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Exclusive: FDA faults quality control at Lilly plant making Trump-touted COVID drug
https://www.reuters.com/article/us-health-coronavirus-lilly-exclusive/exclusive-fda-faults-quality-control-at-lilly-plant-making-trump-touted-covid-drug-idUSKBN26Y30C
This Startup Is Growing Sushi-Grade Salmon From Cells in a Lab
https://www.sciencetimes.com/articles/27402/20200922/growing-sushi-grade-salmon-cells-lab.htm
Wildtype is opening up a pre-order list for select chefs as it focuses on lab-grown, sushi-grade salmon
https://techcrunch.com/2020/09/11/wildtype-is-opening-up-a-pre-order-list-for-select-chefs-as-it-focuses-on-sushi-grade-salmon/
Wildtype... https://www.wildtypefoods.com/
Trillium Therapeutics Receives Notices of Allowance From U.S. Patent and Trademark Office
https://www.biospace.com/article/releases/trillium-therapeutics-receives-notices-of-allowance-from-u-s-patent-and-trademark-office/
STTK > Wrong link... try this:
https://www.businesswire.com/news/home/20201008006086/en/
CRDF (TROV)> Onvansertib is the only PLK1 inhibitor in the clinic AFAIK. BI trialed a PLK1 as a monotherapy but it flamed out in 2016 with no stat significant efficacy and some worrisome AE's. The ESMO poster for the Phase 1/2 trial in mCRC shows Ovansertib in combination with FOLFIRI/bevacizumab looks safe and demonstrated activity...5/11 PRs. As for durability... 2/5 PRs are still undergoing treatment. Of the 3 who discontinued...1 discontinued due to curative surgery, another discontinued because of an unrelated AE and 1 discontinued as a patient decision.
This Twitter thread is a pretty good backgrounder...
$CRDF (formerly Trovagene) 🚀 It had a strong ASCO20 Phase 1b/2 update in 2L mCRC patients using KRAS muts as a biomarker I’m combo w/ FOLFIRI and Avastin. mCRC program is fast tracked. I think its EV should be $200m on this data alone. mCRC data update at ESMO in sept.
— Amit Jolly (@amitkjolly) June 25, 2020
I own KALA.
KALA is developing Eysuvis (loteprednol etabonate steroid) for dry eye disease. KALA had a previous CRL but with stricter inclusion criteria the current Ph 3 data looks approvable... p=0.0002 on the primary and p=.0007 on the secondary endpoints.
https://sports.yahoo.com/3-strong-buy-healthcare-stocks-141549117.html
JNJ COVID-19 vaccine storage temps...
Michigan’s GRAM Inks COVID-19 Vaccine Manufacturing Deal with J&J
https://www.biospace.com/article/michigan-s-gram-inks-covid-19-vaccine-manufacturing-deal-with-j-and-j/
JNJ > As Johnson & Johnson kick-starts phase 3 COVID-19 test, early data show up its promise
https://www.fiercebiotech.com/biotech/as-johnson-johnson-kickstarts-phase-3-covid-test-early-data-shows-up-its-promise
Four Biotech Companies Are Going Public Today. What to Know About Each.
https://www.barrons.com/articles/four-biotech-ipos-are-on-tap-for-friday-51600975588?siteid=yhoof2&yptr=yahoo
Another biotech — Seattle-based Athira — files for an IPO, hoping to finally break through in Alzheimer's
https://endpts.com/another-biotech-seattle-based-athira-files-for-an-ipo-hoping-to-finally-break-through-in-alzheimers/
S-1:
https://www.sec.gov/Archives/edgar/data/1620463/000156459020041369/atha-s1.htm
Moderna's vaccine may have an edge when immunization programs roll out
https://www.biopharmadive.com/news/moderna-pfizer-biontech-coronavirus-vaccine-stability/584209/
97.1% sensitivity & 98.5% specificity....
Thoughts On a New Coronavirus Test (And on Testing)
https://blogs.sciencemag.org/pipeline/archives/2020/08/27/thoughts-on-a-new-coronavirus-test-and-on-testing
What has become clear is the over reliance on PCR testing has rendered the majority of PCR tests useless due to long turnaround times according to this excellent review of the current state of COVID-19 testing from The Atlantic magazine.
Along with the over-emphasis on PCR tests, the lack of at-home antigen tests due to overly strict requirements for approval also contributed to the contagion spreading.
Another issue was the hesitation on the part of test manufacturers to build out high cost infrastructure without gov't assistance to handle pandemic levels of testing that would in all likelihood not be needed in 2-3 years.
Below is an excerpt comparing PCR vs. at-home antigen testing and how massive at-home antigen testing could potentially defeat the virus...
The Plan That Could Give Us Our Lives Back
https://www.theatlantic.com/health/archive/2020/08/how-to-test-every-american-for-covid-19-every-day/615217/
NBA funded Yale saliva test granted EUA by FDA...
https://news.yale.edu/2020/08/15/yales-rapid-covid-19-saliva-test-receives-fda-emergency-use-authorization
Derek Lowe on board w/ nanobodies...
Nanobodies Against the Coronavirus: Something New
https://blogs.sciencemag.org/pipeline/archives/2020/08/13/nanobodies-against-the-coronavirus-something-new
MESO > up 50% on WSJ editorial...
The Treatment That Could Crush Covid
https://www.wsj.com/articles/the-treatment-that-could-crush-covid-11597360709?mod=opinion_lead_pos5
Re: HCQ - Scientists May Be Using the Wrong Cells to Study Covid-19
https://www.wired.com/story/scientists-may-be-using-the-wrong-cells-to-study-covid-19/
Goldman Says Covid-19 Vaccine Approval Could Upend Markets
https://finance.yahoo.com/news/goldman-warns-covid-19-vaccine-035931552.html
LLY > begins Phase 3 trial of COVID-19 neutralizing mAb in nursing homes...
Eli Lilly starts late-stage study of coronavirus drug in nursing homes
https://www.cnbc.com/2020/08/03/eli-lilly-starts-late-stage-study-of-coronavirus-drug-in-nursing-homes.html
Hmmmm... Sorrento picks up color-changing COVID-19 saliva test built by Columbia University fertility clinic
https://www.fiercebiotech.com/medtech/sorrento-picks-up-color-changing-covid-19-saliva-test-built-by-columbia-university
Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates
https://www.nejm.org/doi/pdf/10.1056/NEJMoa2024671?articleTools=true
Re: MRNA vs Pfizer/BioNTech: Derek Lowe analyzes the Pfizer data with comparisons to Moderna's...
More Pfizer Phase I Results: Antibodies, Viral Mutations, and T Cells
https://blogs.sciencemag.org/pipeline/archives/2020/07/20/more-pfizer-phase-i-results-antibodies-viral-mutations-and-t-cells
OpenAI's GPT-3 may be the biggest thing since bitcoin
GPT-3 is the name of Elon Musk's OpenAI language prediction model which uses neural nets and machine learning to generate programming code from short descriptions.
Article written by GPT-3...
https://maraoz.com/2020/07/18/openai-gpt3/
Could this artificial intelligence change programming as we know it?
https://metro.co.uk/2020/07/17/artificial-intelligence-change-programming-know-13002280/
Pfizer CEO Albert Bourla Raises Expectations That the Pharmaceutical Giant Can Deliver a COVID-19 Vaccine by Fall
https://time.com/5864690/pfizer-vaccine-coronavirus/
Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-publication-new-england-journal-medicine (mRNA-1273)
BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing
https://www.prnewswire.com/news-releases/bd-launches-portable-rapid-point-of-care-antigen-test-to-detect-sars-cov-2-in-15-minutes-dramatically-expanding-access-to-covid-19-testing-301088216.html
REGN PR... Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
https://www.prnewswire.com/news-releases/regeneron-announces-start-of-regn-cov2-phase-3-covid-19-prevention-trial-in-collaboration-with-national-institute-of-allergy-and-infectious-diseases-niaid-301088202.html
The only oral vaccine selected by OWS...
"We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated. SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa - nose, mouth or eyes - strongly suggesting that mucosal immunity could serve as the first line of defense,” said Andrei Floroiu, Chief Executive Officer of Vaxart Inc. “In addition, our vaccine is a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.”
No I haven’t. It would be interesting to see which ones sustained their initial pop and which ones reverted.
I searched BV for "bandwagon" - 25 bios so far on the COVID-19 bandwagon. Not including the legit companies like JNJ, PFE, MRNA, AZ etc.
Dexamethasone is the first drug shown to improve survival in COVID-19....
Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19
https://www.recoverytrial.net/files/recovery_dexamethasone_statement_160620_final.pdf
AstraZeneca unveils massive $750M deal in effort to produce billions of COVID-19 shots
https://www.fiercepharma.com/manufacturing/astrazeneca-unveils-massive-750m-deal-effort-to-produce-billions-covid-19-shots
Lilly starts Phase I trial of antibody therapy for Covid-19
https://www.clinicaltrialsarena.com/news/lilly-covid-19-antibody-therapy/
Re: herd immunity and vaccine
Doctor testing Moderna vaccine says it’s ‘simply mind-boggling’ that injection may be ready in 2020
https://www.cnbc.com/2020/05/22/moderna-vaccine-researcher-it-mind-boggling-to-be-done-in-2020.html?recirc=taboolainternal