Novartis milestones be proud ! Management take a bow !

Quote
More "ethical" Behavior by the executives o_O

Novartis Insider Sold Shares in Weeks Before Zolgensma Scandal
By
Patrick Winters
August 18, 2019, 6:59 AM EDT
1000x-1.jpg

A Novartis research lab. Photographer: Qilai Shen/Bloomberg
A Novartis AG manager sold 925,400 francs ($946,000) of shares weeks before a scandal over data for its Zolgensma gene therapy became public.

The sale on July 19 was made by an executive member of the board of directors or a member of the executive committee, according to a Swiss stock exchange filing.
 






Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Novartis AG (NVS)

August 21, 2019

NEW YORK, NY / ACCESSWIRE / August 21, 2019 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Novartis AG (“Novartis” or the “Company”) (NYSE:NVS). Investors who purchased Novartis securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: www.bgandg.com/nvs.

The investigation concerns whether Novartis and certain of its officers and/or directors have violated federal securities laws." data-reactid="12" style="margin-bottom: 1em;">The investigation concerns whether Novartis and certain of its officers and/or directors have violated federal securities laws.

On August 6, 2019, the U.S. Food and Drug Administration (“FDA”) announced that Novartis had submitted manipulated data in its biologics license application (“BLA”) for its gene therapy drug, Zolgensma. The FDA’s announcement continued to say that the Company “became aware of the issue of the data manipulation that created inaccuracies in their BLA before the FDA approved the product, yet did not inform the FDA until after the product was approved.” Novartis is now under FDA investigation and may be subject to further penalties. Following this news, Novartis stock dropped $2.50 per share, or roughly 3%, to close at $88.22 on August 6, 2019." data-reactid="13" style="margin-bottom: 1em;">On August 6, 2019, the U.S. Food and Drug Administration (“FDA”) announced that Novartis had submitted manipulated data in its biologics license application (“BLA”) for its gene therapy drug, Zolgensma. The FDA’s announcement continued to say that the Company “became aware of the issue of the data manipulation that created inaccuracies in their BLA before the FDA approved the product, yet did not inform the FDA until after the product was approved.” Novartis is now under FDA investigation and may be subject to further penalties. Following this news, Novartis stock dropped $2.50 per share, or roughly 3%, to close at $88.22 on August 6, 2019.

If you are aware of any facts relating to this investigation, or purchased Novartis shares, you can assist this investigation by visiting the firm’s site: www.bgandg.com/nvs. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
 






AVEXIS STATEMENT:



Dear Rett Syndrome community,

You may have seen in recent news that on Tuesday, August 6, 2019, the FDA released a statement addressing data concerns with the application for the approval of Zolgensma® (onasemnogene abeparvovec-xioi), a gene therapy currently on the market for patients less than 2 years of age with spinal muscular atrophy (SMA). The FDA as well as AveXis supports the continued use of Zolgensma due to the totality of evidence supporting its overall safety and effectiveness. We have and will continue to work in close cooperation with the FDA to appropriately update our submission and address any identified quality gaps. We remain fully confident in the safety, quality and effectiveness of Zolgensma.

Due to the data integrity concerns related to a specific animal testing procedure used in the development of Zolgensma and included in the application, we have decided to also review data quality and compliance with the preclinical work performed for AVXS-201, our Rett Syndrome gene therapy candidate. Out of caution, and to ensure that we have a robust data package for the FDA we have chosen to repeat and add additional pivotal preclinical studies as well as new quality controls. Once these studies are completed, we will submit the revised IND (investigational new drug application) to the FDA with the goal of rapidly progressing to clinical trials in Rett Syndrome patients. We expect that conducting these additional studies and completing the IND will take until the middle of 2020. At that time we will be in a position to provide further updates to the Rett Syndrome community.

We recognize that this news will cause concern and disappointment. Please know that AveXis remains focused and steadfast in our commitment to the Rett program and to ensuring the highest levels of transparency and integrity with the patients and providers we serve, and health agencies.

“Rett Syndrome continues to be a key focus for AveXis and we maintain a high sense of urgency to progress clinical studies for AVXS-201. We look forward to serving as a trusted member of the Rett Syndrome community and partnering with patients, advocates, physicians and regulators as we work to better understand the clinical impact of gene therapy for this devastating disease.” – Dave Lennon, President of AveXis

We also wanted to share that Page Bouchard, DVM has been appointed Senior Vice President of Research and Chief Scientific Officer, AveXis, effective August 5, 2019. Dr. Bouchard is a 27-year industry veteran with experience in well over 100 Investigational New Drug programs and dozens of New Drug Application/Biologics License Application filings. He has been with Novartis for 10 years and most recently was the Global Head of Preclinical Safety for Novartis Institutes for BioMedical Research (NIBR). He is leading the management team responsible for our Rett program.

Sincerely,

The AveXis Team



RSRT STATEMENT:





All of us at RSRT were shocked and disappointed to read the FDA’s statement released on August 6th regarding data manipulation by AveXis/Novartis for their spinal muscular atrophy gene therapy product, Zolgensma. Top of mind was the question of how this revelation would affect the development of AVXS-201, the Rett Syndrome gene therapy product, so we spent the next couple of weeks gathering information. On August 22 AveXis/Novartis issued a statement to the Rett Syndrome community.

The data manipulation fall out from Zolgensma means a delay to the Rett clinical trial initiation of a year or longer. Given that this trial was on the brink of starting, and that time is of the essence for our children, the delay is a setback for our community. However we are encouraged that AVXS-201 remains a top priority for AveXis/Novartis.

We have spoken to the leadership of AveXis, including the President, Dave Lennon, and are in the process of setting up a meeting with the new Chief Scientific Officer, Page Bouchard. RSRT has extensive and long-standing relationships and resources amongst the scientific and clinical community as well as deep understanding of the Rett scientific landscape. Recognizing that the science underpinning the trial must be rigorously validated, RSRT has assured AveXis/Novartis that we will do everything we can to facilitate AVXS-201 reaching the clinic as quickly as possible.

One of RSRT’s fundamental principles is to drive multiple potentially curative programs forward in parallel. While we are as optimistic as ever in the potential of gene therapy for Rett, we will never put all of our eggs in any one basket, including gene therapy. Rest assured that our other MECP2 targeted programs are progressing.

We are buoyed by the fact that the data in question do not alter the safety or efficacy of the SMA product and that Zolgensma remains on the market and is dramatically saving lives. We hope that our children with Rett will be given, as soon as possible, the same opportunity to heal as children with SMA.


AveXis/Novartis Release Statement on AVXS-201 | RSRT
 


















So MANY Internal Investigations :confused:

The maker of the popular heartburn medication Zantac said Wednesday it has stopped distributing the drug worldwide pending investigations from U.S. and European health regulators into a potentially cancer-causing ingredient in both branded and generic versions of the treatment.

The Sandoz division of the Swiss pharmaceutical corporation Novartis said it made a "precautionary distribution stop" of Zantac and all medicines containing ranitidine, the generic treatment for stomach acid and ulcers.

"Our internal investigation is ongoing to determine further details," the Novartis spokesman added.

The decision follows a Friday announcement from the U.S. Food and Drug Administration that the drug contained a "probable" carcinogenic chemical in a type of nitrosamine called N-nitrosodimethylamine, or NDMA.

The federal agency said NDMA is dangerous in large quantities, but the amount found in the heartburn drugs barely exceeds levels found in common foods. For now, U.S. health officials said patients can continue taking Zantac and similar heartburn medications, but prescription patients can consult their doctors if they want to switch to other treatments

NDMA is the same chemical that has been linked to dozens of recalls of prescription blood pressure drugs in the past year, including a commonly prescribed one called valsartan. The recalled drugs, which were manufactured in China, had higher levels of the NDMA chemical than U.S. health officials deemed acceptable.

Agency officials said the FDA is investigating whether low levels of the carcinogen in heartburn medication is a risk to patients and will post its findings as soon as possible.
 






Wake up and smell the coffee, big turds like Alisha and the better marketing people left the cv div for greener pastures. They left you smaller smelly steamy turds that cant sell a damn thing esp the dummies like cv1 & cv2. Your days are numbered you losers
 






anonymous said:
Wake up and smell the coffee, big turds like Alisha and the better marketing people left the cv div for greener pastures. They left you smaller smelly steamy turds that cant sell a damn thing esp the dummies like cv1 & cv2. Your days are numbered you losers
Click to expand...

Sorry dude but NO ONE was ever good in cardio. Ever. Some of the worst talent in the industry is running that show.
 












Novartis expands recall of heartburn meds to U.S. after finding carcinogen

By ED SILVERMAN SEPTEMBER 24, 2019

After running tests, the Sandoz unit of Novartis (NVS) has expanded its recall of heartburn medicines containing ranitidine and is now pulling the products from the U.S.

The move comes one week after the drug maker halted worldwide distribution of heartburn medicines and regulators in the U.S and Europe disclosed the capsules may contain high levels of a carcinogen. At the time, Sandoz also issued a recall in some European countries and Canada, but did not take the same step in the U.S. while testing was underway.
 






Novartis in political row after denying Belgian toddler compassionate access to gene therapy

Richard Staines
September 24, 2019

The controversy over Novartis’ ultra-pricey gene therapy Zolgensma has intensified after it allegedly refused to supply the one-off therapy to a sick toddler in Belgium on compassionate grounds.

According to The Brussels Times, the family of the toddler named Pia, who suffers from the ultra-rare disease spinal muscular atrophy (SMA) have been running a crowdfunding campaign to pay for treatment with the world’s most expensive drug.

Pia’s family have raised the 1.9 million euros needed to pay for Zolgensma, which has not yet been approved in Europe.

However, according to the report Belgium’s health minister Maggie De Block said the company had refused a request for compassionate use for Zolgensma (onasemnogene abeparvovec).

Compassionate use is allowed in EU laws under strict conditions, where governments can request that patients receive unauthorised medicines if there is no satisfactory alternative and they cannot enter clinical trials.

The Brussels Times reported that De Block’s spokesperson Audrey Dorigo said Novartis had rejected a request for compassionate use, even though the government considered that all conditions were met.

Dorigo told the website that the “refusal is not justified” and cited cases where other pharma companies have agreed to provide unapproved drugs under compassionate use arrangements.

Novartis has issued a statement, saying that it did not comment on individual patient cases, and adding that the drug had been priced “cost effectively” in the US based on Novartis’ analysis of the one-time transformative therapy.

The company added in a statement that “healthcare systems need to find new ways to organise care and provide coverage for treatments that provide a lifetime of benefits.

“As an industry, we are committed to maintaining and intensifying an open dialogue with all stakeholders, to find solutions together to bring new therapies to patients who can benefit in Belgium and elsewhere,” Novartis said.

Zolgensma is under review in Europe, but in July it emerged that the European Medicines Agency’s CHMP scientific committee had removed Zolgensma from an accelerated assessment programme.

The Committee for Medicinal Products for Human Use (CHMP) did not announce the reasoning behind the decision, which means the gene therapy will be reviewed in 210 days rather than the accelerated 150 days.

This paves the way for a potential approval in the final quarter of this year, or the first quarter of 2020 depending on how the review proceeds.

The company is also at the centre of an argument over Zolgensma in the US, where the gene therapy has been approved since May.

Last month politicians urged the FDA to take tough action against Novartis for failing to disclose that manipulated non-clinical data had been included in the Zolgensma filing dossier.

The information dates back to when the drug was in very early development by the biotech AveXis, before Novartis’ $8.7 billion takeover in April last year.
 






NICE delivers final ‘no’ for Novartis’ migraine treatment Aimovig
Blow to patients who have dubbed the treatment 'life-saving'

Article by
Lucy Parsons

26th September 2019

Aimovig.jpg


Novartis has been delivered another ‘no’ for its migraine prevention drug Aimovig (erenumab) from NICE, following draft guidance which rejected the drug earlier this year.

The final appraisal has confirmed that the original decision remains unchanged, with NICE saying that a lack of significant data meant it could not recommend the treatment for routine use on the NHS.

In a statement, NICE said that the trials of Aimovig “excluded people for whom all previous treatments had no therapeutic benefit”. This significant patient population, the cost-effectiveness agency says, represents those who would be most in need of the treatment and the “most clinically important subgroup”.

It also said that the long-term data which Novartis provided did not show that Aimovig had a clear sustained benefit, and that it only included people with episodic migraine and did not specify how many previous treatment they had failed before taking the drug.

The agency also presented concerns that for the chronic migraine subgroup, there was no direct comparison with the current standard of treatment, botulinum toxin type A (Botox), so its superiority is uncertain.

Ultimately, NICE deemed that the cost-effective estimates for the drug are higher than what it deems to be acceptable. Aimovig has a list price of £5,000 per year, although Novartis would have offered NICE a confidential discount. It seems that even with such a discount, the watchdog still does not think it is worth the money based on the data Novartis supplied.

The decision comes as a blow to Novartis, who have said that Aimovig has significant benefits over the current standard of treatment, including its self-administering dosing which means patients do not have to repeatedly attend clinic appointments.

“We’re very disappointed that NICE has not recommended Aimovig for use on the NHS. Clearly this is not the result we’ve been working towards; with chronic migraine patients in England who could benefit from Aimovig being denied routine access to this important treatment option, whilst it is NHS funded in Scotland,” said Haseeb Ahmad (pictured below), managing director UK, Ireland and Nordics and Novartis president UK.

Haseeb_Ahmad_Resized.jpg


Haseeb Ahmad

The preventative medicine is available for use in on the NHS in Scotland – this rejection has been criticised for establishing a post-code lottery of access, with those who cannot afford the medicine cut-off from the potential benefits of the drug.

“This decision is particularly disappointing given NICE has recognised the clinical-effectiveness and tolerability of Aimovig in chronic migraine, and there remains an unmet need for effective and well-tolerated preventive migraine treatments in the UK,” Ahmad added.

The frustration from patients is also profound, with many suffering from migraines describing the drug as ‘life-changing’.

Responding to the news of the rejection, chief executive of The Migraine Trust Gus Baldwin said that it is a “very bad day for chronic migraine patients”.

“My main worry is that I’m yet to find a neurologist who doesn’t want to have the option of being able to prescribe these new types of preventive drugs when they and their patient think it is likely to be in the patient’s best interest. Crucially, these new drugs do not have the nasty side-effects of other preventives already available,” he said.

Since being approved by the European Commission in 2018, Novartis has seen rivals emerge from Eli Lilly (Emgality) and Teva (Ajovy) introduced to the market.

However, Aimovig has established itself as market lead, with Evaluate Pharma estimating sales of $2.05bn in 2024. It also predicts Emgality could hit $1.2bn by this time, with Ajovy forecast to reach $962m.
 


















"My message is that we'll be watching you.

"This is all wrong. I shouldn't be up here. I should be back in the field on the other side of the ocean. Yet you all come to us young people for hope. How dare you!

"You have stolen my dreams and my childhood with your empty words. And yet I'm one of the lucky ones. People are suffering. People are dying. Entire healthcare systems are collapsing. We are in the beginning of a mass extinction of reps, and all you can talk about is money and fairy tales of eternal economic growth. How dare you!
 






Bausch files suit against Novartis unit Sandoz for infringing patents on Xifaxan 550 mg tablets

Published: Oct 1, 2019 7:10 a.m. ET
By
CIARA LINNANE
CORPORATE NEWS EDITOR

Bausch Health Cos. Inc. BHC, +0.69% said Tuesday it is filing a lawsuit against Novartis AG unit Sandoz NVS, -0.57% for the infringement of patents protecting its Xifaxan 550 mg tablets, a treatment for irritable bowel syndrome. The company, formerly called Valeant, said Sandoz infringed 14 patents when it filed an abbreviated new drug application for Xifaxan 550 mg tablets. "Bausch Health remains confident in the strength of the XIFAXAN patents and will continue to vigorously defend its intellectual property," the company said in a statement. Bausch shares fell 1.1% in premarket trade, while Novartis ADRs were down 0.8%.
 






October 14, 2019 10:52 AM EDT

Jason Mast

R&D
US mulls tariffs on Swiss drug exports, weighing on Novartis and Roche – report
The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.


Robert Lighthizer

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Thus far, the China-US trade war’s impact on pharma has been largely spectral, with lots of talk but little action. Economists and politicians on both sides of the Pacific haven’t failed to note the US’s heavy reliance on China for raw pharmaceutical ingredients, with one Chinese economist proposing Beijing cut off sales of antibiotics and pharmaceutical ingredients in response to US tariffs. But so far both Beijing and Washington have carved out exemptions to assure the largely free flow and unfettered manufacture of drugs.

Donald Trump, though, has broadly targeted US trade deficits worldwide, and pharmaceuticals are the leading weight beneath the US’s $18.9 billion trade deficit with Switzerland.

The Swiss drug industry relies heavily on the American market. The US imported $14 billion in pharmaceuticals in 2018, according to the US Trade Office of Representative, over a third of Swiss exports to America.

In 2017, the US accounted for nearly a third of all Swiss pharmaceutical exports.

Swiss pharmaceutical exports by importing country, 2017 – Visualization by MIT’s Office of Economic Complexity
The news comes several months after Trump and Swiss President Ueli Maurer said they were keen on advancing a trade deal. There’s been little word since, but Trump has previously used tariffs as a stick to expedite trade negotiations, notably threatening steep automotive levies on Canada as he sought to renegotiate the North American Free Trade Agreement.

Beijing and Zurich represent opposite ends of the pharmaceutical industry. China is the main global source of antibiotics, supplying, by one reported estimate, 97% of antibiotics for the US and a large portion of the active pharmaceutical ingredients used to manufacture drugs in the US.

Switzerland, despite a population around 8.5 million, exported 11% of the world’s finished drugs in 2017. That was second-most of any country world, behind Germany and ahead of the US.

The US imports 20% of all drugs worldwide. It exports 8.9%.
 






Novartis Hit With Retaliation Suit Over Kickback Scheme
Oct 21st 2019
2 hours ago

A former Novartis employee on Monday launched a revised suit in New Jersey federal court alleging he was fired for objecting to a purported kickback scheme in which the company provided commercial discounts on multiple sclerosis drug Gilenya to Express Scripts Inc. in exchange for Medicare Part D business
 






just go onto any federal district court search engine and search novartis for civil litigation, specifically ADA violations, employment discrimination, FLSA violations, FMLA, Hostile work environment personal injury, etc... yeah, management take a bow. Be proud of the cultural bullying environment you have fostered and nurtured.
 






anonymous said:
just go onto any federal district court search engine and search novartis for civil litigation, specifically ADA violations, employment discrimination, FLSA violations, FMLA, Hostile work environment personal injury, etc... yeah, management take a bow. Be proud of the cultural bullying environment you have fostered and nurtured.
Click to expand...
So typical for big pharma
 






Top Bottom
Back
Quote