Novartis milestones be proud ! Management take a bow !

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Once again Novartis is on the WRONG SIDE OF THE LAW

High Court Won't Block Puerto Rico's Control Of Drug Prices

Law360, New York (October 07, 2013, 7:08 PM ET) -- The U.S. Supreme Court on Monday declined to consider a Novartis Pharmaceuticals Corp. petition objecting to Puerto Rico's regulation of drug prices charged to wholesalers, leaving intact a lower court's finding that the oversight doesn't usurp Congress' power over interstate commerce.

As is customary, the high court offered no explanation for refusing to review the case, which centered on the so-called dormant Commerce Clause, an implied ban on regulation of interstate trade by states or territories that derives from the explicit power over such activity that the U.S. Constitution grants to Congress.

According to Novartis' petition, a Puerto Rico appeals court last year found that the island's Department of Consumer Affairs, known as DACO, can control the Swiss drugmaker's prices because the company markets and promotes its products in the territory, even though they are not physically sold there.

As a result, the court found that there is no intrusion on cross-border commerce, even if the title to the drug products changes hands in other states, specifically New Jersey and Pennsylvania, according to the petition.

Novartis blasted that conclusion, asserting in its petition that "there is no question that the actions intended to be regulated occur outside of Puerto Rico's boundaries."

It is not clear from the petition whether price controls are currently in place or which other drugmakers are affected. Novartis, which has been selling in Puerto Rico for decades, says DACO launched its effort to curb drug costs in 2001 and later demanded a 2 percent discount for island wholesalers.

Counsel for Novartis did not immediately respond to a request for comment, and DACO could not be reached for comment.

In addition to constitutional questions, the matter represents the latest chapter in an ongoing debate over whether government officials should more aggressively try to contain the cost of brand-name drugs whose manufacturers doled out tens of billions of dollars to dissuade Congress from allowing Medicare to negotiate prices when it passed the Affordable Care Act.

Last month, for example, an inspector general's report said Medicare could save more than $3 billion annually under a limited expansion of drug rebates that currently apply only to Medicaid, although federal regulators said they had no intention of pursuing the idea, citing various technical challenges.

Many other countries restrict drug prices far more than the U.S., but there has been resistance to a stronger approach among American lawmakers, especially Republicans, with some observers concerned it could sap money for research and development.

Novartis is represented by Herman G. Colberg and Jorge I. Peirats of Pietrantoni Mendez & Alvarez LLC.

The case is Novartis Pharmaceuticals Corp. v. Department of Consumer Affairs, case number 13-77, in the Supreme Court of the United States.

--Editing by Katherine Rautenberg.
 






Karma is a bitch!!! Hope these fuckers go down in flames.....hate it for the reps cause the jobs are slim out there to make the same type of salary as you can make in pharma. I got out good after being lied on by my manager....got his ass fired though. The dumb non-swimming Democrat never even knew what hit him.
 






Canadian Court Finds Novartis Osteoporosis Drug Not Patentable

By Peter Menyasz

Oct. 9 –The Federal Court of Canada has rejected Novartis Pharmaceuticals Canada Inc.’s bid to block a generic version of the osteoporosis drug Aclasta, finding that the drug is a form of treatment that is not patentable in Canada (Novartis Pharmaceuticals Canada, Inc. v. Cobalt Pharmaceuticals Co., Fed. Ct., No. T-724-12, 9/25/13).

The invention claimed in Novartis’s Canadian patent for zoledronic acid, also called zoledronate and marketed as Aclasta, is the recognition that the product can be administered infrequently, such as once a year in injections of 5 mg, to provide effective treatment for osteoporosis, Justice Roger T. Hughes said in the ruling, made Sept. 25 and made public Oct. 4.

“It is in reality, however contrived the wording of the claim may be, a method of medical treatment; hence, under Canadian law, unpatentable,” Hughes said.

The ruling, which also awarded Cobalt Pharmaceuticals its costs in the case, rejected Novartis’s application for Health Canada to issue a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations to block Cobalt from marketing a generic version of Aclasta.

Novartis did not respond Oct. 7 to a request for comment on the ruling; the company Sept. 27 filed a notice of appeal with the Federal Court of Appeal.
 






California District Attorneys File Slack-Fill Lawsuits Against Pharmaceutical Companies

October 16, 2013 3:49 PM

SACRAMENTO (CBS13) — District attorneys from five California counties are joining in a slack-fill lawsuit against two pharmaceutical companies.

Novartis Pharmaceuticals Corporation and Alcon Laboratories are accused of misleading consumers on the packing of their products.

DAs from Sacramento, Shasta, Fresno, Tulare, and Riverside counties are part of the lawsuit accusing the firms of including less product than their package indicates.
 






WOW !!! lowest of the lows :(


St. Jude Children's Research Hospital, Inc.
v. Novartis Pharmaceuticals Corporation

Complaint for Patent Infringement
Civil Action No. 2:13-cv-02802-JPM-tmp, the Hon. Jon Phipps McCalla presiding.
Filed on Oct. 11, 2013 in the U.S. District Court for the Western District of Tennessee;
 






Bizcommunity.com
By: Sikonathi Mantshantsha | 30 Sep 2013 13:15

The SEC has fined large international companies billions of dollars for corrupt behaviour. German-based Siemens has been fined in the past and it now has drug makers Novartis and GlaxoSmithKline in its spotlight for alleged corrupt practices in China, where they are accused of hiring relatives of influential politicians to improve their chances of doing business in that country.
 






NGO accuses Novartis unit of false advertising

November 3, 2013

Jiji PressA nongovernmental organization filed a criminal complaint with prosecutors against Novartis Pharma K.K., accusing the firm of using manipulated clinical trials data in its advertising.

The group, Medwatcher Japan, claims in papers filed with the Tokyo District Public Prosecutors Office that the unit of Swiss drug giant Novartis AG produced exaggerated ads in violation of the Pharmaceutical Affairs Law and violated the Unfair Competition Prevention Law with fraudulent labeling.

According to the complaint, despite the manipulation of clinical trial data for its hypertension drug Diovan, which was carried out by universities, Novartis Pharma used a research paper claiming the drug was more effective than other drugs in reducing the risk of stroke and angina.

In magazines targeting medical professionals published in January and June 2011, the company cited the improper research paper and advertised exaggerated benefits of the drug and made misleading statements, the NGO said.

The complaint said it is unclear whether there was any institutional involvement by the company or who made the decision to use the data.

Masumi Minaguchi, a lawyer who serves as the NGO’s secretary general, told a news conference: “An unhealthy relationship between the industry and academia is behind the problem. I hope the accusation will lead to an investigation into what has transpired.”

Of the five universities that performed clinical trials on Diovan, Kyoto university and Jikei University have acknowledged data manipulation.
 






State Claims Reinstated In Novartis Elidel FCA Suit
By Juan Carlos Rodriguez 0 Comments
Law360, New York (November 05, 2013, 2:16 PM ET) -- The federal judge overseeing a former Novartis Pharmaceuticals Corp. employee’s whistleblower lawsuit accusing the drugmaker of ripping off Medicaid by promoting off-label uses of
eczema treatment Elidel on Tuesday reinstated some claims she had previously dismissed.

Citing her own “clear error,” U.S. District Judge Gene E.K. Pratter partially granted relator Donald Galmines’ motion for reconsideration of his June dismissal of Louisiana and Massachusetts claims, but declined to reconsider claims under California and Washington, D.C., law.

“While the court has supplemental jurisdiction over all the claims, the California and D.C. claims are barred by Mr. Galmines’ failure to meet those laws’ ‘original source’ requirements,” Judge Pratter said in her order.

Galmines, a former Novartis senior sales consultant, accused Novartis in 2006 of encouraging doctors to prescribe the ointment for children younger than 2 despite lacking U.S. Food and Drug Administration approval to do so. The suit was partially dismissed in June, with the judge agreeing with Novartis that the state false claims statutes “indicate that a relator must file suit in state court.”

“While a court’s exercise of supplemental jurisdiction may be discretionary in some cases ... this court dismissed the state claims at issue here on the mistaken reasoning that the claims had to be filed in state court — i.e., tantamount to holding that the court simply lacked the power to exercise jurisdiction over them,” the judge said.

She said the U.S. Supreme Court, in City of Chicago v. International College of Surgeons, implicitly rejected an argument much like the one Novartis advances in opposition to Galmines' motion for reconsideration, that the state statutes’ language regarding filing in state court bars federal supplemental jurisdiction.

The high court found that although Illinois law established jurisdiction in the state’s circuit courts, and provided that “an action to review a final administrative decision may be commenced in the circuit court of any county,” the statute’s language did not bar the federal court’s supplemental jurisdiction, according to the order.

And the judge noted that other courts of appeals have held that a state may not deprive a federal court of jurisdiction merely by declaring in a statute that it holds exclusive jurisdiction.

“The court declines to interpret the California, D.C., Louisiana, and Massachusetts statutes in question as intended to deprive any otherwise competent federal court of jurisdiction,” Judge Pratter said.

Despite that finding, the judge also had to consider Novartis’ argument that Galmines is not an “original source” under the California and District of Columbia statutes.

She said the California version of the legal definition of an “original source” that was in effect before 2010 required that an original source be someone “whose information provided the basis or catalyst for the investigation, hearing, audit, or report that led to the public disclosure.” That definition has since changed, but the judge said that doesn’t matter.

“The same problem arises with respect to Mr. Galmines’s D.C. law claims,” the judge said. “As the court previously ruled with regard to Mr. Galmines’s Nevada claim, Mr. Galmines does not address these features of the California and D.C. laws nor dispute that he cannot qualify as an original source under California’s or D.C.’s then-operative definitions. The court will not, therefore, reconsider and reinstate Mr. Galmines’s California and D.C. law-based claims.”

Galmines' attorney Frederick M. Morgan of Morgan Verkamp LLC praised the decision on Tuesday.

"We appreciate the careful scholarship embodied in Judge Pratter’s opinion, and are pleased that the court concluded that Congress intended that qui tam relators be able to bring state False Claims Act claims together with federal claims. Clarity on this issue is important for relators, the states, and defendants alike, and Judge Pratter’s decision should put it to bed," Morgan said.

Novartis and its counsel did not immediately respond Tuesday to requests for comment.

Galmines is represented by Frederick M. Morgan of Morgan Verkamp LLC.

Novartis is represented by Manvin S. Mayell and Michael A. Rogoff of Kaye Scholer LLP and Ronald H. Levine of Post & Schell PLC.

The case is United States of America ex rel. Donald R. Galmines et al. v. Novartis Pharmaceuticals Corp., number 2:06-cv-03213, in the U.S. District Court for the Eastern District of Pennsylvania.

--Additional reporting by Linda Chiem and Sindhu Sundar. Editing by Richard McVay
 












WOW just WOW! said:
All these things, really unbelievable
Click to expand...

It is not. It is believable because it ia 1100% true. Like any biz corporation in any capitalist style economy/industry, Novartis is in fact, a criminal mafia style entity.
Their MO is such that includes both legal and illegal practices, by designe and orders and approval from the very top of ths company.
If you want to be one of them (management) you must agree overtly or tacitly to follow the "rules". If you can't due to whatever reason, you'll never make it or last. You could be one of the sales types and other non-management but you still have to do carry out their orders. If you are blessed with the mind that does not realize you are doing the crime for them then you are OK. But if you see through their criminal orders (whatever they are from offlable promo to bribery to whatever) and you need the job, you must look the other way, hold your nose and do it and most do.
The smart ones wll take the advice given by someone here many times: do their shit, pretent you are one of them, collect and file the evidence and when you have enough, do the right thing. Blow the whistle to kingdom come and take them down. You'll feel great and with any luck you'll walk away a rich person with the reward from the govt for doing the right thing. Don't forget, your best friend is the False Claim Act introduced in 1846 by then decent govt that wanted to protect the USA and its people from crooks that every century has. Today such law could not be introduced thanks to the fascist republicans who have only one interest in mind: the rich and their profits/loot they take from you and me and everyone who is not one of them.
So do the right thing and contribute to the eventual takedown of all assholes like Novartis management/bosses. As the man used to say;"Do not let those bastards take you down, you take them dow."
 






"Profits before patient lives" - the NVS way!

Scholarly papers have explored whether standards are too loose. One article, published last year in the Journal of the American Medical Association, called particular attention to three products — AstraZeneca PLC’s cancer drug Caprelsa, Novartis AG’s multiple sclerosis medicine Gilenya, and Boehringer Ingelheim GmbH’s blood thinner Pradaxa — and asked whether their risk-benefit profiles made priority review inappropriate.

The safety record of the drugs raises the question “of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered and with optimal doses not determined," according to the researchers Thomas Moore of the Institute for Safe Medication Practices and Dr. Curt Furberg, then of the Wake Forest University School of Medicine.

In a second article published just days before the freeze on Iclusig sales, the same authors found that drugs receiving expedited approval in 2008 typically used data from trials with less than one-fifth the usual number of patients and that progress was slow on completing mandatory post-approval studies.

In some recent years, nearly half the new drugs cleared by the FDA have used expedited pathways, raising the stakes should those routes be called into question by a review of Iculsig's approval.

“The question one has to ask is: Were there ... safety signals before this?” Kupchyk said. “That might be something that FDA and others wants to look at more closely.”
 






BaslKnows said:
It is not. It is believable because it ia 1100% true. Like any biz corporation in any capitalist style economy/industry, Novartis is in fact, a criminal mafia style entity.
Their MO is such that includes both legal and illegal practices, by designe and orders and approval from the very top of ths company.
If you want to be one of them (management) you must agree overtly or tacitly to follow the "rules". If you can't due to whatever reason, you'll never make it or last. You could be one of the sales types and other non-management but you still have to do carry out their orders. If you are blessed with the mind that does not realize you are doing the crime for them then you are OK. But if you see through their criminal orders (whatever they are from offlable promo to bribery to whatever) and you need the job, you must look the other way, hold your nose and do it and most do.
The smart ones wll take the advice given by someone here many times: do their shit, pretent you are one of them, collect and file the evidence and when you have enough, do the right thing. Blow the whistle to kingdom come and take them down. You'll feel great and with any luck you'll walk away a rich person with the reward from the govt for doing the right thing. Don't forget, your best friend is the False Claim Act introduced in 1846 by then decent govt that wanted to protect the USA and its people from crooks that every century has. Today such law could not be introduced thanks to the fascist republicans who have only one interest in mind: the rich and their profits/loot they take from you and me and everyone who is not one of them.
So do the right thing and contribute to the eventual takedown of all assholes like Novartis management/bosses. As the man used to say;"Do not let those bastards take you down, you take them dow."
Click to expand...

No wonder someone described this business as Pharmafia and this Co as Novamafia. Also, same or some other person declared that this as well as all other industries are run by, not Organized Crime but OCC. Yes that stands for Organized Corporate Crime.
See if you can give an argument that it ain't so. Given the evidence all over cafepharma, you'll have hell of the time to do it.
 






Novartis Fails To Wipe Out $1.3M Zometa Verdict

Law360, New York (November 14, 2013, 5:00 PM ET) -- A Florida federal judge refused Thursday to put aside a $1.3 million judgment against Novartis Pharmaceutical Corp. for allegedly causing a Zometa user's jaw death, ruling that the jury's initial inconsistent verdict is not cause for a new trial.

Novartis moved for another trial in September after plaintiff Nancy Guenther was awarded $300,000 for medical expenses and $1 million for the physical and emotional pain she suffered as the result of her osteonecrosis of the jaw, which was purportedly caused by the bone drug Zometa. The suit stems from multidistrict litigation over the company's Zometa and Aredia drugs.

The jury initially found against Novartis on a negligent failure-to-warn claim, but for the drugmaker on a strict liability claim. However, both parties agreed that the outcome was inconsistent, and U.S. District Judge Gregory Presnell told the jury to reach the same conclusion for both allegations. It then returned a verdict against Novartis on both claims.

“Other than the initial inconsistency, there is absolutely no basis to conclude that this jury disregarded its obligation to seek the truth based on the evidence adduced at trial and the court's instructions on the law,” Judge Presnell said in denying the bid.

Federal law holds that a judge faced with an inconsistent verdict can either instruct the jury to continue deliberating, or order a new trial, according to the judge.

It does not matter that the jury took only about 10 minutes to reach the amended verdict, considering it spent eight hours arriving at the initial determination, he said.

“This was a difficult trial for all concerned, especially the jury,” the judge said. “The days were long, the scientific issues were complex and the presentation of evidence was often tedious. But the jury was punctual and attentive throughout, and their lengthy deliberation is evidence of a conscientious effort to reach a proper verdict.”

The jury was simply confused by the existence of two questions instead of one, Judge Presnell said. Before the verdict, Novartis had pushed for the jury to consider just one question, but Guenther objected and the judge sided with the plaintiff. Other courts “may wish to rethink the wisdom of this course of action,” he said in a footnote.

An attorney for Guenther, Ramon Rasco of Podhurst Orseck PA, said he was unsurprised by the ruling.

“Novartis originally wanted consistency, and they got consistency,” said Rasco, who added that he expected the company to appeal the verdict.

An attorney for Novartis could not be immediately reached for comment on the decision.

Guenther is represented by John Vecchione of Valad & Vecchione PLLC, John Beins of Beins Goldberg & Hennessey LLP and Ramon Rasco of Podhurst Orseck PA.

Novartis is represented by Donald Fowler and Martin Calhoun of Hollingsworth LLP and Michael Thomas of Pennington PA.

The case is Guenther et al. v. Novartis Pharmaceutical Corp., case number 6:08-cv-00456, in the U.S. District Court for the Middle District of Florida.

--Editing by John Quinn.
 






EU regulator likely to fine J&J, Novartis next month - sources

BRUSSELS Fri Nov 22, 2013 8:25am EST

Nov 22 (Reuters) - EU antitrust regulators are set to fine drugmakers Johnson & Johnson and Novartis next month for blocking the sale of a cheaper generic painkiller in the Netherlands, two people familiar with the matter said on Friday.

"The European Commission is likely to issue a decision next month," one of the people said.

In its charge sheet sent to the companies in January, the European Union competition watchdog said the so-called "pay-for-delay" deal against the generic versions of fentanyl hurt Dutch consumers and healthcare providers.

Commission spokesman for competition policy, Antoine Colombani, declined to comment. Johnson & Johnson and Novartis were not immediately available for comment.
 






EU Fine said:
EU regulator likely to fine J&J, Novartis next month - sources

BRUSSELS Fri Nov 22, 2013 8:25am EST

Nov 22 (Reuters) - EU antitrust regulators are set to fine drugmakers Johnson & Johnson and Novartis next month for blocking the sale of a cheaper generic painkiller in the Netherlands, two people familiar with the matter said on Friday.

"The European Commission is likely to issue a decision next month," one of the people said.

In its charge sheet sent to the companies in January, the European Union competition watchdog said the so-called "pay-for-delay" deal against the generic versions of fentanyl hurt Dutch consumers and healthcare providers.

Commission spokesman for competition policy, Antoine Colombani, declined to comment. Johnson & Johnson and Novartis were not immediately available for comment.
Click to expand...

Can anyone deny that this biz is not: Bigpharmafia but simple, pristine Bigpharma. It's run by Organized Corporate Crime (criminals) but by polite, educated, churchgoing, family oriented, ethical, moral etc etc., (mainly) men. Their stable of highly priced crooked lawyers is employed not to defend them from illegal attemts on their security but to justify and cover up their illegal attempts against the govts and the people they supposedly serve.
What a service we get from these mother fuckers.
 






Anonymous said:
Can anyone deny that this biz is not: Bigpharmafia but simple, pristine Bigpharma. It's run by Organized Corporate Crime (criminals) but by polite, educated, churchgoing, family oriented, ethical, moral etc etc., (mainly) men. Their stable of highly priced crooked lawyers is employed not to defend them from illegal attemts on their security but to justify and cover up their illegal attempts against the govts and the people they supposedly serve.
What a service we get from these mother fuckers.
Click to expand...

25 Drug Cos. Put Up $88M To Escape Price-Rigging Suits

Law360, New York (November 20, 2013, 7:41 PM ET) -- Twenty-five pharmaceutical firms, including Sandoz Inc. and Johnson & Johnson, will shell out a collective $88 million to resolve allegations in Louisiana court that they defrauded the state's Medicaid program by artificially inflating wholesale prices, capping a three-year legal saga that ensnared scores of other manufacturers, state officials said Wednesday.

The payouts bring the Bayou State’s haul in suits concerning average wholesale pricing to more than $238 million, marking the final settlements in litigation that targeted
 






Novartis Price Rigging said:
25 Drug Cos. Put Up $88M To Escape Price-Rigging Suits

Law360, New York (November 20, 2013, 7:41 PM ET) -- Twenty-five pharmaceutical firms, including Sandoz Inc. and Johnson & Johnson, will shell out a collective $88 million to resolve allegations in Louisiana court that they defrauded the state's Medicaid program by artificially inflating wholesale prices, capping a three-year legal saga that ensnared scores of other manufacturers, state officials said Wednesday.

The payouts bring the Bayou State’s haul in suits concerning average wholesale pricing to more than $238 million, marking the final settlements in litigation that targeted
Click to expand...

1 state down, 49 to go. BUCKLE UP!!!!!!!!
(uber used for the Rush Limbaugh wanna be since he loves the term) ;)
 












Just Wondering.... What happens if the company gets another strike against them seeing how they are currently on a CIA? Is it like baseball... 3 strikes an you are out(no fed reimburse)???
 






Novartis Can't Apply NJ Punitives Cap In 3 Zometa Suits

By Andrew Scurria

New York (November 26, 2013, 1:54 PM ET) -- Pennsylvania product liability law permitting unlimited punitive damages controls three suits alleging Novartis Pharmaceuticals Corp.’s bone drug Zometa caused jaw injuries, a federal judge said Friday, denying the drugmaker’s attempt to apply softer New Jersey law.

U.S. District Judge Mark. R. Hornak applied Pennsylvania law despite arguments from Novartis that New Jersey, home to its U.S. headquarters, bore the more significant relationship to the punitive damages issue as the site of the alleged corporate misconduct.

The ruling effectively removes a punitive-damages cap of $350,000
 






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