Britain's Oxford Biomedica (OXB.L) said on Friday it had signed a new three-year agreement to potentially make AstraZeneca's (AZN.L) COVID-19 vaccine beyond 2022, but no volumes were defined in an indication of waning demand for the shot.
Friday, July 1, 2022
Takeda Is ‘Now In a Good Phase’ for Growth: CEO
Takeda Pharmaceutical Co.’s shares might be trading at about half of their level before the $62 billion acquisition of Shire in 2018, but the drug pipeline and cash management are helping to change the market’s perception of the company’s long-term value, Chief Executive Officer Christophe Weber said.
“When you do an acquisition like that of this scale — and it’s not only a big acquisition, it was a very big acquisition compared to our size as well — it’s normal that the market gets a little bit frozen,” Weber, 55, said in an interview. “We are in a different phase, now in a good phase. We are confident about our outlook.”
Takeda’s shares are trading at about half of their level from a 2017 peak, giving the Tokyo-based drugmaker a market value of about 6 trillion yen ($44 billion). With cash flow growing, Weber said the company is seeking to reduce debt and return cash to shareholders via dividends and buybacks. Those efforts have started to pay off, with Takeda’s stock price up about 20% this year.
Although Takeda reported a 10% decline in operating profit to 461 billion yen for the fiscal year that ended in March, analysts project, on average, that profit will almost double to a record 920 billion yen for the current fiscal period. That’s well above the company’s own forecast for 520 billion yen. On a core basis, which Takeda defines as excluding taxes, amortization and other charges, operating profit will be closer to 1.1 trillion yen.
Takeda completed a 100 billion yen share buyback in April, and has kept dividends steady. Shareholders should expect this policy to continue, according to Constantine Saroukos, the drugmaker’s chief financial officer.
“We’re very much focused on returning cash to our shareholders,” Saroukos, 51, said in the interview. This “could be in terms of dividend increases in the future, but also share buybacks,” and “with our free cash flow improving, gives us a lot more levers to pull to continue to drive shareholder returns,” he said.
Takeda is assuming an exchange rate of 119 yen to the dollar for the current fiscal year, although this week the yen is trading at around 136 yen, near multidecade lows. If dollar-yen stays at around 130, “we’ll have single-digit, high single-digit upside on our revenue guidance and our earnings per share,” Saroukous said.
More than 80% of Takeda’s revenue is earned abroad. Asked whether the weaker yen, which boosts Takeda’s income converted into its home currency, would allow for more shareholder cash returns, Saroukos said: “The fluctuations of the yen doesn’t change our strategy or capital allocation.”
‘Mind Blowing’
Both the CEO and CFO emphasized that the main beneficiary of the improved cash position will remain the development of new drugs and therapies.
Takeda is “very committed” to the development of a drug to treat narcolepsy and is working hard to make up for an 18-month delay with a backup after terminating its leading project in October, Weber said.
A backup compound called TAK-861 shows efficacy with “a much lower dose” than TAK-994 it scrapped after it caused problematic liver-damage side effects, Weber said. The new drug in development appears to be a better candidate, with mid-stage of clinical trials scheduled for later this year, although Weber declined to comment when the trial will be completed.
“TAK-861’s market potential is equivalent of TAK-994,” said Weber. “We believe that it’s different enough to hope that it will not have the same safety issue while having the same level of efficacy, because the efficacy is mind blowing.”
After the leading compound failed, Takeda’s stock fell about 10% over two days in October. The drugmaker is counting on narcolepsy treatments to make up for a sales decline when Entyvio, its blockbuster drug for ulcerative colitis and Crohn’s disease, eventually faces generic competition. Entyvio, Takeda’s biggest product, generated about 15% of its total revenue for the year ended March.
The company hasn’t seen any biosimilars of Entyvio in development and doesn’t expect the market entry until the end of the decade, and through 2032, when many of the drug patents expire, Weber said.
“It’s impossible that they will be there by the time of the exclusivity expiration,” Weber said of competing products. “We have not been super precise about when, exactly, because there is still a little bit of uncertainty.”
Narcolepsy, a chronic sleep disorder responsible for sudden sleep attacks and daytime drowsiness, affects an estimated 135,000 to 200,000 Americans, according to the US National Institute of Neurological Disorder and Stroke. The market, valued at $2.7 billion in 2020, is projected to more than double to reach $6.7 billion by 2030.
The successful progress of TAK-861 could generate interest in shares, said Stephen Barker, an equities analyst at Jefferies Financial Group Inc. “On the other hand, if they say they’re dropping that one too, that would be bad for the shares.”
The company is also searching for mid- to late-stage assets to make up for the anticipated sales fall of Entyvio, Weber said.
Separately, Weber says he is potentially interested in expanding a partnership with JCR Pharmaceuticals Co. to develop drugs using the company’s cutting-edge technology to transport drugs to the brain called J-Brain Cargo. The companies agreed to jointly develop an experimental drug JR-141 to treat Hunter Syndrome, a rare inherited genetic disorder caused by a missing or malfunctioning enzyme, in September last year.
“The advantage of partnership is you start somewhere,” said Weber, when asked about the potential for the technology’s use in other neurological disorders, such as Alzheimer’s. “It can lead to other opportunities.”
https://finance.yahoo.com/news/takeda-now-good-phase-growth-210000333.html
FDA Declines Emergency Use Authorization for NRx Covid Med
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), ("NRx Pharmaceuticals"), a clinical-stage biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) for a sub-group of patients that in addition to ZYESAMI®, also received Remdesivir and continued to progress. NRx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis.
"As previously communicated, since the futility news of the ACTIV-3b / TESICO Study with ZYESAMI®, our team has already been highly focused on the development of NRX-101 for bipolar depression in patients with Acute and Sub-Acute Suicidality. Though disappointing, this decision by the FDA is not unexpected, given that they had already recently declined Breakthrough Therapy Designation for ZYESAMI®. We will evaluate the options for ZYESAMI® in COVID-19 respiratory failure and other lung disorders once we receive the full data set from the National Institutes of Health (NIH)," said Robert Besthof, interim CEO, NRx Pharmaceuticals.
https://finance.yahoo.com/news/fda-declines-emergency-authorization-zyesami-112300169.html
Thursday, June 30, 2022
Abortion Opponents Don't Want Patients Crossing State Lines
Several national anti-abortion advocacy groups and lawmakers in Republican-led states are pushing forward with plans to block people from crossing state lines to seek the procedure elsewhere.
Since the Supreme Court overturned Roe v. Wade last week, several states have enacted "trigger ban" laws to stop abortion, particularly across the Southeast and Midwest. As part of that, anti-abortion groups are building momentum around the idea of blocking out-of-state travel as well, even discussing it at two national anti-abortion conferences last weekend, according to The Washington Post .
"Just because you jump across a state line doesn't mean your home state doesn't have jurisdiction," Peter Breen, vice president and senior counsel for the Thomas More Society, told the newspaper.
"It's not a free abortion card when you drive across the state line," he said.
The Thomas More Society, a conservative legal organization, is drafting model legislation for state lawmakers to use, which would allow private citizens to sue anyone who helps a resident end a pregnancy outside of a state that has banned abortion. The draft language borrows from the recent Texas abortion ban, which allows private citizens to enforce the law through civil litigation.
The National Association of Christian Lawmakers, an anti-abortion organization led by Republican state legislators, has also begun working with the authors of the Texas abortion ban, the Post reported. The group is exploring model legislation that would restrict people from crossing state lines for abortions.
Relying on private citizens to enforce civil litigation, rather than imposing a state-enforced ban on crossing state lines, could make these laws more difficult to challenge in court.
What's more, the legislation could have a chilling effect on doctors, who may stop performing abortions on people from other states while waiting on courts to intervene and overturn the laws, the newspaper reported.
Not every anti-abortion group is supporting the idea. Catherine Glenn Foster, president of Americans United for Life, said that people access medical procedures across state lines often.
"I don't think you can prevent that," she said.
But some states may still propose these types of bills this year. Legislators in Arkansas and South Dakota, for instance, have already planned special sessions to discuss abortion legislation, which could include the issue. Lawmakers in Missouri have also supported the idea.
In contrast, several Democrat-led states have passed legislation this year to counteract laws that may try to restrict movement across state lines, according to the Post. Connecticut passed a law that offers protection from out-of-state subpoenas issued in cases related to abortion procedures that are legal in the state, and California passed a similar law to protect abortion providers and patients from civil suits.
The Justice Department has warned that it will fight laws that block people from crossing state lines, saying they violate the right to interstate commerce.
"The Constitution continues to restrict states' authority to ban reproductive services provided outside their borders," Attorney General Merrick Garland said in a statement after last week's ruling.
"We recognize that traveling to obtain reproductive care may not be feasible in many circumstances," he said. "But under bedrock constitutional principles, women who reside in states that have banned access to comprehensive reproductive care must remain free to seek that care in states where it is legal."
Sources
The Washington Post: "Antiabortion lawmakers want to block patients from crossing state lines."
U.S. Department of Justice: "Attorney General Merrick B. Garland Statement on Supreme Court Ruling in Dobbs v. Jackson Women's Health Organization."
High Rate of Undiagnosed Major Risk Factors in Ischemic Stroke
Almost two thirds of patients with acute ischemic stroke have at least one undiagnosed major risk factor, new research shows.
The most common of these are dyslipidemia, hypertension, and atrial fibrillation (AF). In addition, many of the study participants were women and were relatively younger.
André Rêgo, MD
These results highlight the need for greater clinician awareness about how this patient population may have unrecognized stroke risk factors, study investigator André Rêgo, MD, Stroke Center, Department of Clinical Neurosciences, Lausanne University Hospital and University of Lausanne, Switzerland, told Medscape Medical News.
He used the example of a younger female patient who lives a sedentary lifestyle, eats an unbalanced diet, takes oral contraceptives, and smokes. "If you add one or two more risk factors, like an undiagnosed dyslipidemia or mild hypertension, that can be a dangerous cocktail," he said.
The findings were presented at the Congress of the European Academy of Neurology (EAN) 2022.
Need for Greater Focus on Prevention
Research shows about 90% of strokes are caused by modifiable risk factors, including hypertension, dyslipidemia, diabetes, AF, structural cardiac disease, high body mass index, smoking, psychosocial issues, physical inactivity, and unhealthy diet.
Some of these risk factors, such as overweight or obesity, are obvious; others, like hypertension and dyslipidemia, are frequently silent.
The analysis included 4354 patients from a database of patients admitted to a single center within 24 hours of a stroke between 2003 to 2018.
About 25.8% were unaware of having major risk factors, and 74.2% had diagnosed risk factors. Participants' mean age was 59.02 years in the unaware group and 73.8 years in the aware group.
When comparing risk factors between the two study groups, investigators focused on hypertension, dyslipidemia, AF, and silent/new coronary heart disease combined with an ejection fraction of less than 35%.
Of the 25.8% of patients with acute ischemic stroke who were unaware that they had stroke risk factors, 67.7% had at least one major risk factor.
In patients with previously undiagnosed risk factors, 61.4% had newly detected dyslipidemia, hypertension (23.7%), AF (10.2%), diabetes (5.2%), ejection fraction of less than 35% (2.0%), and coronary disease (1.0%).
"These results were kind of surprising because in Switzerland, the healthcare system is really good and people are highly educated," said Rêgo.
The unaware group had a higher percentage of smokers as well as more non-White and younger patients. These patients were also less likely to have taken aspirin at stroke onset and more likely to be overweight. Women who were unaware of their stroke risk factors were more likely to be taking contraceptives. There was also a higher frequency of patent foramen ovale–related strokes in the unaware group.
Rêgo believes a combination of elements probably contributes to the underdiagnosis of stroke risk factors, including poor healthcare access and individuals perceiving themselves to be healthy if they're young and not overweight.
Analysis of long-term functional outcomes showed no differences between groups in modified Rankin scale scores after adjusting for age, sex, peripheral artery disease, chronic kidney disease, depression, psychosis, and cancer.
"This probably means that irrespective of etiology, we are treating stroke patients quite well," said Rêgo.
The results may not be generalizable to other countries, he said, noting that Switzerland is "highly developed" with an educated, relatively healthy population. "If we did this study in another context, we probably would see even more undiagnosed risk factors."
Improving the detection of undiagnosed risk factors would require a shift in focus, said Rêgo. "We still have a healthcare system excessively directed toward acute disease and less to chronic diseases and preventive medicine."
Room for Improvement
Commenting for Medscape Medical News, Nicola Rifino, MD, Cerebrovascular Department, University of Milano-Bicocca, Milan Italy, who chaired the session featuring the research, said that the study "sends a clear message" that much more can be done to prevent cerebrovascular ischemic events.
That more than two thirds of patients have undiagnosed vascular risk factors "is certainly surprising," but this finding could serve as "an incentive for clinicians to do more in prevention," he said.
He noted that many risk factors are treatable, both pharmacologically and with changes in lifestyle. "Identifying and treating these risk factors early can likely prevent many of the ischemic strokes that occur on a daily basis."
Dr Rêgo reports no relevant conflicts of interest.
Congress of the European Academy of Neurology (EAN) 2022. Abstract # A-22-04456. Presented June 26, 2022.
FDA’s ban on a popular e-cigarette defies logic
The Food and Drug Administration has once again exposed a deadly menace to Americans’ health: the FDA itself. The rate of smoking has plummeted among Americans in the past decade, but now the agency’s empire-building bureaucrats are doing their best to reverse that trend.
The FDA has ordered Juul to stop selling its electronic cigarette (popularly known as the Juul), the most effective technology ever devised for inducing smokers to quit. The agency is also proposing to limit the amount of nicotine in traditional cigarettes, an approach that has failed in the past to wean smokers off their habit—and would perversely induce them to get their nicotine in more dangerous ways, either by smoking more cigarettes or by buying full-strength ones on the black market.
The Juul ban, temporarily suspended by a federal judge as Juul appeals the FDA’s order, defies not only the principles of public health but also political common sense: Why antagonize millions of voters in an election year by taking away their vaping sticks? The FDA conceded that it could point to no “immediate hazard” to the public from the Juul. It claimed that the company didn’t provide enough information on the Juul’s safety, but that claim is dubious—Juul spent more than $100 million on its application to the FDA. In any case, it’s silly to quibble about minor unknown risks in electronic cigarettes, which the U.K.’s public-health agency estimated to be 95 percent safer than tobacco cigarettes.
The ban makes sense only as a sop to the bureaucrats and special interests threatened by e-cigarettes, which provide the many benefits of nicotine—weight control, improved concentration and cognitive performance, reduced anxiety and better mood—without the thousands of toxins in tobacco smoke. Like caffeine, nicotine creates dependence and causes slight temporary rises in blood pressure, but both are “fairly harmless,” as the British Royal Society for Public Health concluded.
Anti-vaping activists and their allies at the FDA have claimed that e-cigarettes serve as a “gateway” to smoking for teenagers, but the rate of teenage smoking has fallen much faster during the vaping era than in previous years. When e-cigarettes were introduced a decade ago, 13 percent of high school students smoked; today the figure is less than 2 percent.
No one wants to see teenagers addicted to nicotine, but it is already illegal for them to buy e-cigarettes. Surveys show that the rate of vaping among high school students has declined sharply in the past two years, and that most teenage vapers do so only occasionally, often without nicotine. (A majority of them report using vaping devices for marijuana, yet progressive activists aren’t using that as reason to ban marijuana sales to adults.)
The rate of smoking among adults has also declined sharply during the vaping era, especially after the introduction of the Juul, and the health benefits have been obvious. A recent study, which tracked more than 30,000 Americans for six years, found that the rate of cardiovascular disease among e-cigarette users was a third lower than the rate among smokers, and no different from the rate among people who neither smoked nor vaped.
Other studies have shown that e-cigarettes help smokers quit and are far more effective than other nicotine-replacement therapies (like nicotine patches or gum). Even smokers with no intention to quit are much likelier to do so if they use an e-cigarette at least once a day. Juul has been particularly successful because it provides a high dose of nicotine in a form that is absorbed quickly, as in a tobacco cigarette. One study found that 50 percent of smokers who bought Juuls went on to quit smoking within a year. Another showed that smokers are more likely to quit if they use a full-strength Juul rather than one with less nicotine.
This is all wonderful news for public health, but bad news for companies that market less effective smoking-cessation products, as well as for the activists, academics, and bureaucrats who have built careers fighting cigarettes. Now that so many Americans have used vaping devices to quit smoking on their own, how can the anti-smoking activists justify their jobs? A lot of money is at stake: more than $800 million a year that the FDA collects from tobacco user fees, which are supposed to be dedicated to improving health by reducing the harm from tobacco products.
To keep the money flowing, bureaucrats misleadingly defined the e-cigarette as a “tobacco product” and set a new goal of eliminating the regular use of nicotine. Since beginning its campaign against e-cigarettes, the FDA’s Center for Tobacco Products has more than doubled the size of its staff, to over 1,100 people, and it has been dispensing hundreds of millions of dollars annually in outside grants, much of it to nonprofits spreading anti-vaping messages and to researchers who advocate for nicotine prohibition.
Unfortunately, the FDA’s misinformation campaign has been a success, aided by mainstream journalists who created a moral panic by blaming e-cigarettes for deaths that were actually caused by black-market THC products. Early in the vaping era, most Americans realized that e-cigarettes are safer than tobacco cigarettes, but in subsequent surveys a majority say that e-cigarettes are as dangerous or even more dangerous—a mistaken belief that will shorten many smokers’ lives.
Nicotine prohibition is a pointless and unrealistic goal. Alcohol abuse is a much bigger problem than smoking among teenagers, but we’ve learned that banning alcohol sales to adults would create far more problems than it would solve. The same is true for e-cigarettes. If the FDA succeeds in banning Juul and similar products, Americans will simply revert to tobacco cigarettes or turn to modern bootleggers for less safe vaping devices.
“There are at least 4 million adult ex-smokers who quit smoking successfully using e-cigarettes and remain dependent on these products to stay off of cigarettes,” says Michael Siegel of Tufts University, who has been studying tobacco control for three decades. “If the FDA disapproves most electronic cigarettes, the end result will be huge numbers of ex-smokers returning to smoking, which would be a public health tragedy.”
In the FDA’s fantasy world, smokers will be saved once the level of nicotine in cigarettes is lowered to “non-addictive” levels. The agency last week announced plans to limit the level of nicotine in all cigarettes, and it has even declared very low-nicotine cigarettes to be “appropriate for the protection of public health.” It’s a bizarre endorsement for a deadly product, especially considering the past failure of low-nicotine cigarettes to get smokers to quit, as University of Louisville professor of medicine Brad Rodu has pointed out.
“If the only cigarettes the FDA allows are low-nicotine, this is a perfect setup for the black market,” says Rodu, who writes the Tobacco Truth blog. “The FDA has banned Juul, a far less hazardous and uniquely successful cigarette substitute for millions of American adult smokers, while endorsing cigarettes that contain virtually none of the essentially harmless nicotine and all of the toxins of traditional cigarettes. These illogical actions will have no impact on the yearly smoking death toll of a half-million Americans—or they may perversely raise it.”
For now, the best hope for sane policy remains outside the FDA. Perhaps the courts will protect Juul against the FDA’s folly, and perhaps politicians facing reelection will stand up for voters who enjoy nicotine. But as long as the agency—and its $800 million in tobacco fees—remain under the control of nicotine prohibitionists, the FDA will remain hazardous to Americans’ health.
CDC is deceiving us again — this time covering up for unsafe hospitals
If you have to go to the hospital, you don’t want to end up in a dangerous one. The Centers for Disease Control and Prevention knows which hospitals are riskiest, but it’s hiding that information from you — your safety be damned. The feds seem to think they work for the hospital industry, not for you.
Whenever a hospital has a superbug outbreak, the CDC conceals its identity, referring only to “Hospital A.” A lot of good that does patients looking for safe care, especially patients with compromised immune systems, cancer or HIV.
It’s no joke to find out, after you’re already in the hospital, that a superbug is raging room to room or has invaded the nursery where your newborn will be placed. That’s what happens when the CDC hides outbreaks.
Now the CDC is playing statistical tricks to hide how many people have caught COVID in hospitals and to block the public from seeing which hospitals have had the biggest problems — “partly on fears of embarrassing hospitals,” Politico reports.
The stakes are high; 21% of patients who catch COVID in the hospital never make it out, Kaiser Health News found — triple the death rate for patients who don’t catch COVID.
Though the pandemic may be fading, vulnerable patients need to know which hospitals proved proficient at preventing the spread of COVID inside their walls. It’s a safety measure.
Over the course of the pandemic, tens of thousands of patients went into the hospital for other reasons — such as hip surgery, kidney disease or a heart attack — and got infected with COVID.
The CDC is rigging the definition of hospital-acquired COVID to hide this problem.
The agency says only patients who test positive after being hospitalized at least 14 days are considered infected by the hospital. That eliminates almost everyone. The average patient stays only 4.6 days.
The CDC definition also excludes any patient who left the hospital and then developed symptoms or picked up the virus in the emergency room.
It’s a coverup. The United Kingdom and many European countries count COVID infections diagnosed seven or eight days after patients enter as hospital-acquired.
At some hospitals, more than 5% of patients caught COVID there, according to a Kaiser Health News analysis of state data and Medicare billing data. The CDC refuses to name these hospitals, defying Freedom of Information Act requests from the media.
When a plane crashes, the Federal Aviation Administration doesn’t conceal the identity of the airline. Why does the CDC cover up for a hospital?
To be fair, the pandemic hit some regions and some hospitals harder than others. But it’s also true that some hospitals took precautions to stop the virus from spreading and succeeded in providing safer care than others.
Some hospitals tested all incoming patients for the virus and retested days later to be sure. Testing proved critical, because most patients who contracted COVID in the hospitals got it from another patient. At Brigham and Women’s Hospital in Boston, eight out of nine patients who became infected caught COVID from the patient sharing their room, per the Annals of Internal Medicine.
Why didn’t all hospitals test? Blame the CDC, which left it to the “discretion of the facility.”
New Yorkers should demand to see the data the CDC is hiding. Hospital-acquired COVID is a problem here.
In January, during the Omicron surge, rates of hospital-acquired COVID were higher in New York than the national average, though lower than in Washington, DC, according to a Wall Street Journal analysis of unpublished federal data. Trouble is, citywide averages don’t tell you what you need to know — the adequacy of infection prevention in your hospital.
It’s time to end the CDC’s secrecy in the service of hospitals. The CDC’s ploy to hide hospital-acquired COVID is a red flag.
Call the CDC the Centers for Deception and Coverups. The nation should be demanding a health agency that deals honestly with the public. If you have health problems, your life could depend on it.
Betsy McCaughey is a former lieutenant governor of New York and founder of the Committee to Reduce Infection Deaths.
https://nypost.com/2022/06/28/the-cdc-is-deceiving-us-again-by-covering-up-for-unsafe-hospitals/
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