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Wednesday, July 7, 2021

Quidel recalls Lyra Covid test due to high risk of false negatives

 Quidel is recalling its Lyra Covid-19 Assay test due to a high risk of false negative results in patients who actually have high amounts of the virus.

Quidel is a company that produces diagnostic health-care products around the world. The Covid test was given emergency use authorization by the Food and Drug Administration in March. It uses a swab sample from the nasal area to detect RNA that is specific to the SARS-CoV-2 virus.

“False negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death,” the FDA wrote on its website announcing the recall.

False negative results could also lead to further spread of the virus in a community and may put other high-risk individuals at risk of injury or death.

Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use. The company’s shares slumped by about 5% in after-hours trading.

https://www.cnbc.com/2021/07/07/fda-recalls-quidels-lyra-covid-test-due-to-high-risk-of-false-negative-results.html

FOMC Minutes: 'Inflation Risks tilted to upside,' begin reducing asset purchases 'somewhat earlier'

 From the Fed: Minutes of the Federal Open Market Committee, June 15-16, 2021. A few excerpts:

In discussing the uncertainty and risks associated with the economic outlook, participants commented that the process of reopening the economy was unprecedented and likely to be uneven across sectors. Some participants judged that supply chain disruptions and labor shortages complicated the task of assessing progress toward the Committee's goals and that the speed at which these factors would dissipate was uncertain. Accordingly, participants judged that uncertainty around their economic projections was elevated. Although they generally saw the risks to the outlook for economic activity as broadly balanced, a substantial majority of participants judged that the risks to their inflation projections were tilted to the upside because of concerns that supply disruptions and labor shortages might linger for longer and might have larger or more persistent effects on prices and wages than they currently assumed. Several participants expressed concern that longer-term inflation expectations might rise to inappropriate levels if elevated inflation readings persisted. Several other participants cautioned that downside risks to inflation remained because temporary price pressures might unwind faster than currently anticipated and because the forces that held down inflation and inflation expectations during the previous economic expansion had not gone away or might reinforce the effect of the unwinding of temporary price pressures.
...
Participants discussed the Federal Reserve's asset purchases and progress toward the Committee's goals since last December when the Committee adopted its guidance for asset purchases. The Committee's standard of "substantial further progress" was generally seen as not having yet been met, though participants expected progress to continue. Various participants mentioned that they expected the conditions for beginning to reduce the pace of asset purchases to be met somewhat earlier than they had anticipated at previous meetings in light of incoming data. ...

Various participants offered their views on the Committee's agency MBS purchases. Several participants saw benefits to reducing the pace of these purchases more quickly or earlier than Treasury purchases in light of valuation pressures in housing markets. Several other participants, however, commented that reducing the pace of Treasury and MBS purchases commensurately was preferable because this approach would be well aligned with the Committee's previous communications or because purchases of Treasury securities and MBS both provide accommodation through their influence on broader financial conditions. In coming meetings, participants agreed to continue assessing the economy's progress toward the Committee's goals and to begin to discuss their plans for adjusting the path and composition of asset purchases. In addition, participants reiterated their intention to provide notice well in advance of an announcement to reduce the pace of purchases.
emphasis added

https://www.calculatedriskblog.com/2021/07/fomc-minutes-inflation-risks-tilted-to.html

Imugene HER2 vaccine hits target in stomach cancer trial

 A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial.

The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response or better, compared to 29% of patients given only chemo.

The reduction in tumour size was also substantially higher in patients that received HER-Vaxx, according to Imugene, which reported the results at the ESMO World Congress on Gastrointestinal Cancer yesterday.

It also said that the tumour response was aligned to the level of HER2-targeting antibodies generated by the vaccine, which is given as three doses over a 35-day period.

Previously, the biotech has reported results showing that adding HER-Vaxx to chemo reduced the risk of death by 58%, with patients living a median of 14 months compared to around nine months with chemo alone.

HER-Vaxx is a B-cell activating cancer immunotherapy that consists of several B cell epitopes derived from the extracellular domain of HER2.

Imugene hopes that its vaccination approach could generate a more potent anti-HER2 response than antibody-based drugs such as Roche’s Herceptin (trastuzumab) and Perjeta (pertuzumab), which have formed the backbone of treatment for HER2 tumours for years.

The company said in a statement that the vaccine “may provide treatment benefits consistent with traditional monoclonal antibodies with a corresponding adaptive immune response without added toxicity.”

The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.

Among these for example is AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (trastuzumab deruxtecan), which has been approved for third-line use in HER2-positive breast cancer as well as previously-treated HER2-positive gastric cancer, and Seattle Genetics orally-active Tukysa (tucatinib) which was cleared for use alongside chemo in breast cancer last year.

The positive results with HER-Vaxx come just a few days after Imugene reported it had been cleared to start a US clinical trial of its lead oncolytic virus candidate CHECKvacc (CF33-hNIS-antiPDL1) in advanced, triple-negative breast cancer (TNBC).

https://pharmaphorum.com/news/imugene-her2-vaccine-hits-target-in-stomach-cancer-trial/

How Doximity parlayed its popularity with doctors into a blockbuster IPO

 Doximity exploded onto the public markets last month with an IPO that saw share values of the physician social networking startup double in 24 hours.

The company raised $500 million — and the eyebrows of many industry observers — with its stock market debut, its first public fundraise since 2014. More than 10,000 physicians participated in the IPO, making them the biggest collective Doximity shareholder, according to Nate Gross, the company’s co-founder and chief strategy officer.

One secret to the company’s success going from startup to stock market darling: It frequently pulls ideas from physician users and the members of its scientific advisory board, who regularly participate in company brainstorming sessions and events, Gross told STAT. That’s how Doximity came up with the plan to create the telehealth platform Dialer, which launched in 2020.

“We joke that the best ideas come on the second day after the second glass of wine, because it takes time to get a group to the level of candor where the best ideas are freely flowing,” Gross said.

STAT spoke with Gross, who is also a co-founder of the digital health venture firm Rock Health, about what Doximity has been up to since 2014, whether the newly-passed federal information blocking rule could impact its business, and how having a broad investor base might be beneficial for health tech companies. This interview has been edited and condensed for length and clarity.

What prompted you to go public? What have you been up to since 2014?

The timing was right. The entire health care industry has shifted to digital in recent years. We felt our model was working, proven, and would drive growth. It was the time to scale.

Since 2014, we’ve been focusing on the productivity needs of clinicians. Our members can access digital faxing and telehealth, and they have the ability to make referrals and stay up-to-date on the latest medical research in our news feed, our app’s starting point. Since the last funding round, we’ve been investing in each of those segments and working with our physician members to fine tune them to what matters to them.

When you deliver real value to doctors you can run your business responsibly. Taking the time with investors who are patient and will think alongside you about things like fit and membership satisfaction before growth, that’s really important. So in 2014, we had business models that were working well enough where we didn’t have to raise until the IPO.

Your investors aren’t the typical names I’m used to seeing these days in digital health. None of them is explicitly focused on digital health or health care. Is there something about these non-niche backers that you think may have helped or harmed you?

We raised our Series A from Interwest, which has a long history of supporting digital health innovation, and from Emergence Capital Partners. Emergence has backed companies like Salesforce and Zoom, and while those aren’t classic health care companies, there’s a lot we can learn from them. They’re on top of the trends with regard to cloud storage and subscription models, and they have an investment thesis around the deskless workforce: They spend a lot of time thinking about how they can help entrepreneurs who are deskless do well. That works in parallel with our mission, which is to help doctors be more successful with their patients.

Emergence and other investors also helped us take the time to optimize so we could grow organically, virally, without having to spend to acquire. Our advertising spend last year was $2.6 million. That patience is something really special if you want to grow a company with the strongest network effect and the most user trust and alignment.

How has your vision of what Doximity could be changed from 2011, when you launched, to today?

What hasn’t changed is our mission to help doctors be more productive so they can provide better patient care. Our mantra is physicians first — we develop technology that works for doctors and not the other way around.

Now with the interest in our telehealth platform, we’re thinking about how to improve on that experience. A lot of what physicians do during telehealth is educate. We have a vision to expand those capabilities. We recently announced partnership with UpToDate, the online clinical reference, so that doctors can make sure they have access to the latest materials during each visit. And we’ve been building out what we call “wall charts,” which lets doctors pull up a picture of, for example, an anatomical beating heart, so they can show the patient their coronary arteries and make that experience interactive.

Where do you get your ideas for new products?

A lot of them come from our physicians. We spend a lot of time talking to them and during what we call capstone events, or our medical advisory boards, we take a number of ideas over the past year and whittle them down into what we think will make the biggest impact in their day-to-day practice. At end of the event, physicians present to us. We use that as our product roadmap and our compass.

Our telehealth product idea came from a member of our medical advisory board. It was a cardiologist from Northern Florida who had to make a lot of patient calls, and physicians were increasingly concerned about their patients’ ability to call back, whatever hour it might be. That idea eventually became the foundation for our telehealth suite.

In the documents you filed to go public, you estimated Doximity’s total addressable market (TAM) to be $18.5 billion. That’s orders of magnitude smaller than other health tech companies, including Hims & Hers, One Medical, Oscar, and Talkspace. Did you underestimate yourself?

Telehealth is a rapidly changing industry, and there are a lot of different views on how big it will be. We’re extremely bullish on it. We focus on the software component. There are a lot of folks out there trying to be the Amazon of health care — including Amazon itself. Our approach is more like Shopify, where we help existing practices and doctors digitize. We’re not a practice of Doximity-employed doctors out there trying to compete with primary care clinics. We’re helping our members and partners digitize their practices to make them as seamless as possible.

How big of a component of your business does your telehealth offering represent compared with your social networking services?

Our telehealth suite is one of several popular features on the network, but our news feed is far more popular. As far as the business, [telehealth] represents a low single digit percentage of our revenue. It’s still very new, however. We’ve only been working on the enterprise version of it for the past year, and we’ve seen rapid adoption. We have annual subscription agreements with over 150 hospitals just for telehealth.

One of Doximity’s unique offerings involves helping doctors refer patients to other doctors. With the introduction of the information blocking rule, which will likely make this referral process easier, are you worried about new competitors or other potential impacts?

Preventing information blocking has been at the heart and soul of Doximity’s existence for years. The rule has been a long time coming, but there’s still a long way to go. I think there are multiple paths to improvement here. Doctors want information to be able to be exchanged, and we help them do that today with near ubiquity.

What do you think matters the most to the clinicians who use your platform?

In our telehealth product, one popular feature is being able to add an interpreter. That can matter a lot if, say, I have a patient from Ethiopia who speaks Amharic where, to make sure they receive the same quality of care as someone who speaks English, you need that functionality.

And for many people, our telehealth tool might be their first telehealth experience, since many practitioners are older and might be less familiar with this. We want a tech revolution where nobody’s left behind and everyone can participate, so we allow for things like backwards compatibility between voice and video, and from analog phone calls to digital calls. For example, a physician can call their patient and have their hospital phone number appear on the patient’s caller ID, so they’re more likely to answer, and they can call back at any time of day. In a tap doctors can also upgrade calls to video, the same way you and I might do using FaceTime video.

And importantly that’s without making the patient install that software or go through an extra login portal. That helps ensure care can be delivered regardless of a patient’s geography, demographics, etc. and lets clinicians focus on what matters, which is giving the best possible care in every interaction.

https://www.statnews.com/2021/07/07/doximity-ipo-doctors-social-network/

US regulator throws Chemocentryx a debatable lifeline

 Delays to US approval action dates are usually thought of as negative, but the one to Chemocentryx’s avacopan arguably provides a glimmer of hope. This complement factor C5a inhibitor had been written off by some analysts after a mixed adcom vote for ANCA-associated vasculitis in May, but yesterday its Pdufa date, which would have fallen today, was delayed until October 7. Chemocentryx rose 7%, so why could this be good news? Because the delay was prompted by the company’s submission of a filing amendment said to address “points raised” during the adcom. This has been interpreted as a sign, however remote, that the FDA is willing to evaluate new data and other arguments in favour of avacopan’s approval. While Wells Fargo said there was still no clear read-through to approvability, Leerink called the development a surprising apparent change in direction from the FDA. Stifel, meanwhile, provided an analysis suggesting that, in fact, Pdufa date extensions over the past six years have usually resulted in approval. Evaluate Pharma sellside consensus of 2026 avacopan revenue of $799m still looks like a long shot, but at least Chemocentryx has avoided a complete response letter for now.

Pdufa date delays 2015-21
ProductSponsor Indication Approved? 
KanumaAlexionLysosomal acid lipase deficiencyY
Exondys51SareptaDuchenne muscular dystrophyY
Heplisav-BDynavaxHepatitis B preventionN (CRL)*
XermeloLexiconCarcinoid syndromeY
RociletinibClovisT790m NSCLCN (discontinued)
TymlosRadiusPostmenopausal osteoporosisY
AndexxaPortolaAnticoagulantY
PalynziqBiomarinPhenylketonuriaY
InbrijaAcordaParkinson's diseaseY
ZulressoSagePostpartum depressionY
SunosiJazzNarcolepsy/obstructive sleep apnoeaY
XpovioKaryopharmMultiple myelomaY
GvokeXerisHypoglycaemiaY
FinteplaZogenixDravet syndromeY
OcalivaInterceptNASHN (CRL)
EvrysdiRocheSpinal muscular atrophyY
AduhelmBiogenAlzheimer's diseaseY
Vynpenta (avacopan)ChemocentryxANCA-associated vasculitisTBC
Note: *approved 2 yrs after new Pdufa date; CRL=complete response letter. Source: Stifel.

https://www.evaluate.com/vantage/articles/news/snippets/us-regulator-throws-chemocentryx-debatable-lifeline

Javits Center to close as COVID-19 mass vaccination site in NY

 Manhattan’s Jacob Javits Center mass vaccination site will close for good this Friday, as Gov. Andrew Cuomo announced Wednesday the state is turning its focus to boosting inoculations in communities with lower rates.

The move also follows the end of most pandemic-era restrictions after the Empire State celebrated an over 70 percent one-shot vaccination rate for adults, plus the termination of New York’s coronavirus state of emergency last month.

Sites at Suffolk County Community College in Brentwood and SUNY Ulster in Stone Ridge will also shutter operations July 9, as part of the state’s previously announced plan to scale back operations at the one time nearly 30-strong state and federally-run mass vaccination locations.

“We have achieved great progress in beating back the virus and getting enough New Yorkers vaccinated in order to begin getting back to life as we know it, and our mass vaccination sites were key in helping us get here,” said Cuomo in a statement.

General view of vaccination area inside of Jacob Javits Center on the opening day of vaccination site in New York on January 13, 2021.
Javits Center had opened as a COVID-19 vaccination site in January.
Lev Radin/Sipa USA

“As we continue our mission to make the vaccine accessible in every community and to focus our efforts on the areas with lower vaccination rates, we are proceeding with the downscaling of mass vaccination sites so that we can shift resources to where they are needed the most.”

Pop-up vaccination sites run by local governments will serve individuals in the mass sites’ absence, officials said. 

Javits — once heralded as a contender for the largest vaccination site in the country — served as a 24-hour vaccination site and had the capacity to administer 10,000 shots in one day.

The location was also criticized for administering the life-saving shots to an overwhelming majority of non-New York City residents.

The convention center was also converted into a US Army field hospital at the onset of the COVID-10 crisis — and despite having a 1,000-bed capacity, treated just 1,094 coronavirus patients between March and May of 2020.

State officials also famously denied the admission of virus-infected nursing home patients from Brooklyn’s Cobble Hill Health Center, after facility officials desperately reached out to the state for assistance in controlling the virus. 

 People wait in a line stretching around the Jacob K. Javits Convention Center on midtown Manhattan's west side, to receive a coronavirus disease (COVID-19) vaccine.
Many residents outside of NYC received the vaccine at Javits Center.
Mike Segar/File Photo/Reuters

A little over 60 percent of New Yorkers of all ages have received one jab, along with just over 72 percent of those 18 and up, according to the Centers for Disease Control.

Nearly 55 percent have completed their vaccine series, as well as 66 percent of adult New Yorkers.

https://nypost.com/2021/07/07/jacob-javits-center-to-close-as-covid-19-mass-vaccination-site-in-ny/

Highly transmissible delta variant is now the dominant Covid strain in the U.S.

 The highly transmissible delta variant is now the dominant coronavirus strain in the United States, surpassing the alpha variant, according to Covid-19 modeling data released by the Centers for Disease Control and Prevention.

Delta, the variant that was first found in India and is now in at least 104 countries, represented 51.7% of new Covid cases in the U.S. over the two weeks ended July 3, according to recently updated estimates by the CDC. Meanwhile, the proportion of new cases caused by alpha, which was first found in the U.K., was just 28.7% over the same time period, according to the U.S. agency.

In recent weeks, U.S. health officials have warned that delta was on track to become the dominant variant in the U.S., as its prevalence in the nation doubles about every two weeks. On June 22, a little over two weeks ago, White House chief medical advisor Dr. Anthony Fauci said delta made up about 20% of all new cases in the U.S.

The World Health Organization, which has called delta the “fastest and fittest” variant yet, expects it to become the dominant form of the disease worldwide. Delta is estimated to be about 55% more transmissible than the alpha variant, according to a report by the WHO.

President Joe Biden on Tuesday once again pushed for all eligible Americans to get Covid vaccinations, stressing the importance of being protected against delta.

Despite the U.S. being on track to hit 160 million people fully vaccinated in the coming days, Biden said, millions remain unvaccinated against Covid, “and because of that, their communities are at risk, their friends are at risk, the people they care about are at risk.”

“This is an even bigger concern because of the delta variant,” the president said.

There are still about 1,000 counties in the U.S. that have vaccination coverage of less than 30%, CDC Director Dr. Rochelle Walensky told reporters last week. The counties are mostly located in the Southeast and Midwest, she said, and the agency is already seeing increasing rates of disease in these places due to further spread of the delta variant.

Scientists and other health experts fear the variant will cause a surge in new cases this fall, hitting those who remain unvaccinated the hardest, unless states can vaccinate more people.

“I think there are two Americas,” said Dr. Paul Offit, a pediatrician and vaccine advocate who has served on advisory panels for both the CDC and the Food and Drug Administration. “There is the vaccinated America and the unvaccinated America, and I think the unvaccinated America is about to pay a price for that.”

The White House announced last week it is deploying Covid-19 response teams across the nation focused on combating the variant. The teams, composed of officials from the CDC and other federal agencies, will work with communities at higher risk of outbreaks.

https://www.cnbc.com/2021/07/07/cdc-data-shows-delta-is-now-the-dominant-covid-variant-in-the-us.html