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For a moment, i thought it was $ENTA.
another contributor to vaccine injury rates could be that there are more vaccines and specifically more than can be co-administered. If you are a side sleeper you may want both in the same arm, but you need a deltoid large enough to be able to get both and still not veer into a sensitive location in that arm
Vaccine injury:
Further thoughts FWIW: My operating assumption, given the apparent large increase in reported SIVRA (severe inflammation of shoulder joint (not just muscle soreness) after vaccine) is it's a combination of much more immunogenic vaccines combined with lax shot placement (reminder - I watched my pharmacist argue to inject at joint, not 2 or 3 fingers down). Lax shot placement wouldn't have mattered anywhere near as much when the vaccines were a lot less immunogenic, but now... .
And I don't expect the FDA to do anything about it until it's a scandal because vaccines are now politically coded - eg the CDC and FDA both behaved badly wrt COVID vax (CDC tried to prioritize Black's over elderly (and only reversed when the slides became public), and I watched FDA try to hide children vax data).
FTR - I favor vaccines. Strongly (eg I just got Novavax, will get pneumococcal soon). But no good comes of prioritizing social manipulation over data transparency. However Public Health has moved strongly in wrong direction.
VNDA- Vanda is a bit miffed at the FDA. They say their data supported approval and the FDA ignored it. They are also a bit put off by the length of time the FDA took to respond.
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
https://finance.yahoo.com/news/fda-declines-approve-vandas-marketing-110000957.html
Vaccine shoulder injury
muscle soreness is obviously common, but it sounds to me like you got the shot too high in the shoulder - that kind of injury is not that rare and in fact happened to my mom who years later has shoulder pain. Glad you are feeling better but just an FYI for future that it may be the administration and not what's in the vaccine
I won’t get flu vaccine until early October. That timing will protect me from trick-or-treaters getting me sick but the six month window of maximum protection should carry me through February.
SHOULD HAVE GOTTEN THE COVID BOOSTER when I first saw it offered at the local pharmacy. Thought to myself, “I’m busy, I’ll come back later.”
Then, BAM, I got Covid for the first time in early September.
10/16/2023 Is Novavax COVID Vaccine_Better_Than_mRNA Vaccines? What We Know So Far
Novavax’s protein-based vaccine is the latest FDA-authorized COVID booster available this fall. Here’s what you should know
https://www.scientificamerican.com/article/is-the-novavax-covid-vaccine-better-than-mrna-vaccines-what-we-know-so-far/
I don’t have a strong view but I think nvax is still directed at jn1 while mrna vaccines have been updated to kp2 which is the predominant strain now. I recently got flu and pfe same day (nvax wasn’t an option) fwiw
Novavax reduces viral load by 2.78 log10, while the Moderna vaccine was 2.12. The log10 scale is 10x for each step, indicating Moderna reduces viral load by just over 100x, and Novavax reduces viral load by over 600x. No significant reductions seen for others. pic.twitter.com/gMepaVZkr4
— Daniel Park (@Daniel_E_Park) September 14, 2024
Re: Novavax
This is the first time that I've seen it offered at our local CVS, they offer Moderna, Pfizer and now Novavax covid vaccines. I've been alternating Moderna and Pfizer but I am thinking of going with Novavax. Although I'm not convinced that there's much benefit in getting my 6th or 7th booster (I can't keep track) plus natural immunity from one or two infections, beyond the relatively short period the antibodies hang around.
Anyone have a strong view on protein v. mrna vaccines?
agree totally - probably feel like crap with that amount of adjuvant
GSK—Phase-3 trial co-administering Shingrix and Arexvy meets_primary_endpoint:
https://www.businesswire.com/news/home/20240917307121/en
Co-administration of these two vaccines may work from an immunological standpoint, but I wouldn’t want to try it!
Interesting comments by the Novartis CEO Vas Narasimhan on obesity market.
Novartis not joining the ‘frenzy’ of weight loss drugs, CEO says:
Small molecules have typically shown off target effects. Asceletis preclinical data looks promising but they will need to show GI effects that are not "consistent with the incretin class" or worse to have a market impact.
As a side note, this is the Chinese company Viking sued for stealing trade secrets on VK2809 in early 2023. VKTX alleged that Ascletis received confidential information about VK2809 while discussing a partnership as part of a confidential disclosure agreement in 2016 and 2019. The company said that Ascletis then abruptly ended the talks after reviewing the confidential information and its Chief Executive founded a sister company, Gannex Pharma, to develop a rival therapy for NASH. Ascletis has since halted their NASH compound development so the suit is now moot.
Lots of NASH companies in the obesity race now (e.g VKTX, ALT) as they presumably felt GLP1's had promise in that indication only to pivot.
See https://www.evernorth.com/advocate for complaint and further information. My own views, in part, are posted on the AMRN board earlier today. Any resemblance between the Titanic and an iceberg is purely coincidental.
Close to 100%, IMO.
Novo Nordisk says Ozempic a 'very likely' target in next Medicare drug pricing talks
A top executive at Novo Nordisk (NVO) warned Tuesday that the company’s diabetes therapy Ozempic will likely be selected for the next round of Medicare drug pricing negotiations, which aim to seek discounts for blockbuster meds supplied to the federal healthcare program.
“It is very likely that Ozempic will be part of negotiations in the coming round, and we’re ready for that,” said Ulrich Otte, Novo’s (NVO) senior vice president of finance & operations at Cantor Global Healthcare Conference in New York.
A year ago, the U.S. Centers for Medicare & Medicaid Services unveiled the first ten drugs targeted for the initial round of pricing negotiations.
https://seekingalpha.com/news/4150413-novo-nordisk-ozempic-targeted-medicare-pricing-talks
I find it hard to believe that Cigna/Express Scripts wants to go through the legal discovery process that precedes a trial.
Cigna, Express Scripts and its sub sue FTC today in Missouri.
The complaint raises issues re a July 2024 Report published by FTC about high drug prices, and asserts the FTC has exceeded its power in issuing the Report.
https://www.prnewswire.com look for Express Scripts
www.wsj.com
Reuters, Bloomberg, Fierce Biotech Health also cover the issues raised in the 30 page complaint.
Teoxane has_the contractual right to_end_its_agreement_with_RVNC_if_there_is_a_change_of_control; from Section 16.4 (page 66) of the Teoxane Agreement filed with the SEC as Exhibit 10.43 to RVNC’s 2020 10-K:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001479290/000147929020000042/rvnc1231201910-k.htm
Hong Kong-listed Ascletis Pharma has oral small-molecule GLP-1 agonist that can also be dosed monthly by subcutaneous injection, according to the company:
https://www.prnewswire.com/news-releases/ascletis-enters-the-obesity-drug-space-with-announcement-of-two-ongoing-us-phase-i-clinical-trials-utilizing-its-small-molecule-glp-1r-agonist-asc30-for-both-once-monthly-subcutaneous-injection-and-once-daily-oral-tablet-for-the-302249778.html
If they do, it will have to be disclosed in the SEC filings for the tender offer (assuming the tender offer happens).
SEC filings for a tender offer are rather similar to those for an IPO in terms of the required disclosures.
I still wonder if some RVNC insiders have an undisclosed position in Crown.
It depends why the tender doesn't go through. If it's because Crown lacks the funding or otherwise fails to close when 50% of the shares have been tendered, Crown pays $43,140,000. If it's because less than 50% of the shares are tendered and not withdrawn, Revance pays $28,760,000.
Does Crown face a penalty if the tender doesn’t go through?
The merger agreement contains as exhibits equity and debt committments sufficient to fund the tender and merger; the equity committment is guaranteed by various Hildred Capital funds. The actual committments are not attached to the merger agreement filed with the SEC, available here: https://www.sec.gov/ix?doc=/Archives/edgar/data/0001479290/000119312524198448/d876039d8k.htm
Here is a bit of background on Hildred and Crown from a March 2024 article in the WSJ:
What do you know about Crown and it's ability to carry out this transaction?
Comments on RVNC’s price action today:
#msg-175091717
#msg-175091770
IBO IPOs 1.73M* shares @$3.00:
https://www.globenewswire.com/news-release/2024/09/16/2946794/0/en/Impact-BioMedical-Inc-Announces-Pricing-of-Initial-Public-Offering.html
KAPA IPOs 1.78M* shares $4.00:
https://www.globenewswire.com/news-release/2024/09/16/2946812/0/en/Kairos-Pharma-Prices-6-2-Million-Initial-Public-Offering.html
PFE phase-2 cachexia trial meets primary endpoint—data presented at ESMO and published in NEJM:
https://www.businesswire.com/news/home/20240913347614/en
BNTX's data must look very good indeed for the EV to increase by ~40% in one day.
VNDA 5.10 - "tradipitant" PDUFA for treatment of gastroparesis set for Wednesday, September 18th. Anyone have an over-under-estimate on potential FDA approval?
https://www.drugs.com/history/tradipitant.html
ICPT will soon have no approved product when Ocaliva for PBC is withdrawn:
https://www.medpagetoday.com/gastroenterology/generalhepatology/111955
Sooo--- my question is who needs IL-5 approval other than greedy pharma?
This discussion is on topic. NAC is well researched and superior to any pulmonary treatment on the market.
I inhaled HCL accidentally in H.S. chem class....
I developed serious asthmatic symptoms...
Approximately 30 years later I discovered NAC. 600mg 3x per day and gradually my asthma symptoms disappeared.
THEN COMES COVID.. and things got worse.
... while in the hospital (twice) I was given gadolinium.
I was given Cipro for a routine UTI in the late '90s. It was poison . I died, was resuscitated, and gradually got better with NAC 600mg 3x per day abd other nutritional supplements. In 2018 I went to the ER with a routine UTI and was given Cipro again without realizing it. My so-called physician at the time told me I would get "antibiotic resistance" if I didn't continue to take it I took a few more doses, but gave it up because I could feel the toxins in my body.
I was able to find a good physician who understood these issues and I was getting better.
Then come COVID - I got pretty sick, and they gave me gadolinium with an MRI. I was too sick to know what was happening to me.
Then they gave it to me again..
Early this year I made an appointment with a neurologist. She ordered an MRI with gadolinium contrast before our first appointment.
This time I was coherent and remembered that Dr. Lu had told me not to allow tests with gadolinium, so I called the Dr. and informed her that I was not supposed to get this contrast with an MRI. She told me "You're wrong, you've gotten it before".
So I went through my medical record and discovered that I was given two MRI's with gadolinium during the COVID debacle.
So now I know why I can't taste or smell properly and why I have additional mitochondrial damage....
.... and now you know why I will never allow any doctor with the UC Health system to touch me again.
I now take 1200 MG NAC every time I have pulmonary or inflammatory symptoms... three or four times during the day and I might wake up at night and take more.
There is no way you can O.D. on NAC.
IMO it is a better treatment for asthma (and mitochondrial dysfunction) than anything out there.
The AI stuff repeated below has a lot of nonsense included...
NAC will help you avoid anaphylaxis, it can not cause it...
It is a readily available supplement, not a prescription drug.
It can make your pee stink, but I have not experienced any other negative side effects and I routinely consume 3600 mg per day or more.
Trust me I know. From Google AI:
Today’s IPO scorecard:
MBX +48% (#msg-175080329)
BCAX +30% (#msg-175080303
ZBIO +7% (#msg-175080210)
Addendum—The "10-minute" characterization in the header of Roche's PR is seriously misleading, IMO.
HALO’s own PR (https://www.prnewswire.com/news-releases/halozyme-announces-fda-approval-of-roches-subcutaneous-ocrevus-zunovo-with-enhanze-for-people-with-relapsing-and-primary-progressive-multiple-sclerosis-302247928.html ) does not say “10-minute” in the header, but rather in the body of the PR, where readers are able to see the context and hence are less likely to be misled.
AUPH about to be "Tang'd "
(HALO again)—FDA approves Roche’s subcutaneous Ocrevus for MS:
https://finance.yahoo.com/news/fda-approves-ocrevus-zunovo-first-172300395.html
This is not a typical subcutaneous procedure—from the same PR:
covid antivirals in development have negative value period. This might change with how the FDA handles ensitrelvir
EMTs administer whole blood to trauma victims_in_pilot_program:
https://www.bostonglobe.com/2024/09/09/metro/canton-blood-trauma-ambulance-transfusion/
Related article on “low-titer group O whole blood”:
https://pubmed.ncbi.nlm.nih.gov/36730210/
MBX IPO’s 11.7M* shares @$16.00:
https://www.globenewswire.com/news-release/2024/09/12/2945666/0/en/MBX-Biosciences-Announces-Pricing-of-Initial-Public-Offering.html
BCAX IPO’s 20.2M* shares @$18.00:
https://www.globenewswire.com/news-release/2024/09/13/2945680/0/en/Bicara-Therapeutics-Announces-Pricing-of-Upsized-Initial-Public-Offering.html
ZBIO IPO’s 15.2M* shares @$17.00:
https://www.globenewswire.com/news-release/2024/09/13/2945685/0/en/Zenas-BioPharma-Announces-Pricing-of-Upsized-Initial-Public-Offering.html
AVIR phase-3 COVID trial fails—stock rises:
https://www.globenewswire.com/news-release/2024/09/13/2945844/0/en/Atea-Pharmaceuticals-Provides-Update-on-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Bemnifosbuvir-for-Treatment-of-COVID-19.html
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