Name one thing that Ramona and Christophe have down right……

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Well it certainly isn’t this: once again Takeda screwed the pooch. Neuroscience is going by the wayside. Leadership cannot get out of their own way. Since we are in cancel culture, our leadership needs to be cancelled.


FDA denies Denali's Takeda-partnered Alzheimer's drug from entering clinic
by Kyle LaHucik |
Jan 13, 2022 8:59am
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This is not Takeda's first setback in Alzheimer's; the Japanese Big Pharma axed a diabetes med in January 2018 after realizing it wasn't effective in the memory-robbing disease. (chellestein/Pixabay)
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The FDA has thrown Denali Therapeutics' Alzheimer's med into murky waters with a clinical hold before the drug even enters human trials. The move also impacts Takeda, which just last month moved forward on the pair's 2018 deal by opting to co-develop the drug.


The news alarmed investors, sending Denali's shares down 11% to $34.37 apiece as of 11:03 a.m. Eastern time Thursday. Denali started clinic-readying studies of DNL919 last January, which triggered an $8 million payment from Takeda last year. The drug is part of a $150 million upfront pact inked four Januaries ago.

DNL919, an antibody transport vehicle, or ATV, was slated for clinical entry in the first half of this year, and safety and biomarker data were planned for the second half, Denali announced Monday at the annual J.P. Morgan Healthcare Conference. That's also when the biotech disclosed Takeda moved forward with the drug collab.



The South San Francisco biotech disclosed the news Wednesday morning after receiving an email from the FDA after market close Tuesday, and the company expects an official clinical hold letter in about 30 days.

RELATED: Denali makes ALS play, hustling Sanofi-partnered drug into phase 2 and sharing early data on internal program

The ATV drug is aimed at activating TREM2 in the hopes of improving microglial function, the "resident immune cells of the brain," Denali said. Function loss in the TREM2 receptor is associated with increased risk for Alzheimer's, according to the biotech.

DNL919 is one of seven molecules Denali had hoped to test in the clinic this year, the company said during its J.P. Morgan presentation this week. Other investigational meds are being studied in Parkinson's, amyotrophic lateral sclerosis, frontotemporal dementia and others.

For Takeda, this isn't the pharma's first setback in Alzheimer's drug development. The pharma and partner Zinfandel Pharmaceuticals failed to turn an approved diabetes med into an Alzheimer's treatment and in January 2018, axed a phase 3 trial, not-so-aptly-named TOMORROW.

The Alzheimer's field has been buoyed by a wave of investor and scientific interest in the past year, especially since the FDA's controversial greenlight of Biogen's Aduhelm. That drug has faced blowback across the board, including a proposal from Centers for Medicare & Medicaid Services this week that Medicare will cover Aduhelm but only for patients in qualifying clinical trials. Industry groups have since given the thumbs up to the proposal.
 




















They told us to vote for bide. They had conference calls with the head of vaccines that told blatant lies. They asked the company to specify our race, gender, sexuality and pronouns.
 








anonymous said:
The US business unit pretty terrible .
Now to be fair, Entyvio has been good since they too over.
Click to expand...

Let’s take a step back here

#1: No, CW and Ramona can’t take credit for Entyvio. We got lucky in head to head trial that we are better than Humana and that’s JAK have safety concerns. R&D folks way before CW and Andy saw the potential in Entyvio

#2: If you want to give credit to CW for a Entyvio, than why did CW way over spend for Shire.

Just as Abbvie and Merck have thrived on basically 1 drug (Humira and Kytruda), so too could have Takeda thrived on a single blockbuster and invested more wisely.

Let’s get back to the Shire buyout

CW spent $65B for what

The H&I franchise runs a very slim margin. It is a very capital intensive business that Baxter executives spun off for a reason, to cash in on an Abbvie like spin off and because it has crappy margins for the tremendous costs associated with paying donors and manufacturing/ production costs

For legacy Shire products, Vyvance has 2 years left (4 years at time of acquisition). So you spent $65B on $15B in gross revenue. Are you kidding me.

Do we want to give credit to CW for the vaccine division debacle and debacle with Oncology division with failure and failure

So CW and his ego got in the way of making a wise business decision. To pay for this screw up, it is sell, sell, and restructure.

Did CW acquire a pipeline that is worth $50B ($65B- $15B). No way.

Sell assets, sell South American rights, sell anything and everything you can to make numbers look good. Reduce headcount, sell Chicago complex at pennies on the dollar, do tax write off to help with numbers

Hopefully Entyvio will keep patent protection beyond 2026. If it does, then thank patent attorneys and not CW or Ramona
 




I worked on the commercial team of the OBU in two different roles over the past ten years. I have never worked at such an unethical company. When I could no longer pass the red face test, it was time to go. And what was I going to do, go to compliance to report leadership? Like that would have gone well for me.

Unethical behavior starts at the top. I’m not saying CW or R are personally unethical, but the shit that went on in the OBU was a joke. And it was really a shame since there are some good talented folks there, but if you have ethics you can’t stay.
 




anonymous said:
Let’s take a step back here

#1: No, CW and Ramona can’t take credit for Entyvio. We got lucky in head to head trial that we are better than Humana and that’s JAK have safety concerns. R&D folks way before CW and Andy saw the potential in Entyvio

#2: If you want to give credit to CW for a Entyvio, than why did CW way over spend for Shire.

Just as Abbvie and Merck have thrived on basically 1 drug (Humira and Kytruda), so too could have Takeda thrived on a single blockbuster and invested more wisely.

Let’s get back to the Shire buyout

CW spent $65B for what

The H&I franchise runs a very slim margin. It is a very capital intensive business that Baxter executives spun off for a reason, to cash in on an Abbvie like spin off and because it has crappy margins for the tremendous costs associated with paying donors and manufacturing/ production costs

For legacy Shire products, Vyvance has 2 years left (4 years at time of acquisition). So you spent $65B on $15B in gross revenue. Are you kidding me.

Do we want to give credit to CW for the vaccine division debacle and debacle with Oncology division with failure and failure

So CW and his ego got in the way of making a wise business decision. To pay for this screw up, it is sell, sell, and restructure.

Did CW acquire a pipeline that is worth $50B ($65B- $15B). No way.

Sell assets, sell South American rights, sell anything and everything you can to make numbers look good. Reduce headcount, sell Chicago complex at pennies on the dollar, do tax write off to help with numbers

Hopefully Entyvio will keep patent protection beyond 2026. If it does, then thank patent attorneys and not CW or Ramona
Click to expand...

That might all be true, but you still have to give them credit for Entyvio. Fully under their leadership. End of conversation.
CW trying to diversify on buy making a purchase was a good move, but he got the wrong deal. For him to sit back and purely relay on any product would be a bad move.
There is still pipeline left to save that purchase.

You can’t just look at it like all the work was done by R&D and Andy aren’t theirs. It’s a 100% CW and Ramona’s because they put these team in place.

I mean come on you have to be fair…
 




















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