-Minn.) brought up the database in order to clarify that the final draft provision would let states maintain their own databases and also get access to the federal claims data, which would include employer-sponsored plan claims, when they need it.
The senators didn’t discuss the bill’s proposed contract reforms, bans on all-or-nothing clauses, or anti-tiering and anti-steering agreements, which hospitals hotly contest.
Sean Cavanaugh, chief administrative officer for the accountable care organization Aledade, said those contract reform provisions would have the most impact on out-of-pocket costs.
“If I had to quantify the magnitude, the ones that are specifically labeled pro-competition about particular hospital negotiating tactics, I think those will have the most direct and immediate,” Cavanaugh said during the hearing.