Tuesday, August 28, 2018
Medtronic: Reduced symptoms in patients treated with Cryoballoon
Medtronic announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life, reduced symptoms from abnormal heart rhythms, and low incidence of reinterventions and repeat ablation procedures. The study evaluated patients with symptomatic persistent atrial fibrillation treated with the Medtronic Arctic Front Advance Cryoballoon, and the results were presented at the 2018 European Society of Cardiology Congress in Munich. The Arctic Front Advance Cryoablation System is not approved for treating persistent AF in the United States. Patients treated with cryoballoon ablation experienced clinically meaningful changes in Quality of Life scores, with a 7.1 point average improvement in physical quality, and a 3.3 point average improvement in mental health quality component scores. Patients experienced a significant reduction in symptoms: While 92 percent of patients had symptoms such as dizziness, palpitations and fatigue prior to cryoablation, only 16 percent of patients had arrhythmia-related symptoms a year after treatment. The severity of symptoms also decreased after cryoballoon treatment, from 2.1 to 1.3 using the European Heart Rhythm Association AF Symptom Score, and New York Heart Association class improved by one or more functional class in 47 percent of patients. Although patients entering this study already had progressed to an advanced AF disease stage which traditionally has been more difficult to treat, the study found that only 17 of the 101 patients in the trial required a repeat ablation at the time of an arrhythmia recurrence. In addition, direct current cardioversion, a procedure to reset an abnormal heart rhythm back to normal, was only required for eight patients at the time of recurrence. Further, only 3 patients in sinus rhythm remained on antiarrhythmic medication at the completion of the study. The primary CRYO4PERSISTENT AF study results, presented earlier this year and published this week in the Journal of the American College of Cardiology: Clinical Electrophysiology, demonstrated that 60.7 percent of patients were free from all atrial arrhythmias, at one year following a single PVI-only cryoballoon ablation procedure. The study findings also demonstrated short and predictable procedure times of 53 +/- 22 minutes with the cryoballoon and a low complication rate of 4 percent.
https://bit.ly/2PKLQ4Q
JMP says Pfizer data ‘impressive,’ but leave room for Alnylam’s Onpattro
JMP Securities analyst Konstantinos Aprilakis said Pfizer’s (PFE) tafamidis demonstrated an “impressive” reduction in both all-cause mortality and cardiovascular-related hospitalization in patients with TTR amyloid cardiomyopathy, but he still sees “significant opportunity” for Alnylam’s (ALNY) Onpattro to capture market share given the lack of statistically significant benefit for tafamidis in hereditary vs. wild-type patients and the lack of apparent dose response effect between 80mg and 20mg doses of tafamidis. He maintains an Outperform rating and $198 price target on Alnylam, saying the Pfizer readout removed a significant overhang on the shares.
Monday, August 27, 2018
Humana Accelerates Digital Health and Analytics Activities
Names Heather Cox Chief Digital Health and Analytics Officer
Enhances product design capability with Humana Studio H in Boston’s Seaport neighborhood
Expects to employ as many as 250 in Boston within five years
Humana Inc. (NYSE: HUM), one of the nation’s leading health and well-being companies, announced today a series of moves designed to advance its capabilities in the areas of technology, digital health and analytics in support of its integrated care delivery model and its ongoing work to develop differentiated health care experiences.
Humana will establish a center for digital health and analytics, to be known as Humana Studio H, in Boston’s Seaport neighborhood, where it can take advantage of a deep local talent pool and partnerships. Studio H will focus on pioneering new products and services that will then be developed for use across the organization. The company expects to employ as many as 250 individuals at this Boston location within the next five years. To help lead this effort, the company has named Heather Cox to the newly created position of Chief Digital Health and Analytics Officer, reporting directly to Humana President and CEO Bruce Broussard.
In her new role, Cox will be accountable for building Humana’s digital care delivery operations and leading enterprise analytics. Integrating these critical capabilities across the organization will further accelerate Humana’s move toward differentiated health care experiences. Cox brings 25 years of experience to the role, most recently serving as Chief Technology and Digital Officer at USAA, where she led the teams responsible for designing and building personalized and digitally-enabled end-to-end experiences for USAA members. Prior to USAA, Cox was the CEO of Citi FinTech at Citigroup, Inc., helping the company adapt to a future dominated by mobile technology, and she headed Card Operations, reshaping customer and digital experience for Capital One. Cox will be based in Boston and oversee much of the work coming out of Studio H.
In addition to the Digital Health and Analytics group, a team of individuals focused on creating a new health experience for seniors will also reside in Studio H under the direction of Beth Bierbower, who has been with the company in a number of senior-level leadership positions. Bierbower also reports directly to Broussard.
Humana Studio H will take shape in Boston’s Seaport neighborhood, where Humana has entered into a lease agreement for approximately 40,000 square feet of office space on two floors at 281 Summer Street. The location affords access to the area’s wealth of talent in digital technology, analytics and experience design, in one of the city’s most dynamic neighborhoods. Humana will build out the space using an open floor plan, designed to promote interaction and collaboration, and the company expects to complete the project in the summer of 2019.
Philips cardiac care products showcased at ESC 2018
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, is highlighting its latest innovations in cardiac care at the ESC Congress2018 in Munich, Germany from August 25-29.
At the show Philips is introducing the EPIQ CVx cardiovascular ultrasound system, which is specifically designed to increase diagnostic confidence and simplify workflow for clinicians. As the incidence of cardiovascular diseases continues to rise and an increasing number of patients require chronic care over long periods, Philips is helping its customers build seamless cardiovascular care ecosystems that break the boundaries standing in the way of organizing care around the patient.
Anatomical intelligence powers ultrasound innovations in visualization and quantification
Built on the powerful EPIQ ultrasound platform, EPIQ CVx is specifically designed to increase diagnostic confidence and simplify workflow for clinicians in cardiac care, giving them more time to interact with their patients and reducing the need for repeat scans. It includes higher processing power, exceptional image clarity and sharpness, improved exam efficiencies and more robust and reproducible quantification, enabled by anatomical intelligence. Philips also is introducing the EPIQ CVxi, specifically tailored for use in the interventional lab [1].
The EPIQ CVx includes TrueVue, which gives clinicians the ability to see photorealistic renderings of the heart, improving cardiac anatomy analysis by offering detailed tissue and depth perception imaging through a new virtual light source. Building on Philips HeartModelA.I., it also includes Dynamic Heart Model, which uses anatomical intelligence to automatically quantify left ventricle function to produce a multi-beat analysis for adult patients. On the EPIQ CVxi, EchoNavigator helps interventional cardiologists more clearly oversee procedures along with the location of key anatomical structures by combining live ultrasound and X-ray information in one intuitive view.
‘Anatomical intelligence – combining 3D organ modeling, image slicing, and proven quantification – is helping make ultrasound exams easier to perform and more reproducible,’ said Bich Le, Business Leader Ultrasound, Philips. ‘It’s already providing clinicians with sophisticated, yet easy-to-use processing tools, and helping them quickly and more confidently identify anatomy and anomalies, assess disease states, determine treatment, and guide interventions. Our new EPIQ cardiac ultrasound solutions utilize latest advances in anatomical intelligence, offering cardiologists tailored diagnostic and interventional applications, including for pediatric requirements.’
Anatomical intelligence – combining 3D organ modeling, image slicing, and proven quantification – is helping make ultrasound exams easier to perform and more reproducible.
Advancing minimally invasive therapies with integrated solutions
Through innovation, acquisitions and partnerships, Philips continues to develop its portfolio for minimally invasive therapies, including interventional imaging systems, smart catheters, planning and navigation software, and service. Philips recently completed the acquisition of EPD Solutions, an innovator in image-guided procedures for arrhythmias (heart rhythm disorders). EPD’s cardiac imaging and navigation system [2], which will be shown at ESC 2018, helps electrophysiologists navigate the heart by generating a detailed 3D image of the cardiac anatomy, while also pinpointing the location and orientation of catheters during the diagnostic and therapeutic procedures for cardiac arrhythmias.
‘By seamlessly integrating both structural and functional data in the cath lab – from X-ray and Ultrasound, alongside hemodynamic monitoring and other sources – we’re creating a more intuitive environment that helps clinicians focus on treating the patient,’ said Bert van Meurs, Business Leader Image Guided Therapy, Philips. ‘With our next-generation Azurion image-guided therapy platform at its heart, our integrated portfolio of solutions enables clinicians to decide, guide, treat and then confirm the best treatment. Our acquisition of EPD adds a breakthrough technology that has the potential to enhance the efficacy of cardiac arrhythmia procedures.’
Building a seamless cardiovascular care ecosystem
With the shift to value-based care, healthcare providers are increasingly focused on balancing the need to provide the highest quality care with managing their operational costs. Through innovative care and pathway management there are growing opportunities to build scalable and sustainable cardiovascular healthcare models to drive improved treatment and outcomes, simplify data and insight gathering, remove excess costs from the system, and improve the care experience for patients. Philips has developed an integrated portfolio of products and solutions, combined with consultancy and services, which is enabling healthcare providers to improve diagnosis and care for cardiovascular patients, helping to optimize the length of their stay in hospital.
At ESC 2018 Philips is introducing its Interventional Hemodynamic system, which includes a patient monitoring device mounted at the table-side and a workstation in the control room with a user interface designed to simplify hemodynamic monitoring and assessment. The users in the control room can also perform hemodynamic analyses and display them in the exam room. Displaying all relevant physiologic waveforms and analyses at the table-side supports the clinician in making a real-time assessment of the patient’s condition during an intervention.
Also on show is Philips’ next-generation cardiovascular image and information management system, IntelliSpace Cardiovascular 3.1. Designed to help streamline workflow and improve operational performance throughout the cardiovascular service line, the latest version features enhanced security and enterprise protocols, seamless access to Philips’ QLAB and TOMTEC software tools, and the addition of browser-based reporting of stress echo tests.
Philips will also showcase Refinity ST, the next-generation rotational intravascular ultrasound (IVUS) catheter which provides detailed and accurate measurements of the vessel. With exceptional deliverability, 5F guide compatibility, and a 45 MHz high-resolution image, Refinity ST is designed to help clinicians meet the needs of their most complex percutaneous coronary interventional cases.
Pfizer recalls kids’ fever/headache medicine on chance of overdose
A packaging mistake prompted Pfizer to recall one lot of Children’s Advil Suspension Bubble Gum Flavor.
The instructions for the medicine are in milliliters. The dosage cup is marked in teaspoons. Even if parents pouring the kiddie Advil weren’t worried about their suffering offspring’s fever or headache, this milliliters-to-teaspoons conversion is not one companies expect United States parents to make.
“Pfizer performed a Health Hazard Assessment which concluded that the use of the impacted product has a chance of being associated with the potential overdose,” the recall notice posted on Publix’s website explained. “The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness.”
Lot No. R51129 with an expiration date marked as “11/20” is being recalled. Customers with the recalled medicine can return it for a refund or exchange for a properly packaged lot.
Customers with questions can call Pfizer at 800-882-3845.
Adamis Pharmaceuticals Provides Business Update
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided a business update.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, said, “We have been receiving a considerable amount of inquiries from investors, and although it is our policy not to comment on stock price activity, we believe that now is a good time to provide an update on Symjepi™ and to reiterate several factors that we believe will deliver shareholder value going forward.”
SYMJEPI (epinephrine) Injection 0.30mg
Adamis remains excited about the potential for our FDA approved Symjepi Injection 0.30mg to be an affordable alternative treatment for patients who are at increased risk of anaphylaxis. We believe that we have selected an excellent collaborator, Sandoz, to take on the challenges within this market. As a division of the Novartis Group, Sandoz has the proper resources and expertise to support broad patient access to this important product. We have been monitoring the development efforts of the generic version of EpiPen® for the last two years and have anticipated an eventual approval. Symjepi is not an auto-injector like the EpiPen or its generic equivalent. It is a small, pre-filled syringe containing epinephrine. Symjepi remains a simple, intuitive, easy-to-use product that has displayed several positive attributes as discussed in our published human factors studies comparing Symjepi to EpiPen.
As for the timing of the launch for Symjepi, we are working closely with Sandoz to prepare a successful launch.
SYMJEPI (epinephrine) Injection 0.15mg
Our low dose Symjepi product candidate is still under review with the US Food and Drug Administration (FDA). The agency has provided the company with a PDUFA date of September 27, 2018. If approved, Sandoz has the rights to commercialize this product in the US. The approval has no effect on the timing of the launch of the high dose product.
Future Milestones
Some of the company’s future milestones include the following:
- Commercial launch for Symjepi in U.S.
- FDA approval of lower dose (0.15mg) Symjepi
- Announcement of ex-U.S. strategy for Symjepi
- Filing of NDA for naloxone injection
- Filing of NDA for the sublingual tadalafil (Cialis®) product
- Commencement of Phase 3 studies for beclomethasone
- Growing net revenue of outsourcing facility by 30% over 2017
Dr. Carlo added, “With all of the reported shortages of epinephrine products, we believe that there is a great opportunity for a simple, easy-to-use device like Symjepi within the anaphylaxis market. With several upcoming milestones in our pipeline, a strengthened cash position, and a solid commercialization partner for Symjepi, we believe that Adamis is poised for substantial growth for the foreseeable future.”
Upcoming Conference Presentation
Adamis will present at the 20th Annual Global Investment Conference sponsored by HC Wainwright & Co. at the St. Regis New York Hotel on September 5, 2018. The presentation time is scheduled for 4:15pm Eastern Time.
Call for reversing the decision to deny the Ebola vaccine to pregnant women
The exclusion of pregnant and lactating women from an effort to vaccinate people exposed to the Ebola virus in the current outbreak is wrong, indefensible, and should be reversed, three public health experts wrote Monday in an opinion article published in STAT.
The Johns Hopkins University experts argued it is unfair to deny pregnant and lactating women the experimental vaccine if they wish to take it, given the great risk Ebola poses to them. The fatality rate is 80 percent or higher for pregnant women who contract Ebola, and nearly all survivors miscarry.
The decision was made by the Democratic Republic of the Congo’s health ministry, based on the advice of two expert panels that advise it on use of experimental Ebola therapies and vaccines. But the DRC’s position echoes the recommendations of the World Health Organization on how to use Merck’s still-unlicensed Ebola vaccine.
“The … vaccine will give pregnant women, and the children they are carrying, a chance to live. Without it, most of the pregnant women infected with Ebola, and almost all of their infants, will die,” wrote Ruth Faden, Ruth Karron, and Carleigh Krubiner in their commentary.
A total of 111 cases have been recorded since the outbreak was declared on Aug. 1, and 72 of those people have died.
A ring vaccination program has been mounted to try to halt spread of the virus. In this program — like the one undertaken in another outbreak in the country earlier this year — the Merck vaccine is being offered to contacts of known cases and the contacts of contacts. Anyone over the age of 1 can be vaccinated. Anyone, that is, except pregnant and lactating women.
The exclusion is based on safety concerns due to the fact that the vaccine is made with live viruses. It’s not Ebola, but rather a livestock virus called vesicular stomatitis virus that doesn’t cause disease in people. The VSV virus has been modified to contain a protein from Ebola viruses that teaches the immune system to recognize and fight Ebola.
Those vaccine viruses cannot infect a recipient with the deadly disease. But live virus vaccines are typically more reactogenic, meaning they are more likely than killed-virus vaccines to make a recipient feel achy, or run a fever, or experience soreness at the injection site. There is also at least theoretical concern that the viruses in the vaccine could pass through the placenta to the fetus, Karron told STAT in a joint interview with her co-authors, but she added there is little evidence that live virus vaccines are harmful in pregnancy.
Still, in general there is wariness about giving pregnant and lactating women any drug or vaccine that hasn’t been tested in this population. But researchers and companies are also leery about testing drugs or vaccines in pregnant and lactating women — and women in this demographic were excluded from the clinical trials that studied the Merck vaccine.
There is a vicious cycle at play here, said Faden, former director of the Johns Hopkins Berman Institute of Bioethics.
“People will say, ‘Well, where’s the evidence this vaccine is safe in pregnancy?’ Well, how can we know if we’ve never tested it in pregnancy? ‘Well, we couldn’t test it in pregnancy because it’s not safe to test it in pregnancy,’” she said. “And if you can’t get off that … little spinning wheel, pregnant women and their babies are going to be left out indefinitely.”
The three experts — Karron is a pediatrician and professor at Hopkins’s public health school, and Krubiner is a policy fellow at the Center for Global Development in Washington, D.C. — are part of a project called PREVENT. The acronym stands for Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies.
They wrote the commentary on their own, but say their position on the unfairness of the current Ebola vaccination policy is shared by the other members of the group.
The PREVENT initiative stems from work to advocate for more research in women. For years, drugs in development were mostly tested in men, a practice that failed to recognize that women are biologically different and that results found in men might not extrapolate faithfully to women.
While progress has been made on that front, Faden said, pregnant women are still largely absent from clinical trials, resulting in a paucity of information about whether new drugs and vaccines are safe for them. The goal may be to protect these women and the fetuses they carry, but that impulse to protect harms them as a consequence, she and her colleagues argued.
Karron noted that women are more likely to be caregivers, meaning if there is Ebola in a community, they may be at greatest risk of contracting it. And in some countries where Ebola is transmitted, women have more children, spending many years either pregnant or breastfeeding.
According to the CIA World Factbook, the mean age at which women have their first child in DRC is just under 20 years old and, on average, women have 4.4 children each. In the United States, the comparable figures are 26.4 years old and 1.9 children apiece.
“It further disadvantages a much larger population,” Karron said of the policy not to offer this vaccine to pregnant and lactating women.
A Belgian gynecologist who works with Doctors without Borders supported the call to change the policy. Dr. Séverine Caluwaerts volunteered with MSF — the group is known by the acronym for its name in French — during the West Africa outbreak of 2014 through 2016.
After it ended, Caluwaerts published a heartrending account of a seven-months-pregnant woman who was brought to an Ebola treatment center in Forécariah province, Guinea. The woman, 25, was a known contact of a case, but had been denied access to the ring vaccination trial because she was pregnant.
Severely ill when she entered the treatment center, the woman went into early labor, giving birth to a little girl named Nubia who, miraculously, survived. The mother died.
(Caluwaerts said the child is now 2 1/2 years old; her former caregivers follow her progress, thinking of her as “a miracle child.”)
“We absolutely don’t agree with the decision of WHO and the Congolese government not to administer the vaccine to pregnant women,” Caluwaerts said. “We would at least give them the choice.”
“The risk-benefit is so much in favor of giving the vaccine.’’
The final decision on whom to vaccinate rests with the DRC government, not the WHO, said Dr. Peter Salama, the global health agency’s deputy director-general of emergency preparedness and response.
“I’m not trying to absolve WHO of responsibility here,” Salama said on Friday. “But ultimately it is up to the country’s research and ethical review bodies to weigh up what is simply not a black-and-white decision.”
But those expert panels were likely guided in their deliberations by the WHO’s recommendation against using the vaccine in pregnant and lactating women.
Interestingly, until recently the WHO also recommended against giving the vaccine to children under the age of 6, because of a lack of data to show it is safe and effective in children younger than 6. But that guidance was amended to include children ages 1 and older, if they are contacts of Ebola cases, or contacts of contacts. That is the approach that was used in the earlier Ebola outbreak in western DRC.
Salama conceded that decision was made without evidence to guide it. “It’s a good point. We don’t have a lot of data for the 1- to 6-year-old group. But we do have for slightly older children some data at least,” he said.
The agency also has a little data on the safety of the vaccine in pregnant women, though it has never published what it knows in the scientific literature. In the initial ring vaccination trial that showed the Merck vaccine is protective, roughly 20 pregnant women were inadvertently vaccinated. That can happen in clinical trials because in the early weeks of pregnancy, women often are not aware of their status.
In fact, the evidence gained from inadvertent vaccinations is likely why the WHO advises that in yellow fever outbreaks, pregnant women should be vaccinated — even though the yellow fever vaccine is made with live viruses. The vaccine has been in use for decades.
Faden and her colleagues argue it makes no sense to recommend use of the yellow fever vaccine in pregnant women, but withhold vaccine to protect against Ebola, a more deadly pathogen. Salama, though, said the analogy is not a good one; the yellow fever vaccines in use have been licensed.
“These [Ebola vaccines] are investigational products of which we have very limited data even to use in non-pregnant populations,” Salama said.
Caluwaerts’s report on Nubia’s mother mentioned the women who had been inadvertently vaccinated with the Ebola vaccine. It may be their only reference in the scientific literature. She’d learned about the data from the lead author of the initial ring vaccination trial, the WHO’s Ana Maria Henao-Restrepo.
“She hasn’t published her data yet on the 20 women who were accidentally vaccinated,” said Caluwaerts. “She just said orally at a conference that they are fine and that the babies are fine, but we haven’t seen it in writing. MSF would love to be able to see this in writing, also to be able to advocate more for the vaccine for pregnant women.’’
STAT reached out to Henao-Restrepo, but she did not reply.
Salama acknowledged there are data on these cases, but suggested there isn’t enough there to know that it’s safe to give this vaccine to pregnant women. “So far we don’t have any evidence — again, it’s very preliminary — to suggest major adverse outcomes related to vaccination,” he said. “But that’s based on an extremely small sample size.”
Still, Faden, Karron, and Krubiner argue that in the face of plenty of evidence that Ebola infection is generally deadly for pregnant women and their fetuses, the greater risk lies in not vaccinating pregnant women exposed to Ebola in this outbreak.
“It’s just unfair,” Faden said. “You’ve got other segments of the population who are at the same, or probably in some cases, less risk than pregnant women, and they’re being provided vaccine. Pregnant women are not being provided vaccine without adequate justification.”
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