Vanda Pharmaceuticals initiated with a Buy at Stifel. analyst Derek Archila initiated Vanda Pharmaceuticals with a Buy rating and $30 price target, citing the base business, Fanapt acceleration, and readouts from two meaningful clinical programs.
https://thefly.com/landingPageNews.php?id=2790379
Thursday, September 13, 2018
Unity Biotech CEO: Can ‘absolutely’ create meds to slow, reverse aging ills
- Unity Biotechnology wants to create drugs that slow, halt or even in some cases reverse specific diseases of aging, says Unity Biotech CEO Keith Leonard.
- “The evidence is mounting, both in our company and outside, that you can intervene and you can change the course of these specific diseases,” he says.
This biotech company is trying to stop or reverse age-related diseases
Unity Biotechnology wants to create drugs that slow, halt or even in some cases reverse specific diseases of aging, CEO Keith Leonard told CNBC on Thursday.
In fact, he said, the company can “absolutely” do it.
“The evidence is mounting, both in our company and outside, that you can intervene and you can change the course of these specific diseases,” Leonard said on “Power Lunch.”
The company is targeting a “powerful biology” called cellular senescence, which is the aging of an individual cell and how it affects disease.
There is already a phase one trial underway for osteoarthritis, which Leonard hopes to have the results for during the first quarter of next year, he said.
Other diseases that could eventually be treated include the loss of cardiac and pulmonary function as well as cognitive and vision function — “things we have come to accept as part of the normal course of aging,” he said.
In the near future, he anticipates, diseases can be treated as they emerge in patients.
“In the far future, we can imagine a world where you can go into the clinic once or twice a year and have your senescent cells removed and kind of you [are] maintained in a more youthful, vigorous state.”
Leonard’s comments caused the stock to soar almost 18 percent before trading was halted for volatility. After trading resumed a short time later, Unity Biotech shed some of those gains. It was up about 8 percent in midafternoon trading.
The biotech company, which has a market cap of $916 million, has attracted the attention of tech giants such as Amazon founder Jeff Bezos and PayPal co-founder Peter Thiel. Both have invested in Unity Biotech, which has received more than $300 million in funding, including $85 million raised after going public this past May.
‘Chronic Pain Affects 20% of Americans’: CDC
Chronic pain affected about 20% of U.S. adults in 2016 and high-impact chronic pain — severe enough to interfere with life or work activities most days — affected 8%, according to the CDC.
That translates to 50 million people with chronic pain and about 20 million people with high-impact chronic pain, reported James Dahlhamer, PhD, of the CDC’s Division of Health Interview Statistics in Hyattsville, Maryland, and colleagues in Morbidity and Mortality Weekly Report.
This is the first-ever CDC assessment of high-impact chronic pain. Population-based estimates of chronic pain among American have ranged from 11% to 40%, with considerable variance among different segments of the population.
Chronic pain contributes to an estimated $560 billion each year in direct medical costs, lost productivity, and disability programs. In 2016, the National Pain Strategy, the first national population health-level plan for pain prevention, treatment, and management, called for more precise estimates to establish the prevalence of chronic pain and guide population-wide pain interventions.
In response, CDC researchers analyzed data from 33,028 adults in the 2016 National Health Interview Survey, a cross-sectional, in-person, household poll. They defined chronic pain as pain on most days or every day in the past 6 months, and high-impact chronic pain as chronic pain that limited life or work activities on most days or every day during the past 6 months.
The analysis showed that in 2016, an estimated 20.4% of U.S. adults (50 million) had chronic pain and 8.0% (19.6 million) had high-impact chronic pain, with rising prevalence tied to advancing age.
The age-adjusted prevalence of both chronic pain and high-impact chronic pain was significantly higher among women, and among adults who had worked previously but were not currently employed, adults living in or near poverty, and rural residents. It was significantly lower among people with at least a bachelor’s degree compared with other education levels.
This analysis is limited by self-reported data which may be subject to recall bias, the researchers noted. The data are cross-sectional, so causal inferences cannot be made. This may be especially important for socioeconomic status, which can be both a risk factor for, and a consequence of, chronic pain.
Dahlhamer reported no conflicts. Other authors reported relationships with Pain Medicine journal, Pfizer, and inVentive.
LAST UPDATED
FDA OKs AstraZeneca’s Lumoxiti for type of leukemia
The FDA approves AstraZeneca’s (AZN -1.1%) Lumoxiti (moxetumomab pasudotox-tdfk) injection for the treatment of adult patients with relapsed/refractory hairy cell leukemia (HCL) who have received at least two prior lines of systemic therapies, including a purine nucleoside analog.
Orphan Drug-tagged Lumoxiti is an anti-CD22 recombinant immunotoxin. It consists of an antibody that binds to protein found on B-lymphocytes (CD22) that is fused to a toxin. Once the molecule is internalized by the cancer cell, the toxin leads to cell death by inhibiting protein translation. Specifically, the cell cannot read the information from messenger RNA so it cannot build proteins and dies.
Cardiologist: 4 things needed before Apple Watch monitors heart conditions
Hands on with the new Apple Watch Series 4
Apple announced a slew of new health features for its Apple Watch on Wednesday, including an FDA-cleared electrocardiogram sensorthat is designed to alert users to potential problems with their heart so they get to a doctor in time.
But cardiologists aren’t yet convinced that it will be a net positive for their patients. The device could save lives — and already is — but it also comes with a set of risks.
Stephen Lam | Reuters
Jeff Williams, Chief Operating Officer of Apple, speaks about the the new Apple Watch Series 4 at an Apple Inc product launch event at the Steve Jobs Theater in Cupertino, California, September 12, 2018.
For starters, doctors could be overwhelmed by healthy patients with Apple Watches rushing to the emergency room with inaccurate results. Or worse still, some patients might not go to the doctor if they think their Apple Watch is monitoring them when it isn’t.
Adam Feuerstein@adamfeuerstein
Well…. Think about all the additional leisure time you’ll have now.
Ethan Weiss@ethanjweissNet net I bet there is going to be a massive increase in inbound flow from my patients as well as probably trips to the office and ER visits, but it will be interesting….
“It can be game-changing for heart health if it is accurate,” says Patricia K. Nguyen, assistant professor of medicine in the cardiovascular division at Stanford University.
But Nguyen told CNBC she needs to know a lot more about how the technology works before making that assessment. She told me there are four key things she’d need to see to get comfortable recommending it to patients.
1. What data did Apple show the FDA?
First, Nguyen would want to take a closer look at the data that Apple presented to the FDA to get clearance for its new sensor, as well as the alert system that informs patients if there’s a potential problem. That’s pretty standard for clinicians, who will often take time to review data rather than simply relying on an FDA approval alone.
David Lim@LimOpinion
David Lim@LimOpinionYou can find the @US_FDA @Apple de novo clearances here:
OTC ECG Software: https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf …
Photoplethysmograph analysis software: https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180042.pdf …Slightly curious what DEN190043 is – but it’s a dead page.
2. Comparison against the Zio Patch
Second, she’d want to see researchers conduct a head-to-head comparison of the Apple Watch’s electrocardiogram compared to the current gold standard, the Zio Patch, which doctors routinely recommend to patients at a higher risk of medical conditions such as atrial fibrillations. She’d need to see that Apple’s product is as accurate and sensitive (or close to it) as the current alternatives on the market.
Apple will need to prove to the medical community through studies like these that it won’t deliver an abnormally high rate of false positives (people who think they have a condition when they don’t) and false negatives (people who think they’re fine when they’re not).
3. Diverse patient set
Thirdly, these tests would need to be performed using a diverse set of patients. If Apple Watch only studies relatively young and healthy people, it doesn’t necessarily mean that it would work well for older patients with more serious medical problems.
Christina FarrInteresting that Jeff Williams noted it won’t catch “every instance” of AFib. What I’m concerned about is the opposite.The last thing doctors will want is freaked out — and totally healthy — Apple Watch users rushing to ER (super expensive outcome, too). #AppleEvent
4. Proof it works when people are moving
Finally, and most importantly, it’s well known in medical circles that sensors can often work well in a lab when the patient is sitting still. But would the Apple Watch provide accurate data if the patient is moving around?
“It would need to be accurate,” says Nguyen, “in all types of patients when they are sitting, moving and exercising.”
Bausch bankruptcy risk arguably off table with settlement, says Jefferies
Bausch Health (BHC) yesterday announced an important settlement for Xifaxan with first to file Teva (TEVA), allowing for generic entry in January of 2028, Jefferies analyst David Steinberg tells investors in a research note. One could argue the settlement takes Bausch’s bankruptcy risk off the table given the “long runway and greater certainty to future cash flows” from what is the company’s most important drug, the analyst contends. Further, the deal could also allow the company to refinance its debt at more attractive terms. Steinberg keeps a Buy rating on Bausch Health with a $27 price target.
Teva attracts attention from pharma, private equity for $500M sale of Medis
Teva has been working to pay down tens of billions of dollars of debt since it purchased Allergan’s generics suite for more than $40 billion. Now, the company’s Medis unit has attracted attention from industry players and private equity firms, according to Bloomberg.
A second round of bidding has begun for Medis, an Iceland-based outfit that develops generic drugs for other pharmaceutical companies that could be worth $500 million in a sale, according to the news service. Interested buyers include Recipharm, Brazil’s EMS and private equity firms, and a buyer could be identified by year’s end, sources tell the publication.
Teva last year said it was weighing a sale of the business. At the time, a spokesperson said “Teva is looking at every opportunity to focus our business and streamline operations, processes and structure.” A sale would be contingent on reaching a deal and achieving regulatory approval, the company’s representative added.
Along with Medis, Teva last year reportedly put some respiratory products up for sale. At the time, Bloomberg reported the products could attract offers of $500 million to $2 billion.
Last fall, as it continued to work to pay down debt, Teva offloaded its women’s health offerings in a series of deals worth nearly $2.5 billion.
Teva’s move to sell certain business units comes after its massive Allergan generics buy in 2016. After that, things have taken a serious turn for the worse for the drugmaker. Generic prices have eroded in the U.S., forcing the company to reduce its sales guidance by more than $1 billion twice. The company has also had to kick off a massive round of downsizing, shut down plants and slash its dividend.
But efforts to cut its debt led by new CEO Kåre Schultz have drawn praise from analysts. Just last week, the Israeli drugmaker said it would slash it further with a tender offer to pay up to $400 million of notes that were due in 2019 and 2020.
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