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Bill Ending Orphan Drug Exclusivity Loophole Clears House
https://www.fdanews.com/articles/202847-bill-ending-orphan-drug-exclusivity-loophole-clears-house
Busy MB today - if this FDA notice was included in today’s discussion, please excuse the duplication.
https://www.fdanews.com/articles/202759-fda-releases-finalized-guidance-on-postapproval-cmc-changes
Of interest - Merck’s presentation at ASCO 2021:
https://www.firstwordpharma.com/node/1825933?tsid=28®ion_id=2
This may have been posted as it is from last month - admittedly, I sometimes miss embedded links. From David Geffen School of Medicine UCLA:
https://cancer.ucla.edu/Home/Components/News/News/1656/1631
Prayers being said for you and your family. May the angels surround you and walk with you during these difficult days. Much strength is coming to you from members on this board and surely this good energy has a purpose.
FDA declines to approve Merck & Co.'s Keytruda for high-risk, early TNBC
https://www.firstwordpharma.com/node/1814129?tsid=28®ion_id=6
So very sorry for your loss. Prayers being sent to you and your daughter.
AstraZeneca today issued the following statement from Pascal Soriot, Chief Executive Officer.
“We are deeply saddened by the news that José Baselga, Executive Vice President Oncology R&D, and member of our Senior Executive Team, has passed away.”
https://www.astrazeneca.com/media-centre/press-releases/2021/statement-on-the-passing-of-jose-baselga.html
This is a “question straight out of left field,” but it is Friday:
Might the cash funding be meant for a small biotech acquisition. Perhaps one already connected to Cognate BioServices?
Merck & Co. pulls small-cell lung cancer indication for Keytruda in US
https://www.firstwordpharma.com/node/1805337?tsid=28®ion_id=6
Referring to the CRL/Cognate PR, it is noted: “Dark Horse Consulting Group, Inc. is acting as Charles River’s strategic advisor.”
Dark Horse Consulting has recently added Donald Fink, former FDA CMC reviewer, to their staff.
https://darkhorseconsultinggroup.com/fdas-donald-fink-to-join-dark-horse-consulting-group-as-master-practice-expert-regulatory/
Apologies if this is duplicate info……
In addition to Anne Lodge’s association with NWBO, Cellero’s leadership team page lists their VP Research & Technology, Benjamin Tjoa, PHD, as having had a position with NWBO:
Benjamin Tjoa, PHD - VP Research & Technology
“As a Senior Scientist at Northwest Biotherapeutics, Dr. Tjoa studied human dendritic cell basic biology, in vitro generation, antigen-loading, maturation, pre-clinical dendritic cell-based cancer vaccine studies, and assay developments. He published over 20 scientific articles and earned two patents.”
Appreciate updated info ABC - thank you.
Please note the time of your post: 2.11.21 @ 2:21:12
Isaiah 21:11-12
A voice calls to me
from the Seir mountains in Edom,
“Night watchman! How long till daybreak?
How long will this night last?”
The night watchman calls back,
“Morning’s coming,
But for now it’s still night.
If you ask me again, I’ll give the same answer.”
How very heartbreaking to read your story. My sincerest sympathies.
Cognate and Nucleus Biologics Announce Partnership
https://www.cognatebioservices.com/insights/cognate-and-nucleus-biologics-announce-partnership
"https://www.latimes.com/business/story/2021-01-26/gamestop-short-squeeze-stupid
What’s interesting about this LA Times article and the mention of NWBO is that the Executive Chairman at LA Times is Patrick Soon-Shiong (biotech billionaire and CEO of NantKwest/NantHealth). I recollect he was involved in the Cancer Moonshot 2020 a few years back.
For those of you following INmune - up significantly in pre-market. PR released this date:
https://www.marketwatch.com/investing/stock/inmb
https://www.inmunebio.com/index.php/en/news-2/2021/446-muneioncnnouncesro1595oundtoecreaseeuro20210121
Sorry to learn your Mom has passed over, Marzan. Her long life has benefitted you with many wonderful and comforting memories to sooth the days ahead. You and your family will be in my prayers.
Of Interest:
BMS Gives Up on Small Cell Lung Cancer Indication for Opdivio
https://www.fdanews.com/articles/200806-bms-gives-up-on-small-cell-lung-cancer-indication-for-opdivio
Jimmy667
Thanks, It appears the plot may thicken!
kind of you to respond, BWIS
Thank you
To our more learned SEC experts: What is the purpose of filing a Rights Agreement?
Filed by INMB 30 Dec 2020 (cousin of NWBO)
https://sec.report/Document/0001213900-20-045474/
Of interest:
Buffett's Berkshire bets on Big Pharma, invests in four drugmakers
“In a regulatory filing detailing its U.S.-listed stock holdings as of Sept. 30, Berkshire disclosed $5.7 billion of new healthcare stakes, including more than $1.8 billion each in Abbvie Inc, Bristol-Myers Squibb Co, Merck & Co and $136 million in Pfizer Inc.”
Noted comment in article:
“The sector has become more efficient as big drug companies partner with smaller, inventive rivals,” Armstrong added. “But you will always need companies with scale for manufacturing and distribution, including vaccines with global application.”-Armstrong
Article:
https://www.reuters.com/article/us-investment-funds-berkshire/buffetts-berkshire-invests-in-several-big-drugmakers-idUSKBN27W2TS
Applause….applause! You continue to be the Prima Ballerina on the NWBO stage.
Your sister is in my prayers; you are in my prayers.