Apple has at least 40 doctors across various teams, CNBC says

• If anyone was wondering whether Apple is serious about healthcare, recent reporting that the Silicon Valley tech giant currently has between 40 and 50 physicians working on various teams should answer the question.
• Hires include Rajiv Kumar, a Stanford University pediatric endocrinologist who used HealthKit to help patients manage diabetes, and Ricky Bloomfield, a Duke University physician and health IT expert. Many haven’t updated their LinkedIn pages or disclosed their Apple roles, CNBC reports, citing two people with knowledge of Apple’s hiring.
• The growing medical presence could convince other doctors that health apps for Apple Watch and other devices are worth investing in and raise the company’s image as a serious medical solutions company.

Tech companies have increasingly had their eyes on the digital health space as providers and payers look to areas like Big Data analytics and AI to improve diagnosis, increase workplace efficiencies and reduce clinical and administrative costs.

Funding for digital health startups soared to $3.3 billion across 93 deals in the third quarter of this year, according to Rock Health. Investment for the year hit $6.8 billion, outpacing 2017’s yearlong total of $5.7 billion.

With a stable of medical experts nearing 50 strong, Apple apparently sees itself in healthcare for the long haul.

Since 2016, the company has acquired digital health companies, including personal health records platform Gliimpse and sleep tracking startup Beddit, which detects heartbeats and breathing rhythms and relays information via Bluetooth to a companion app on iPhone or other compatible device.

The company is also rumored to be working on noninvasive blood sugar tracking sensors and assembling a team to develop custom processors to interpret health-related data collected by sensors in wearables and other devices.

Apple ventured deeper into healthcare with the September FDA approval of a first-of-its-kind electrocardiogram monitor in its latest Apple Watch. The embedded ECG app is classified as a Class II medical device and indicated for over-the-counter use by adults over the age of 22.

This year also saw the launch of a group of primary care clinics for Apple employees and the debut of personal health records on iPhones.

In yet another venture, Apple is partnering with Zimmer Biomet to study Apple Watch in supporting patients before and after knee and hip replacement surgery. A clinical trial will assess the impact of mymobility, an app that connects patients to surgical care teams via Apple Watch, on outcomes.

https://www.healthcaredive.com/news/apple-has-at-least-40-doctors-across-various-teams-cnbc-reports/544369/

Celiac Vaccine in Clinical Trials at Columbia

The only proven therapy for celiac disease—an autoimmune disorder that affects up to 3 million Americans—is to avoid dietary gluten. But this strategy is not always practical. Recent data from Columbia researchers suggest that as many as one-third of “gluten-free” restaurant meals contain trace amounts of the protein, which comes from wheat, rye, and barley. That is disconcerting for those with celiac disease, because even a tiny amount of gluten can launch an immune-system attack on the intestinal lining that can cause severe abdominal pain, diarrhea, and vomiting.

In a few years, people with celiac may have a vaccine to protect themselves against accidental exposure to gluten. One of the first candidates, called Nexvax2, has just begun a phase 2 clinical trial that will test the vaccine’s effectiveness. Eligible patients will soon be able to enroll at Columbia’s Celiac Disease Center.

The CUIMC Newsroom spoke with Peter Green, MD, director of Columbia’s Celiac Disease Center, about the vaccine trial and the need for therapies for those with celiac disease.

Why are researchers testing therapies for celiac disease?

To prevent intestinal damage, individuals with celiac disease must completely avoid gluten. But this can be very difficult, and despite people’s best efforts many are inadvertently consuming gluten. Apart from the immediate effects of gluten on the GI system, the inflammation caused by the immune system’s reaction to gluten can prevent nutrients from being absorbed properly, which may lead to serious health problems such as osteoporosis, anemia, and infertility.

So, there’s been great interest in developing therapies—including vaccines—for people with celiac disease.

There are several drugs in the pipeline, and Columbia is participating in many of these studies. In addition to the vaccine trial, we are involved in studies to develop enzymes that may help individuals with celiac disease digest gluten and a drug that may prevent gluten from getting into the bowel wall.

There are many other steps in the immune process that may offer potential therapeutic targets, though this vaccine is at the most advanced stage of development.

How does the vaccine work? Is it different from other vaccines, like the flu shot?

Most vaccines protect us from infectious agents, like viruses and bacteria. This celiac vaccine is a different type of immunotherapy, analogous to allergy shots, which increase an individual’s tolerance to a particular substance that triggers a big reaction. Celiac disease isn’t an allergy, but people with this condition develop a heightened immune reaction when they ingest gluten, similar to how people with an allergy to ragweed react when exposed to the plant.

The celiac vaccine is designed to reprogram the immune system so that it doesn’t go on the attack after small amounts of gluten are ingested. The vaccine does not prevent celiac disease from developing; it’s only useful for people who’ve already been diagnosed.

What will be tested in this new clinical trial?

Previous (phase 1) studies looked primarily at safety and have shown that the vaccine is well-tolerated, with no side effects. These studies have also identified a dose that may protect people from small amounts of gluten.

This phase 2 clinical trial, which is expected to enroll about 150 individuals with celiac disease in the U.S., Australia, and New Zealand, will help us determine if therapeutic vaccines are an appropriate way to protect individuals with celiac disease from the damage caused by ingesting gluten.

Because the trial tests the vaccine’s effectiveness over a limited period, additional studies will be needed to determine the dosing frequency to achieve a robust protective response.

Could anyone with celiac disease benefit from the vaccine?

This particular vaccine is designed for those with a gene called HLA-DQ2.5, one of the two genes that increase the risk of celiac disease. Individuals with the other celiac gene, HLA-DQ8, will not respond to this vaccine. By far, the majority of those with celiac disease—around 90 percent—have HLA-DQ2.5.

The vaccine will not be administered to people who have HLA-DQ2.5 but have not developed any celiac symptoms. Fewer than 1 in 50 people with the gene go on to develop celiac disease, so the risk for these people–often family members of celiac patients–is not great enough to warrant giving them the vaccine.

Would the vaccine allow someone with celiac disease to consume as much gluten as they wanted?

As with all of potential therapies for celiac disease, the vaccine is designed to protect those who consume a small amount of gluten due to food contamination. If that works, then studies can be performed to assess whether the vaccine protects against exposure to larger amounts of gluten that may be found in non-gluten-free foods.

https://www.cuimc.columbia.edu/news/celiac-vaccine-clinical-trials-columbia

Neos Therapeutics Announces Settlement with Teva on Cotempla XR-ODT® Patent

Neos Therapeutics, Inc. (NEOS), a pharmaceutical company focused on developing, manufacturing, and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technology platforms, today announced that it has entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA, Inc. (“Teva”) to resolve all ongoing litigation involving Neos’ patents protecting its Cotempla XR-ODT^®(methylphenidate) extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration to market a generic version of that product.

Under the settlement and license agreement, Neos has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT^® under the Teva ANDA beginning on July 1, 2026, or earlier under certain circumstances.

The settlement and licensing agreement is confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice.

“We are pleased to have reached this settlement and will continue to defend our innovative medicines against any challenge,” said Jerry McLaughlin, Chief Executive Officer of Neos Therapeutics.

https://finance.yahoo.com/news/neos-therapeutics-announces-settlement-teva-123000044.html

Commerce Department Won’t Publish Data During Shutdown

The economic data produced by the Commerce Department’s Census Bureau and Bureau of Economic Analysis won’t be released during the government shutdown, a spokeswoman said Wednesday.

The partial U.S. government closure entered its fifth day on Wednesday as President Trump and Congress remained at an impasse over his demand for more funding for a border wall, leaving hundreds of thousands of workers furloughed or working without pay. Some of those workers include Commerce Department economists and staff.

Data released by the department include new-home sales, housing construction, trade, orders for long-lasting durable goods, gross domestic product, inflation and personal income and spending.

Investors often depend on these reports to make trades, which affect stock values, bond yields and the value of the dollar. Businesses use them to make investment planning decisions. Federal Reserve officials depend on them to make interest-rate decisions that ripple through the economy.

The Labor Department said it will continue to release the data it compiles, including new claims for jobless benefits, the monthly employment report and other inflation measures. This means that on Thursday, Labor will publish the weekly claims report at 8:30 a.m. Eastern Standard Time, as scheduled, while the Commerce Department won’t release the November home-sales data.

The longer the government remains closed, the larger the impact, as release dates pass for other key reports. As of Wednesday, there were no indications emerging that Mr. Trump and Congress would find a way to end the stalemate.

https://www.marketscreener.com/news/Commerce-Department-Won-t-Publish-Data-During-Shutdown-Update–27799459/

Ex-Insys CEO to plead guilty to opioid kickback scheme

The former chief executive of Insys Therapeutics Inc has agreed to plead guilty to participating in a scheme to bribe doctors to prescribe a powerful opioid medication in order to boost its sales, U.S. prosecutors said on Wednesday.

Michael Babich, who resigned as the Arizona-based drugmaker’s CEO in 2015 and was due to face trial next month, has agreed to plead guilty to conspiracy and mail fraud charges, federal prosecutors in Boston disclosed in a court filing.

Five former Insys executives and managers indicted along with Babich, including John Kapoor, the company’s founder and former chairman, remain scheduled to go on trial in late January. They have pleaded not guilty.

The terms of Babich’s plea deal were not disclosed, and it was unclear whether he would agree to cooperate with prosecutors and testify at that trial, as has another former Insys executive who recently pleaded guilty to racketeering conspiracy.

Prosecutors requested a Jan. 9 plea hearing. A lawyer for Babich, 42, declined to comment.

The case centers on Subsys, Insys’ under-the-tongue spray for managing pain in cancer patients. It contains fentanyl, an opioid 100 times stronger than morphine.

Prosecutors allege that from 2012 to 2015, Kapoor, Babich and others conspired to bribe doctors in exchange for prescribing their patients Subsys. Prosecutors said they also defrauded insurers into paying for Subsys.

Prosecutors allege Insys paid doctors kickbacks in the form of fees to participate in speaker programs ostensibly meant to educate medical professionals about Subsys that were actually shams.

The case has been brought amid a national opioid addiction epidemic. According to the U.S. Centers for Disease Control and Prevention, opioids were involved in around 47,600 overdose deaths in 2017.

Babich, who was originally indicted in 2016, is married to a former Insys sales representative, Natalie Babich, who in 2017 pleaded guilty to conspiring to pay kickbacks and became a government witness.

She testified this month at the trial of Christopher Clough, a former physician assistant in New Hampshire accused of accepting kickbacks from Insys. A federal jury in Concord, New Hampshire convicted Clough on Dec. 18.

In August, Insys said it had agreed to settle a related U.S. Justice Department probe for at least $150 million.

https://www.marketscreener.com/INSYS-THERAPEUTICS-INC-40225123/news/Insys-Therapeutics-Ex-Insys-CEO-to-plead-guilty-to-opioid-kickback-scheme-27799351/

Kala Application for Dry Eye Med Accepted for Review by FDA

– KPI-121 0.25% expected to be the first product indicated for the temporary relief of signs and symptoms of dry eye disease, if approved –

– PDUFA target action date of August 15, 2019 –

Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY™ mucus-penetrating particle (MPP) Drug Delivery Technology, today announced that the New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration (FDA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 15, 2019. If approved, KPI-121 0.25% is expected to be the first product indicated for the temporary relief of the signs and symptoms of dry eye disease, which would include treatment of dry eye flares.

“All currently marketed FDA-approved pharmaceutical treatments for dry eye disease are chronic therapies and are typically used in patients with chronic or persistent dry eye symptoms,” said Dr. Edward Holland, Director of Cornea Services, Cincinnati Eye Institute and Professor of Clinical Ophthalmology, University of Cincinnati. “The vast majority of patients experience episodic dry eye flares that are characterized by acute exacerbations of signs and/or symptoms. An FDA-approved, safe and effective short-term treatment for dry eye disease, including dry eye flares, will represent an important new treatment option for patients and prescribers.”

KPI-121 0.25% utilizes Kala’s proprietary AMPPLIFY Drug Delivery Technology to enhance penetration into target tissues of the eye. In preclinical studies, the AMPPLIFY technology increased delivery of loteprednol etabonate (LE) into ocular tissues more than three-fold compared to current LE products by facilitating penetration through the tear film mucins. The AMPPLIFY technology also underpins INVELTYS™ (loteprednol etabonate ophthalmic suspension) 1%, the first twice-a-day corticosteroid for the treatment of post-operative inflammation and pain following ocular surgery, which was approved by the FDA in August 2018.

The NDA submission for KPI-121 0.25% was supported by data from one Phase 2 and two Phase 3 efficacy and safety trials, STRIDE 1 and STRIDE 2 (STRIDE – Short Term Relief In Dry Eye), studying over 2,000 patients with dry eye disease. Based upon the FDA’s recommendation, Kala also initiated an additional Phase 3 clinical trial, STRIDE 3, in July 2018, evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The Company expects to report top-line results for STRIDE 3 in the fourth quarter of 2019.

https://www.biospace.com/article/releases/kala-pharmaceuticals-announces-new-drug-application-for-kpi-121-0-25-percent-for-dry-eye-disease-has-been-accepted-for-review-by-the-u-s-food-and-drug-administration/

Capricor Places Voluntary Hold on DMD Drug Following Allergic Reaction

Capricor Therapeutics has placed a voluntary hold on its Phase II clinical trial for a Duchene Muscular Dystrophy treatment on hold after a patient experienced a severe allergic reaction during dosing.

First reported by Reuters, Capricor announced the voluntary hold in a filing with the U.S. Securities and Exchange Commission on Dec. 21. The Los Angeles-based Capricor said the patient experienced the reaction during the infusion process. The patient was part of a blinded test, so it is unclear if the individual was dosed with Capricor’s experimental treatment, CAP-1002, or a control. In its filing, Capricor said the patient responded well to medical treatment and at this time, is asymptomatic.

Capricor said it notified the FDA of the reaction and is working with the regulatory agency on a mitigation plan. The company’s filing did not indicate how long the hold will be placed on the trial, dubbed HOPE-2. For the trial, the company had anticipated enrolling approximately 84 boys with DMD who have seen their ability to walk diminish due to the loss of muscle function that occurs with the disease. Capricor believes that if the primary endpoint is reached, the HOPE-2 Trial could serve as a potential registration trial.

Capricor’s CAP-1002 consists of allogeneic cardiosphere-derived cells, which contain cardiac progenitor cells. CAP-1002 has been shown to exert potent immunomodulatory activity and stimulate cellular regeneration, the company said. Last year, Capricor announced six-month data from the Phase I/II DMD trial assessing CAP-1002. In that trial, the asset demonstrated statistically significant improvement compared to control. Patients treated with CAP-1002 demonstrated statistically-significant improvement in certain measures of upper limb function compared to control. CAP-1002 was generally safe and well-tolerated over the initial six-month follow-up period.

DMD is a genetic disorder that is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500 boys born worldwide, about 200,000 people. The condition is universally fatal, and death usually occurs before the age of 30. Currently, there is only one approved DMD treatment in the United States, Sarepta Therapeutics’ Exondys 51, which skips the exon 51 mutation in DMD patients.

CAP-1002 is designed to release exosomes that are immunomodulatory. The exomes are then designed to apply anti-inflammatory, anti-fibrotic, and anti-apoptotic effects on the patients. Last summer, following a meeting with the FDA, Capricor Chief Executive Officer Linda Marban said by ameliorating the myocyte damage induced by dystrophin mutations, CAP-1002 has demonstrated the ability “to preserve and improve the structure and function of dystrophic skeletal muscle.” Marban said CAP-1002’s mechanism of action supports its potential to be a standalone therapy as well as an adjunct to dystrophin-modulating agents.

While it is unknown if the allergic reaction is a result of dosing with CAP-1002, this would not be the first setback that drug has experienced. Last year, CAP-1002 failed in a mid-stage trial for the treatment of adults who have experienced a large heart attack with residual cardiac dysfunction. That failure forced the company to make some cuts, including layoffs.

https://www.biospace.com/article/socal-s-capricor-places-voluntary-hold-on-dmd-drug-following-allergic-reaction-in-blinded-trial-patient/