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Tuesday, June 9, 2020

FDA to review nicotine pouches from Altria joint venture

Altria (MO -0.9%) Client Services announces that the FDA has accepted for review marketing applications from joint venture Helix Innovations LLC seeking approval of 35 on! nicotine pouch products.
The company says they are tobacco leaf-free and available in seven flavors and five nicotine levels.
Distribution began at the end of Q1 to over 28K stores, including the top five convenience store chains by volume.
https://seekingalpha.com/news/3581664-fda-to-review-nicotine-pouches-from-altria-joint-venture

New National Guidance on Screening for Illicit Drug Use

A national expert task force has issued new guidance on screening for unhealthy drug use in adult patients.
Based on the latest evidence, the US Preventive Services Task Force (USPSTF) recommends that in the primary care setting all patients 18 years of age and older be screened for illicit drug use and misuse of prescription medications.
“Unhealthy drug use can have a devastating impact on people and families, but the good news is that clinicians can do something to help,” Karina W. Davidson, PhD, USPSTF vice chair, told Medscape Medical News.
Davidson is senior vice president of research, and dean of academic affairs, at the Feinstein Institutes for Medical Research at Northwell Health, Long Island, New York.
The final recommendation was published online June 9 in JAMA.

Referral to Treatment Critical

An estimated 12% of US adults and 8% of adolescents ages 12 to 17 years report unhealthy use of prescription or illegal drugs, one of the most prevalent preventable causes of death, injury, and disability in the United States, said Davidson.
A 2008 report by the USPSTF concluded there was insufficient evidence at that time to recommend universal drug screening for adults or adolescents.
To update this recommendation the task force commissioned reviews of the evidence on screening. They found no randomized controlled trials examining outcomes of screening versus not screening in asymptomatic adult patients with no diagnosis of drug abuse.
Screening adults, including pregnant women, involves asking one or more questions about drug use or drug-related risks in a face-to-face, print, or audio-visual format. It does not involve urine, saliva, or blood testing for the presence of drugs. The new recommendation does not pertain to patients already diagnosed with a substance use disorder.
Other reviews examined the accuracy of available screening tests and evidence that interventions reduce related negative outcomes.
“We found many more short, reasonable, and valid screener tests showed evidence that interventions work to either improve abstinence or reduce relapse,” said Davidson.
The investigators concluded that screening for unhealthy drug use in adults has “moderate net benefit” but only when diagnostic and treatment services are available.
“We did not find evidence that screening alone, without effective treatment, is beneficial,” said Davidson.
“Clinicians should ensure they have the appropriate referrals for diagnostic work-up and effective treatment, and that they have those ready at hand if someone does screen positive.”
Davidson acknowledged that screening in adults may have potential “complications” that could lead to unintended harms including privacy issues, discouraging patients who don’t want to be screened from seeking healthcare, and possible medical and sociolegal consequences of reporting positive screening results.
“We propose that primary care clinicians understand their local, state, and national reporting regulations so they know what consequences may or may not accrue to a patient,” said Davidson.
She also noted that regulations differ across jurisdictions and that some have mandatory reporting of drug abuse.
However, in general, “asking patients if they have a problem, and connecting them to the treatment they need, results in benefit,” she said.

No Teen Screening

The USPSTF did not find enough evidence to be able to assess the benefits and harms of screening for unhealthy drug use in adolescents.
It concluded that for adolescents the evidence is still insufficient, and so the benefits and harms of drug screening in teens can’t be determined at this time.
That’s not to say that unhealthy drug use among teens is not a major public health problem, said Davidson. Indeed, the evidence review suggests it is one of the most preventable causes of morbidity and mortality for adolescents.
Unfortunately, Davidson said, almost none of the many screening tests the task force examined had been investigated in more than one study, she said.
Nevertheless, she added, this doesn’t preclude physicians from asking young patients about drug use.
“We encourage physicians to decide for themselves what is best to do while we call for more research” in this area, said Davidson.
The investigators note that pharmacotherapy, often provided with individual or group counseling, is the standard treatment for opioid use disorders.
Disorders involving use of cannabis, stimulants, and other nonopioid drugs, are usually treated with psychosocial interventions that involve behavioral approaches, including cognitive behavioral therapy.
The investigators also note that managing patients who screen positive for unhealthy drug use is commonly accompanied by other interventions, including testing for blood-borne pathogens; assessment of alcohol and tobacco use, misuse, and dependence; screening for comorbid mental health disorders; and pain assessment in patients abusing opioids.
“It’s unclear how often clinicians should screen for unhealthy drug use in adults. This is one of the areas where we have called for further research,” said Davidson.
The USPSTF is an independent, voluntary body. The US Congress mandates that the Agency for Healthcare Research and Quality (AHRQ) support the operations of the USPSTF. Recommendations made by the USPSTF are independent of the US government. They should not be construed as an official position of AHRQ or the US Department of Health & Human Services.
JAMA. 2020;323:2301-2309. Full text
https://www.medscape.com/viewarticle/932016#vp_1

American Cancer Society Update: ‘It Is Best Not to Drink Alcohol’

In its updated cancer prevention guidelines, the American Cancer Society (ACS) now recommends that “it is best not to drink alcohol.”
Previously, ACS suggested that for those who consume alcoholic beverages, intake should be no more than 1 drink per day for women or 2 per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive.
The guidelines, revised for the first time since 2012, also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity.
Commenting on the guidelines, Steven K. Clinton, MD, PhD, associate director of the Center for Advanced Functional Foods Research and Entrepreneurship at the Ohio State University, Columbus, explained that he didn’t view the change in alcohol as that much of an evolution. “It’s been 8 years since they revised their overall guidelines and during that time frame, there has been an enormous growth in the evidence that has been used by many organizations,” he said.
But importantly, there is also a call for action from public, private, and community organizations to work to together to increase access to affordable, nutritious foods and physical activity.
“Making healthy choices can be challenging for many, and there are strategies included in the guidelines that communities can undertake to help reduce barriers to eating well and physical activity,” said Laura Makaroff, DO, American Cancer Society senior vice president.
The guidelines were published today in CA: A Cancer Journal for Clinicians.
The link between cancer and lifestyle factors has long been established, and for the past 4 decades both government and leading nonprofit health organizations, including the ACS and the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR), have released cancer prevention guidelines and recommendations that focus on managing weight, diet, physical activity, and alcohol consumption.
In 2012 the ACS issued guidelines on diet and physical activity, and their current guideline is largely based on the WCRF/AICR systematic reviews and Continuous Update Project reports, which were last updated in 2018. The ACS guidelines also incorporated systematic reviews conducted by the International Agency on Cancer Research (IARC) and the US Departments of Agriculture and Health and Human Services (USDA/HHS), and other analyses that were published since the WCRF/AICR recommendations were released.

Emphasis on Three Areas

The differences between the old guidelines and the update do not differ dramatically, but Makaroff highlighted a few areas that have increased emphasis.
An area that Makaroff highlighted is alcohol, where the recommendation is to avoid or limit consumption. “The current update says not to drink alcohol, which is in line with the scientific evidence, but for those people who choose to drink alcohol, to limit it to one drink per day for women and two drinks per day for men.”
Thus, the change here is that the previous guideline only recommended limiting alcohol consumption, whereas the update suggests that, optimally, it should be avoided completely.
Time spent being physically active is critical. The recommendation has changed to encourage adults to engage in 150 to 300 minutes (2.5 to 5 hours) of moderate-intensity physical activity, or 75 to 150 minutes (1.25 to 2.5 hours) of vigorous-intensity physical activity, or an equivalent combination, per week. Achieving or exceeding the upper limit of 300 minutes is optimal.
“That is more than what we have recommended in the past, along with the continued message that children and adolescents engage in at least 1 hour of moderate- or vigorous-intensity activity each day,” she told Medscape Medical News.
The ACS has also increased emphasis on reducing the consumption of processed and red meat. “This is part of a healthy eating pattern and making sure that people are eating food that is high in nutrients that help achieve and maintain a healthy body weight,” said Makaroff.
A healthy diet should include a variety of dark green, red, and orange vegetables; fiber-rich legumes; and fruits with a variety of colors and whole grains, according to the guidelines. Sugar-sweetened beverages, highly processed foods and refined grain products should be limited or avoided.
The revised dietary recommendations reflect a shift from a “reductionist or nutrient-centric” approach to one that is more “holistic” and that focuses on dietary patterns. In contrast to a focus on individual nutrients and bioactive compounds, the new approach is more consistent with what and how people actually eat, ACS points out.
The ACS has also called for community involvement to help implement these goals: “Public, private, and community organizations should work collaboratively at national, state, and local levels to develop, advocate for, and implement policy and environmental changes that increase access to affordable, nutritious foods; provide safe, enjoyable, and accessible opportunities for physical activity; and limit alcohol for all individuals.”

No Smoking Guns

Clinton noted that the guidelines are consistent with the whole body of current scientific literature. “It’s very easy to go to the document and look for the ‘smoking gun’ ­— but the smoking gun is really not one thing,” he said. “It’s a pattern, and what dieticians and nutritionists are telling people is that you need to orchestrate a healthy lifestyle and diet, with a diet that has a foundation of fruits, vegetables, whole grains and modest intake of refined grains and meat. You are orchestrating an entire pattern to get the maximum benefit.”
Makaroff is an employee of the ACS. Clinton has disclosed no relevant financial relationships.
CA Cancer J Clin. Published online June 9, 2020. Full text
https://www.medscape.com/viewarticle/931995#vp_1

Malaysia to continue using hydroxychloroquine on Covid-19 patients

The Malaysian health ministry said it will continue to use hydroxychloroquine on Covid-19 patients despite the World Health Organization (WHO) suspending clinical trials of the drug as a potential treatment for the disease.
Health director-general Dr Noor Hisham Abdullah, however, stressed that health authorities were using it “off label” which, he had explained previously, meant it was not recommended.
“Hydroxychloroquine is not a treatment but it can delay or stop the progression into Category 4 and 5. And maybe that’s why we are seeing a low mortality rate,” he said at his daily briefing here today.
Hydroxychloroquine has been commonly used for treatment of malaria for the last 40 years.
Last month, WHO suspended clinical trials of hydroxychloroquine as a precaution after a study suggested the drug could increase the risk of death among Covid-19 patients.
Noor Hisham also said the ministry was using lopinavir and ritonavir, which are widely used for the treatment and prevention of HIV and AIDS, on Covid-19 patients “off label”.
He explained that the ministry was placing children below 12 under the “high risk” group for Covid-19 infections due to immunity concerns.
“Their immunity may differ, sometimes they are not immune, and it is important to look into it,” he said.
He said while there were no Covid-19 mortalities of children under 12, it was the ministry’s role “to protect the children”.
He was asked why children below 12 were classified as a high risk group despite local and international data showing they were less likely to get infected or die from the disease.
https://www.msn.com/en-my/news/national/govt-to-continue-using-hydroxychloroquine-on-covid-19-patients/ar-BB15fhb4?li=BBr8Hnu

Flu shot makers gear up, get creative, for critical vaccination season

With the novel coronavirus continuing its global spread and a second wave threatening the United States later this year, experts worry an influx of influenza patients and COVID-19 patients will hit U.S. hospitals at the same time.
All the more reason to push flu shots—and pharma’s working to ramp up not only for the increased demand but also for the logistical challenges of vaccinating millions of people during a pandemic.
Manufacturers distributed about 170 million flu vaccine doses to the U.S. last year. This year, they’re aiming to increase that by about 20 million, Elaine O’Hara, Sanofi Pasteur’s North America head of commercial operations, told FiercePharma. Vaccine makers are already producing their doses, with plans to start shipping later this summer.
Later this year, companies, health officials and patient advocates plan to encourage flu vaccination to serve two public health goals—to reduce the risk of simultaneous infections or consecutive infections, and to reduce the burden on healthcare systems, said Seqirus’ David Ross, VP of commercial operations in North America.
“Flu immunization is not a distraction from the COVID battle,” Ross said. “It’s a primary tool in this battle.”
COVID-19 is a “very fast and very elusive” pathogen that could devastate healthcare systems when combined with a medium or worse flu season, O’Hara said. CDC director Robert Redfield has been raising alarms over a combination of flu and coronavirus outbreaks this fall and winter, and again reminded a House of Representatives committee about the threat last week.
“In the name of public health, it is so important for people to get vaccinated this year,” O’Hara said.
Sanofi is getting ready to ship up to 80 million flu vaccine doses this year, she said—an increase from 70 million last year. Seqirus shipped 52 million doses last year, and it’s planning to increase that number by about 10% for the coming season, Ross said. GlaxoSmithKline, the third major flu vaccine player, shipped 46 million doses last year and is planning to ship 50 million this year, a spokesman said.

Challenges to vaccination

But even as flu vaccines carry increased importance this year, getting them to people—and increasing the number of overall vaccinations—will be tougher because of social distancing measures, experts said.
O’Hara said she fears a “perfect storm” of a new wave of COVID-19 spooking people into isolation again—even when that includes avoiding a flu shot. Sanofi is working with health systems, doctors and others to provide “best practices” for administering vaccines during the pandemic. Those could include curbside or parking lot immunizations, one-way traffic in clinics, and more, she said.
There are encouraging signs from Australia, Ross said. The country, which is in the midst of its vaccination effort, is seeing higher rates of immunization amid the pandemic thanks to “creative solutions.”
What changes can Americans expect changes to routine flu vaccinations this year? They could include clinics set up in parking lots, parks or community centers to allow for appropriate distancing between people. Plus, flu vaccinations could start earlier and go later than usual, Ross said.
Experts want to do whatever it takes to make sure flu vaccines aren’t wasted, O’Hara said. During the H1N1 pandemic, many doses were eventually discarded, she said.
“We’re really trying to prevent that from happening,” she said.
https://www.fiercepharma.com/vaccines/flu-vaccines-take-even-more-importance-amid-covid-19-but-challenges-await-experts

WuXi Biologics in lease agreement for 3rd U.S. facility in global expansion push

WuXi Biologics is in the midst of gung-ho global expansion effort to spread the CDMO’s roots outside of its Chinese home base. Only a month after announcing its first major U.S. investment, WuXi Biologics has now knocked together two major lease agreements in short succession.
WuXi Biologics signed a 10-year lease agreement to occupy a 66,000-square-foot clinical manufacturing facility in Cranbury, New Jersey, that will become its third plant in the U.S., the CDMO said Monday.
The Cranbury facility will eventually employ 100 and will be fully operational by the end of 2020, WuXi said. The facility will include 6,000 liters of bioreactor space along with process development and quality control labs and other supporting functions.
WuXi Biologics’ entry into the Cranbury hub comes quickly after the Chinese CDMO announced plans to occupy two other facilities in the Northeast.

In May, WuXi clinched a deal to build its first U.S. biologics facility at a 46-acre master-planned manufacturing hub dubbed The Reactory in Worcester, Massachusetts.
The two-story, 107,000-square-foot facility will cost $60 million and employ 150 when it is fully operational in 2022, WuXi said in a release. According to the Worcester Telegram & Gazette, the Worcester City Council in January inked a 20-year, $11.5 million tax increment financing plan to coax WuXi, which will be the The Reactory’s first occupant.
WuXi targeted the greater Boston area for its “talented workforce and impressive biotech network,” WuXi Biologics CEO Chris Chen, Ph.D., said at the time.
“We stand ready and able to help our global partners advance their innovative and life-saving ideas,” Chen said. “Together, I am confident that we have much to contribute to the biologics industry and patients worldwide.”
In May, WuXi followed up that big investment with a lease agreement for a 33,000-square-foot process development lab in King of Prussia, Pennsylvania, the CDMO said.

WuXi’s U.S. push is part of its effort to expand globally. In April 2018, WuXi said it would lay out $392 million to build a biologics facility in Dundalk, Ireland, and create a campus of 2.8 million square feet. That project, its first outside of China, has been in the works for several years and snagged support from Ireland’s development agency. The Dundalk plant will eventually employ 400.
In October 2019, WuXi said it would also build a 15,520-square-meter, three-story vaccines manufacturing facility at the Dundalk site. WuXi said it would produce $150 million worth of vaccines a year for 20 years as part of a $3 billion deal with unnamed partner.
Plus, WuXi has expansion plans in Germany; in January, it announced a deal to take over a Bayer plant in that company’s home city of Leverkusen.
WuXi said it would use the facility for its own purposes but also to provide backup supply for Bayer’s hemophilia drug Kovaltry if needed.
https://www.fiercepharma.com/manufacturing/wuxi-biologics-inks-lease-agreement-for-3rd-u-s-facility-global-expansion-push

Costa Rica to resume use of hydroxychloroquine for COVID-19

Costa Rican health authorities said Monday that the country plans to resume its use of hydroxychloroquine to treat coronavirus patients.
The announcement came from Román Macaya, the executive president of the Costa Rican Social Security System (CCSS), even as he acknowledged the drug’s efficacy against COVID-19 has not yet been proven.
“Efficacy is something we have to answer with a clinical study,” Macaya said.
The CCSS had temporarily stopped using hydroxychloroquine for COVID-19 in late May after a study published in The Lancet prompted the World Health Organization (WHO) to do the same.
That study — which indicated that using the drug on hospitalized coronavirus patients could increase their chances of dying — has since come under independent criticism, and the WHO has resumed its own hydroxychloroquine study.
In Costa Rica, all patients — including those with minor symptoms or who are asymptomatic — are offered the option to take hydroxychloroquine upon their diagnosis, as long as they don’t have contraindications to the drug, Macaya said.
The country has provided the drug to coronavirus patients since conferencing with Chinese experts in April, according to Mario Ruíz, Medical Manager of the CCSS.
Costa Rica has a low case fatality rate (.75%), and fewer than 5% of known active coronavirus cases are currently hospitalized.
“We can’t say that’s a result of this medication, but we can’t discard it either,” Macaya said last month. The CCSS has not released data comparing the outcomes of patients treated with hydroxychloroquine to other methods.
On Monday, Macaya suggested that CCSS’s commitment to daily check-in calls for everyone infected with SARS-CoV-2 has helped keep deaths low.
The daily conversations and ongoing symptom tracking ensure that patients are hospitalized at the appropriate time, Macaya said. 
Costa Rica to resume use of hydroxychloroquine for COVID-19 treatment