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“ADVENT is a customer of autolomous, not a partner, I believe.Please correct.”
Of interest as Advent BioServices is a partner with Autolomous:
Autolomous and Vineti form strategic partnership to deliver end to end solutions
https://autolomous.com/autolomous-vineti-partnership/
Thank you very much for this informative post.
FDA Awards 11 Grants to Clinical Trials to Develop New Medical Products for Rare Disease Treatments
“Some of the new awards fund clinical studies of products for use in brain cancers.”
“Brian Goldner of Hasbro dies of prostate cancer at age 58.”
NRNR….
Suggested question for DI: Might we expect a new nwbio.com website soon?
Apologies if this article was previously posted:
Merck & Co. rumoured to be Acceleron suitor
https://www.firstwordpharma.com/node/1866829?tsid=28®ion_id=3
Speaking of INmune Bio:
Dr. Tesi, President & CEO, is presenting this afternoon to Oppenheimer Healthcare Summit.
Dr. Tesi will present to Cantor Fitzgerald’s Global Healthcare Conference next Wednesday.
Side note: INmune Bio will be opening a new office in Boca Raton, FL., on October 1st.
https://www.inmunebio.com/index.php/en/news-2/2021/472-muneioncnnouncesarticipationatpcomingnvest20210920
Cristina Trento, Head of Quality Assurance
….. new addition to Advent Bio senior staff
https://www.adventbio.uk/our-team
“Anyone in the industry see contracts for components like albumin or maturation products being set up for Charles Rivers Labs or Advent?”
Of interest:
INmune filing S-3 and 8-K this afternoon:
https://www.inmunebio.com/tmp/66781c6ea573f382106d75762d8aa285fdbb1957bdcfceeca1ef86644e787a2e.pdf
https://www.inmunebio.com/tmp/21c4540f6388e7d9a77fd31e3c773df30ac44b1ed140cece602026a389645587.pdf
“Nice. What is going on over at Inmune, TF?”
Applause for INmune Bio today,,,
https://www.cnbc.com/quotes/INMB
That amplification is off and running.
Of interest: EMA vs. FDA
Anemia Drug Rejected by FDA Wins EU Approval
August 24, 2021
Astellas Pharma and Fibrogen have received EU approval for Evrenzo (roxadustat) for treating adults with anemia associated with chronic kidney disease (CKD) — mere days after the FDA rejected the drug for the same indication in the U.S.
The episode marks a rare moment of regulatory discord between the health agencies. The European Medicines Agency’s Committee for Medicinal Products for Human Use gave the drug the thumbs up in June after evaluating the drugmakers’ pivotal phase 3 program. That led to the EU’s approval last week. For its part, the FDA called for additional study data in rejecting the drug, likely tied to safety concerns brought up by the agency’s advisory committee at a meeting last month.
And with this approval, Evrenzo becomes the first oral hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) enzyme inhibitor to be approved for EU use, beating out GlaxoSmithKline, which recently touted positive topline phase 3 results for its investigational CKD-linked anemia drug daprodustat.
HIF-PH inhibitors work by activating the body’s natural response to lowered blood oxygen levels and reduces the need for injectable red blood cell stimulating agents that are usually administered with intravenous iron to combat anemia.
“Accelerating the pathway for new treatments" That statement says a lot IMO
“I don’t know how I can explain this any more clearly than I have over today’s posts.”
Your posts amplify the message quite well. I am appreciative.
“je ne comprends pas.( as to how this sec filing relates to nwbo)”
“Agreed, except this company will not exist 2yrs from now, IMO. Sold upon positive data and FDA approval submission. They clearly have no experience or resources to help patients after topline. It would be ego only to go it alone....at the expense of dying patients. The fastest way to help people is to get this to market asap via BP.”
Many of our NWBO posters are also supporters of INmune Bio and thought the new SEC report would be of interest:
https://sec.report/Document/0001387131-21-007427/
“This is my own take: LP was advised to publish the results by the SAB and others, and is using the journal publishers as an excuse not to release TLD in advance…because she’s so terrified of AF.”
…..and, there you have it! I don’t believe that NWBO is a favorite of the media; follow the money!
“Pharmaceutical ad spending continued its upward climb last year. Spending topped $6.46 billion in 2018, according to Kantar Media, for an increase of 4.8% over the previous year.”
https://www.fiercepharma.com/marketing/kantar-tallies-6-5-billion-for-pharma-ad-spending-2018-abbvie-humira-ranks-as-top
I’m very aware of his service, we both did the same job in the Army, it’s a very small group.
Congressman Brian Mast….
On September 19, 2010, while clearing a path for United States Army Rangers in Kandahar, Mast took a wrong step into an IED along the road. The explosion resulted in the amputation of both his legs and his left index finger.
Apologies if this info was posted earlier today - it’s dated 22 June 2021.
Updated info on FDA/Biogen controversy: Take note of second paragraph.
https://www.firstwordpharma.com/node/1840069?tsid=28®ion_id=6
Of interest to those following this FDA story on Biogen/Eisai’s recent drug approval:
Public Citizen calls for removal of senior FDA officials in wake of Aduhelm approval
https://www.firstwordpharma.com/node/1838171?tsid=28®ion_id=6
“Public Citizen on Wednesday called for the resignation or removal of three of the FDA's most senior officials in the wake of the agency's decision to grant accelerated approval to Biogen and Eisai's Aduhelm (aducanumab) for patients with Alzheimer's disease. The letter, sent to Xavier Becerra, Secretary of the US Department of Health and Human Services, branded the move "indefensible" and said it "showed a stunning disregard for science."
In the letter, Public Citizen asked for those most responsible for the FDA's decision on Aduhelm to resign or be removed, including Acting Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni and CDER's office of neuroscience director Billy Dunn. The consumer advocacy organisation suggested that the "litany of flaws" in the regulator's review of the drug is lengthy, while the decision has "eviscerated the agency's standards for approving new drugs."
The letter concluded that Becerra "should direct the next Acting FDA Commissioner to consider whether the agency's approval of [Aduhelm] should be withdrawn."
CherryTree….
I think it is notable that three professionals stepped down from the AdCom in this particular case and that is my interest. In further reading, I found this article to be more specific in defining the difference between the AdCom and the Agency conclusions:
“The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.
The FDA on Monday gave the drug "accelerated approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s, rather than proof of a clear benefit against the disease.”
https://www.nbcnews.com/news/us-news/third-member-fda-advisory-panel-resigns-over-alzheimer-s-drug-n1270428
The decision seems odd to me; however, the story here is intriguing and I have no idea how these decisions might affect NWBO.
In addition, I am watching INmune Bio’s Alzheimer product XPro1595. INmune was invited to make a presentation on May 26th to Maxim Group.
https://www.inmunebio.com/index.php/en/news-2/2021/456-muneionctoarticipateinlzheimeriseaseanel20210524
Although this post is not specifically NWBO, it is an ongoing FDA issue of import to the industry:
Third member of FDA expert panel exits amid Alzheimer's drug flap
https://www.firstwordpharma.com/node/1836755?tsid=28®ion_id=2
I'm speechless
Not NWBO but FDA AdCom news:
FDA AdCom roster shrinks as two quit over Aduhelm approval
https://www.firstwordpharma.com/node/1836323?tsid=28®ion_id=6
“If a company can dedicate time to going into the details on currently not a very frequented page, then - as an IT consultant myself - this doesn't tell me something that is written in stone, but it definitely DOES tingle my bells.”
Thank you Senti. Your comments always add credibility to a post. I’ve read the presentation several times. I also noted that CRL is scheduled to participate in upcoming conferences - 1st one was this morning:
https://ir.criver.com/?_ga=2.210533461.1178105903.1622568146-275367970.1622568146
Gary
I join with fellow posters on this board in sending healing wishes and fervent prayers for your good health and comfort.
Interesting read:
May 27, 2021……
Charles River Labs - 2021 Presentation to Management:
https://ir.criver.com/static-files/59070f24-f1cb-44e9-b128-baa53b4196ba
Of interest:
Proposed US bill seeks $30 billion in "BioBonds" to fund clinical studies
https://www.firstwordpharma.com/node/1831060?tsid=28®ion_id=6
“New job for Kevin Duffy.”
“Fantastic! I made reference to this about a month ago. Drugmakers shouldn't be allowed to slow walk a drug with orphan status, which I think is the real point.”
Yes, thank you Flipper, I noted that. My thoughts were rooted in the “potential of future application” and resulting value.
Bill Ending Orphan Drug Exclusivity Loophole Clears House
https://www.fdanews.com/articles/202847-bill-ending-orphan-drug-exclusivity-loophole-clears-house