Biotech week ahead, Mar. 8

 Biotech stocks continued to move southward in the week ended March 5, as the broader market extended its sell-off. Though light on news, the week did witness earnings releases from smaller biopharma companies, coronavirus vaccine program updates, mixed FDA rulings and clinical readouts.

Morphic Holding Inc MORF 1.39% was among the biggest gainers of the week after the company reported a positive early-stage readout in inflammatory bowel disease patients.

M&A momentum continued, as Amgen Inc. (AMGN) announced a deal to buy Five Prime Therapeutics, Inc. FPRX 0.63% in an $1.9-billion all-cash deal.

Here are the key catalysts for the unfolding week:

Conferences

Chardan's 3rd Annual Microbiome Medicines Summit: March 8

H.C. Wainwright Global Life Sciences Conference: March 9-11

Barclays Global Healthcare Conference: March 9-11

15th International Conference on Alzheimer's and Parkinson's disease: March 9-14

Clinical Readouts

Prothena Corporation plc PRTA 0.9% will present at the Alzheimer's and Parkinson's disease conference new preclinical data on a treatment for Alzheimer's disease. The treatment targets an anti-tau antibody, which is thought to play a role in the disease. The company says targeting a certain antibody called a novel epitope with PRX005 has shown superior results. The presentation is scheduled for Thursday, March 11, between 7:30 a.m. and 7:45 a.m.

Earnings

Monday

Minerva Neurosciences, Inc. NERV 1.06% (before the market open)
Syndax Pharmaceuticals, Inc. SNDX 4.43% (after the close)
Castle Biosciences, Inc. CSTL 1.04% (after the close)
SI-BONE, Inc. SIBN 0.96% (after the close)
Avadel Pharmaceuticals plc AVDL 2.12% (after the close)

Tuesday

Xeris Pharmaceuticals, Inc. XERS 2.02% (before the market open)
Trevena, Inc. TRVN 0.48% (before the market open)
InspireMD, Inc. NSPR 5.87% (before the market open)
Marinus Pharmaceuticals, Inc. MRNS 4.03% (before the market open)
DarioHealth Corp. DRIO 10.25% (before the market open)
Gamida Cell Ltd. GMDA 1.54% (before the market open)
Evelo Biosciences, Inc. EVLO 2.88% (before the market open)
ANI Pharmaceuticals, Inc. ANIP 3.87% (before the market open)
Aquestive Therapeutics, Inc. AQST 4.5% (after the close)
Brickell Biotech, Inc. BBI 0.86% (after the close)
Cytosorbents Corporation CTSO 0.69% (after the close)
Cumberland Pharmaceuticals Inc. CPIX 2.66% (after the close)
MiMedx Group, Inc. MDXG 5.06% (after the close)
Inari Medical, Inc. NARI 2.45% (after the close)
Lyra Therapeutics, Inc. LYRA 2.64% (after the close)

Wednesday

Bio-Path Holdings, Inc. BPTH 5.57% (before the market open)
Harvard Bioscience, Inc. HBIO 8.44% (before the market open)
BioDelivery Sciences International, Inc. BDSI 0.75% (before the market open)
Clearside Biomedical, Inc. CLSD 2.77% (after the close)
DiaMedica Therapeutics Inc. DMAC 0.58% (after the close)
Five Prime Therapeutics FPRX 0.63% (after the close)
Flexion Therapeutics, Inc. FLXN 0.26% (after the close)
Harpoon Therapeutics, Inc. HARP 7.78% (after the close)
Lantern Pharma Inc. LTRN 2.54% (after the close)
TFF Pharmaceuticals, Inc. TFFP 5.02% (after the close)
Lexicon Pharmaceuticals, Inc. LXRX 1.8% (after the close)
Protagonist Therapeutics, Inc. PTGX 3.59% (after the close)
OrthoPediatrics Corp. KIDS 2.37% (after the close)

Thursday

Burning Rock Biotech Limited BNR 5.37% (before the market open)
BioXcel Therapeutics, Inc. BTAI 5.21% (before the market open)
Aldeyra Therapeutics, Inc. ALDX 0.09% (before the market open)
Achieve Life Sciences, Inc. ACHV 1.44% (after the close)
Capricor Therapeutics, Inc. CAPR 5.53% (after the close)
Lineage Cell Therapeutics, Inc. LCTX 0.53% (after the close)
Geron Corporation GERN 1.69% (after the close)
Chembio Diagnostics, Inc. CEMI 1.83% (after the close)
Ocular Therapeutix, Inc. OCUL 6.81% (after the close)
Nabriva Therapeutics plc NBRV 2.29% (after the close)

https://www.benzinga.com/general/biotech/21/03/20044204/the-week-ahead-in-biotech-march-7-13-conference-presentations-and-more-earnings

NY officials removed fuller tally of nursing home deaths

 Gov. Andrew Cuomo’s administration insisted Friday that a quest for scientific accuracy, not political concerns, prompted members of his COVID-19 task force to ask the state health department to delete data last summer from a report on nursing home patients killed by the coronavirus.

The Wall Street Journal and The New York Times, citing documents and people with knowledge of the administration’s internal discussions, reported late Thursday that aides including secretary to the governor Melissa DeRosa pushed state health officials to edit the July report so it counted only residents who died inside long-term care facilities, and not those who died later after being transferred to a hospital.

At the time, Cuomo was trying to deflect criticism that his administration hadn’t done enough to protect nursing home residents from the virus. About a third of the state’s nursing home fatalities were excluded from the report as a result of the change.

The revelations about the removal of the higher fatality number come as the Democrat also faces accusations he sexually harassed two former aides and a woman that he met at a wedding.

Cuomo had apologized Wednesday for acting “in a way that made people feel uncomfortable” but rejected calls for his resignation and said he would fully cooperate with the state attorney general’s investigation into the sexual harassment allegations. Federal investigators are scrutinizing his administration’s handling of nursing home data.

Top Democrats in the state have said they want those investigations to conclude before they make a judgment about Cuomo’s conduct, but in the wake of Thursday night’s report, a few state lawmakers renewed calls for the governor to either resign or be ousted.

“And Cuomo hid the numbers. Impeach,” tweeted Queens Assembly member Ron Kim, who said Cuomo bullied him for criticizing how Cuomo withheld nursing home data.

White House Press Secretary Jen Psaki said Friday that the allegations that Cuomo aides deleted data from the report was “troubling” and said the White House “certainly would support any outside investigation.”

The July nursing home report was released to rebut criticism of Cuomo over a March 25 directive that barred nursing homes from rejecting recovering coronavirus patients being discharged from hospitals. Some nursing homes complained at the time that the policy could help spread the virus.

The report concluded the policy didn’t play a major role in spreading infection.

The state’s analysis was based partly on what officials acknowledged at the time was an imprecise statistic. The report said 6,432 people had died in the state’s nursing homes.

State officials acknowledged even then that the true number of deaths was higher because the report was excluding patients who died in hospitals.

But they declined at the time to give any estimate of that larger number of deaths, saying the numbers still needed to be verified.

In fact, the original drafts of the report had included that number, then more than 9,200 deaths, until Cuomo’s aides said it should be taken out.

State officials insisted Thursday that the edits were made because of concerns about accuracy. The administration initially released data about how many nursing home residents died at both hospitals and nursing homes, but quietly stopped in early May.

“While early versions of the report included out of facility deaths, the COVID task force was not satisfied that the data had been verified against hospital data and so the final report used only data for in facility deaths, which was disclosed in the report,” Department of Health Spokesperson Gary Holmes said.

The governor’s office didn’t respond to questions from The Associated Press about whether Cuomo himself was involved in removing the higher death total from the report.

Scientists, health care professionals and elected officials assailed the report at the time for flawed methodology and selective stats that sidestepped the actual impact of the directive.

The administration refused for months to release more complete data. A court order and state attorney general report in January forced the state to acknowledge the nursing home resident death toll was higher than the count previously made public.

DeRosa told lawmakers earlier this month that the administration didn’t turn over the data to legislators in August because of worries the information would be used against them by President Donald Trump’s administration.

“Basically, we froze, because then we were in a position where we weren’t sure if what we were going to give to the Department of Justice or what we give to you guys, what we start saying was going to be used against us while we weren’t sure if there was going to be an investigation,” DeRosa said.

Cuomo and his health commissioner recently defended the March directive, saying it was the best option at the time to help free up desperately needed beds at the state’s hospitals. And they’ve argued community spread is the biggest risk factor for nursing homes, and that it’s unlikely that most hospital patients treated for COVID-19 were contagious once they arrived.

“We made the right public health decision at the time. And faced with the same facts, we would make the same decision again,” Health Commissioner Howard Zucker said Feb. 19.

The state now acknowledges that at least 15,000 long-term care residents died, compared to a figure of 8,700 it had publicized as of late January that didn’t include residents who died after being transferred to hospitals.

https://apnews.com/article/reports-ny-officials-altered-count-nursing-homes-death-58b0f62d0f88328e911d0d5c65bbf7fe

After Seniors, Those with Intellectual Disabilities at Greatest Risk of Death from COVID

 Intellectual disability puts individuals at higher risk of dying earlier in life than the general population, for a variety of medical and institutional reasons.  A new study from Jefferson Health examined how the COVID-19 pandemic has affected this group, which makes up 1-3% of the US population. The study, published today in the New England Journal of Medicine (NEJM) Catalyst, found that intellectual disability was second only to older age as a risk factor for dying from COVID-19.

“The chances of dying from COVID-19 are higher for those with intellectual disability than they are for people with congestive heart failure, kidney disease or lung disease,” says lead author Jonathan Gleason, MD, the James D. and Mary Jo Danella Chief Quality Officer for Jefferson Health. “That is a profound realization that we have not, as a healthcare community, fully appreciated until now.”

The authors examined 64 million patient records from 547 healthcare organizations between January 2019 to November 2020 to understand the impact of the COVID-19 pandemic on patients with intellectual disabilities. They identified variables such as COVID-19, intellectual disability or other health conditions, as well as demographic factors such as age.

The results showed that those with intellectual disabilities were 2.5 times more likely to contract COVID-19, were about 2.7 times more likely to be admitted to the hospital and 5.9 times more likely to die from the infection than the general population.

“Our failure to protect these deeply vulnerable individuals is heart-breaking,” says co-author Wendy Ross, MD, a developmental and behavioral pediatrician and director for the Center for Autism and Neurodiversity at Jefferson Health. “I believe that if we can design a system that is safe and accessible for people with intellectual disabilities, it will benefit all of us.”

The authors write that patients with intellectual disabilities may have less ability to comply with strategies that reduce the risk of infection, such as masking and social distancing. In addition, the researchers showed that these patients are more likely to have additional health conditions that contribute to a more severe course of COVID-19 disease. The results of the study highlight how these issues become compounded in this population.

“We need to understand more about what is happening with these patients,” says Dr. Gleason. “I do believe these patients and their caregivers should be prioritized for vaccination and healthcare services. We should reflect on why we have failed this vulnerable population, and how we can better serve them during this health crisis, and into the future,” Dr. Gleason says.  “Even prior to the pandemic, individuals with intellectual disabilities have had poor health outcomes. We need to do much better.”

The authors suggest key action steps that require a rapid response. “First, those with intellectual disabilities and their caregivers should be prioritized for vaccines by organizations that set federal guidelines, including the CDC,” says Dr. Gleason. “Second, federal and state healthcare regulatory offices should measure access, quality and safety in this population in order to track our ability to improve health outcomes for these patients. Finally, the United States should redesign the care model for individuals with intellectual disabilities.” 

“As an organization deeply committed to advocating for the health of one of the most marginalized populations – those with intellectual disabilities (ID) – we have seen the need for people with ID to be prioritized as a high-risk group during this pandemic.  It’s devastating to hear that people with ID are almost six times more likely to die from COVID-19,” said Alicia Bazzano, MD, PhD, MPH, Chief Health Officer of the Special Olympics. “Most health authorities do not recognize that people with ID who get COVID-19 have a much higher risk of dying. Special Olympics is grateful to the Jefferson team for shining a spotlight on these devastating numbers." 

Article Reference: Jonathan Gleason, Wendy Ross, Alexander Fossi, Heather Blonsky, Jane Tobias, Mary Stephens, “The Devastating Impact of COVID-19 on individuals with intellectual disabilities in the United States,” NEJM Catalyst, DIO: 10.1056/CAT.21.0051, 2021. https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0051

https://www.newswise.com/coronavirus/after-the-elderly-those-with-intellectual-disabilities-are-at-greatest-risk-of-death-from-covid-19/?article_id=747305

87.6% in Japan poll say Olympics should be canceled or postponed again

 The opening ceremony of the Tokyo Olympics on July 23, 2021 is approaching four months, but the event is still uncertain.

　The rate of increase in the number of people infected with the new coronavirus in Japan has exceeded a temporary peak, and the state of emergency has been lifted outside the Tokyo metropolitan area. However, there is no reason to be optimistic that it will continue to converge smoothly.

　On March 3rd, the British Times published a column entitled "It's Time to Cancel" about the Olympics and Paralympics, and the option of canceling is becoming more and more realistic worldwide.

　Therefore, "Bungei Online" conducted the following questionnaire regarding the holding of the Tokyo Olympics and Paralympics.

Q. Do you think the Tokyo Olympics should be held from July 2021 as scheduled?

 

　A. Should be held from July 2021 as scheduled

　B. Should be canceled

　C. Should be postponed again after next year

　D. I don't know

Questionnaire results 63.1% answered "should be canceled" and 24.5% answered "reposted"

　Despite the short voting period from January 25th to February 25th, 2021, this survey has a total of 1590 votes (71.5% for men and 28.5% for women) from a wide range of people aged 20 to 92. ) Gathered.

　Overall, 9.4% said they should hold the event from July 2021, 63.1% said they should cancel it, 24.5% said they should postpone it again, and 3.0% said they didn't know.

Many of the reasons for the opinion that "it should be held" were that "cancellation has a large economic loss", but there are also voices that it is meaningful to hold it now, saying that "an image with nobody symbolizes the corona disaster". Was seen. 10.3% of men answered that they should hold the event.

　As for the reason why many opinions were concentrated on "should be stopped", there were many opinions who insisted on the priority of corona countermeasures, saying that "a cluster may occur in Tokyo". Some complained of the gap with the current restrictions, saying, "Even though eating out is restricted, the Olympics cannot be held."

　Most of the reasons for "should be postponed again", which can be said to be in the middle, were "the facility I made is wasteful" and "I want to determine the effectiveness and spread of the vaccine".

https://bunshun.jp/articles/-/43846

Shopify store sells fake COVID vaccine certs for $20

 Scammers lost little time setting up online stores to sell fraudulent COVID-19 vaccination certificates after the first jabs started to be used in the US, says DomainTools.

The cybersecurity specialist identified the first Shopify-backed store selling fake certificates on January 31, a few weeks after the US immunisation programme got underway. The covid-19vaccinationcards.com storefront redirected to vaccination-cards.com and was selling cards for $20 apiece, or four for $60.

DomainTools’ senior security researcher Chad Anderson writes in a blog post that the cards carried the logo of the US Center for Disease Control and Prevention (CDC).

“Though selling a printed card is not necessarily illegal, the pricing, logo, and cardstock of these “vaccination records” demonstrate a level of intent to pass as legitimate cards from the CDC,” according to Anderson, who says another recent example of the scam was the sale of UK-themed cards on eBay.

“The DomainTools Research team has reached out to Shopify regarding this site and is monitoring for similar instances of COVID-19 vaccine cards,” he adds.

With no nationwide, or even international, database for verifying vaccinations in place, paper record cards are currently the only way to tell if an individual has been vaccinated, but are easy to forge.

DomainTools notes that social media is flooded with people proudly displaying their vaccination certificates in the US, giving “would-be fraudsters a chance to copy details such as batch numbers and other information”, and the government is recommending these images be taken down.

What is needed is a set of standards for a digital certificate that could be used to allow public access to venues, or to ease international travel, according to proponents of ‘vaccine passport’ schemes. Greece, Israel, the UK and the EU have all started either introducing such a certificate or are considering doing so.

Singapore meanwhile has said there needs to be a secure, mutually recognised certification scheme, and that using digital rather than printed certificates could help to ensure authenticity. Meanwhile, the International Air Transport Association (IATA) has said it plans to unveil a digital COVID-19 Travel Pass within the next few weeks.

The pass takes the form of an app that verifies a passenger has had the tests or vaccines required to enter a country, and aims to revitalise the beleaguered travel industry.

https://www.securingindustry.com/security-documents-and-it/shopify-store-sells-fake-covid-vaccine-certs-for-20/s110/a13088/#.YEOkV2hKjal

WHO, SII Warn Of Raw Materials Shortage For COVID Shots, Cite US Law As 'Serious' Limit

 

• The head of Serum Institute of India (SII) and the World Health Organization’s chief scientist said that COVID-19 vaccine makers are amid a global shortage of the raw materials to manufacture the shots, Bloomberg reported.
• SII’s CEO Adar Poonawalla told a World Bank panel that a U.S. law blocking the export of certain key items, including bags and filters, will likely cause serious bottlenecks.
• WHO’s chief scientist Soumya Swaminathan also added that there is a shortfall of required vials, glass, plastic, and stoppers.
• SII, the largest vaccine maker, is licensed to produce COVID-19 vaccines from AstraZeneca Plc (NASDAQ: AZN) and Novavax Inc (NASDAQ: NVAX).
• Those supply disruption concerns have cropped up after the Biden administration announced plans to use the Defense Production Act to boost supplies needed for Pfizer Inc’s (NYSE: PFE) vaccines.
• “There is a shortage of materials, of products that you need for the manufacturing of vaccines,” said Swaminathan. “This is where again you need global agreement and coordination not to do export bans.”
• Last month, Financial times discussed vaccine manufacturers’ struggle to secure supplies of giant plastic bags used in bioreactors that mix pharmaceutical ingredients, thus creating a bottleneck, resulting in more vaccine rollout delays.
• WHO will hold meetings on Monday and Tuesday next week to discuss these issues.

https://www.benzinga.com/general/biotech/21/03/20028069/who-sii-warn-of-raw-materials-shortage-for-covid-19-shots-cites-us-law-as-serious-limit-bloomberg