Novartis milestones be proud ! Management take a bow !

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Novartis to shuffle jobs to support product launches
ZURICH Tue Jan 21, 2014 6:33am EST

(Reuters) - Swiss drugmaker Novartis (NOVN.VX) plans to reorganize parts of its domestic workforce, cutting up to 500 jobs in its pharmaceutical division to free resources for new roles to support the product launches, the company said on Tuesday.

As part of the reorganization, the axe will fall on its pharmaceutical division, where Novartis plans to cut up to 500 jobs. Most will be in support functions at its headquarters as well as operational roles in development.

Last November Novartis announced plans to close sites in England and Austria and said it would cut about 500 jobs at its research operations
 






Novartis to close Suffern plant; hundreds to be affected

All 525 employees to be affected, officials say
Jan. 21, 2014

SUFFERN — The Novartis Pharmaceuticals Corp. announced Tuesday that it will be closing its Old Mill Road plant in the next two to three years, a move that will affect hundreds of local employees.

Julie Masow, a company spokeswoman, said the process of closing the plant will begin in the second quarter of 2014 and continue until 2016 or 2017. Some employees who perform “necessary functions” will be transferred to other facilities. All of the plant’s 525 employees will be affected, she said.

“Suffern has supplied the Novartis network, its customers and patients with quality products for many years and we acknowledge and appreciate the significant contributions our associates have made to the organization,” Masow said in an email Tuesday. “This difficult decision was a strategic choice made to optimize our manufacturing infrastructure.”
 






Novartis Denied EU Panel Nod for Serelaxin Heart Drug
By Eva von Schaper and Naomi Kresge Jan 24, 2014 8:51 AM ET

Novartis AG (NOVN) failed to win backing from European regulators for its serelaxin treatment for acute heart failure, a product the company still says has the potential for $1 billion in annual sales.

It wasn’t clear whether the drug’s effects would be of clinical importance, the European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement today. The committee also cited concerns about how a patient trial was run and how data was analyzed. Novartis said it will file a new application seeking approval to begin marketing the drug on the condition that it undergo another review once a bigger trial begun in September is finished.

The panel’s decision slows Novartis’s plan to build a portfolio of heart-failure drugs around serelaxin, a man-made version of a hormone found in pregnant women, and the experimental compound LCZ696. The Basel, Switzerland-based drugmaker needs to replenish its product line-up as the heart medicine Diovan and cancer treatment Gleevec, its biggest sellers, start to lose patent protection. The two made up about $9.1 billion of Novartis’s $56.7 billion in 2012 revenue
 






Attorney General Bob Ferguson joins lawsuit against Novartis Pharmaceuticals Corporation
Jan 26, 2014 at 8:19PM

Attorney General Bob Ferguson today filed a motion to intervene in a civil lawsuit against Novartis Pharmaceuticals Corporation.

The suit alleges Novartis paid kickbacks to BioScrip, Inc., a pharmacy headquartered in New York, to boost sales of Novartis’ drug, Exjade. Exjade was approved by the Food and Drug Administration in late 2005 for the treatment of chronic iron overload due to blood transfusions.

Washington announced its settlement with BioScrip earlier this month. BioScrip agreed to pay $15 million to the federal government and state governments to resolve Medicaid and Medicare claims related to the scheme.

Washington’s total share of the settlement was roughly $98,000 with nearly $43,000 returning directly to the state Medicaid program and the remainder returning to the federal government for its share of Washington’s Medicaid program. The federal government matches state funds to support the Medicaid program in Washington.

Washington was one of the six states leading the BioScrip settlement negotiations.

“When companies don’t play by the rules, they put valuable Medicaid dollars at risk,” Ferguson said. “Washington and other states want these companies to know we are paying attention and will fight vigorously for the vulnerable patients they serve.”

Washington joins New York and eight other states that announced they were intervening in the lawsuit against Novartis when the case was unsealed on Jan. 8, 2013. California has also intervened.

Kickbacks provided to promote drug, downplay side effects

The lawsuit alleges Novartis launched its kickback scheme in 2007, when it became concerned that patients were discontinuing use of Exjade because of side effects.

The government alleges Novartis provided the kickbacks to induce BioScrip to try to keep patients on the drug as long as possible. The states further contend that BioScrip employees made thousands of phone calls to Exjade patients and downplayed the side effects of the drug.

Small network distributed drug creating intense competition

Until 2012, when it sold most of its pharmacy business, BioScrip operated a specialty pharmacy that shipped prescription drugs to Medicaid patients around the country.

When Novartis launched Exjade, it created a closed distribution network, including BioScrip and two other specialty pharmacies selected by Novartis, to fill most prescriptions of the drug in the U.S.

Novartis controlled which pharmacies filled many of the prescriptions for Exjade through this small network. The civil lawsuit against Novartis alleges the company used its control of Exjade prescriptions as well as various rebates and discounts to pay kickbacks to BioScrip.

Novartis used Exjade Scorecard to refer additional patients to pharmacies

The state-federal investigation found Novartis created an ‘Exjade Scorecard’ to measure how long patients took Exjade. Novartis used this scorecard to refer more new patients to the pharmacy that kept patients on the drug the longest.

BioScrip often won this competition and received valuable new patient referrals as a result. A former BioScrip supervisor stated under oath that this competition and the rebates provided by Novartis “caused [BioScrip] to be focused exclusively on the number of orders and refill rates, rather than on patient care.”

Case originated with whistleblower

The case was initiated by a whistleblower, under the New York’s False Claims

Act and other state statutes. That case is captioned U.S. ex rel. Kester, et al. v. Novartis Pharmaceuticals Corporation, et al., No. 11-CIV-8196 (U.S.D.C. S.D.N.Y.).
 












Novartis lays off more people in Lincoln
4 hours ago • By MATT OLBERDING / Lincoln Journal Star

Novartis has laid off more people at its Lincoln plant.

Novartis spokeswoman Julie Masow said the company earlier this month laid off 27 workers at the plant at 10401 U.S. 6. and eliminated another 58 open positions. That was the second phase of a three-phase restructuring plan Novartis announced last April in response to chronic quality-control troubles at the plant.
 










































Novartis to lay off 92 from East Hanover office, among hundreds nationwide

Alexi Friedman/The Star-Ledger By Alexi Friedman/The Star-Ledger
February 06, 2014

Novartis Pharmaceuticals will lay off 760 employees from its nationwide sales and support staff, including 92 who work in East Hanover, the drugmaker's U.S. headquarters.

A Novartis spokesman today said 59 of those 92 workers live in New Jersey.

The layoffs are part of a company-wide reorganization, which the drugmaker has said is aimed at supporting the launch of new products this year. Last month, Novartis said it would shutter its Suffern, N.Y., plant, and lay off all 500 workers. More than 200 of those employees live in New Jersey.

The most recent job cuts come from the company's pharmaceutical and general medicines division, said spokesman Eric Althoff.

He said the company will offer "enhanced severance packages" to employees and job service assistance. Workers were notified this week.
 












Scanner on Novartis for giving 'fake' documents
Company says have responded to notice, cooperating with DCGI
Sushmi Dey | New Delhi February 10, 2014 Last Updated at 00:50 IST

Swiss drug maker Novartis might face tough action from the country's drug regulator for allegedly giving fake documents while seeking renewal of registration for Tiamulin Hydrogen Fumerate (80 per cent granules), sources said.

The Drugs Controller General of India (DCGI) has issued a show-cause notice to the company and could even suspend distribution and marketing of the product, a senior official in the regulator's office told Business Standard. "We are evaluating strong action against the company and drug alerts to all zones, sub-zones and state drug controllers have been issued," the official said.

Confirming the receipt of the notice, Novartis said one of the documents given with the application could be fake. "Novartis has responded to the notice and shall extend full cooperation to the authorities. Novartis has a strong code of conduct with zero tolerance for deviations," a Novartis spokesperson said.

The product is used for respiratory diseases in the poultry industry. According to the official, Novartis imports the product to India, made at Sandoz in Austria.

While pharmaceutical sector sources said it was a big contributor to Novartis' animal product business in the country, the company refused to disclose sales of the product in India.

The alleged deviation in Novartis' documentation was found by the authorities during an inspection of the company's Shivsagar Estate office in Mumbai. A team headed by Deputy Drugs Controller

K Bangaruranjan visited the company's Animal Health Business Unit during January 21-24 and verified the documents for the drug. The authorities also met senior officials of the company, sources said. The company officials failed to answer about the alleged fake documents.

The senior DCGI official said: "Our inspectors will go and inspect other factories of the company as well," the official said. He said the company had a total of 26 products registered in India.
 






DCGI asks Novartis to explain 'violations' in papers on drug manufacture
By Soma Das, ET Bureau | 10 Feb, 2014, 04.05AM IST

NEW DELHI: India's drug regulator has asked NovartisBSE -1.58 % to explain "violations" in papers relating to the manufacturing origin of a veterinary drug, with a European agency having ruled that the document the Swiss company submitted was fake.

This has prompted the watchdog to begin a wider inquiry into the records submitted by the company to assess whether any of the other documents it has filed with the Indian regulator's office are "fraudulent" in nature.

The January 28 show-cause notice issued to the Swiss company by the Drug Controller General of India (DCGI) came after the European Directorate of Quality Medicine (EQDM) confirmed that the document showing the drug as having been manufactured at its Tyrol, Austria, facility was spurious.

DCGI has suspended sales of tiamulin hydrogen fumarate (80% granule), used in poultry. It has sought an explanation for the "violation" in 10 days, apart from asking for detailed documentation for all imported products.

The drug regulator has identified another 26 products imported by Novartis and is checking their papers for authenticity. Any falsification of origin is "a grave violation", a DCGI official office told ET. "We would have to check and ensure that its documents on all other imported products are in order and real."

Novartis has annual sales of $58 billion globally while its Indian arm, a listed entity, posted annual revenue of a little more than .`900 crore in FY13. The Indian drug regulator's suspicions were aroused after coming across another application of the company displaying an identical certificate number, but citing a different manufacturing site at Trento, Italy.

"Subsequently, on our request, director, EQDM, Council of Europe, confirmed our suspicion and informed us that the certificate of Novartis claiming that the drug was manufactured at its Austria site is fake," said the official.


The Indian arm of the Swiss company confirmed that it had received a show-cause notice from DCGI alleging that one of the documents submitted along with an application for renewal of registration was not genuine.

"Novartis has a strong code of conduct with zero tolerance for deviations. Novartis has responded to the notice and shall extend full cooperation to the authorities," a company spokesperson said, without divulging the contents of its response. "The product is an antimycoplasma respiratory animal drug used for respiratory disease in the poultry industry. We do not as a policy disclose individual product sales," she added.

As part of its inquiries, a DCGI team of four officials headed by deputy drug controller K Bangarurajan conducted an inspection at Novatis India's Mumbai office for four days toward the end of January.

"When the company officials were questioned by the officials during inspection to detail the trail of the 'fake' certificate, they claimed that the documents were sent from Novartis' headquarters, in Basel, Switzerland.

They however, claimed that the documents were lost in transit, after which the India office received a scanned copy through email," an official said. However, when company executives were asked for a copy of the emailed version, they said it wasn't retrievable as the system automatically deletes emails after 60 days.
 






of 2014

Novartis Cancer Unit To Pay $8M To Settle Securities Row
By Michael Lipkin 0 Comments

Law360, Los Angeles (February 11, 2014, 9:29 PM ET) -- Novartis AG subsidiary Genoptix Inc. will pay nearly $8 million to end a putative securities class action alleging the company misrepresented customer demand for diagnostic cancer testing and didn't disclose factors dragging down demand, according to a settlement stipulation filed Tuesday in California federal court.

Lead plaintiff City of Ann Arbor Employees’ Retirement System and Genoptix asked the court to preliminarily approve the settlement, which would provide $7.7 million plus interest to class members who bought Genoptix stock between July 2009 and June 2010.
 






Novartis got $550,000 from taxpayers for job retention

12 February 2014, 11:07 am by egarcia in business

Novartis got $550,000 from taxpayers to retain 338 jobs and create 50 new ones in 2005.

Last month the pharmaceuticals giant announced that it will close its Suffern plant and layoff 525 workers, and Lohud.com subsequently asked economic development officials whether Novartis had received any taxpayer subsidies in the past decade.

Rockland County officials said they could not recall giving Novartis any money, but on Friday Empire State Development confirmed that it gave Novartis a grant.

Large corporations like Novartis often get taxpayer cash after suggesting that they might move out of New York or downscale their operations without the subsidies. Typically the hand-outs come with a promise to maintain the jobs for an agreed upon number of years.

Empire State Development did not say for how long Novartis was to maintain the promised jobs.
 






Fleecing Taxpayers said:
Novartis got $550,000 from taxpayers for job retention

12 February 2014, 11:07 am by egarcia in business

Novartis got $550,000 from taxpayers to retain 338 jobs and create 50 new ones in 2005.

Last month the pharmaceuticals giant announced that it will close its Suffern plant and layoff 525 workers, and Lohud.com subsequently asked economic development officials whether Novartis had received any taxpayer subsidies in the past decade.

Rockland County officials said they could not recall giving Novartis any money, but on Friday Empire State Development confirmed that it gave Novartis a grant.

Large corporations like Novartis often get taxpayer cash after suggesting that they might move out of New York or downscale their operations without the subsidies. Typically the hand-outs come with a promise to maintain the jobs for an agreed upon number of years.

Empire State Development did not say for how long Novartis was to maintain the promised jobs.
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This is one of million plus, plus, plus proofs that America, the so called bastion of free capitalisam and free market, does not have free market at all. What it has corporate/rich fuckers's socialism. It is all regulated and managed by the state. BY THE RICH FOR THE RICH.
It's been like that almost for ever and it's not going to change to any other system, that would hurt the power elite. If you really had a true free market, the elite would not do as well as they do and you, the folks would do far better than you are. The whole system is stacked up against you and what is worse, most believe it ain't so. Thus the elite can do anything they want to fuck you and you'll take it and like it, as Bogart said it in one of this movies, as he was slapping the guy's face;"You'll take it and like it".
That is what your govt and elite are doing to you, they are slapping you, abusing you and you like it. Don't you?
 






February 16, 2014 1:46 pm

Novartis puts pressure on India over patent abuse

By Andrew Ward in London and Amy Kazmin in New Delhi

Novartis has urged US and European governments to “apply pressure” on India to respect intellectual property and warned New Delhi that its stance on patents is deterring investment.

Joe Jimenez, chief executive of the Swiss drugmaker, urged India to follow China’s example and embrace strong IP rights as a way to develop its economy.

“India is a big, important growing market but it is not a place to do research and development,” Mr Jimenez told the Financial Times. “If you do not have strong protection of IP, you cannot invest in . . . medical science.”

The Indian Supreme Court infuriated Novartis last year after it rejected the pharmaceutical group’s application for a patent for an updated version of its cancer drug Glivec. The Supreme Court verdict was one of several Indian court rulings that have overturned or rejected patents from Western drug companies, including Roche and Pfizer.

Tensions are particularly high over pharmaceuticals. In a country where 70 per cent of medical costs are paid out of pocket by the sick, or their families, the government and courts have tended towards narrow interpretations of patent protection for costly, life-saving medicines in a bid to allow wider access to cheaper generics.

Drugmakers are worried that India’s approach – including a law that sets a higher standard for issuing patents than in other countries – will become a model for other developing countries, threatening to undermine the industry’s business model in the world’s fastest growing markets.

http://www.ft.com/cms/s/0/bdaf5880-96de-11e3-a274-00144feab7de.html#axzz2tX6NWaN3
 






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