Any comments on Pfizer possible acquisition? Tia

Pfizer in Talks to Acquire Seagen in Deal Likely Valued at More Than $30 Billion
[free link] https://www.wsj.com/articles/pfizer-in-early-stage-talks-to-acquire-seagen-3f53309e?st=bsdygjfjllzsy2g&reflink=desktopwebshare_permalink

...

The talks are at an early stage and there is no guarantee there will be a deal, the people said. A number of hurdles would need to be overcome, including the potential for a stringent antitrust review of any proposal. If there is a deal, it would be big: Seagen has a market value of some $30 billion and would be expected to command a premium over that.

Any comments on Pfizer possible acquisition? Tia

Pfizer in Talks to Acquire Seagen in Deal Likely Valued at More Than $30 Billion
[free link] https://www.wsj.com/articles/pfizer-in-early-stage-talks-to-acquire-seagen-3f53309e?st=bsdygjfjllzsy2g&reflink=desktopwebshare_permalink

...

The talks are at an early stage and there is no guarantee there will be a deal, the people said. A number of hurdles would need to be overcome, including the potential for a stringent antitrust review of any proposal. If there is a deal, it would be big: Seagen has a market value of some $30 billion and would be expected to command a premium over that.

Burton, D.R., Topol, E.J. Toward superhuman SARS-CoV-2 immunity?. Nat Med (2020). https://doi.org/10.1038/s41591-020-01180-x

To the Editor - If asked, many scientists would probably agree with the statement ‘Natural infection gives better immunity than vaccination’. Indeed, if one survives the infection, there are certainly many pathogens for which natural infection induces stronger immune responses and more long-lived immunity than does vaccination. Measles is prototypic of this. While there was a clear risk, after infection, of death, encephalitis and pneumonia before there was a vaccine, survivors gained lifelong immunity. Vaccination against measles, on the other hand, requires two shots and may not offer lifelong complete protection but has proven to be good enough to keep the disease in check when widely implemented.

In contrast to the measles virus, there are a number of pathogens for which vaccination generates stronger immune responses and more-effective protection against disease than does natural infection. In these cases, the man-made vaccine is ‘superhuman’; that is, it gives humans immune responses superior to those generated in response to infection. …

Where does the coronavirus SARS-CoV-2 lie along the spectrum of natural infection versus vaccine-induced protective efficacy? The answer to this question will be known only as more data are collected from ongoing natural infection and vaccine studies; the initial results from interim analyses by Pfizer/BioNTech and Moderna of mRNA vaccines against SAR-CoV-2 showing a reduction in infections of around 95% are very encouraging7. …

Overall, we are optimistic, given the number of platforms being investigated and the huge ongoing efforts, that a vaccine (or vaccines) against COVID-19 with immune responses and protection superior to that achieved through natural infection is an achievable goal.

FDA: COVID-19 Vaccine

To translate, FDA--through briefing materials to its vaccine advisory committee--has made public what evidence it wants for a COVID vaccine emergency use authorization. The information that the White House has blocked from release via a guidance document. https://www.fda.gov/media/142723/download

The VRBPAC doc appendix II includes a summary of answers to questions about EUA requirements, including the median 2 months of safety follow-up. So the info gets published anyway...

The VRBPAC doc appendix II includes a summary of answers to questions about EUA requirements, including the median 2 months of safety follow-up. So the info gets published anyway...

— Derrick (@dgingery) October 6, 2020

138) OK, somebody is going to ask which vaccine I would take. After seeing all the human data I would likely go with Pfizer or Novavax. But that might change, based on data coming up from Phase III trial. I am also kinda curious about Sanofi.

138) OK, somebody is going to ask which vaccine I would take. After seeing all the human data I would likely go with Pfizer or Novavax. But that might change, based on data coming up from Phase III trial. I am also kinda curious about Sanofi.

— Florian Krammer (@florian_krammer) September 28, 2020

1) SARS-CoV-2 Vaccines - I promised a Tweetorial and here we go. This is going to be long and nerdy. But I'll make sure it is easy to understand. If you want more details, please just read this:

1) SARS-CoV-2 Vaccines - I promised a Tweetorial and here we go. This is going to be long and nerdy. But I'll make sure it is easy to understand. If you want more details, please just read this: https://t.co/XBnamI2pKk

— Florian Krammer (@florian_krammer) September 28, 2020

[OA] Krammer, F. SARS-CoV-2 vaccines in development. Nature (2020). https://doi.org/10.1038/s41586-020-2798-3

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 in China and caused a coronavirus disease 2019 (COVID-19) pandemic. To mitigate the public health, economic and societal impacts of the virus, a vaccine is urgently needed. The development of SARS-CoV-2 vaccines was initiated in early January 2020 when the sequence of the virus became available and moved at record speed with one Phase I trial already starting in March 2020 and currently more than 180 vaccines in various stages of development. Phase I/II trial data is already available for several vaccine candidates and many have moved into Phase III trials. The data available so far suggests that effective and safe vaccines might become available within months rather than years.

Here's all you need to know about the Russian vaccine.


Putin won’t come to New York for UNGA session as COVID-19 situation remains unstable
https://tass.com/russias-foreign-policy/1198751

MOSCOW, September 8. /TASS/. Russian President Vladimir Putin will not come to New York for the UN General Assembly session, as the epidemiological situation in the USA remains unstable, Kremlin Spokesman Dmitry Peskov told TASS on Tuesday.

"For obvious reasons, the president won’t come [to the UN General Assembly], like many other leaders. From the viewpoint of ensuring security, including epidemiological security, the security of the president, the head of state, the situation remains unstable, especially in such places as New York. So of course, a trip there is not advisable right now," Peskov said.

Earlier, Peskov said that Putin would address the 75th session of the UN General Assembly in a video format. …

Five Point Holdings ...

Cheech & Chong Up In Smoke

Tommy Chong & Five Point Holdings To Open Dispensaries In 5 States
http://latfusa.com/article/2020/6/tommy-chong-five-point-holdings-to-open/

The Daytime Beauty Awards' Zen Award honoree and Godfather of Cannabis, Tommy Chong of "Cheech & Chong" has entered into dispensary license with Five Point Holdings Inc. and partnered with Cheech Marin to develop a five state dispensary chain.

Five Point Holdings Inc. is a diversified cannabis branding company with decades of dispensary retail, branding, and media experience is pleased to announce its licensing agreement (the "Agreement") with Cheech & Chong's management company to license the Cheech & Chong Brand to initially open dispensaries in California, Nevada, Arizona, Illinois and Washington.

The license will allow the company to develop experiential cannabis dispensaries utilizing the Cheech & Chong brand name. …

Thanks for the reply. Short mention of Rem at the bottom.


Roche rheumatoid arthritis drug fails to help COVID-19 patients in Italian study
https://uk.reuters.com/article/us-health-coronavirus-roche-hldg/roche-rheumatoid-arthritis-drug-fails-to-help-covid-19-patients-in-italian-study-idUKKBN23O3GG

(Reuters) - Roche’s rheumatoid arthritis drug Actemra failed to help patients with early-stage COVID-19 pneumonia in an Italian study, the latest instance in which an anti-inflammatory drug has fallen through in a coronavirus trial.

Despite the setback, the Swiss drugmaker said that it is pressing ahead with testing Actemra in another trial against COVID-19, the disease caused by the new coronavirus.

Actemra did not reduce severe respiratory symptoms, intensive care visits, or death any better than standard treatments, the Italian Medicines Agency (Aifa), Italy’s drugs regulator which authorized the study, said in a statement on Wednesday.

The trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness.

“Although not effective in all patients with COVID-19 pneumonia, it is possible that selected subgroups of patients may have a better response,” Aifa said.

Sales of Actemra jumped 30% in the first quarter, Roche said in April, on hopes it would help in the fight against the new coronavirus.

Its failure to do so in the Italian study now adds to questions about the role of drugs like Actemra, which are designed to inhibit interleukin-6 (IL-6) proteins associated with dangerous inflammation, in treating COVID-19.

A similar IL-6 inhibitor, Sanofi and Regeneron’s arthritis drug Kevzara, failed in a trial in April to help a group comprised of severely ill and critically ill patients, leading the drugmakers to continue to test high doses of Kevzara only in those considered critically ill with COVID-19.

Detailed data from the Italian Actemra study, which involved 24 medical centres, will be sent to a scientific journal.

Meanwhile, Roche has completed enrolment of its own Actemra study in patients hospitalized with severe COVID-19 pneumonia. That “will provide robust evidence about the benefit/ risk profile”, a Roche spokesman said, with data expected in the next few months.

Last month Roche also announced plans to study whether combining Actemra with Gilead Sciences Inc’s antiviral treatment remdesivir works better against severe COVID-19 pneumonia than remdesivir alone.

COVID-19

Thanks in advance or any info. A family friend has been diagnosed with COVID-19 and is now hospitalized. They have reached out for info on the experimental drugs below. I am concerned for the speed to begin these drugs before use of dexa/rem. Or, how this might delay/interfere with their use should that be needed. His Sa02 is now ~90. It was 95+ a day ago. I do not have more clinical details at this time.

I would appreciate anything on the following use and MOA. Again, Tia.

A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia (COVASTIL)
https://clinicaltrials.gov/ct2/show/NCT04386616

Genentech
https://www.gene.com/

New projections from CDC in documents obtained by New York Times shows steady rise in number of cases and deaths from #covid19 over next several weeks, reaching about 3,000 daily deaths on June 1st and about 200,000 new cases each day by end of the month. https://int.nyt.com/data/documenthelper/6926-mayhhsbriefing/af7319f4a55fd0ce5dc9/optimized/full.pdf

I am truly sorry to say, Remdesivir is probably worthless, and we are seeing some fascinating drug company shenanigans, a thread. https://threadreaderapp.com/thread/1256242036015063042.html


I just saw this thread by @MarkHoofnagle and feel compelled to respond to clarify some things.

Disclaimers: I am not an ID expert. I am a Medical Intensivist in the Military. These are not the official views of the DoD. Just my personal opinions. No financial COIs.

I just saw this thread by @MarkHoofnagle and feel compelled to respond to clarify some things.

Disclaimers: I am not an ID expert. I am a Medical Intensivist in the Military. These are not the official views of the DoD. Just my personal opinions. No financial COIs.

1/ https://t.co/znxCAmmEqu

— Kevin K. Chung, MD (@chungk1031) May 2, 2020

More pro/con at twitter link https://twitter.com/MarkHoofnagle

Urologists & Masks ...

[Re: Santa Clara Study] USC-LA County Study: Early Results of Antibody Testing Suggest Number of COVID-19 Infections Far Exceeds Number of Confirmed Cases in Los Angeles County
http://createsend.com/t/j-296D9D8CE54262BB2540EF23F30FEDED

Los Angeles (April 20, 2020) – USC and the Los Angeles County Department of Public Health (Public Health) today released preliminary results from a collaborative scientific study that suggests infections from the new coronavirus are far more widespread – and the fatality rate much lower — in L.A. County than previously thought.

The results are from the first round of an ongoing study by USC researchers and Public Health officials. They will be conducting antibody testing over time on a series of representative samples of adults to determine the scope and spread of the pandemic across the county.

Based on results of the first round of testing, the research team estimates that approximately 4.1% of the county’s adult population has antibody to the virus.

Adjusting this estimate for statistical margin of error implies about 2.8% to 5.6% of the county’s adult population has antibody to the virus— which translates to approximately 221,000 to 442,000 adults in the county who have had the infection.

That estimate is 28 to 55 times higher than the 7,994 confirmed cases of COVID-19 reported to the county by the time of the study in early April. The number of COVID-related deaths in the county has now surpassed 600.

“We haven’t known the true extent of COVID-19 infections in our community because we have only tested people with symptoms, and the availability of tests has been limited,” said lead investigator Neeraj Sood, a USC professor of public policy at USC Price School for Public Policy and senior fellow at USC Schaeffer Center for Health Policy and Economics. “The estimates also suggest that we might have to recalibrate disease prediction models and rethink public health strategies.”

The results have important implications for public health efforts to control the local epidemic.

Check Link for more info ...

Lead Scientists in USC-LA County Study to Discuss Early Results of Groundbreaking Antibody Testing of Select Cases in LA County: Evidence Suggests COVID-19 Cases Higher than Previously Estimated

Los Angeles (April 20, 2020) – USC and the Los Angeles County Department of Public Health (Public Health) today will release preliminary results from a collaborative scientific study that suggests infections from the new coronavirus are far more widespread – and the fatality rate much lower — in L.A. County than previously thought.

The results are from the first round of an ongoing study by USC researchers and Public Health officials. They will be conducting antibody testing over time on a series of representative samples of adults to determine the scope and spread of the pandemic across the county.

Lead scientists will be available for an in-depth discussion and to answer questions related to this important research.

WHEN: Monday, April 20, 2020 at 2:30 p.m.

WHERE: Live via WebEx. Click: https://bit.ly/2wM7jpo to register and join via computer or smart phone. When prompted, enter the information requested and the event password: DPH-USC

ICYMI ...

Liu S-L, Saif LJ, Weiss SR, Su L. No credible evidence supporting claims of the laboratory engineering of SARS-CoV-2. Emerging Microbes & Infections 2020;9:505-7. https://doi.org/10.1080/22221751.2020.1733440

There are also rumours that the SARS-CoV-2 was artificially, or intentionally, made by humans in the lab, and this is highlighted in one manuscript submitted to BioRxiv (a manuscript sharing site prior to any peer review), claiming that SARS-CoV-2 has HIV sequence in it and was thus likely generated in the laboratory. In a rebuttal paper led by an HIV-1 virologist Dr. Feng Gao, they used careful bioinformatics analyses to demonstrate that the original claim of multiple HIV insertions into the SARS-CoV-2 is not HIV-1 specific but random [15]. Because of the many concerns raised by the international community, the authors who made the initial claim have already withdrawn this report.

Evolution is stepwise and accrues mutations gradually over time, whereas synthetic constructs would typically use a known backbone and introduce logical or targeted changes instead of the randomly occurring mutations that are present in naturally isolated viruses such as bat CoV RaTG13. In our view, there is currently no credible evidence to support the claim that SARS-CoV-2 originated from a laboratory-engineered CoV. It is more likely that SARS-CoV-2 is a recombinant CoV generated in nature between a bat CoV and another coronavirus in an intermediate animal host. More studies are needed to explore this possibility and resolve the natural origin of SARS-CoV-2. We should emphasize that, although SARS-CoV-2 shows no evidence of laboratory origin, viruses with such great public health threats must be handled properly in the laboratory and also properly regulated by the scientific community and governments.

...

[OA] Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nature Medicine 2020. https://doi.org/10.1038/s41591-020-0820-9

To the Editor — Since the first reports of novel pneumonia (COVID-19) in Wuhan, Hubei province, China there has been considerable discussion on the origin of the causative virus, SARS-CoV-23 (also referred to as HCoV-19). Infections with SARS-CoV-2 are now widespread, and as of 11 March 2020, 121,564 cases have been confirmed in more than 110 countries, with 4,373 deaths.

SARS-CoV-2 is the seventh coronavirus known to infect humans; SARS-CoV, MERS-CoV and SARS-CoV-2 can cause severe disease, whereas HKU1, NL63, OC43 and 229E are associated with mild symptoms. Here we review what can be deduced about the origin of SARS-CoV-2 from comparative analysis of genomic data. We offer a perspective on the notable features of the SARS-CoV-2 genome and discuss scenarios by which they could have arisen.

Our analyses clearly show that SARS-CoV-2 IS NOT A LABORATORY CONSTRUCT OR A PURPOSEFULLY MANIPULATED VIRUS.

…

Comments, Thoughts, Opinions, ... Tia

“Evidence for widespread infection already (including asymptomatic). Accumulating evidence in this direction will mean going back to normal sooner, will vindicate skeptics like Ioannidis, and require revisiting prognositications of months to years social distancing.”

Evidence for widespread infection already (including asymptomatic).

Accumulating evidence in this direction will mean going back to normal sooner, will vindicate skeptics like Ioannidis, and require revisiting prognositications of months to years social distancing https://t.co/wK9EvL8HLv

— Antonio Regalado (@antonioregalado) April 3, 2020

Day M. Covid-19: four fifths of cases are asymptomatic, China figures indicate. BMJ 2020;369:m1375. http://www.bmj.com/content/369/bmj.m1375.abstract

New evidence has emerged from China indicating that the large majority of coronavirus infections do not result in symptoms.

Chinese authorities began publishing daily figures on 1 April on the number of new coronavirus cases that are asymptomatic, with the first day’s figures suggesting that around four in five coronavirus infections caused no illness. Many experts believe that unnoticed, asymptomatic cases of coronavirus infection could be an important source of contagion.

A total of 130 of 166 new infections (78%) identified in the 24 hours to the afternoon of Wednesday 1 April were asymptomatic, said China’s National Health Commission. And most of the 36 cases in which patients showed symptoms involved arrivals from overseas, down from 48 the previous day, the commission said.

China is rigorously testing arrivals from overseas for fear of importing a fresh outbreak of covid-19.

Tom Jefferson, an epidemiologist and honorary research fellow at the Centre for Evidence-Based Medicine at the University of Oxford, said the findings were “very, very important.” He told The BMJ, “The sample is small, and more data will become available. Also, it’s not clear exactly how these cases were identified. But let’s just say they are generalisable. And even if they are 10% out, then this suggests the virus is everywhere. If—and I stress, if—the results are representative, then we have to ask, ‘What the hell are we locking down for?’”

…

In an article on the website of the Centre for Evidence-Based Medicine, Jefferson and Carl Heneghan, director of the centre and editor of BMJ EBM, write, “There can be little doubt that covid-19 may be far more widely distributed than some may believe. Lockdown is going to bankrupt all of us and our descendants and is unlikely at this point to slow or halt viral circulation as the genie is out of the bottle.

“What the current situation boils down to is this: is economic meltdown a price worth paying to halt or delay what is already amongst us?”3 [Covid-19 – The tipping point? https://www.cebm.net/2020/03/covid-19-the-tipping-point ]

Apologies if posted ...

Thoughts on the Gautret et al. paper about Hydroxychloroquine and Azithromycin treatment of COVID-19 infections
https://scienceintegritydigest.com/2020/03/24/thoughts-on-the-gautret-et-al-paper-about-hydroxychloroquine-and-azithromycin-treatment-of-covid-19-infections/

...

This study gained an enormous amount of attention because it reports very encouraging results of a small study in which COVID-19 patients were treated with hydroxychloroquine. This is great news in the midst of a pandemic outbreak for a viral disease for which there is not good current treatment, which is why this paper was quickly published.

Unfortunately, there are many potential problems with the way the data and the peer review process were handled. The discussion is still ongoing on PubPeer, with 2 posts on either the preprint (40 comments as of today) or the published version (3 comments). Let’s take a closer look at the paper and discuss some possible problems. Note that part of the text in this blog post has been previously posted by me on Pubpeer and on Twitter.

...

Is this related? Why 80 patients. It appears they are treating many more. Randomization?

The real lesson here is, had you randomized the 503 pts you have already treated with this experimental combo in this wasteful uncontrolled study, you would already know the answer, instead these data prove nothing.

The real lesson here is, had you randomized the 503 pts you have already treated with this experimental combo in this wasteful uncontrolled study, you would already know the answer, instead these data prove nothing@statsepi https://t.co/rZj9D1uHkd

— Vinay Prasad MD MPH (@VPrasadMDMPH) March 27, 2020

BREAKING UPDATE on hydroxychloroquine + azithromycin treatment in South France

COVID-19 positive patients at Méditerranée Infection University Hospital = 1416
Deaths = 11

Patients treated with HCQ + AZ = 503
Deaths = 1

BREAKING UPDATE on hydroxychloroquine + azithromycin treatment in South France

COVID-19 positive patients at Méditerranée Infection University Hospital = 1416
Deaths = 11

Patients treated with HCQ + AZ = 503
Deaths = 1@raoult_didier #COVID2019 #COVID https://t.co/nscre9mWvW pic.twitter.com/6NWXM23NgK

— James Todaro, MD (@JamesTodaroMD) March 26, 2020

Cellphone tracking could help stem the spread of coronavirus. Is privacy the price?
https://www.sciencemag.org/news/2020/03/cellphone-tracking-could-help-stem-spread-coronavirus-privacy-price#

“IT IS POSSIBLE TO STOP THE EPIDEMIC.” That’s the message splashed atop a website built by a University of Oxford team this week to share new research on the spread of the novel coronavirus. https://045.medsci.ox.ac.uk/

Below that hopeful statement comes a big caveat: To stop the virus’ spread, health officials need to find and isolate the contacts of infected people—lots of them—and fast. Such contact tracing is a mainstay of infectious disease control. But the Oxford team is one of several now advocating for a new approach: tapping into cellphone location data to track the spread of infection and warn people who may have been exposed.

...

[Video] This shows the location data of phones that were on a Florida beach during Spring Break. It then shows where those phones traveled.

First thing you should note is the importance of social distancing. The second is how much data your phone gives off.

This shows the location data of phones that were on a Florida beach during Spring Break. It then shows where those phones traveled.

First thing you should note is the importance of social distancing. The second is how much data your phone gives off. pic.twitter.com/iokUX3qjeB

— Mikael Thalen (@MikaelThalen) March 26, 2020

[Video] Remember, the above video is just the movements of cell phones from one Florida beach.

The cell phone location data out of greater Manhattan is even more telling.

Remember, the above video is just the movements of cell phones from one Florida beach.

The cell phone location data out of greater Manhattan is even more telling. pic.twitter.com/cKCxX2BOf4

— Mikael Thalen (@MikaelThalen) March 27, 2020

Mary C. Sound and Fury in the Microbiology Lab. Science 2012;335:1033. http://science.sciencemag.org/content/335/6072/1033.abstract

Raoult's entire opus appears to be written in big numbers. A recent PubMed search showed him as an author on more than 1400 papers, including the description of more than 60 new bacterial species and one new bacterial genus, which Drancourt named Raoultella. But some scientists grumble that manuscripts out of Raoult's lab often contain errors, for instance, as a result of unchecked genetic sequences.

Indeed, problems in a paper about a mouse model for typhus got his lab in hot water in 2006. A reviewer for Infection and Immunity, a journal published by the American Society for Microbiology (ASM), discovered that four figures in a revised manuscript were identical to figures in the original manuscript, even though they were supposed to describe a different experiment.

In letters to ASM, made available by Raoult, second author Christian Capo and last author Jean-Louis Mège, a group leader, accepted “full responsibility” for the problem, which they said involved only two figures. Capo, in his letter, wrote that he had made an innocent mistake; Mège wrote that Capo had subsequently failed to show the revised manuscript to other authors, who were on vacation, before resubmitting it. But after consulting its ethics panel, ASM banned all five authors, including Raoult, from publishing in its journals for a year. “We are not entirely comfortable with the explanation provided,” ASM officials wrote to Mège. “Misrepresentation of data … is an affront to the ethical conduct of scientific inquiry.”

Capo and Mège accepted the decision, but Raoult wrote ASM that he wasn't at fault and that the “collective punishment” was “very unfair.” He appealed the ban, also on behalf of two other co-authors, but lost. Furious, he resigned from the editorial board of two other ASM journals, canceled his membership in the American Academy of Microbiology, ASM's honorific leadership group, and banned his lab from submitting to ASM journals, in which he had published more than 230 studies. His name has been on only two ASM journal papers since, both published in 2010. To clear his name, Raoult sent his ASM correspondence to French colleagues in 2007, along with a letter defending himself. “If I had been in the United States, I would have sued,” he wrote.

Chloroquine genius Didier Raoult to save the world from COVID-19
As COVID19 pandemic rages on, French microbiologist Didier Raoult offers a cure. President Trump is convinced, but is Raoult's research reliable, here and in general?
https://forbetterscience.com/2020/03/26/chloroquine-genius-didier-raoult-to-save-the-world-from-covid-19/

Coronavirus COVID-19 pandemic is about to be stopped by a stroke of a French “genius” with a history of publishing manipulated data. The charismatic Didier Raoult, director of the Research Unit in Infectious and Tropical Emergent Diseases (URMITE) in Marseille has found a cure: the humble chloroquine, cheap unpatented substance used to treat malaria and autoimmune diseases lupus and rheumatism.

The substance so far failed in all antiviral therapies, but this didn’t prevent Raoult from deciding that chloroquine can cure corona virus infections, serious side effects notwithstanding. To prove that, Raoult treated 26 patients at his institution with the derivative hydroxychloroquine, alone and in combination with the antibiotic (meaning antibacterial!) drug azithromycine. The study was not randomised, ethically approved only after it already began, and it was not really controlled: the 16 control patients were treated in different clinics.

...

Statistical review of Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial.
https://zenodo.org/record/3724167#.XnlUwIhKhGM

The following review has been prepared by members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers are all qualified statisticians with experience in clinical trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of COVID-19 treatments, independent of journal specific review processes.

We aim to provide timely, constructive, focused, clear advice aimed at improving both the research outputs under review, as well as future studies. Given our collective expertise (clinical trial statistics) our reviews focus on the designs of the trials and other statistical content (methods, presentation and accuracy of results, inferences).

Here we review Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial, by Gautret et al. When we started our review, the paper was being circulated via Google Drive. Shortly after, it was accepted for publication in the International Journal of Antimicrobial Agents, and posted on MedRxiv.org. However, these versions of the study report were the same as the one we reviewed, indicating no or limited external peer review for the final published version.

Coronavirus (COVID-19) Resources for Pharmacists
https://www.idstewardship.com/coronavirus-covid-19-resources-pharmacists/

Many pharmacists across the world are working hard to keep up with therapeutic options for coronavirus / SARS-CoV-2 / COVID-19. This webpage was created to provide insights and resources for pharmacists helping to manage this pandemic. Take note that updates to the page will be made periodically as permitted and the content here may not be completely up-to-date as the situation is evolving quickly. Also beware that much of the data identified below is of relatively poor quality in terms of utility for determining what should be done in clinical practice.

Additionally, there are many potential COVID-19 therapies, I list several at the bottom, but do not discuss them in depth. Some of these can potentially lessen the cytokine storm associated with COVID-19 and help with managing acute respiratory distress syndrome (ARDS).

MOST IMPORTANTLY: Thus far no antiviral drug has been proven to work against COVID-19 in humans, although many randomized controlled trials are ongoing. Inclusion in this webpage is not an endorsement for use of any of these drugs for COVID-19.

Pls wash your hands.
https://twitter.com/BenjaminEnfield/status/1240314309852508166?s=20

So far I've treated 5 confirmed COVID-19 patients reqiring hospitalization, and currently have 14 suspected cases... and I can tell you that in 18 years of medical practice I've never seen anything like this. [Physician/ Hospitalist] https://twitter.com/BioBreakout/status/1238866531838316544?s=20

Do you know who BioBreakout is?

[OA] Touret F, de Lamballerie X. Of chloroquine and COVID-19. Antiviral Research 2020;177:104762. http://www.sciencedirect.com/science/article/pii/S0166354220301145

Highlights
• In vitro data suggest that chloroquine inhibits SARS Cov-2 replication.
• In past research, chloroquine has shown in vitro activity against many different viruses, but no benefit in animal models.
• Chloroquine has been proposed several times for the treatment of acute viral diseases in humans without success.
• The outcomes of some current clinical trials of chloroquine in China have been announced, without access to the data.
• Peer review of the results and an independent assessment of the potential benefit for patients are essential.

Recent publications have brought attention to the possible benefit of chloroquine, a broadly used antimalarial drug, in the treatment of patients infected by the novel emerged coronavirus (SARS-CoV-2). The scientific community should consider this information in light of previous experiments with chloroquine in the field of antiviral research.


Here is link to your cite:

[OA] Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies [published online ahead of print, 2020 Feb 19]. Biosci Trends. 2020;10.5582/bst.2020.01047. doi:10.5582/bst.2020.01047 https://www.jstage.jst.go.jp/article/bst/advpub/0/advpub_2020.01047/_article

America’s Cattle Ranchers Are Fighting Back Against Fake Meat
https://www.wsj.com/articles/americas-cattle-ranchers-are-fighting-back-against-fake-meat-11574850603?mod=e2tw

On a rainy September morning, a pair of cattle ranchers browsed the refrigerated meat cases at a Walmart Inc. store in Mandan, N.D., snapping cellphone photos of an unwelcome invader among the shrink-wrapped ground beef: Beyond Meat Inc. patties, made from pea protein and coconut oil. After a separate check at a nearby local supermarket, the ranchers headed to the North Dakota Department of Health. They showed officials the photos and warned of food-safety risks from mixing plant burgers with the traditional beef kind.

Their message: Meatless burgers don’t belong on beef’s turf.

...

Over the past two years, the beef industry has pushed legislation that restricts terms like “beef” and “meat” to the kind raised on the hoof, not products derived from plants or future ones developed using animal cells in labs. Various labeling laws are now are on the books in 12 states and were considered this year in 15 others, with a federal bill introduced in October.

For restaurants and grocery stores, growth is coming not from the real thing, but from a new generation of meatless products that combine proteins from soy or yellow peas with potato starch, beet juice and other ingredients to more closely mimic beef’s sizzle and juiciness. U.S. retail meat sales fell 0.4% in the past 12 months through October, while sales of alternative meat grew 8%, according to market-research firm Nielsen. In the 12 months before that, meat sales fell 0.8% while sales of alternatives rose 21%.

Plant-based alternatives amount to the equivalent of just 1% of the total volume of meat sold in the U.S., according to Nielsen. But some beef producers see an existential threat in the growth of meat-alternative makers like Beyond and Impossible Foods Inc.

For a hint at the threat they face, they point to dairy farmers’ years-long losing battle against almond, soy and other imitation milks that have captured about 10% of sales, while consumption of traditional cows’ milk has declined.

[Not The Onion] Breakthrough Gene Therapy Clinical Trial is the World's First That Aims to Reverse 20 Years of Aging in Humans
https://www.prnewswire.com/news-releases/breakthrough-gene-therapy-clinical-trial-is-the-worlds-first-that-aims-to-reverse-20-years-of-aging-in-humans-300963496.html

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ -- Libella Gene Therapeutics, LLC ("Libella") announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world's only treatment to cure and reverse aging by 20 years. https://www.libellagenetherapeutics.com/

Under Libella's pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.

Using gene therapy to express active telomerase (hTERT) in humans has the potential to treat many of the age related diseases, including Aging itself. This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse Aging. https://clinicaltrials.gov/ct2/show/NCT04133649?term=libella+gene+therapeutics&draw=2&rank=2

Is there a FDA Approved CRISPR treatment? Tia

Me trading with zero commissions

Me trading with zero commissions pic.twitter.com/ytvrLbnrj8

— Ramp Capital (@RampCapitalLLC) October 9, 2019

Cancer patients are being denied drugs, even with doctor prescriptions and good insurance
https://www.fresnobee.com/news/local/article232478212.html

Norma Smith was diagnosed with stage-three cancer in December.

There are four stages to cancer, and number three means the cancer – in Smith’s case, a blood cancer, multiple myeloma – had spread extensively.

As it attacked cells in Smith’s bone marrow, an important part of the immune system, the 62-year-old was eager to start treatments to stop it. What happened instead in the months that followed was Smith’s pharmacy denying and delaying chemotherapy treatments prescribed by Smith’s medical doctor over and over again.

Smith, a retired special education teacher in Fresno, and her husband, Rodney, a retired school psychologist and director of special education, consider their “very expensive” health insurance coverage to be “the best.”

But that insurance didn’t ensure Smith would get the drugs she needed when facing CVS Specialty Pharmacy – the pharmacy their insurance required them to use. Cancer drugs prescribed by Smith’s oncologist were denied because they didn’t follow the standard protocol sequence of medications that Smith’s pharmacy benefit manager, CVS Caremark, had in their guidelines.

That means pharmacy benefit managers have the authority to trump a doctor’s medical judgment without seeing patients or knowing their full medical history, and without accountability for the consequences of what happens to sick people.

Smith is among thousands of documented cases of patients who have been denied needed medications in this way. Doctors and other medical professionals say these denials are only expected to get worse as the country’s largest health insurance companies and pharmacies are increasingly joining forces.

These elusive middlemen with the authority to deny doctors’ prescriptions based on company policies are sometimes referred to as PBMs for short. Doctors and patients believe they are causing life-threatening problems for people like Smith.

...

From their own website … LMAO

“We are at a moment in healthcare where people are willing to try [buy] anything, because they are so frustrated. We have to ask, how can we empower people?“
Glen Tullman https://www.livongo.com/signum.html

How Will Cultured Meat and Meat Alternatives Disrupt the Agricultural and Food Industry?
A number of meat alternatives are evolving, each with the potential to disrupt the multibillion-dollar global meat industry.
https://www.atkearney.com/retail/article/?/a/how-will-cultured-meat-and-meat-alternatives-disrupt-the-agricultural-and-food-industry

Meat alternatives have the potential to disrupt the multibillion-dollar global meat industry. The essential questions, however, are which of those new products have the most disruption potential, what are the resulting shifts within the value chain, and who will benefit most?

Based on our work in the global agriculture, food, and meat industry, we shed some light on the major disruptive trends and provide a trigger point to redirect the strategies of companies affected.

…

Reliable data is difficult to obtain, but according to the American Oil Chemists’ Society (AOCS) and our own field research, it takes about 7 kg of grain in dry weight to produce 1 kg of live weight for bovine in feedlots, around 4 kg of grain in dry weight per 1 kg of live weight for pigs, and for poultry it is just over 2 kg in dry weight.

However, as this is live weight and not meat, all byproducts—which account for about 40 percent of live weight—must be subtracted.1 Hence, in the example of poultry, around 3 kg of grain are required to produce 1 kg of meat.2

Bearing in mind that meat has on average the same calories per kg as a mix of wheat, maize, rice, and soy beans, the conversion of the 46 percent of worldwide feed production into meat adds less than 7 percent to worldwide available food calories.3

This in turn implies that 44 percent of today's global agricultural production (37 percent plus 7 percent) would be enough to feed most humans.

It is worthwhile to note that a plant-based diet would not only provide the same calories but also have the same nutritional value if crops are chosen accordingly to have enough protein. Hence, we could feed around twice as many humans with today’s global harvest if we did not feed livestock but rather consumed the yield ourselves.

Based on the current worldwide population of 7.6 billion humans, we would have food for an additional 7 billion people. This number would increase even further if less of the harvest ended up in biofuel and industrial use or if waste could be reduced.

…

At the current stage, it is hard to tell how fast the disruption will come about. However, one can already observe how wholesalers, retailers, and consumer goods companies are trying to find a lucrative starting position by purchasing exclusive distribution rights or through acquisition of start-ups (for example, Tesco bought distribution rights for the Beyond Meat Burger). Therefore, we have qualitatively forecasted the development of the meat market until 2040 based on reliable economic data as well as on our research and conversations with numerous experts in the field.

…

Based on A.T. Kearney analysis, around one-third of the global meat supply will be provided by these new technologies within the next 10 years (see figure 9). It is noteworthy that the demand for conventional meat declines by 3 percent despite a global increase in meat consumption of 3 percent per year.

Novel vegan meat replacements will show a strong growth in the transition phase (until 2030), whereas cultured meat—with an annual growth rate of 41 percent per year—will outgrow novel vegan meat replacements between 2025 and 2040 due to technological advancements and consumer preferences.

…

All in all, cultured meat and new meat replacement products are going to disrupt the $1,000 billion conventional meat industry with all its supplier companies. This disruption is supported by a general shift toward consumption of non-meat proteins (for example, legumes and nuts) as a consequence of new lifestyle trends, all aimed at a more sustainable and healthier diet, as well as regulatory measures against conventional meat.

Already today, we can observe the formation of a new customer segment made up of “passionate meat eaters” who take care of their diet but for whom a vegan or vegetarian diet is still not an option. In this context, the discussion about cultured meat as well as meat replacement products and how they can be produced in terms of large-scale batches at attractive prices may seem very technical and unemotional.

Most 'meat' in 2040 will not come from dead animals, says report
https://www.theguardian.com/environment/2019/jun/12/most-meat-in-2040-will-not-come-from-slaughtered-animals-report

Most of the meat people eat in 2040 will not come from slaughtered animals, according to a report that predicts 60% will be either grown in vats or replaced by plant-based products that look and taste like meat.

The report by the global consultancy AT Kearney, based on expert interviews, highlights the heavy environmental impacts of conventional meat production and the concerns people have about the welfare of animals under industrial farming.

“The large-scale livestock industry is viewed by many as an unnecessary evil,” the report says. “With the advantages of novel vegan meat replacements and cultured meat over conventionally produced meat, it is only a matter of time before they capture a substantial market share.”

The conventional meat industry raises billions of animals and turns over $1tn (£785bn) a year. However, the huge environmental impacts have been made plain in recent scientific studies, from the emissions driving the climate crisis to wild habitats destroyed for farmland and the pollution of rivers and oceans.

Companies such as Beyond Meat, Impossible Foods and Just Foods that use plant ingredients to create replacement burgers, scrambled eggs and other products are growing rapidly. AT Kearney estimates $1bn has been invested in such vegan products, including by the companies that dominate the conventional meat market. Beyond Meat raised $240m when the company went public in May and its shares have more than doubled since.

Other companies are working on growing meat cells in culture, to produce real meat without needing to raise and kill animals. No such products have yet reached consumers, but AT Kearney predicts cultured meat will dominate in the long term because it reproduces the taste and feel of conventional meat more closely than plant-based alternatives.

Uber IPO

A lot has been said about the Uber IPO prospectus but maybe none as cogent as this FT comment.

A lot has been said about the Uber IPO prospectus but maybe none as cogent as this FT comment. pic.twitter.com/sa3ACm0zTA

— Colin Charles (@bytebot) April 14, 2019

Thanks for the note.

It would seem positive that they mentioned Mylan. Speculation, but could any Mylan deal be headed south. Thus, a reason for the SP.

I sold at high 20s from ~14. And, then got back in at 20!!! SMH ...

Botox Rivals Create New Wrinkles for Allergan
New pricing and new claims to longer-lasting effects from Botox competitors could entice beauty treatment customers to try something new
https://www.wsj.com/articles/botox-rivals-create-new-wrinkles-for-allergan-11554721201

Allergan AGN 0.19% PLC’s multibillion-dollar Botox franchise is once again under attack from new competitors, threatening a core business at a time when the drugmaker is already battling other challenges.

The anti-wrinkle treatment, approved for cosmetic use in 2002, helped create an $8 billion-plus global market for beauty-enhancing drugs. Its ballooning sales propelled Allergan up the ranks of drugmakers. Botox’s world-wide sales of $3.6 billion last year contributed more than a fifth of Allergan’s total revenue.

Those sales are now at risk: A longstanding rival recently rejiggered its marketing to spur sales. A newly approved wrinkle treatment is expected to launch soon. And a third company is trying to develop its own frown-line therapy that lasts longer than Botox.

The volleys come at a challenging time for Allergan, whose shares have fallen about 40% since a recent peak in July 2017, partly because the company’s No. 2-selling product—a dry-eye drug called Restasis, with more than $1 billion in sales—is losing patent protection. Allergan has also faced a series of setbacks in new-drug development.

...

[Ketamine] FDA experts offer a big thumbs up for J&J’s flawed application to market esketamine for major depression ...
https://endpts.com/fda-experts-offer-a-big-thumbs-up-for-jjs-flawed-application-to-market-esketamine-for-major-depression-but-trial-failures-safety-questions-spur-concerns/

By a wide margin — 14 yes, 2 no and 1 abstention — the panel concluded that J&J had offered “substantial evidence of the effectiveness of esketamine,” an intranasal version of a powerful anesthetic called ketamine, better known in party circles as ‘Special K.’

The key safety issue is the known link between the longtime use of ketamine and neurotoxicity. The researchers relied on preclinical dog and rat studies to make their case — hardly the gold standard on safety data. But the panel seemed content that a long-term safety study on a postmarketing basis would be enough, with 15 voting that J&J had successfully outlined the safety profile for an initial approval. And at least one of the authorities noted that currently used depression drugs also have safety issues with longtime use.

The money question:

Do the benefits outweigh the risks? Yes: 14. No: 2. Abstain: 1.

Stealth Research: Lack of Peer-Reviewed Evidence from Healthcare Unicorns

[OA] Cristea IA, Cahan EM, Ioannidis JPA. Stealth research: lack of peer-reviewed evidence from healthcare unicorns. European Journal of Clinical Investigation 2019;0:e13072. https://doi.org/10.1111/eci.13072

Key Messages
• Start-ups are widely accepted as key vehicles of innovation and disruption in healthcare, positioned to make revolutionary discoveries.
• Most of the highest valued start-ups in healthcare have a limited or non-existent participation and impact in the publicly available scientific literature.
• The system of peer-reviewed publishing, while imperfect, is indispensable for validating innovative products and technologies in biomedicine.
• Healthcare products not subjected to peer-review but rather based on internal data generation alone may be problematic and non-trustworthy.

In 2014, one of us (JPAI) wrote a viewpoint article coining the term “stealth research” for touted biomedical innovation happening outside the peer-reviewed literature in a confusing mix of “possibly brilliant ideas, aggressive corporate announcements, and mass media hype”.

These reflections were prompted by Theranos, a medical diagnosis start-up company; Theranos had not published any peer-reviewed papers [1] but made claims that its technology would “disrupt medicine.” However, in contrast to the tech sector, in healthcare published peer-reviewed research is essential to ensure a minimum threshold of transparency, accountability, and credibility for the underlying work in the scientific community.



Lack of transparency in healthcare startups risks another Theranos implosion
https://techcrunch.com/2019/01/28/lack-of-transparency-in-healthcare-startups-risks-another-theranos-implosion/

Are more Theranos -style scandals looming for investors in healthcare startups?

A team of researchers associated with the Meta-Research Innovation Center at Stanford thinks so. They’ve published a paper warning investors in life sciences startups that a systemic lack of transparency exists in their portfolio companies — creating the possibility for more multi-billion-dollar implosions and scandals like the one that toppled Theranos and its charismatic founder, Elizabeth Holmes.

Indeed, one of the study’s authors, Dr. John Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford and director of the University’s PhD program in Epidemiology and Clinical Research, was among the first people to identify the risks associated with Theranos and its “stealth research.”

Now Dr. Ioannidis and his co-authors, Ioana A. Cristea and Eli M. Cahan, have published a study surveying the publicly available research from the largest privately held companies in the healthcare space, and found them lacking.

…

Does iHub automatically post to Twitter. If not, might this not help increase traffic if people know it would help their exposure. Or, if possible Twitter to iHub.

$VKTX - Citron Publishes the Smoking Gun on Ligand Pharmaceuticals
https://citronresearch.com/citron-publishes-the-smoking-gun-on-ligand-pharmaceuticals/