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What are longevity supplements, and are they safe? – MarketWatch

Aches and pains. A growing waistline. Diminishing eyesight, hearing loss, memory lapses. These are the woes of growing older for some people, once considered inevitable. But recent, exciting discoveries in the fast-growing field of longevity science have some doctors and researchers pronouncing that these symptoms of aging may one day be treatable with pharmaceuticals, gene therapies or other yet-to-be-discovered medical technologies.

Many people havent been content to wait, though. Dozens of commercial producers are selling hundreds of so-called longevity supplements right now, and sales data suggest anawful lot of peopleare trying them. But do they work? Are they even safe?

To find out, we scoured the latest research and interviewed two top scientists in the field. What we learned suggests that you may want to hold off on ordering a supply, or at least do your research very carefully.

There is a solid handful of compounds that look very promising in the scientific quest to slow the aging process. One of the most exciting is nicotinamide adenine dinucleotide, or NAD, which has been shown to extend both the lifespans and youthful function of yeast and animals in clinical trials. Human trials are ongoing, with only a handful published to date.

NAD (also often written as NAD+) is a substance found in every cell in your body, which controls all kinds of metabolic processes, including the regulation of sirtuins, the so-called longevity genes. As you age, your NAD+ levels decline, and scientists think it is perhapsthisdecline that leads toall sortsof other age-related declines.

Also read: Should you invest in the new longevity funds?

The working theory, then, is that if we can boost our NAD+ levels as we age, we can slow our decline tremendously. Lab studies on yeast and rodentslend strong supportto that theory. The most recent studies have primarily involved the administration of either nicotinamide riboside (NR) or nicotinamide mononucleotide (NMN), which is then converted into NAD in the body.

To learn more about NAD, Next Avenue talked to Dr. Shin-Ichiro Imai, professor of developmental biology at the Washington University School of Medicine in St. Louis. Along with Leonard Guarente, Imai discovered the link between NAD and sirtuin control in 1999. Hes been studying the molecule ever since.

There have been 10 human clinical trials using NR, most at very high dose, with no safety issues, Imai said. Most of those trials, however, lasted for a duration of weeks or months at most.

Is it safe to take NAD-boosting supplements continuously, for years?

NMN and NR have already been available in Japan and the U.S. since 2015, and some people have been taking it since then, Imai noted. Anecdotally, I havent heard of any side effects from the taking of these supplements.

Some trials, however, have recorded mild side effects including headaches, nausea, diarrhea and skin flushing.

See: 3 aging experts tell how they decided on where to grow older

More troubling, however, is the conclusion of a 2019 study that showed a possible link between elevated levels of NAD and tumor growth in isolated cells and animals. Rugang Zhang, deputy director at the nonprofit Wistar Institute Cancer Center in Philadelphia, was the lead researcher on that study.The study, published in the UK journal Nature Cell Biology, did not find that NAD causes cancer, rather that elevated levelsappeared to accelerateoncogenesis (tumor formation) already in motion.

We dont want to oversell the results of our study, Zhang said. Lots of studies in the literature have clearly demonstrated that as normal cells age, there is lower NAD. So, supplementing NAD could be beneficial. Its possible that NAD boosters could help people live longer and healthier. Were not saying that if people take NAD boosters they will get cancer. This was a very early study on mouse models, and more study is needed.

He suggests a course of action grounded in a deep preponderance of evidence: At the end of the day, we just need more knowledge, through more research. We need the scientific community to come to a consensus. The risk to potential benefit remains to be seen.

Mucking up the risk/benefit ratio further is the fact that supplements are onlyvery lightly regulatedby the U.S. Food and Drug Administration, with the testing, evaluation and labeling of such products left up to manufacturers. This presents another dilemma for those considering longevity supplements: theres no sure way of knowing exactly what youre getting.

The results of the few published human clinical trials to date unequivocally show that taking NR boosts levels of NAD in the body. But apparently, more NAD doesnt translate to more youthful function.

See: There are six types of retirees which are you?

Unfortunately, those studies have not yet shown any significant efficacy, Imai said.

And thats when the substance administered is of lab-grade purity. So what about the typical supplements available online?

There are so many products out there, Imai lamented, particularly for NMN, but Im concerned about the quality.

Indeed, a 2020meta-analysisof NAD trials surmised: it seems likely that side effects linked to interventions that target NAD metabolism more likely arise from impurities rather than the supplements themselves, since this industry generally operates without rigorous control of quality and standardization.

Imais lab has evaluated a number of commercially available NAD-boosting supplements, but found only two of lab-grade purity. Imai wouldnt disclose the names of the products (both Japanese-made), as he doesnt endorse supplements. But he did note that they are extremely expensive.

Dont miss: What is the secret to aging well?

Finally, we asked someone whod taken an NAD-booster to share her experience. Kim Oberdorfer, an air-traffic controller in Oakland, Calif., wasnt impressed.

I took [a popular NR supplement] for about two months and it just gave me these dull headaches. I was having hot flashes last February, and when I told my sister Im 47, shes 53 about how horrified I was to be having them so young, she goes, Are you sure its not just a reaction to an NAD supplement? said Oberdorfer. At the time I wasnt really working out much, but my sleep schedule was really messed up and I heard it was good for that as well. I didnt think it helped at all.

Rashelle Brownis a longtime fitness professional and freelance writer with hundreds of bylines in print and online. She is a regular contributor for NextAvenue and the Active Network, and is the author of Reboot Your Body: Unlocking the Genetic Secrets to Permanent Weight Loss (Turner Publishing). Connect with her on Twitter and Instagram @RashelleBrownMN.

This article is reprinted by permission fromNextAvenue.org, 2021 Twin Cities Public Television, Inc. All rights reserved.

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Pipeline Report 2021: Promising drugs tick along across a range of conditions – Features – MM&M – Medical Marketing and Media

As the world haphazardly endeavors to defeat a deadly virus, the pharma industry has found itself charged with delivering a miracle cure in a compressed, unprecedented time frame, no less. But as drug developers swim hard and fast to neutralize COVID-19 with vaccines and therapeutics, they are also working to get other important drugs approved amid looming threats of halts and delays.

Indeed, even as the industry prioritizes everything essential as the pandemic rages, could the current emphasis on speed and efficiency spur a new (and faster) normal for drug development timelines, approvals and regulations? Time will tell, but 2021 is looking to be a big year for the pharma pipeline.

COVID-19 vaccines have been in the spotlight this year, a focus which is only expected to intensify in 2021. While usual vaccine development and approvals take decades, multiple drug developers are aiming to shorten this process to around 18 months. But while Pfizer, Moderna and Johnson & Johnson are among the current frontrunners with novel vaccine approaches, the lack of precedence for both mRNA and adenoviral vector vaccines render them high-risk, high-reward endeavors. With emergency use authorizations (EUAs) expected by year end or early 2021, we should be hearing major Phase III data verdicts for these vaccines around mid-2021.

Meanwhile, significant progress has been made with COVID-19 therapeutics, particularly in the wake of Gileads Veklury (remdesivir) approval in October. While analysts anticipate the drug to bring in around $1.5 billion by the end of 2020, new mixed data and a high price has drawn some skepticism on whether Gilead can sustain its market traction. This may pave the way for other candidates, such as Regenerons antibody cocktail REGN-COV2 or InflaRxs C5a inhibitor IFX-1.

Beyond COVID-19, many promising drugs continue to tick along in late-stage trials and approval discussions. Oncology, ever an essential priority for drug developers, boasts a robust pipeline, led by J&J/Legend Biotechs CAR-T therapy Cilta-cel. Its expected to be approved next year for multiple myeloma, along with Bristol Myers Squibbs direct competitor Ide-cel.

Next year could also be a pivotal year for Iovance, which is set to release data and file for the approval of Lifileucel, potentially the first cell therapy approved for solid tumors. New combination therapies could also offer incremental upside to the current treatment paradigm, with Nektar/Bristol Myers Squibbs bempegaldesleukin/nivolumab combo vying for approval to treat melanoma and other solid tumors.

Meanwhile in neurology, a final verdict on Biogens controversial resurrection of aducanumab for Alzheimers disease a potential $15 billion dollar drug is expected in March 2021. However, a negative vote in early November by the FDA advisory committee doesnt bode well for its chances. Though a future approval hasnt been ruled out, more studies could be a likely scenario. Meanwhile, AbbVie and Biohaven Pharmaceuticals continue to evolve their migraine franchises with 2021 regulatory filings for atogepant and zavegepant, respectively.

Non-COVID immunology drug development continues to be dominated by skin conditions, with UCBs bimekizumab on the cusp of approval for moderate-to-severe psoriasis patients. Similarly, BMS is awaiting additional Phase III data for its oral psoriasis drug BMS-986165, which could be a game-changer, in terms of convenience, for patients with moderate-to-severe disease.

Several other candidates are expected to be approved for atopic dermatitis. The wild card might be Arenas etrasimod, currently in Phase III trials for ulcerative colitis, which has potential in other autoimmune indications.

Gene therapy continues to make its mark in blood disorders, with both UniQure and Biomarin developing hemophilia candidates dangling the promise of one-time therapies for patients who are used to aggressive treatment regimens. Meanwhile, Bluebird Bios LentiGlobin awaits further approvals for sickle cell disease and beta thalassemia next year.

Elsewhere, Myovant is attempting to battle AbbVie in the womens health space, via an expected approval of Relugolix for uterine fibroids. Merck looks forward to a long-awaited approval verdict for its heart failure drug vericiguat in a niche population. And Fabrys patients could have a new and safer enzyme replacement therapy option with the impending approval of Protalixs PRX-102.

In other words, buckle up in advance of another epic and unpredictable year for pharma.

(Agents profiled in this report were chosen in consultation with inThought Research, inDemic, Adis R&D Insight, Ipsos Healthcare and GlobalData. Analyses of featured products include the latest clinical data, revenue forecasts, expected launch dates and likelihood of success as of early November 2020.)

Most anticipated products

Pfizer/BioNtech, Phase III

Type: mRNA vaccine

Where the clinical trials are: BNT162b2 is an mRNA vaccine, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein at a 30g dose level in a two-dose regimen. Interim data as of early November showed that the vaccine was 95% effective. While emergency use authorization could arrive as early as late-Q4 2020, the primary analysis of the Phase III trial is expected in Q2 2021, which could enable mass vaccinations thereafter.

InDemic comment: Pfizers criteria for what constitutes a case of COVID-19 is less stringent than that of its competitors, and this will allow the company to tally up cases more quickly for an earlier readout. While it could generate some skepticism from regulators and the scientific community, Pfizer is also tracking severe cases of COVID-19 and other metrics for efficacy in its vaccine trial. Pfizers refusal to accept federal money for its vaccine development shows confidence in its technology. Dr. Sam Sun, director, InDemic Foundation

What physicians are saying: This candidate was poised to apply for emergency use authorization by late November. Orders for millions of doses have already been placed by U.S., EU and Japanese governments, highlighting the readiness to react to the imminent availability of this much-needed product. Rhoda Schmuecking, head, virology and vaccines CoE, Ipsos

Moderna, Phase III

Type: mRNA vaccine

Where the clinical trials are: mRNA-1273 is an mRNA vaccine that encodes a SARS-CoV-2 spike protein that is stabilized in the prefusion (before infection) conformation. The vaccine is in an ongoing Phase III trial with early reports showing a 94.5% efficacy rate and, even if interim analyses spur emergency use authorization for high-risk individuals in late Q4 2020 or early Q1 2021, a full analysis for widespread approval is due in Q2 2021.

InDemic comment: Moderna is a pioneer in developing mRNA therapeutics. Overall, Moderna has shown consistency and transparency with its vaccine program, which may aid in its uptake and eventual rollout to the public. Its strict definition of what constitutes a COVID-19 case could mean it takes longer for Moderna to produce a final readout. However, that sacrifice could generate greater significance for its readout. Sun

What physicians are saying: With the first interim analysis in November, the possibility of vaccines from Pfizer/BioNTech and Moderna being made available for emergency use authorization before the end of this year certainly makes this a very dynamic space to watch. Schmuecking

Johnson & Johnson, Phase III

Type: human adenoviral vector

Where the clinical trials are: Ad26.COV2.S is composed of a recombinant, replication-incompetent adenovirus type 26 (Ad26) vector, constructed to encode the SARS-CoV-2 spike protein. J&Js 60,000-patient Phase III trial is testing the single-dose vaccine versus placebo. However, the trial was paused in mid-October due to a safety signal of unknown significance. While this could impact its future in the race, the trial was resumed in late October.

InDemic comment: The vaccines one-dose regimen makes it attractive compared to other candidates. Its recent safety event may not be as serious as the rare neurological reactions experienced by two patients on AstraZeneca/Oxford Universitys adenoviral vaccine trial, which was paused in September. J&Js vaccine technology, Advac, has been used in other approved vaccines, and 100,000 patients have been vaccinated with this technology without a concern. Sun

What physicians are saying: Should the late-stage study prove positive, J&J expects to be able to supply 1 billion doses of its vaccine beginning early next year. While this is later than the mRNA vaccine candidates, J&Js boldness with the size of trial and one-shot dose makes it a very interesting option added to the mix. Schmuecking

Gilead, post-approval

Type: anti-viral

What the clinical trials have shown: Remdesivir (brand name Veklury) received full approval from the FDA in October, making it the first antiviral available to treat COVID-19. That approval was based on data from the ACTT-1 study sponsored by the National Institutes of Health, which found a significant benefit in time to recovery and a non-significant trend toward improved survival at 29 days. However, preliminary findings from the WHO Solidarity trial, which followed 11,366 adults at 405 hospitals in 30 countries, found that remdesivir has little or no impact on survival.

InDemic comment: The available data indicate that remdesivir does not improve mortality and might even worsen mortality in COVID-19 patients with severe disease who require high levels of supplemental oxygen or mechanical ventilation. For that reason, it may only be appropriate to consider this drug for hospitalized COVID-19 patients with mild to moderate disease. The conflicting data on survival may also impact Gileads ability to command the high price of $2,600 per course. Sun

What physicians are saying: In lieu of an available vaccine for COVID-19, remedisvir, along with other antivirals in development, provides a valuable option in physicians treatment armamentarium. Schmuecking

Regeneron, Phase III

Type: passive immunotherapy

What the clinical trials have shown: Results from Regenerons ongoing Phase II/III trial in non-hospitalized patients showed that its antibody cocktail significantly reduced viral load and patient medical visits. The company will use this data for an emergency use authorization of REGN-COV2 low-dose to treat mild-moderate patients, for potential 2021 approval. However, the drugs potential is less clear in severe patients: In late October, an independent monitoring committee recommended halting enrollment of patients with high oxygen requirements on its hospitalized patient trial, due to an unfavorable risk/benefit profile.

InDemic comment: REGN-COV2 and other antibody therapies against COVID-19 are expected to show substantial efficacy in reducing hospitalizations. REGN-COV2 also fills an unmet need in that it can be used for outpatients with COVID-19, whereas both remdesivir and dexamethasone are used for hospitalized patients. Sun

What physicians are saying: A premature EUA could hamper ongoing investigations needed to solidify efficacy data and offer better utility insight, according to physicians interviewed by Manasi Vaidya and Reynald Castaneda, associate editors of GlobalDatas Pharma investigative news team. Larger datasets on clinically relevant secondary endpoints, such as reduced hospitalization, are needed for stronger EUA consideration. The ability to manufacture adequate mAbs to provide access to patients is likely to be an issue in the event of a premature EUA, the experts added.

InflaRx, Phase III

Type: complement inhibitor

What clinical trials have shown: In previous trials, IFX-1 was shown to reduce kidney injury, lung emboli and mortality from multi-organ failure, so IFX-1s Phase III trial was initiated to enroll severe COVID-19 patients, with a primary endpoint of mortality. Interim data is expected in March 2021, dependent on enrollment.

InThought comment: The Phase III trial of IFX-1 is enrolling a specific population of very sick COVID-19 patients. Its primary endpoint is objective and clinically meaningful, and its Phase II trial showed that IFX-1 may reduce mortality of COVID-19 multi-organ failure. With a dearth of treatments for severe/critically ill COVID-19 patients, we believe IFX-1s interim data in early 2021 will support the use of complement inhibitors for severe COVID-19 pneumonia. It could also be synergistic with the use of dexamethasone. Sun

Most anticipated products

Johnson & Johnson, pre-registration

Indication: late-stage multiple myeloma

What the clinical trials have found: Cilta-cel is a CAR-T therapy targeting BCMA (B-cell maturation antigen) and a Phase Ib/II study in refractory multiple myeloma is expected to yield a 2021 approval. Longer-term follow-up data from the study demonstrated a 100% overall response rate and an 86% stringent complete response rate at a median of 11.5 months.

InThought comment: The 100% response rate is the main focus of this drug, which, along with its FDA breakthrough therapy designation, has placed Cilta-cel as an emerging frontrunner in the competitive BCMA space. Amanda Weyerbacher, senior principal, inThought Research

Credit Suisse revenue forecast: $427 million by 2025

What physicians are saying: Despite its race (with Bristol Myers Squibbs Ide-cel) to be the first CAR-T therapy approved for multiple myeloma, there is likely to be high anticipation for Cilta-cel as physicians and patients (who have progressed through a number of drug classes) look for strong and durable outcomes Amy Butcher, director, global oncology monitor, Ipsos

Roche, Phase I/IIb

Indication: relapsed or refractory follicular lymphoma

What the clinical trials have found: Mosunetuzumab is a bispecific T-cell engager that targets CD3 and CD20. The FDA granted breakthrough therapy designation for relapsed or refractory follicular lymphoma in July based on a Phase I/Ib GO29781 study demonstrating high response rates and durable complete remissions in people with relapsed or refractory non-Hodgkins lymphoma.

InThought comment: Roche is in active discussions with the FDA for accelerated approval in this indication. Continued updates are expected to build on already promising data, while a subcutaneous formulation could offer at-home administration and patient convenience, which has been set at a higher bar in the time of COVID. Weyerbacher

Credit Suisse revenue forecast: $250 million by 2025

What physicians are saying: Trial results garnered much attention because it achieved efficacy in patients who had already been through four to five different treatments, and even included patients who had undergone CAR-T therapy. This will be a welcome new weapon for patients with an extremely poor prognosis. Alessandra Franceschetti, director, global oncology monitor, Ipsos

Nektar, Bristol Myers Squibb, pre-registration

Indication: melanoma, RCC, NSCLC

What the clinical trials have found: Nektar and BMS are examining the drug combination for a range of solid tumors, including first-line melanoma, renal cell cancer and lung cancer. Phase II melanoma data showed an overall response rate of 53%.

InThought comment: This combination has shown promising activity across a number of solid tumor indications that improve upon current immunotherapy approaches. While melanoma is the most advanced, renal cancer is looking to come out on top. Matt Presby, senior analyst, InThought Research

Credit Suisse revenue forecast: $1.75 billion by 2025 in all indications

What physicians are saying: Although early-stage, the data indicate that the combination could lead to durable responses with a possible advantageous toxicity profile over some other immuno-oncology combinations. Eric Blouin, SVP, Ipsos

Iovance, Phase II

Indication: metastatic melanoma

What the clinical trials have found: Lifileucel is an autologous cell therapy technology, which uses tumor-infiltrating lymphocytes (TILs) from a patients own tumors. In a Phase II metastatic melanoma trial of 66 heavily treated patients, the objective response rate (ORR) was 36%.

InThought comment: Lifileucel could be on track to be the first cell therapy approved for solid tumors. The TILs technology appears to achieve responses on par with or better than currently approved options for second- and third-line melanoma, while responses in cervical cancer (LN-145) are three times greater than current immuno-oncology agents. Presby

What physicians are saying: While Phase II data has shown good antitumor activity and durable response rates, the drug carries a complex manufacturing and delivery process. A Biologics License Application (BLA) submission is expected in 2021 following the FDAs request for additional data on the proposed potency assays. Mo Muhsin, director, oncology, Ipsos

Most anticipated products

Biogen, pre-registration

Indication: Alzheimers disease

What the clinical trials have found: Aducanumab is a monoclonal antibody targeting aggregated forms of beta-amyloid found in the brain. Phase III development of the drug started in late 2016 and was stopped in March 2019 after an independent group analysis deemed the trials not worth continuing because the drug was not expected to reach the trials primary endpoint.

However, in October 2019, Biogen decided it would submit the data for regulatory approval after re-analyzing a larger dataset that showed aducanumab reduced clinical decline in patients at higher doses. On November 6, the FDA advisory committee verdict voted strongly against approving aducanumab on its current dataset. A final verdict from the FDA is due on March 7.

InThought Comment: It will be more difficult, although not impossible, for the agency to ignore this strong no-confidence stance. Standards need to be kept as high as established. For this population, at least in the beginning, the effects of a pharmaceutical intervention proven efficacious in trials is highly likely to have almost imperceptible clinical effectiveness in real life in many cases, if not the majority. That will be difficult enough. We really need to be as certain as humanly possible here. Leon Henderson-MacLennan, medical adviser, InThought Research

Credit Suisse revenue forecast: $15.4 billion by 2025

What physicians are saying: There are currently no disease-modifying treatments available for Alzheimers. If aducanumab gains approval by the FDA, it could represent the first real signs of hope for the millions of people impacted by this devastating disease. Scott Morano, VP, healthcare, Ipsos

AbbVie, pre-registration

Indication: migraine

What the clinical trials have found: AbbVies atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist being developed for first-line migraine prevention. A positive Phase III trial showed a significant reduction in mean monthly migraine days over 12 weeks compared to placebo. AbbVie is planning regulatory filings in the U.S. and Europe in 2021.

InThought comment: Atogepant has a good shot to ride on the coattails of the rapid adoption of oral migraine and carve out a significant portion of the multibillion-dollar migraine market. Yet more mature data is awaited to elucidate its exact differentiation and positioning to competitors and which patient setting this drug will truly be used for. Henderson-MacLennan

Credit Suisse revenue forecast: $723 million by 2025

What physicians are saying: The past two years have seen radical improvements in the treatment options available for the prevention of migraine. Atogepant represents another giant step forward with its oral formulation that could make the CGRP receptor agonist much more palatable for PCPs and therefore more accessible to patients. Morano

Biohaven Pharmaceuticals, pre-registration

Indication: migraine

What the clinical trials have found: A pivotal Phase II/III study showed that zavegepant at 10mg and 20mg doses was statistically superior to placebo on co-primary endpoints of pain freedom and freedom from most bothersome symptoms at two hours. It also showed rapid onset of pain relief at 15 minutes with a favorable toxicity profile and no signal of hepatotoxicity. An NDA filing is expected in the second half of 2021.

InThought Comment: While more data is still awaited, zavegepant is being watched keenly because of its differentiated intranasal route of administration. This is likely a safe choice and could allow Biohaven to carve out a niche portion of the migraine market. Henderson-MacLennan

GlobalData consensus forecast: $563 million in 2026

What physicians are saying: CGRP treatments have proven effective for migraine. Zavegepant represents another innovation in not only providing potentially both acute and preventive treatment, but also in an administration-friendly intranasal formulation. Its also potentially a treatment for COVID-19. Morano

Most anticipated products

UCB, pre-registration

Indication: moderate to severe psoriasis

What the clinical trials have found: Bimekizumab is an IL-17 inhibitor that suppresses both IL-17A and IL-17F, which are two key cytokines driving inflammatory processes. UCB has completed three successful Phase III trials of bimekizumab, showing superior skin clearance at week 16 compared to placebo and AbbVies blockbuster Humira. The drug has a PDUFA approval date in March 2021 and is also being examined for treatment of psoriatic arthritis and ankylosing spondylitis.

InThought comment: Bimekizumab has shown stronger efficacy compared to IL-17a inhibitors such as Novartis Cosentyx and Lillys Taltz, while theoretical concerns of suicidal ideation associated with suppressing more of the IL-17 pathway (sparked by Amgens IL-17RA inhibitor Siliq) have so far not played out. Therefore, strong efficacy with a fast onset of action and clean safety profile makes bimekizumab likely to be approved and an exciting new option for psoriasis patients. Adam Schaffner, senior principal, InThought Research

Credit Suisse revenue forecasts: $308 million in psoriasis and $692 million in all indications by 2025

What physicians are saying: While Cosentyx was the first-in-class IL17 to market in psoriasis and has been very successful to date, recent Phase IIIB head-to head trials showed superiority to Cosentyx for PASI 100 at week 16 and week 48. It will be interesting to see how bimekizumab fares on the psoriasis market versus other IL17s and IL23s. Nicola Bailey, SVP, head of autoimmune CoE, Ipsos

Bristol Myers Squibb, Phase III

Indication: psoriasis

What clinical trials have found: BMS-986165 is an oral TYK2 inhibitor currently in Phase III trials for moderate to severe psoriasis. Phase II trials showed significant skin clearance after 12 weeks, while topline data from its first Phase III study announced in early November showed superiority to blockbuster drug Otezla. Thats a drug that BMS would have inherited through its acquisition of Celgene in 2019, but was instead sold to Amgen for $13 billion. That now seems like a worthwhile trade-off. The second Phase III data are expected in the Q1 2021.

InThought comment: BMS-986165 demonstrated impressive efficacy similar to IL-23 injectable drugs such as AbbVies Skyrizi and J&Js Tremfya, but as an oral option it could be a game changer for patients with moderate-to-severe disease looking for a more convenient self-administration option. The drug has a lot of buzz around it as it is being pursued in other indications, including inflammatory bowel diseases. Schaffner

Credit Suisse revenue forecast: $2.3 billion in all indications

What physicians are saying: BMS-986165 is touted as a future best-in-class oral drug with a new mechanism not seen in psoriasis. In addition to its oral convenience, it is exciting in that it is so far noted for a good side-effect profile, with possibly no sacrifice on efficacy. Bailey

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BWW Feature: Online Theatre You May Have Missed – Broadway World

Homemakers Festival at HOMEMcr

Many theatre productions have been made available during the pandemic lockdown in the UK while stages have been quiet and venues closed. We take a look at some of the highlights you may have missed online over the past few months.

As theatre's future remains uncertain, with a new tiered system looming, donations are welcomed by all the venues and companies listed. Happy viewing.

Shakespeare

Rob Myles's The Show Must Go Online started eight months ago and finished on the 19 November. Each full-length play was cast and rehearsed within a week and then streamed live. The whole series of Complete Works remains available on YouTube, along with four Shakespearean mashups presented with Quirk Books.Table Top Shakespeare

Forced Entertainment's Table Top Shakespeare began two months ago with Macbeth and finished a week ago with The Tempest. Each play is abridged and performed by one actor using kitchen utensils as characters and props. The average length is around fifty minutes, and they are entertaining both for younger audiences and those new to the bard. The whole series remains available until the 30 November.

Southwark Playhouse's production of Twelfth Night, directed by Anna Girvan, is available on their website.

Swinging The Lens's production of Richard II, with a cast of women of colour, is on the company's YouTube channel, and was originally presented at Shakespeare's Globe in 2019.

Both the Royal Shakespeare Company and Jermyn Street Theatre (JST) have tackled Shakespeare's Sonnets. The RSC's Sonnets in Solitude currently has more than fifty readings available; JST has completed the full set. You can find both the RSC and JST on YouTube. From 23-30 November, a full show of the Sonnets has been made available via theThe Shows Must Go On YouTube channel.

Tim Crouch has created a trio of shows focusing on Shakespearean characters (Banquo, Malvolio, and Peaseblossom). You can find these on Crouch's Vimeo channel.

The Barn Theatre, Cirencester, created three series of short pieces under the title Bard from the Barn. Co-produced by Aaron Sidwell, they place characters from Shakespeare into modern situations and the series can be found on their YouTube channel.

MusicalsMyth - The Musical

Dave Malloy's Ghost Quartet was added to YouTube in March 2020. This is an earlier version of the show which ran at the Boulevard Theatre in 2019.

Myth - the Musical was filmed at The Other Palace in March 2018. Written by Sam Cassidy, it has been available on Nick Ross Media's YouTube channel since the beginning of lockdown.

Three weeks ago, Glow-Worm Productions added their production of Mongolian Death Worm, a puppet musical written and performed by James Ure and Michael A Grant, to their YouTube channel.

Only the Brave, a musical by Rachel Wagstaff and Matthew Brind, filmed at the Wales Millennium Centre in 2016, was made available on Vimeo by AdVision TV in April 2020.

Adam Lenson Productions have been extremely active over the past few months: their SIGNAL Online concerts and specials remain available on YouTube, and they have recently moved into time-limited ticketed productions.

Short playsTranshuman and other short playscurrently available online

Compacts, a series of ten original short plays and monologues, is available on YouTube and showcases work written by Rick Allden. The average length is eleven minutes, and the shows focus on a range of voices and situations.

Lights Down Productions showcases female-led new writing across ten short plays. The Light On Showcase allows the playwrights to try out new pieces in the short format. Writers include Caley Powell, Emilie Maybank, and Judy Upton and are performed over a video link. The full series is available on the company's YouTube channel.

Golden Age Theatre Company have made seven short plays available on their YouTube channel. The company is "dedicated to creating theatre which explores big ideas in both historical and contemporary settings". The plays are typically 30-40 minutes long and explore a wide variety of subjects. The most recent plays are Infantophobia, about a woman who has a fear of children, and Transhuman, a sci-fi piece (both by Ian Dixon Potter).

The Coronavirus Theatre Club was formed seven months ago and now has more than forty short plays available on their YouTube channel. The pieces are sharp, energetic, and thoughtful, and include pieces written by Alice Murray, Alex Britt, Aurelia Gage, and Victoria Saxton. Running times range from three to twelve minutes.

Over at Queen's Theatre Hornchurch, Ten Tiny Plays feature snapshots of time across pieces running at an average of two minutes long. Writers include Lauren Bracewell and John Dunn. You can find these on the theatre's YouTube channel.

A remote series by Mark Goldthorp, Distanced comprises six short plays which were uploaded over the past four weeks. At an average running time of eight minutes, they can be enjoyed as separate entities or in one go online.

National eTheatr streamed between April and July 2020, with a wide range of plays from ten minutes long up to an hour in length. Barry McStay developed the project to provide work for theatre artists during the first national lockdown. You can find an archive of all the streams on their YouTube channel.

The Ow Am Ya! Theatre Company's project, Emerge, shares the work of their Youth Theatre Company on the subject of 2020. Currently, seven plays are available, including work by Poppy Tooth and Lauren Hindley. All have a running time of around three minutes and are available on the company's YouTube channel.

Tales From The Edge is a series of short-film monologues, filmed during lockdown and featuring characters "on the edge of society". These were uploaded between May and August 2020 and run at around fifteen minutes each. They can be viewed on YouTube.

Fringe festivalsThornhill Theatre Space'sWorldwide Virtual Fringe

Many fringe companies and festivals have moved online for 2020. Those that are still available or just starting include the following:

The HOMEmakers festival at Home in Manchester. You can access a range of audio and video recordings, and games, on a PWYC basis on the theatre's website. Access is available until 31 December.

The Hope Theatre in Islington has launched Hope at Home, which comprises five monologues. They will be released online on the theatre's YouTube channel each week from 23 November.

During the summer, the Thornhill Theatre Space's Worldwide Virtual Fringe ran on Facebook, and all thirty videos remain available, ranging from podcasts, plays, musical showcases, readings, and behind the scenes discussions. They have recently moved into offering selections from new musicals, including Astrom Club and No, You Can't.

The Space in Limehouse made several Zoom production readings available on their YouTube channel including their 2.0 Fest and ScriptSpace.

Scenesaver has collated many fringe performances from around the world in one place, available on free registration. It is this year's hub for the Off-West End Theatre Awards (OnComms).

Recently they have launched a "Theatre Club" where viewers can watch and discuss shows together. Donations are welcomed either to the site itself or to individual productions. Both the Reading and Wandsworth Arts Fringe have archived this year's productions on this site.

Children's showsHalf Moon Theatre at Home

Half Moon Theatre has been making productions available throughout lockdown. The House That Jackson Built is available online on a Pay What You Can basis from 28 November, and Butterflies from 12 December. Once booked, the recording can be watched for seven days.

On Unicorn Theatre's YouTube channel, you can find readings of Philip Pullman's Grimm Tales (until 21 February 2021) and Roald Dahl's The Twits (until 30 November 2020). Both are suitable for young children from the ages of 8-12.

Little Angel Theatre has made some short pieces available on their YouTube channel under the umbrella title Puppetry Sofa Series, with more planned before Christmas. They are also streaming two productions (Reach for the Stars, until 6 December; and Wow! Said the Owl, from 2-31 December via Zoom, at the cost of 13.50 per household).

What theatre shows have you enjoyed watching online? Let us know on Twitter!

Photo credits: HomeMCR, Forced Entertainment, The Other Palace, Golden Age Theatre, Thornhill Theatre Space, Half Moon Theatre

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Neurology Software Market to 2025: Growth Analysis by Manufacturers, Regions, Types and Applications – AlgosOnline

A recent research on ' Neurology Software market', now available with Market Study Report, LLC, is a thorough study on the latest market trends prevailing in the global business sphere. The report also offers important details pertaining to market share, market size, profit estimations, applications and statistics of this industry. The report further presents a detailed competitive analysis including growth strategies adopted by key players of the industry.

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This Week in Washington IP: Antitrust in the Ninth Circuit, Shaping Artificial Intelligence and Promoting Security in 5G Networks – IPWatchdog.com

This week in Washington IP events, the House of Representatives remains quiet during district work periods, while the Senate focuses this week on the nomination of Amy Coney Barrett to serve on the U.S. Supreme Court. Various tech related events will take place at policy institutes this week, including several at the Center for Strategic & International Studies exploring efforts to maintain American leadership in semiconductor manufacturing and innovation in the intelligence community. The Hudson Institute is hosting a virtual event this week to discuss the impacts of the Ninth Circuits recent decision to overturn Judge Lucy Kohs injunction against Qualcomms patent licensing practices.

The Hudson Institute

Antitrust in the 21st Century: The Ninth Circuits Decision in FTC v. Qualcomm

At 12:00 PM on Monday, online video webinar.

In early August, a panel of circuit judges in the U.S. Court of Appeals for the Ninth Circuit issued a unanimous 3-0 decision in favor of Qualcomm in its appeal against Judge Lucy Kohs ruling in favor of the Federal Trade Commission (FTC), which featured an injunction against Qualcomm for its patent licensing practices in the semiconductor industry. While the FTC pursues en banc review of the Ninth Circuits decision, this event will explore the FTCs chances for success on that petition as well as current guiding principles for those operating at the intersection of intellectual property rights and antitrust law. Speakers at this event will include Judge Paul R. Michel (Ret.), Former Chief Judge, U.S. Court of Appeals for the Federal Circuit; Richard A. Epstein, Professor of Law, New York University, Senior Fellow, Hoover Institution, and Professor Emeritus and Senior Lecturer, University of Chicago; Dina Kallay, Head of Competition (IPR, Americas, and Asia-Pacific), Ericsson; and Urka Petrov?i?, Senior Fellow, Hudson Institute.

Center for Strategic & International Studies

American Leadership in Semiconductor Manufacturing

At 2:00 PM on Tuesday, online video webinar.

This June, Representatives Michael McCaul (R-TX) and Doris Matsui (D-CA) introduced H.R. 7178, the Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act. If enacted, the bill would create a tax credit for entities investing in semiconductor manufacturing facilities, among other incentives meant to support domestic chipmakers. This event, which will focus on the importance of maintaining dominance in the semiconductor sector in the face of growing challenges from China, will feature a discussion between Rep. McCaul, who is also Co-Chair, House Semiconductor Caucus & Lead Republican, House Foreign Affairs Committee; and James Andrew Lewis, Senior Vice President and Director, Technology Policy Program.

Information Technology & Innovation Foundation

How Will Quantum Computing Shape the Future of AI?

At 9:00 AM on Wednesday, online video webinar.

The power of quantum computing to compute algorithms more quickly than classical computing relies in large part upon the nascent technologys ability to model extremely complex problems, giving quantum computers the ability to create stronger forecasts in sectors where many variables come into play, such as weather predictions. In artificial intelligence (AI), quantum algorithms could be a great boon in solving complex problems like climate forecasts and discovering novel drug compounds, so those nations which can take the lead in quantum computing will also likely have an edge in AI development. This event will feature a discussion with a panel including Hodan Omaar, Policy Analyst, Center for Data Innovation, ITIF; Freeke Heijman, Director, Strategic Development, QuTech Delft; Joseph D. Lykken, Deputy Director of Research, Fermi National Accelerator Laboratory; Markus Pflitsch, Chairman and Founder, Terra Quantum AG; and moderated by Eline Chivot, Senior Policy Analyst, Center for Data Innovation, ITIF.

The Hudson Institute

The Future of American Spectrum Policy: Is DoDs Request for Information the Best Direction?

At 3:00 PM on Wednesday, online video webinar.

In early August, the White House and the U.S. Department of Defense (DoD) announced a plan to devise a spectrum sharing framework that frees up 100 megahertz (MHz) of continuous mid-band spectrum currently held by the DoD to be auctioned by the Federal Communications Commission (FCC) for supporting the growth of 5G networks across the U.S. A request for information (RFI) issued by the DoD on September 18 to identify innovative solutions for dynamic spectrum sharing which effectively supports national security while freeing up additional spectrum to be used by the 5G industry. Speakers at this event will include Harold Furchtgott-Roth, Director, Center for the Economics of the Internet; Michael ORielly, Commissioner, FCC; Robert McDowell, Former Commissioner, FCC; and Grace Koh, Ambassador and Special Advisor, Bureau of Economic and Business Affairs.

U.S. Patent and Trademark Office

Hear From USPTO Experts at the State Bar of Texas Advanced Intellectual Property Litigation Course

At 9:00 AM on Thursday, online video webinar.

On Thursday morning, the USPTO kicks off a two-day series of intellectual property litigation workshops being offered in partnership with the Intellectual Property Law Section of the State Bar of Texas. USPTO experts speaking at this event will include Molly Kocialski, Director, Rocky Mountain Regional Office; Miriam L. Quinn, Administrative Patent Judge, Patent Trial and Appeal Board; Todd J. Reves, Office of Policy and International Affairs; and Megan Hoyt, Dallas Regional Outreach Officer.

Center for Strategic & International Studies

Innovation in the Intelligence Community

At 3:00 PM on Thursday, online video webinar.

The U.S. intelligence community is careful to maintain secrecy in its operations but this can come at a cost to that sectors ability to support the development of innovative technologies like quantum computing and artificial intelligence. However, a recent report on the innovation race in the intelligence community issued by House Permanent Select Committee on Intelligences Subcommittee on Strategic Technologies and Advanced Research provides several recommendations for the intelligence community to support tech development in areas crucial for national security. This event will feature a discussion on the report between Representative Jim Hines (D-CT), Chairman, House Permanent Select Committee on Intelligences Subcommittee on Strategic Technologies and Advanced Research; and James Andrew Lewis, Senior Vice President and Director, Technology Policy Program.

Center for Strategic & International Studies

Sharpening Americas Innovative Edge

At 11:00 AM on Friday, online video webinar.

Although the United States lept to the forefront of global tech dominance thanks in large part to federal investment in R&D programs, the nations research funding continues to follow an outdated Cold War-era funding model for research. This event coincides with a report released by CSISs Trade Commission on Affirming American Leadership which outlines a national strategy for developing important technology sectors so that the U.S. can remain ahead of its global counterparts in those fields. This event will feature a discussion with a panel including Ajay Banga, CEO, Mastercard; Richard Levin, Former President, Yale University; Kavita Shukla, Founder and CEO, The FRESHGLOW Co.; and moderated by Matthew P. Goodman, Senior Vice President for Economics and Simon Chair in Political Economy, CSIS.

The Heritage Foundation

5G: The Emerging Markets Trojan Horse

At 1:00 PM on Friday, online video webinar.

The United States and several governments across Europe have sounded the alarm in recent years over the risks of foreign surveillance of domestic networks enabled by the use of network infrastructure hardware developed by growing Chinese telecom firms like Huawei and ZTE which have close ties with the Chinese communist government. While these developed nations have taken steps to prevent such issues in the 5G supply chain, governments in Africa and other developing areas of the world are forced to choose between protecting national security and building these crucial networks. Speakers at this event will include Bonnie Glick, Deputy Administrator, United States Agency for International Development; Joshua Meservy, Senior Policy Analyst, Africa and the Middle East; and hosted by Klon Kitchen, Director, Center for Technology Policy.

U.S. Patent and Trademark Office

2020 Patent Public Advisory Committee Annual Report Discussion

At 1:00 PM on Friday, online video webinar.

On Friday afternoon, the USPTOs Patent Public Advisory Committee (PPAC) will convene a meeting to discuss the annual report that the committee will prepare on the agencys policies, performance and user fees which will be delivered to the White House and Congress by the end of the fiscal year.

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Comprehensive Analysis on Stem Cell Therapy Market based on types and application – AlgosOnline

The ' Stem Cell Therapy market' study Added by Market Study Report, LLC, provides an in-depth analysis pertaining to potential drivers fueling this industry. The study also encompasses valuable insights about profitability prospects, market size, growth dynamics, and revenue estimation of the business vertical. The study further draws attention to the competitive backdrop of renowned market contenders including their product offerings and business strategies.

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According to the research analysis, the Stem Cell Therapy market is estimated to generate commendable returns and showcase a y-o-y growth rate of XX% over the period of 2020-20205.

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Stem Cell Therapy Market segments covered in the research report:

Regional segmentation: North America, Europe, Asia-Pacific, South America, Middle East and Africa

Product types: Autologous and Allogeneic

Applications spectrum: Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases and Others

Competitive outlook: Osiris Therapeutics, Molmed, JCR Pharmaceutical, NuVasive, Anterogen, Chiesi Pharmaceuticals, Medi-post, Pharmicell and Takeda (TiGenix

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