60% of people being admitted to UK hospitals are unvaccinated - adviser

 Britain’s Chief Scientific Adviser Patrick Vallance said that 60% of people being admitted to hospital with COVID-19 are unvaccinated, correcting an earlier statement he made on Monday.

Vallance earlier said at a news conference with Prime Minister Boris Johnson that 60% of people being admitted to hospital with COVID-19 have had two doses of vaccine.

“Correcting a statistic I gave at the press conference,” Vallance said on Twitter. “About 60% of hospitalisations from COVID are not from double vaccinated people, rather 60% of hospitalisations from COVID are currently from unvaccinated people.”

https://www.reuters.com/article/health-coronavirus-britain-hospital-vall/corrected-60-of-people-being-admitted-to-uk-hospitals-are-unvaccinated-adviser-idUSL9N2N1013

Coronavirus Stocks Are Zooming Higher

 Shares of a clutch of healthcare companies involved directly or tangentially in the fight against the coronavirus were doing very well on Monday. Moderna (NASDAQ:MRNA), for one, was up by nearly 10% in midafternoon trading, while Co-Diagnostics (NASDAQ:CODX) was trailing close behind. 

Meanwhile, both Novavax (NASDAQ:NVAX) and Vaxart (NASDAQ:VXRT) were outpacing that pair, with 16% and 11% gains, respectively. BioNTech (NASDAQ:BNTX) was a relative laggard, rising "only" 5.7%.

The key reason for these increases is simple: Because of its powerful delta variant, the coronavirus is very much on the rise again. According to New York Times data, statistics from Sunday indicate the 14-day change in new cases in the U.S. was a worrying 140% increase, with fatalities rising 33%.

So the need for a harder and wider vaccine push is obvious; such a move would clearly benefit both Moderna and BioNTech. These companies (including BioNTech partner Pfizer) provide two of only three coronavirus vaccines authorized by the Food and Drug Administration. It should also help Co-Diagnostics, which is a high-profile maker of a COVID-19 testing product.

If the coronavirus surge continues, it's very possible we'll face an "all hands on deck," situation with vaccines. Perhaps the ones being developed by vaccine-focused biotechs Novavax and Vaxart will be authorized by the FDA.

Novavax plans to file for Emergency Use Authorization for its NVX-CoV2373 this quarter, and Vaxart will certainly be on investors' radar due to the oral vaccine it's currently developing -- despite the fact that this program has attracted its share of controversy.

https://www.fool.com/investing/2021/07/19/why-coronavirus-stocks-are-zooming-higher-today/

Messenger RNA vaccine pioneer Katalin Karikó on journey to Covid-19 vaccines

 In the span of the Covid-19 pandemic, and thanks to the success of two of the currently available vaccines for SARS-CoV-2, messenger RNA, or mRNA, went from being an obscure cell biology concept understood and mentioned only by scientists to being a household term.

But the technology behind the mRNA vaccines from Moderna and Pfizer and BioNTech is anything but new. Developed over an arduous 40 years, it was the result of an unlikely success story. One of the key figures behind this achievement was Katalin Karikó, senior vice president of the German biotech company BioNTech and adjunct associate professor at the University of Pennsylvania.

Speaking at the 2021 STAT Breakthrough Science Summit Wednesday, Karikó shared how despite many, many failures — including demotions, grant rejections, and more — she was clear in her focus. “I always looked to RNA [as a way] to develop therapeutics,” she said, and shared details about her journey to BioNTech as well as her unyielding faith in the technology she was developing.

Around the world for mRNA

Karikó grew up in Hungary, where at 16 she already knew she wanted to be a scientist, and her dedication to mRNA took her around the world. She wanted to go wherever the best mRNA science was, if that meant academia or biotech, Japan or Pennsylvania, where she worked at Arbutus Biopharma, previously Tekmira. “I was just so determined to go somewhere, do something” with RNA, she said. In 1990, she ended up in Philadelphia, studying the mechanisms of mRNA biology at Penn.

On persevering against the odds

Even though Karikó’s breakthrough research has brought her recognition, and with it grant money, her trajectory was not without its low points. For the first 40 years of her research career, she did not receive a single R01 grant, the main way the National Institutes of Health funds scientists. “There were low points, but every time something went wrong, I tried to focus on the things I could change,” she said. Seeing progress, no matter how gradual, kept her going. “Whether we got more protein, better delivery, or any kind of data, that gave us the push when we were deep in the problems,” she recalled.

Karikó compared the trajectory of science to rowing, the sport in which her daughter Susan Francia, won Olympic gold medals on the U.S. team in 2008 and 2012. Because rowers face away from the direction in which they’re headed, “They don’t see the finish line, they don’t see how far it is, they just kind of sense it. Science is sometimes like that,” she said.

When biotech calls

Slowly, Karikó started moving into biotech, first by founding her own company, RNARx, in 2006, and then by advancing to bigger companies. Again, she knew exactly where to go: “I was focusing on companies that already had [mRNA] formulations in humans, because then maybe I could help.” She ended up at BioNTech, where she has been since 2013.

Karikó said that biotech has a lot of upsides over academia. “We have to have a product that is functional and will cure people. It was just so much better than a paper, then another paper that maybe nobody will read.”

When Covid-19 hit at the beginning of 2020, BioNTech and Karikó switched into overdrive to develop the elements necessary for a vaccine based on their mRNA biology. After months of work, Karikó recounted how, one Sunday night in Philadelphia — her daughter’s birthday, no less — she received a call saying that the vaccine had worked. She wasn’t all that surprised. “I was very happy but [it was] kind of expected,” she said. Seeing not only “the clinical trial data but also how well this modified RNA worked in other infectious disease vaccines was always so powerful.”

Then on Dec. 18, 2020, she got the BioNTech vaccine she had a hand in developing. When she went outside, health care workers who were also getting their vaccines started clapping for her. “They were just so happy. I’m not a very emotional person, but I just cried a little.”

On her newfound fame

When asked her thoughts on possibly being considered for the Nobel prize, Karikó instead focused on the collaborative nature of science and how so many contributions to the mRNA vaccine by others may be overlooked. “Many scientists, just like me, work for years and years and nobody knew about them. And so, I have to represent all of them,” she said.

But she is nostalgic for the days before her newfound fame and workload, she said. “Sometimes I wish I could have that [extra time] back. When I read the title of a very exciting paper, I feel that I would never have time to read that, and I want to because that’s my favorite thing to do.”

The future of mRNA

Karikó sees mRNA, either in the form of vaccines or a therapeutic, as a powerful tool to treat everything from viruses and pathogens to autoimmune diseases, she said. At the beginning of this year, her group published a mouse study showing how an mRNA vaccine could be used to prevent immune system attacks that are common in multiple sclerosis. Although this particular vaccine has a long way to reach the clinic — about two years, she predicted — she believes that her preferred molecule will continue producing new therapies: “I am very hopeful that more and more products will be reaching the market,” Karikó said.

https://www.statnews.com/2021/07/19/katalin-kariko-messenger-rna-vaccine-pioneer/

G1 Therapeutics Gets Fast Track Designation for Breast Cancer Treatment

 G1 Therapeutics Inc. said the U.S. Food and Drug Administration has granted fast track designation to Cosela trilaciclib investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer.

The company said Cosela is currently being evaluated in a Phase 3, placebo-controlled study in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for triple negative breast cancer.

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. A drug that receives fast track designation may be eligible for more frequent engagements with the FDA to discuss the drug's clinical development plan, eligibility for accelerated approval and priority review, and rolling review.

https://www.marketscreener.com/quote/stock/G1-THERAPEUTICS-INC-34912629/news/G1-Therapeutics-Gets-Fast-Track-Designation-for-Breast-Cancer-Treatment-35891020/

Ligand Pharmaceuticals Shares Rise After FDA Approves Vaxneuvance

 Ligand Pharmaceuticals Inc. shares were up 7% at $120.70 after the company said its partner, Merck, has received approval from the U.S. Food and Drug Administration for Vaxneuvance for the prevention of invasive disease caused by Streptococcus pneumoniae in adults 18 years of age and older.

The company said Vaxneuvance is a 15-valent pneumococcal vaccine using its CRM197 vaccine carrier protein, which is produced using the patent-protected Pelican Expression Technology platform.

Under the terms of its licensing agreement with Merck, Ligand earned a $2 million milestone payment upon the FDA's approval of Vaxneuvance and is entitled to a low-single-digit royalty on net product sales.

Merck plans to submit a supplemental regulatory licensure application with the FDA later this year for the use of Vaxneuvance in children.

https://www.marketscreener.com/quote/stock/LIGAND-PHARMACEUTICALS-IN-17306/news/Ligand-Pharmaceuticals-Shares-Rise-7-After-FDA-Approves-Vaxneuvance-35892768/

Dementia at Young Ages More Common Than Previously Thought

 

Young-onset dementia -- dementia before age 65 -- may be more prevalent than previously thought, a systematic review and meta-analysis showed.

Based on 74 studies of nearly 2.8 million people, the global age-standardized prevalence of young-onset dementia was 119.0 per 100,000, corresponding to 3.9 million people ages 30 to 64, reported Sebastian Köhler, PhD, of Maastricht University in The Netherlands, and co-authors in JAMA Neurology.

This prevalence is higher than estimates from the two most referenced reports, both retrospective register-based studies, that showed a prevalence of 54.0 and 42.3 per 100,000 population, the researchers noted.

"Although this is higher than previously thought, it is probably an underestimation owing to lack of high-quality data," Köhler and colleagues wrote.

Age-standardized prevalence was similar in women and men, highest in upper-middle-income countries, and highest for Alzheimer's disease, followed by vascular dementia and frontotemporal dementia.

"At one time in the not-too-distant past, young-onset dementia was considered a disease, whereas later-onset dementia was considered the inevitable consequence of aging," observed David Knopman, MD, of the Mayo Clinic in Rochester, Minnesota, in an accompanying editorial. "We now reject such a formulation, but within that misguided dichotomy is a recognition of the dramatic differences in prevalence and incidence of young-onset dementia compared with later-onset dementia."

"Young-onset dementia is a particularly disheartening diagnosis because it affects individuals in their prime years, in the midst of their careers, and while raising families," Knopman added. "Most dementia care is geared for older patients, and as a consequence, services are rarely available to address the needs of someone diagnosed with dementia in their 50s who has dependent children at home and a spouse who must continue working."

In their study, Köhler and co-authors examined 95 studies published from January 1990 through March 2020 in a systematic review and included 74 of these studies, spanning 2,760,379 unique patients, in a meta-analysis. They estimated age-specific prevalence in 5-year bands from ages 30 to 64.

Because pooling would apply the same weight to each age group, the researchers standardized results by the WHO world standard population of 2000 to 2025, the U.S. standard population of 2000, and the European standard population of 2011 to 2020.

Overall, register-based studies reported lower prevalence estimates than cohort studies. Estimates in low-income countries and younger age ranges were scarce.

Age-standardized prevalence estimates per 100,000 population were 159.4 in Europe and 114.7 in the U.S., due mainly to differences in population ages. This corresponded to 500,000 people in Europe and 200,000 in the U.S. with young-onset dementia.

Estimates per 100,000 ranged from 1.1 in people ages 30 to 34 to 77.4 in people ages 60 to 64. Overall, young-onset Alzheimer's disease had the highest prevalence, at 41.1 per 100,000. However, until age 50, Alzheimer's had a lower prevalence than vascular dementia and frontotemporal dementia.

"The diminishing prevalence of dementia at younger ages means that epidemiological case finding almost always relies on passive surveillance methods," Knopman noted.

"The acknowledged disadvantage of passive surveillance for dementia is the lack of control of diagnostic methods across numerous clinicians, raising the possibility of undercounting or overcounting cases owing to misdiagnosis (e.g., young-onset dementia as a psychiatric disorder or vice versa) or of noncontact by the young patient with dementia with the medical system," he pointed out.

"Milder cases are almost certainly likely to be undercounted; therefore, prevalence estimates in the meta-analysis could be higher if the full spectrum of symptomatic cognitive impairment was recognized."

The analysis had several limitations, Köhler and co-authors acknowledged. Studies from Africa and low-income countries were underrepresented. In addition, 41 studies reported only on people ages 60 to 64. Some studies had small samples. At times, dementia diagnosis was either defined poorly or not reported properly.

"To yield more accurate and comparable prevalence estimates in the future, efforts should be made to conduct more cohort studies and to standardize procedures and reporting of prevalence studies," the researchers wrote.

Disclosures

This study was supported by the Gieskes-Strijbis Foundation, Alzheimer Netherlands, and the Dutch Young-Onset Dementia Knowledge Center.

Researchers reported relationships with ZonMw, NWO, CVON, Combinostics, Fujifilm, Roche, AVID, Health-Holland, Topsector Life Sciences & Health, EU Joint Programme-Neurodegenerative Disease Research, Stichting Dioraphte, Stichting Equilibrio, Pasman Stichting, Biogen, Life-MI, Philips, Novartis NL, Neurocast, ADX-Neuroscience, Boehringer Ingelheim, Danone, Eisai, WebMD, Oxford Health Policy Forum CIC, Australian National Health and Medical Research Council, Ministry of Health Singapore, and Temasek Foundation.

Knopman reported serving on a data safety monitoring board for the Dominantly Inherited Alzheimer Network study; serving on a data safety monitoring board for a tau therapeutic for Biogen but receiving no personal compensation; serving as an investigator in clinical trials sponsored by Biogen, Lilly Pharmaceuticals, and the University of Southern California; consulting for Hoffman-LaRoche, Samus Therapeutics, Third Rock, and Alzeca Biosciences but receiving no personal compensation; and receiving grants from NIH.

Primary Source

JAMA Neurology

Source Reference: Hendriks S, et al "Global prevalence of young-onset dementia: a systematic review and meta-analysis" JAMA Neurol 2021; DOI: 10.1001/jamaneurol.2021.2161.

Secondary Source

JAMA Neurology

Source Reference: Knopman DS "Young-onset dementia -- new insights for an underappreciated problem" JAMA Neurol 2021; DOI: 10.1001/jamaneurol.2021.1760.

https://www.medpagetoday.com/neurology/dementia/93626

FDA approves Nevro’s Senza system to treat chronic pain with diabetic neuropathy

 Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN.

The Redwood City, Calif.-based company’s stock was up nearly 6%, to 152.54 per share, by afternoon trading today.

Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation. The company is touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication for treating PDN (painful diabetic neuropathy).

FDA approval follows the published results of the SENZA-PDN trial in JAMA Neurology, which demonstrated the safety and efficacy of the spinal cord stimulation (SCS) system.

In April, Nevro touted results from the randomized SENZA-PDN trial, which met its prespecified primary endpoint by demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS, Nevro said. The trial pitted Senza, plus conventional medical management (CMM), against CMM alone in 216 patients across 18 centers in the U.S.

In addition to meeting the primary endpoint, the system delivered statistically significant, clear differences from the best available medical treatments in seven of eight secondary endpoints.

The company said it plans to immediately initiate the commercial launch activities for Senza in the U.S. under its recently launched HF branding as “HFX for PDN.” Nevro anticipates mid-to-single-digit million revenue contributions from PDN in 2021, with the majority generated in the fourth quarter.

A broader penetration and larger revenue contribution from Senza for PDN should come in 2022 and beyond, Nevro said, with international phased launch plans in the United Kingdom, Germany and Australia planned for next year.

“This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and who are unable to find relief with currently available pharmacologic options,” Nevro chairman, CEO & president D. Keith Grossman said in the release.  “We are thrilled that we can now begin commercial launch activities in the U.S. and believe this new indication will be an important driver of the long-term growth of our business for years to come.”

Analysts from Truist said revenue estimates for Nevro could move higher, based on early physician enthusiasm regarding Senza as a new solution for patients.

Investors have been expecting a second-quarter miss with lowered numbers for the full year, the analysts noted, and while uncertainty remains on guidance, positive updates on trends or early anecdotal comments related to Senza and PDN “should be well-received with the stock at current levels.” As a result, the analysts maintain their position that Nevro stock stands in the “buy” category.

https://www.massdevice.com/fda-approves-nevro-spinal-cord-stimulation-to-treat-chronic-pain-with-diabetic-neuropathy/