Vas should resign

https://act.credoaction.com/sign/novartis-trump

Tell Novartis CEO Vas Narasimhan: Resign from your position and stop blocking Medicare from negotiating lower prescription drug prices.

 

YES !!!!

 

Vas won't resign, but maybe he should sell some shares...

a curiously timed filing:

Issuer Novartis AG
Date 05.08.2019
Transaction executed by an executive member of the board of directors / member of the executive committee
Type of transaction Sale
Type of rights Registered Shares
Total amount of rights 8'545
Transaction Value CHF 1.00
ISIN CH0012005267
Further transaction details Establishment of a Trading Plan - Sale(s) to Cover of up to 8,545 shares (final number subject to performance testing at vesting) vesting under employee participation programs at best market price between 17 January 2020 and 28 February 2020

Management transactions – SIX Exchange Regulation

coincidental?

 

OMG !
Didn't Believe it at first but maybe they are manipulating the numbers for bonus so they come in at forecast with those number of shares Vas has a lot of skin in the game

 

You morons realize this is more than a year old? Stop slacking and get back to work. Vas isn't going anywhere. We are lucky to have him.

 

tick tock; how much time does Vas have left here? The walls are closing in on him.

 

Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation
by Eric Palmer |
Aug 13, 2019 10:11am

Novartis, which last week was publicly shamed by the FDA for manipulating data tied to the application of its gene therapy Zolgensma, has said that it launched an investigation in March, as soon as it learned of the issue.

But records from the lab where the manipulation arose suggest that the company’s investigation may not have been as deep or wide as the Swiss drugmaker has proclaimed.

Documents referenced in a Form 483 by the FDA, which inspected the lab a month after it learned of the falsified records, also suggest the data-fudging began at least in early 2018 and could have been uncovered by managers at AveXis during several steps in the clinical outcome assessment.

Novartis has claimed that the company launched an internal probe when a scientist raised the allegations in March, and by early May had determined that scientist was correct. It didn't inform the FDA about the allegations until June 28, more than a month after Zolgensma was approved. Novartis said it needed to complete its probe before telling the FDA.

RELATED: FDA ready to crack down as Novartis reveals manipulated Zolgensma data

But the FDA inspection report says it found that Novartis’ gene unit AveXis didn't open a Nonconformance Report into the potentially manipulated assay tests “until 15 May 2019" even though the "initial allegation is documented as having been reported on 14 March 2019.”

The issues exploded on the scene last week when acting FDA chief Ned Sharpless, M.D., announced its investigation. The agency said it has determined that the falsification was limited to “a small portion of the product testing data that was contained in the marketing application,” and that the drug was safe and effective and should remain on the market.

But Sharpless also tweeted that the agency "will use its full authorities to take action, if appropriate, which may include civil or criminal penalties."

RELATED: Novartis CEO: 'We did the best we could' in Zolgensma data manipulation probe

In a call with investors, Novartis CEO Vas Narasimhan declared the drugmaker had not tried to mislead the FDA and didn’t want to inform the agency until it knew exactly what had happened and whether the falsification put patients at risk. He said the investigation found the mismanaged data involved a potency assay Novartis no longer used in testing Zolgensma during production. Narasimhan said the Novartis' team did the “best we could."

Perhaps, but the Form 483 shows that some reports had date discrepancies noted during a historical data review on January 31, 2018. A nonconformance report also showed that that an assay "was not completed at the time of (clinical outcome assessment) generation and approval" for one lot. But the FDA says no one investigated further.

There was also a nonconformance report opened on Aug. 23, 2018 when discrepancies were found in the “data that was used to calculate relative potency for AVXS-101 Drug Product.” Then on Oct.15, 2018, another NCR was filed after inconsistencies were found in previously reported mouse. A quality control employee was verbally informed about the issue but didn’t require it be documented in writing.

Other issues uncovered by inspectors included that vivarium employees who had responsibilities for manufacturing functions were reporting to an R&D scientist with no GMP experience.

RELATED: Sanders, Warren join team of senators blasting Novartis' Zolgensma data rig

The FDA has said it is continuing to investigate. Five Senate Democrats are also urging the agency to hold AveXis accountable for its “malfeasance, including through all appropriate criminal, civil and regulatory actions against the company.”

On top of that, the lawmakers are demanding Sharpless explain why the FDA decided last October to withdraw a regulation that would have required drugmakers to promptly report suspected falsified data, and whether the FDA plans to reinstate it in the wake of the AveXis case.

 

Novartis Internal Investigation-
If you know anything about Novartis’ internal investigations, then you know what a complete sham they are.

 

Not good with several other recent quality and ethics missteps Is this now the culture.

 

I feel another culture survey coming on...

 

LOL! You are right.

 

You mean a survey that doesn’t actually report how the “associates” feel about the company, just the upper management “this place is great” feelings?

 

The whole Avexis just gets worse and worse.

Vas had time to fire the Chief Scientific Officer before notifying the FDA

 

Novartis replaced AveXis chief scientist, R&D head amid Zolgensma uproar

The departure of Brian and Allan Kaspar is notable, as both played significant roles at AveXis, which Novartis bought last year for $8.7 billion.

Brian Kaspar, formerly a clinical trial investigator at Nationwide Children's Hospital, was a scientific co-founder of AveXis and served as its chief scientific officer since June 2015. He at one point owned the largest stake in the biotech held by an individual, at 6.7%. According to an April regulatory filing, Kaspar stood to receive more than $380 million related to the Novartis acquisition.

AveXis directly employed Allan Kaspar as vice president of research and development since early 2014.

Both were placed on administrative leave in May, when Novartis was in the process of investigating internal allegations that testing data comparing two versions of Zolgensma in mice had been manipulated. The company concluded technical reviews in late June, when it informed the FDA of the discrepancies it had found.

That acknowledgement to regulators, however, came roughly a month after the approval of Zolgensma, a fact that spurred the FDA to issue an unusual warning of potential civil or criminal penalties for AveXis and, by extension, Novartis.

Wilson Bryan, head of the FDA's Office of Tissues and Advanced Therapies, indicated in an agency memo that had the FDA known of the data issues, it wouldn't have approved Zolgensma when it did.

 

the data in question was "corrected" 1 week prior to pre-license inspection of Alexis facility....in FEBRUARY!

In discussion with Shannon Lindberg, I noted that the incorrect validation report RPT-859 v1.0 needed to be updated in the BLA, and she agreed. In daily summary discussion on the afternoon of 2/14/19, I noted that the change to this validation report had only been finalized on 2/7/19 and therefore it was understandable that the BLA had not yet been updated with the correct version of this report, but this incident and other incidents at the San Diego and Libertyville sites highlight the need for managed documents such as RPT-859 to be updated in the relevant BLA or IND submission when errors are discovered or major changes are made. The firm agreed to update the BLA with the new version of RPT-859 and to provide a plan for improvement of their regulatory submission of managed documents.​

https://www.fda.gov/media/129932/download

 

Firing the culprits. is a typical response to lay blame rather that address the underlying problems. How this was handled looks bad and raises a number of questions beside the data manipulation including, the timely detection of the issue coupled with taking appropriate timely actions once detected including reporting.

 

There are too many red flags. You should have heard Vas today. Shameless...
But completely understandable given the position he finds himself in.

 

Matters not one iota if Vas resigns...

Why?

Because Novartis, like any other company, is a market-free zone. It's a hierarchy. A miniature Soviet Union with central planning.

New boss, same as the old boss.

Unboss?

"Leadership" takes you all for fools !

 

Not defending him . To the contrary I think Novartis gives lip service to compliance quality and ethics just look at all the issues that have occurred and it’s demonstrated lack of support for such activities.

 

Reps literally get fired over a text message sent to a coworker or to a provider. The stress of having a compliant dinner program makes it not worth doing. BPO harassing reps over minor issues while Novartis is bribing Michael Cohen, bribing Greek officials and falsifying clinical study data. Vas needs to go.