Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). The combination of TECENTRIQ®(atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel]) helped people live significantly longer compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). In addition, the TECENTRIQ combination reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone. Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming oncology congress.
“The results of the IMpower130 study add to the growing evidence showing the clinical benefit of TECENTRIQ-based combinations in the treatment of advanced non-squamous non-small cell lung cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will share these results with global health authorities with the goal of bringing this potential treatment option to people with this disease.”
Currently, Genentech has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines. This is the third positive Phase III study evaluating TECENTRIQ alone or in combination to demonstrate an OS benefit for people with NSCLC.
https://bit.ly/2xmEKyo
Monday, May 28, 2018
Machines Screen for Melanoma
A study suggests that a machine-learning algorithm may be just as good as trained dermatologists for determining whether suspect lesions are melanomas or not. In this 150-Second Analysis, F. Perry Wilson, MD, looks to a future where these algorithms are as ubiquitous at CT scanners are today.
Is this a melanoma?
Is this?
What about this?
Telling the difference between a benign mole (the first and third images) and a melanoma like image number two requires significant training.
And even the best dermatologists make mistakes. But rapidly developing research in the field of computer vision may give us a new weapon in the fight against this deadly disease. The most compelling data to date, comes from this paper, appearing in the Annals of Oncology.
Let’s go through the basics of this paper before we get to the really interesting implications for the future.
Researchers curated a set of 100 dermoscopy images of suspect lesions — like the ones I showed you earlier. These were deliberately chosen to be difficult to diagnose. Of the 100 images, 20 were melanomas and 80 were benign melanocytic nevi. The pictures were sent to 58 dermatologists, who made their diagnoses.
But there was a 59th reader of the images, though: an algorithm called a convolutional neural network. A convolutional neural network is a type of machine-learning algorithm particularly suited to image recognition — it’s what powers much of the optical character and facial-recognition software bouncing around Silicon Valley and, presumably, the optic systems of your standard Cylon.
In any case, applying convolutional neural networks to medical image classification is, pardon the pun, a no-brainer.
How’d the computer do?
Alan Turing would be proud.
The algorithm missed only one of the 20 melanomas. The average dermatologist missed three. The neural net had a bit of an itchy trigger finger though, identifying 29 of the 80 benign lesions as melanomas compared to 23, on average, for the humans. Here’s one of the lesions it got wrong, courtesy of the lead author, Dr. Holger Haenssle (© Prof. Dr. H. Haenssle, Dept. Dermatology, University of Heidelberg, Germany).
Overall, only 13 of the 58 dermatologists had better diagnostic performance than the neural network.
Basically, the neural network detected more melanomas, at the price of a few more false-positives as you can see here.
This is actually ideal for a screening test, which is where I think algorithms like this really shine. Convolutional neural networks are really hard to build, but once that step is done, they can be widely deployed and don’t require more computational power than what you have on your smartphone. This means that primary care or even self-directed screening of suspicious skin lesions may become a reality soon.
But let’s not all board the hype train right away. This was only 100 images; there was limited representation of all the varieties of lesions and skin types. In a real-world setting, the algorithm may suffer.
Still, I think it’s clear that algorithms like these are the next wave of medical advancement, similar to ultrasound, CT scan, and genetic testing before them. Provided the machines don’t, you know, rise up and destroy us all, these brains in silico are coming soon to a clinic near you.
F. Perry Wilson, MD, MSCE, is an assistant professor of medicine at the Yale School of Medicine. He is a MedPage Today reviewer, and in addition to his video analyses, he authors a blog, The Methods Man.
6 Biotechs Launch IPO Plans in Last Days of May; Iterum Adjusts IPO Goals
It’s been a busy month for IPOs. Numerous biotech companies announced their intentions to publicly list their stock on an exchange in the U.S. or abroad in order to gain new funding to advance developmental programs.
BioSpace put together a list of some of the most recent announcements. In the last week alone six companies have announced their IPO intentions before the month of May ends.
AvroBio – Cambridge, Mass.-based AvroBio, a leader in lentiviral-based gene therapies, filed a preliminary prospectus with the U.S. Securities and Exchange Commission on May 25 to raise $86 million in an initial public offering. In its S-1 filing, the company said it intends to use the proceeds to advance its lead clinical product, AVR-RD-01, for the treatment of Fabry disease. AVR-RD-01 is being pushed into Phase II testing. Additional funding will be used to support the ongoing investigator-sponsored Phase 1 trial, the company said. The company also intends to use proceeds for other candidates. It will advance AVR-RD-02 for the treatment of Gaucher disease into Phase I/II clinical trials, push AVR-RD-03 for Pompe disease further into preclinical development and finally to advance AVR-RD-04 for the treatment of cystinosis. AvroBio intends to trade under the symbol AVRO.
Kezar Life Sciences – On May 24 Bay Area-based Kezar Life Sciences, with a focus on developing treatments for autoimmune diseases, filed a preliminary prospectus with the SEC to raise $80 million in an IPO. In its S-1 filing, Kezar said it intends to use the funds raised through the IPO to advance its KZR-616 drug candidate, a first-in-class selective immunoproteasome inhibitor, through the clinic for the treatment of lupus and lupus nephritis. That program is currently in a Phase Ib/II trial. Additionally, the company said it will use the funds to study KZR-616 for the treatment of idiopathic inflammatory myopathies, as well as up to three additional autoimmune indications into a Phase Ib or Phase II clinical trial, the company said in its prospectus.
Kezar closed out its first quarter of 2018 with $47.1 million in cash and cash equivalents. The company filed its IPO plans weeks after it strengthened its leadership team with a new chief medical officer and a new chief financial officer. The company intends to list under the ticker symbol KZR.
Xeris Pharmaceuticals – Chicago-based Xeris Pharmaceuticals also filed its preliminary prospectus for an IPO on May 24, less than one month after it secured $55 million in fundingfrom a Series C and a loan agreement. The funds raised earlier in May will be used to prepare a New Drug Application for its ready-to-use glucagon rescue pen to treat severe low blood sugar in diabetes patients. Xeris intends to file its NDA next quarter. Additionally, the company said it intends to use the funds for potential commercialization. With the IPO, Xeris intends to raise $75 million to further support the planned commercial launch of the G-Pen device, the company said in its filing with the SEC. In February the U.S. Food and Drug Administration (FDA) granted its Orphan Drug Designation for the ready-to-use device for the treatment of Hyperinsulinemic Hypoglycemia.
At the end of the first quarter of the year, Xeris said it had $58.1 million in cash or cash equivalents. Xeris plans to list under the ticker XERS.
Magenta Therapeutics – Cambridge, Mass.-based Magenta Therapeutics said it intends to use the expected $100 million from an IPO to advance its portfolio of bone marrow transplant medications. Magenta filed its preliminary prospectus on May 24. The filing comes weeks after securing $52 million in a Series C financing. In its S-1 filing with the U.S. Securities and Exchange Commission, the company said it intends to use the funding to specifically advance the development of two clinical assets, MGTA-456 and MGTA-145. The Phase II MGTA-456 is the company’s most advanced asset. Magenta in-licensed MGTA-456 last year from Novartis. MGTA- 456 is a first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist. Magenta believes MGTA-456 has the potential to treat patients with higher cell doses than otherwise possible and to have access to better HLA-matched cord blood units. In April the company dosed the first patient in Phase II MGTA-456 trial. The patient has an undisclosed inherited metabolic disorder, the company said at the time. Magenta will trade on the Nasdaq under the symbol MGTA.
Aptinyx – On May 23, one day after strengthening its relationship with Allergan, the company set its sights on an $80 million IPO. The company is looking to raise funds to support its NMDA programs to treat neurological disorders, including depression. The lead product for Aptinyx, NYX-2925, in two Phase II studies in chronic pain. One study is testing the therapeutic in patients with painful diabetic peripheral neuropathy and the second is for the treatment of fibromyalgia. Aptinyx anticipates topline data from these two studies in the first half of 2019. The company also has a second candidate, NYX-783, for the treatment of post-traumatic stress disorder. Additionally, the company intends to move NYX-458 into the clinic for the treatment of cognitive impairment associated with Parkinson’s disease.
As of the end of March, Aptinyx had $82.4 million in available funds. The company said those funds are not sufficient enough to take NYX-2925 through Phase III studies. The company will trade under the symbol APTX.
Verrica Pharmaceuticals – On May 22 West Chester, Penn.-based Verrica Pharmaceuticals planned an IPO with the hopes of raising $86 million. The company intends to use funds gained from the IPO to advance its lead product, VP-102, a proprietary topical therapy for several common skin conditions, including Molluscum contagiosum (warts) and Verruca Vulgaris (plantar warts). It is launching two Phase III trials with top-line results expected next year. It the results are positive, the company anticipates filing a New Drug Application with the FDA. Verrica intends to trade under the symbol VRCA on the Nasdaq.
Iterum Therapeutics — Earlier in May Iterum Therapeutics announced its intentions for an IPOwith the hope of raising $92 million. However, on May 25 the company said priced its IPO at $13 per share, which was lower than expected. Now the company anticipates raising $80 million. The funds will be used to advance the Phase III clinical trials of both oral and IV formulations of sulopenem, the company’s lead compound, which is a novel penem anti-infective with oral and IV formulations. Iterum acquired sulopenem, which is in the same class of antibiotics as penicillin, from Pfizer in 2015.
Those companies filed IPOs within the last week, however, Bay Area-based GRAIL, Inc., is rumored to be looking at filing an IPO on the Hong Kong Exchange. Last week the company secured $300 million in an oversubscribed Series C financing from Chinese investors. The company, which merged with Hong Kong-based Cirina, Ltd. last year, intends to launch a screening test for the early detection of nasopharyngeal cancer this year in the area.
FDA Action Alert: TherapeuticsMD and Kitov Pharmaceuticals
The Memorial Day Holiday is making the U.S. Food and Drug Administration (FDA)’s schedule a bit more complicated, although the agency approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) for phenylketonuria (PKU) just before the holiday. PKU is a rare genetic disease, observed at birth and can cause seizures and neurological and neuropsychiatric problems. The company expects to launch the drug commercially in the U.S. by the end of June. It is also being evaluated by the European Medicines Agency.
And although it had a PDUFA action date of Monday, May 28 (Memorial Day in the U.S.), the agency approved Amgen’s supplemental BLA (sBLA) for Prolia (denosumab) to treat patients with glucocorticoid-induced osteoporosis (GIOP) a week early, on Monday, May 21. This was the fifth indication approved for Prolia, which was originally approved in 2010 for osteoporosis.
Here’s a look at two more FDA decisions coming up this week.
1.TherapeuticsMD. Headquartered in Boca Raton, Florida, TherapeuticsMD is expecting a decision on its resubmission of its New Drug Application (NDA) for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule to treat moderate-to-severe vaginal pain during sex (dyspareunia) due to menopause. The PDUFA date is Tuesday, May 29. The resubmission is a complete, class 2 response to a Complete Response Letter (CRL) the company received on May 5, 2017. The company submitted additional endometrial safety information on September 14, 2017, outside of an official review cycle. If approved, the company hopes to launch the drug in the third quarter of this year.
“The acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date will allow us to maintain our timelines for launch as early as July 2018,” said Robert Finizio, the company’s chief executive officer, in a statement in December 2017. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in the United States who suffer from symptoms of VVA.” VVA is vulvar and vaginal atrophy.
2. Kitov Pharmaceuticals. Kitov, based in Tel Aviv, Israel, expects the FDA to approve its KIT-302 by May 31. The NDA was filed in October 2017. KIT-302 is a patented combination of celecoxib and amlopidine to treat osteoarthritis pain and hypertension simultaneously. If approved, the drug will be marketed under the brand name Consensi.
Both components of the drug are FDA approved. Pfizer’s Celebrex (celecoxib) is a COX-2 inhibitor to treat osteoarthritis. Pfizer’s Norvasc (amlodipine besylate) is a calcium channel blocker for lowering blood pressure.
“The acceptance of filing of our NDA for KIT-302 represents a key achievement toward commercialization of our lead drug candidates,” said J. Paul Waymack, the company’s chairman and chief medical officer, in a 2017 statement. “We intend to work closely with FDA as it reviews the NDA. We look forward to FDA rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018.”
Exercise helps treat addiction by altering brain’s dopamine system
New research by the University at Buffalo Research Institute on Addictions has identified a key mechanism in how aerobic exercise can help impact the brain in ways that may support treatment—and even prevention strategies—for addiction.
Also known as “cardio,” aerobic exercise is brisk exercise that increases heart rate, breathing and circulation of oxygen through the blood, and is associated with decreasing many negative health issues, including diabetes, heart disease and arthritis. It also is linked to numerous mental health benefits, such as reducing stress, anxiety and depression.
“Several studies have shown that, in addition to these benefits, aerobic exercise has been effective in preventing the start, increase and relapse of substance use in a number of categories, including alcohol, nicotine, stimulants and opioids,” says Panayotis (Peter) Thanos, PhD, RIA senior research scientist and senior author of the study. “Our work seeks to help identify the underlying neurobiological mechanisms driving these changes.”
Using animal models, Thanos and his team of researchers found that daily aerobic exercise altered the mesolimbic dopamine pathway in the brain. Dopamine is a key neurotransmitter associated with substance use disorders, playing an important role in reward, motivation and learning.
“Current work is looking at whether exercise can normalize dopamine signaling that has been changed by chronic drug use, as this may provide key support of how exercise could serve as a treatment strategy for substance abuse,” he says.
“Further studies that focus on people with substance use disorders should help researchers develop new methods to integrate exercise into treatment regimens that may help prevent relapses,” Thanos adds.
Genes, environment and schizophrenia—new study finds placenta is missing link
Hiding in plain sight, new research shines a spotlight on the placenta’s critical role in the nature versus nurture debate and how it confers risk for schizophrenia and likely other neurodevelopmental disorders including ADHD, autism, and Tourette syndrome. This new scientific frontier, with far-reaching implications for maternal and child health, creates the possibility that scientists can more accurately predict who is at risk of mental illness, and develop strategies to prevent or lessen their occurrence by increasing the resiliency and health of the placenta.
The study, “Convergence of placenta biology and genetic risk for schizophrenia,” was led by researchers at the Lieber Institute for Brain Development and published in Nature Medicine. “For the first time, we have found an explanation for the connection between early life complications, genetic risk, and their impact on mental illness and it all converges on the placenta,” said Daniel R. Weinberger, who led the team of investigators on the study and is CEO of the Lieber Institute for Brain Development (LIBD).
In contrast to prior studies that focused on how genes related to behavioral disorders directly alter prenatal brain development, this novel research found that many genes associated with risk for schizophrenia appear to alter early brain development indirectly, by influencing the health of the placenta. The research showed that these genes are “turned on” in the placenta during complicated pregnancies and signal a placenta under duress.
While the subject of myth and ritual in many cultures, the placenta remains a scientifically neglected human organ, despite its essential role for supplying nutrients and chemicals critical for normal prenatal development. Indeed, the placenta is the only organ removed from a human body that is not routinely sent to the laboratory for examination.
For over a quarter of a century, brain development during pregnancy and shortly after birth has remained central to a hypothesis that schizophrenia is a neurodevelopment disorder. However, the biological mechanisms involved were poorly understood. Previous studies have shown that genetic variants alone increase the odds of developing schizophrenia by only a fraction, while early life complications during pregnancy and labor can increase risk by up to 2-fold. The Lieber Institute investigators studied over 2800 adult individuals, 2038 of whom had schizophrenia, of various ethnic backgrounds from four countries, including the USA, Europe and Asia. All had undergone genetic testing and were surveyed for obstetrical history information.
Researchers found a prominent interaction between genes associated with risk for schizophrenia and a history of a potentially serious pregnancy complication. Individuals having high genetic risk and serious early life complications have at least a fivefold greater likelihood of developing schizophrenia in comparison to individuals with similarly high genetic risk but no history of serious obstetrical complications. This led to a series of analyses of gene expression in multiple placenta tissue samples, including samples of placenta from complicated pregnancies that include preeclampsia and intrauterine growth restriction. The results showed a striking and consistent turning on of the schizophrenia genes in these placentae and the more they were turned on, the more the placenta showed other signs of being under stress, for example, being more inflamed.
A Clue to Higher Male Risk for Schizophrenia
One of the many mysteries of developmental behavioral disorders, including schizophrenia, autism, ADHD, dyslexia, and Tourette Syndrome is why their incidence is 2-4 times greater in males than in females. The Lieber Institute team findings may shed light on this mystery. They found that the schizophrenia genes turned on in the placenta from complicated pregnancies were dramatically more abundant in placentas from male compared with female offspring. The placenta appears to be at least part of the explanation for the sex bias associated with these disorders.
“The surprising results of this study make the placenta the centerpiece of a new realm of biological investigation related to how genes and the environment interact to alter the trajectory of human brain development,” said Weinberger.
Further research into this emerging frontier of clinical medicine will advance the understanding of the biological interplay between placental health and neurodevelopment. There is a potential to discover novel approaches to therapeutic treatments and prevention strategies, and ultimately reduce the incidence of neurodevelopmental behavior disorders.
Explore further: Assisted reproduction may up risk of placental anomalies
More information: Gianluca Ursini et al, Convergence of placenta biology and genetic risk for schizophrenia, Nature Medicine (2018). DOI: 10.1038/s41591-018-0021-y
‘Exergaming’ a Good Workout for Less-Active Heart Failure Patients
When patients regularly included simulated sports activities using a video-game console into their daily routine in a randomized trial, overall their self-perception of well-being improved along with functional capacity.
But not every patient with heart failure who exercised using the Wii Sports(Nintendo) gaming console reaped the benefits. Some defied expectations that high adherence would translate to bigger gains.
Those assigned to use the gaming console showed better improvements in 6-minute walk distance over 3 months compared with patients given “motivational support” to increase their activity levels. But there wasn’t a strong correlation between gaming time and functional response.
That might have something to say about how an “exergaming” strategy in patients with heart failure in practice might or might not effectively complement more traditional approaches to promoting exercise, researchers speculate.
The primary finding of the HF-Wii study, reported at the European Society of Cardiology 2017 Congress, showed that patients assigned to exergaming had better 6-minute walk test (6MWT) results than the control group.
The new findings of improved self-perceived well-being as well as the unexpected relationship between exergaming adherence and functional outcomes were reported here this week at the European Society of Cardiology (ESC HF) Heart Failure 2018 by principal investigator Tiny Jaarsma, PhD, of Linköping University, Sweden.
Exergaming as done in the trial “requires rigorous physical exercise” and consists of simulated sports activities like golfing, bowling, or playing tennis by the patient, alone or with other participants, said Jaarsma during her presentation.
Addressing those audience members who seemed unfamiliar with Wii Sports and exergaming in general, Jaarsma explained, “It’s not doing a Sudoku on your phone, it is really being physically active and intended as a workout.”
Experience in patients with heart failure, she said, suggests that “it increases motivation, increases activity, promotes better health behaviors, and improves exercise capacity and health.”
In 2010, the American Heart Association (AHA) controversially entered a partnership with Nintendo in which the company donated $1.5 million to the organization, which for its part allowed its “heart check” emblem to be displayed on the packaging of Wii exergaming systems. The emblem was in use to identify consumer products the AHA certified as healthy lifestyle choices.
To be sure, the benefits of increased activity levels in heart failure are well recognized; often the challenges are patient engagement in and continued adherence to an exercise program. Exergaming seems to meet those challenges in various ways, Jaarsma pointed out for theheart.org | Medscape Cardiology. Most of the patients had fun playing the simulated sports, which can be done conveniently at home.
Also, exergaming can be performed alone or as a family activity, the latter of which was a big draw for some patients. “When we did a pilot study several years ago, we saw that the amount of time playing was related to having grandchildren,” Jaarsma said. Their support and participation, it was thought, helped encourage the grandparents with heart failure to use the gaming device more often.
HF-Wii assigned 605 patients with heart failure to a recommendation to use the Wii Sport console for at least 30 minutes a day or to receive “motivational support only” and standard advice about exercise.
Wii consoles were provided to patients and installed in their homes for free. Patients received introductory lessons on their use and were given continued access to technical support, Jaarsma said.
There were no requirements for study entry based on NYHA functional class or left-ventricular ejection fraction. The patients were primarily in Sweden but also the Netherlands, Germany, Italy, Israel, and the United States.
Adherence to the exergaming time recommendation varied. Just over a third of patients, 34.8%, achieved more than 90% of the prescribed usage time. About half, 49.5%, fulfilled more than 60% of the exergaming prescription.
But a surprisingly large 17% of the exergaming group never used the console. They showed significantly less 6MWT improvement over 3 months compared with either the control group or those who actually used the Wii console regardless of adherence level.
Otherwise, there was no observed dose-response effect; those achieving all or nearly 100% of the recommended usage showed about as much 6MWT improvement as users with lower adherence.
“Those people who were really highly adherent, they were of course the people who had already been exercising — younger, fitter — so they could easily do 80%” of the recommended level, Jaarsma said. Put another way, she said, patients who used the Wii system the most were those with the least to gain from it.
Pointing in part to the 17% of patients in the exergaming group who didn’t use the system, Christopher M. O’Connor, MD, of the Inova Heart & Vascular Institute, Falls Church, Virginia, said he’d been hoping that adherence in the trial would be “a little bit better, because adherence is the big thing with exercise.”
Patients in the HF-ACTION trial adhered to their exercise protocol at about the same level that HF-Wii patients adhered to their exergaming recommendation, O’Connor told theheart.org | Medscape Cardiology. That’s “curious” because in the earlier trial, “we were asking people to exercise on a treadmill 200 minutes a week for two-and-a-half years.”
O’Connor isn’t involved in HF-Wii but co-chaired HF-ACTION, which had randomly assigned about 2300 patients with heart failure to usual care with or without supervised exercise-training sessions plus a home-based exercise regimen. Patients in the intervention group showed dose-response relationships between exercise and functional capacity, quality of life, and 90-day survival.
If exergaming could be shown to produce gains like those seen in HF-ACTION, he said, it could be recommended as offering benefits similar to those from conventional exercise. It could then serve as one exercise option among many for individual patients, and choice itself, O’Connor said, might improve compliance.
As assigned discussant following Jaarsma’s presentation, Loreena M. Hill, PhD, of Queen’s University Belfast, UK, said the study “really demonstrates very positive results” and shows that the exergaming option is acceptable to patients. But it would be prudent to explore its long-term impact, she said, before exergaming should be recommended in clinical practice.
The previously reported functional benefits from exergaming in the trial included a 33-meter longer 6MWT distance (P = .002) at 3 months compared with the control group.
Table. Mean Current and Expected Well-Being Scoresa at 3 Months in HF-Wii
| ENDPOINTS | EXERGAME GROUP | CONTROL GROUP | P |
|---|---|---|---|
| Current well-being | 6.6 | 6.2 | < .05 |
| Expected well-being | 7.6 | 7.4 | < .05 |
a. Cantril Ladder of Life scales ranging from 1 to 10.
In the new HF-Wii secondary analysis, patients in the exergaming group compared with controls showed significantly better responses from baseline to 3 months on Cantril Ladder of Life scales for current and expected well-being.
But there were no significant differences in responses based on the Hospital Anxiety and Depression Scale or in quality of life by the Minnesota Living With Heart Failure Questionnaire.
Jaarsma agreed that exergaming would likely serve as one exercise option among many for most patients, but it likely won’t provide substantial functional gains for heart failure patients who are already active. If they walk a dog three times a week or bike for an hour, for example, “the Wii won’t add to that.”
Nintendo did not provide Wii systems or other support for the trial. Jaarsma and Hill have reported no relevant financial relationships. O’Connor discloses consulting fees from Novella and Amgen; ownership or partnership or being a principal in BisCardia; and research support from Otsuka, Roche Diagnostics, BG Medicine, Critical Diagnostics, Astellas, Gilead, GE Healthcare, and ResMed.
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