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Sunday, April 12, 2020

Amneal running out of hydroxychloroquine material: co-CEOs

Amneal Pharmaceuticals (NYSE:AMRX) may soon run out of the raw ingredients to make hydroxychloroquine because Finland is keeping the drug for domestic use, the company’s co-CEOs tell Reuters.
Amneal has committed to producing 20M hydroxychloroquine tablets by mid-April, but will face challenges making any more after that because of difficulties acquiring active ingredients from its supplier in Finland, co-CEOs Chirag Patel and Chintu Patel say.
Hydroxychloroquine has been promoted by many, including Pres. Trump, as a potential treatment against Covid-19, and demand for the drug has soared worldwide to the extent that some countries such as India have placed restrictions on its export.
Amneal manufactures hydroxychloroquine in India, and the co-CEOs say the company is working with India to provide an exception to ship its finished product to the U.S.
https://seekingalpha.com/news/3559986-amneal-running-out-of-hydroxychloroquine-raw-material-co-ceos-say

Biotech week ahead, April 13

Biotech stocks moved higher last week along with the broader market. The week witnessed a few clinical readouts and pre-announcements that reflected the coronavirus (COVID-19) impact.
Keros Therapeutics Inc KROS 7.42% had a dream debut, with the company pricing the shares at the high-end of the estimated range and the shares closing the debut session about 26% higher than the IPO price.
This upcoming week is likely to continue to see more pre-announcements and disclosures regarding how the COVID-19 pandemic is impacting operations, cash position, financials and clinical trials.

Conferences

Needham Virtual Healthcare Conference: April 14-15

PDUFA Date

The FDA is set to rule Saturday on Urogen Pharma Ltd’s URGN 6.23% NDA for UGN-101 (mitomycin gel), which is being evaluated for the treatment of low-grade, upper tract urothelial cancer.
Clinical Readouts
Vir Biotechnology Inc VIR 1.37% on Wednesday will present at a Key Opinion leader call, an update on its Phase 1/2 hepatitis B virus clinical trial with small interfering ribonucleic acid VIR-2218. Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. ALNY 4.48%.
See Also: Novavax Identifies COVID-19 Vaccine Candidate, Human Testing To Begin In Mid-May

Mid-April Schedule

Ascendis Pharma A/S ASND 0.5%: top-line data from PaTH Forward Phase 2 study of TransCon hGH in treating hypoparathryroidism
Gilead Sciences, Inc. GILD 1.97% could release results from the Phase 3 China studies of remdesivir for the treatment of COVID-19 (sell-side estimate a mid-April release)

Early Q2 Schedule

Axsome Therapeutics Inc AXSM 3.52%: top-line data from the Phase 2/3 study dubbed ADVANCE-1 that is evaluating AXS-05 for treating agitation in patients with Alzheimer’s disease
SCYNEXIS Inc SCYX 2.45%: top-line data from Phase 3 VANISH program, evaluating oral ibrexafungerp for the treatment of Vulvovaginal Candidiasis
Ovid Therapeutics Inc OVID 0.35%: data from the signal-finding Phase 2 ROCKET trial in Fragile X syndrome along with SKYROCKET, its non-interventional trial in Fragile X syndrome.
Iterum Therapeutics PLC ITRM 3.58%: top-line results from the Phase 3 study of sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection

Earnings

Monday
  • Amarin Corporation plc AMRN 4.13% (after the close)
Tuesday
  • Johnson & Johnson JNJ 1.4% (before the market open)
Thursday
  • Abbott Laboratories ABT 1.36% (before the market open)
  • Intuitive Surgical, Inc. ISRG 1.31% (after the close)
https://www.benzinga.com/general/biotech/20/04/15777861/the-week-ahead-in-biotech-urogen-fda-decision-amarin-j-j-earnings-and-more-covid-19-updates

Chronic Pain and COVID-19 — Pain patients may be hit harder than others

Chronic pain patients may be more susceptible to COVID-19, and if infected with the virus, may face different consequences than others.
“There is a complex relationship between chronic pain and the immune system,” said Samer Narouze, MD, PhD, of Western Reserve Hospital in Cuyahoga Falls, Ohio.
“Generally speaking, chronic pain patients can be considered immunocompromised, mainly because so many are elderly and have multiple comorbidities,” he noted. “Many also are on long-term opioid therapy, and this is known to interact with the immune system. Some are on steroids, which also may induce immunosuppression.”
A number of resources are available to guide chronic pain treatment during the COVID-19 outbreak, including guidelines published jointly by the American Society of Regional Anesthesia and Pain Medicine and the European Society of Regional Anesthesia and Pain Therapy.
Pain management during COVID-19 is particularly important to prevent emergency room visits, Narouze said. “Our role is to keep the patient safe at home, minimizing face-to-face interactions,” he noted. “Keep the patient comfortable and safe, so they don’t have to see you or go to the ER.”
Opioids and COVID-19
Patients who use opioids to manage pain need to be especially careful during COVID-19, Narouze observed. “I don’t want to say this is the time to tell pain patients to stop opioid therapy, because they want it for a good reason,” he said. “But they should be mindful that the more you take it, the more you lose respiratory reserves, and you may not be able to fight this infection. We’re not sure — we don’t have data yet — but this makes sense.”
As with many virus-related diseases, COVID-19 can present with extensive muscle aches and pains, noted Jeffrey Fudin, PharmD, of the Stratton VA Medical Center in Albany, New York. “This can aggravate various pain syndromes, particularly those involving muscle and bone,” Fudin pointed out. If a patient has chronic back, neck, or orofacial pain, excessive coughing may worsen it.
“Since this virus affects respiration, there is no doubt that patients on opioids are at an elevated risk of sedation, opioid-induced respiratory depression, and increased mortality,” Fudin said. “Although there have been no specific studies about COVID-19 patients, I’m confident that for persons on one or more sedating drugs in addition to opioids, the risk is even higher,” he added. These drugs include most antidepressants, skeletal muscle relaxants — especially cyclobenzaprine (Flexeril and others) and carisoprodol (Soma) — and anticonvulsants.
“Moreover, for drugs delivered by transdermal routes, such as fentanyl and buprenorphine, elevated body temperature can increase medication absorption,” he added.
Pain patients on opioids should be prescribed emergency naloxone, Narouze emphasized. “Naloxone saves lives, and patients don’t have to go to the ER if they have overdosed,” he said. “We need to do more education here. We need to educate our patients and their partners how to use naloxone if needed.”
During the COVID-19 public health emergency period, the Drug Enforcement Administration has waived federal requirements for in-person visits before prescribing controlled substances and has issued prescribing guidelines.
“An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance, subject to specific conditions,” Fudin explained. “These conditions include, among other things, that the practitioner must sign and date the multiple prescriptions as of the date issued and write on each separate prescription the earliest date on which the prescription can be filled. But some states have stricter laws that require shorter supplies.”
Beyond Opioids
Chronic pain patients may be on oral steroids or may have received a recent steroid intervention, and thus may have an altered immune response, Narouze noted. Steroids, for example, have been associated with a higher risk of influenza, “so we try to avoid steroid injections,” he said. If steroids are needed, the duration of immune suppression may be less with drugs like dexamethasone, he added.
A clinician in France suggested ibuprofen and other NSAIDs may increase the COVID-19 disease severity, but “there is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID-19,” the European Medicines Agency said in a statement.
During the pandemic, many patients may not be able to attend regular physical therapy sessions to help manage pain, but a number of online tools can teach them how to perform exercises at home. “We need to encourage continued movement and adaptive exercise options,” said Beth Darnall, PhD, of Stanford University in Palo Alto, California. The American Chronic Pain Association linked to resources to help patients stay active during the pandemic, she noted.
Clinical video visits are key to promoting patient health and safety, Darnall emphasized. This holds for medical, psychology, and social work consultations, she said: “More than ever, patients need access to all three.” Online support groups also can help pain patients remain connected at a time when people are more isolated.
Importantly, pain patients need to know how to get help if they need it during COVID-19. “Allay patient concerns,” Darnall advised. “If possible, send out messages to patients alerting them to steps being taken to ensure their access to care during COVID-19 and help them prepare for delays in certain services.”
https://www.medpagetoday.com/clinical-challenges/pain-management/85857

Fauci says return to normal life could gradually begin ‘next month’

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, pointed to a glimmer of hope that came from a dark week where coronavirus death counts hit record highs, claiming that the numbers may hint at a promising future.
Fauci said that while the numbers of those who succumbed to COVID-19 rose drastically in recent days — the U.S. hit 2,000 deaths and New York had its highest number of casualties in a single day — new hospital cases were on the decline.

“At the same time that a place like the New York metropolitan area had a really terrible, terrible week of suffering and death, nonetheless the indications of that part of this machine that drives this outbreak is starting to level off,” Fauci told CNN‘s “State of the Union.”
Fauci explained that the same day that New York had its highest number of deaths, other statistics were encouraging.
“When you look at the admissions, the hospitalizations, the intensive care, and the need to intubate, that not only has flattened, it’s starting to turn the corner. So that’s what we’re hopeful [for], and it’s cautious optimism that we are seeing that decrease, and if you look at the patterns of the curves in other countries, once you turn that corner hopefully we’ll see a very sharp decline.”
Fauci warned that it will be a difficult balance to keep the numbers from going back up when the country eventually gets back to normal.
“You want to make sure you don’t do something prematurely and precipitously, at the same time you pay attention to the need to try and get back to normal.”

Fauci also noted that the U.S. will have to be ready to deal with new cases once social distancing measures are lifted or eased, particularly in places like New Orleans and New York City.
“If you start and when one starts to relax some of those restrictions, we know that there will be people who will be getting infected. I mean, that is just reality. The critical issue is to be able to in real time identify, isolate and contact trace. That’s called containment.”
As far as when the U.S. could see a return to normal daily life, Fauci said it is unlikely that it will happen all at once.
“It is not going to be a light switch,” he said. “It’s going to be depending where you are in the country, the nature of the outbreak that you already experienced, and the threat of an outbreak that you may not have experienced.”
Fauci did predict that a return to normal life could begin “at least in some ways maybe next month,” but noted the difficulty in making predictions of that nature. He expressed hope that a gradual process could result in it being safe for Americans to go out to the polls in November for the presidential election. He also warned that a rebound could happen in the fall, but hoped that the country would be better prepared in that even than it was when the outbreak first hit.
https://www.foxnews.com/politics/fauci-expresses-cautious-optimism-over-latest-coronavirus-statistics

COVID-19 Is Making Psychiatric Treatment Tougher

In the best of times, it can be hard to get mental health treatment. But these definitely aren’t the best of times, and even for people who have established relationships with mental health professionals, the coronavirus pandemic is making it harder to find the right care.
The good news is that insurance companies are often reimbursing for telehealth behavioral health services now (even if they weren’t before), and regulations on how mental health professionals can practice are relaxing.
And, for most people, telehealth sessions can be helpful, according to Dr. Shabana Khan, a member of the American Psychiatric Association’s committee on telepsychiatry.
“Telepsychiatry can be used across the lifespan for a wide variety of conditions, including depression and anxiety,” Khan said. She said she’s also used it to treat more serious conditions, such as chronic schizophrenia.
For people in crisis, Khan said providers can do initial evaluations through telemedicine, and if a higher level of help is necessary, they can send people for emergency psychiatric care.
For most people, telemedicine for mental health care can be convenient, and right now, “it can literally save lives,” by keeping people at home, Khan said.
In general, telemedicine is well received by both patients and clinicians, she said. “Some clinicians are surprised at how much patients are embracing the new technology,” Khan added.
Still, the American Psychiatric Association is concerned that not everyone who wants services can get them. Because not everyone has access to a computer or fast internet service, the American Psychiatric Association recently asked the U.S. Centers for Medicare and Medicaid Services to ease requirements and allow telephone appointments.
Vaile Wright is director of clinical research and quality for the American Psychological Association. She said, “It’s very normal for people to feel anxious and fearful right now. These feelings can motivate us to protect ourselves and do things like washing hands and social distancing. It’s [a concern] when fear and anxiety lead us to avoid and isolate and panic.”
Of course, it’s not easy to tell these days if someone is being prudent when they isolate, or if they’re in trouble.
One sign that you should seek help: Your symptoms are interfering in your life or causing you distress, Wright said.
“Don’t wait until it gets too bad,” she said. “If symptoms start to interfere with your life — maybe you can’t get your work done from home or are having trouble attending classes, or if you’re neglecting responsibilities or not taking care of yourself or your family, reach out.”
That doesn’t mean you need to talk to a mental health professional if you have a bad day or two. Almost everyone is struggling now with distraction and loneliness. But, Wright said, if you’ve had symptoms for two weeks or more, you would probably benefit from talking to a clinician.
Wright suggested contacting your primary care doctor or your insurer for recommendations and to find out who is covered by your insurance.
“Most providers have moved to some sort of telehealth platform,” she said. “The rules for this vary from state to state.”
Whether you’re getting professional mental health care or not, Wright emphasized it’s important to try to stay social as much as you can — even with stay-at-home orders in place.
“There are still ways to virtually connect with others, though it will take some creativity and effort,” she said. “But, it’s important to meet your social needs, even when it might be easier to isolate.”
More information
The American Psychological Association offers advice on finding local mental health resources. If you or someone you know is thinking about suicide, call the National Suicide Prevention Lifeline at 800-273-8255.

SOURCES: Shabana Khan, M.D., committee on telepsychiatry, American Psychiatric Association, and child and adolescent psychiatrist, NYU Langone Health, New York City; Vaile Wright, Ph.D, director of clinical research and quality, American Psychological Association, Washington, D.C.
https://consumer.healthday.com/infectious-disease-information-21/coronavirus-1008/covid-19-is-making-psychiatric-treatment-tougher-756563.html

Heart Patients Should Ask About Home-Based Cardiac Rehab

For those with heart problems, home-based rehab can take the place of hospital-based cardiac rehabilitation during the current coronavirus pandemic, heart experts say.
“Home-based cardiac rehab is a solution to help provide cardiac rehabilitation to patients with heart disease in a home setting, and to help them survive and thrive during this challenging period of time,” said Dr. Randal Thomas. He’s a preventive cardiologist and medical director of the Mayo Clinic’s Cardiac Rehabilitation Program, in Rochester, Minn.
“Home-based cardiac rehabilitation is much more than just going for a walk at home,” Thomas said in a clinic news release. “It is a structured, standardized, evidence-based approach to apply all therapies — lifestyle, medication and otherwise — that are known to help people with heart disease do better, feel better and live longer.”
Mayo Clinic has used home-based cardiac rehab with a small number of patients over the years, but the coronavirus pandemic has made it necessary to transition all cardiac rehab to home-based settings in a matter of weeks.
If you qualify for cardiac rehab, ask your care provider if at-home rehabilitation is an option for you as well.
According to Thomas, there are many reasons why home-based cardiac rehab is so important right now.
A big advantage of home rehab is that it keeps patients out of the hospital. Home rehab also ensures that patients get cardiac rehab wherever they live, while social distancing from others, especially other older patients with heart disease.
In-home rehab also promotes healthier eating, which is helpful as most restaurants are closed, Thomas said.
Rehab is also good for mental and emotional health. Taking charge of your health can have a positive effect.
At-home rehab can also help you quit smoking. Not smoking lowers the risk of developing COVID-19 because smoking makes it easier for the virus to get into body cells. Smoking also damages lung tissues, making them easier to infect, he explained.
Home-based rehab connects patients with medical professionals who can help them through recovery after a heart attack or surgery.
Through in-person assessments, phone calls, online messaging, wearable monitoring devices and other approaches, cardiac rehabilitation professionals help guide heart patients through the same components of care, just as in a hospital-based program, Thomas said.
More information
For more on cardiac rehabilitation, head to the American Heart Association.
https://consumer.healthday.com/infectious-disease-information-21/coronavirus-1008/heart-patients-should-ask-about-home-based-cardiac-rehab-756435.html

DOD, UW Medicine testing app that can predict infection outbreaks

Seattle-based University of Washington Medicine is rolling out a smartphone app to 25,000 study participants to screen for virus infections and predict outbreaks sooner, according to a news release.
The Defense Department’s Defense Advanced Research Projects Agency is funding the project, which will include collecting information from four cohorts of participants over a two-year period. Participants are recruited for 12 weeks at a time and are asked to record their symptoms daily.
“This is a huge opportunity for us to get a sense as to whether or not phones could basically become a personal screener for an illness without having to go to a drive-in screening clinic or to a hospital to figure out if a pandemic is blooming,” said Patricia Arean, PhD, a psychiatry and behavioral sciences professor at UW Medicine.
Despite being in the middle of a pandemic, Dr. Arean said it’s a good time to collect data and build out the predictive algorithm from the app so the researchers can start to test the technology in the fall and winter.
The app is called the Health and Injury Prediction and Prevention Using Complex Reasoning and Analytic Techniques Integrated on a Cellphone App, or HIPPOCRATIC app.
https://www.beckershospitalreview.com/consumerism/dod-uw-medicine-testing-app-that-can-predict-infection-outbreaks.html