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Novartis milestones be proud ! Management take a bow !

Discussion in 'Novartis' started by Anonymous, Jun 2, 2011 at 8:42 AM.

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  1. Anonymous

    Anonymous Guest

    Novartis to pay millions in fines for off-label marketing of drug

    September 30, 2010

    Novartis Pharmaceuticals Corp. has agreed to pay $422.5 million in civil and criminal fines for promoting drugs for uses that had not been approved by the FDA
    Novartis agreed to plead guilty and pay a criminal fine of $185 million for off-label marketing of the antiepileptic drug Trileptal
    It also will pay $237.5 million in civil penalties for off-label marketing of that drug and for offering financial inducements for doctors to prescribe Trileptal and five other Novartis medicines - Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin. The "kickbacks" included payments for speaker programs, advisory board memberships, entertainment, travel, and meals to encourage doctors to prescribe the drugs.


    Novartis Fined $250 Million in Sex Discrimination Suit
    By REUTERS
    Published: May 19, 2010
    Drug maker Novartis must pay $250 million in punitive damages for discriminating against thousands of female sales representatives over pay, promotion and pregnancy, a federal jury ruled on Wednesday.


    Off-Label Marketing Suit Costs Novartis $72M
    New York (May 4, 2010) -- Two Novartis AG units have agreed to pay $72.5 million to settle a whistleblower suit alleging they knowingly marketed the cystic fibrosis drug Tobi for uses not approved by the U.S. Food and Drug Administration.



    IBS Drug Zelnorm Taken Off U.S. Market
    FDA: Voluntary Withdrawal Due to Risk of Heart Attack, Stroke, Chest Pain
    By Todd Zwillich
    WebMD Health News
    Reviewed by Louise Chang, MD
    March 30, 2007 -- A popular drug for irritable bowel syndrome and constipation was pulled from the U.S. market Friday amid new evidence that it raises the risk of heart attacks and strokes.
    Novartis, the manufacturer of Zelnorm, confirmed that Food and Drug Administration officials asked for the drug’s withdrawal


    Sept 2007
    Prexige Receives "Not Approvable" Letter in the US Despite Being One of the Most Studied COX-2 Inhibitors
    Novartis to continue discussions with FDA and believes Prexige a valuable treatment option for appropriate patients with osteoarthritic pain

    Australia Forces Novartis To Withdraw Prexige
    2 Comments
    By Ed Silverman // August 11th, 2007 // 9:10 am
    The government took action after two deaths and two liver transplants, among eight serious reactions, were suffered by people who took the painkiller.


    Novartis CEO: Galvus' future is uncertain
    January 17, 2008 — 7:59am ET
    Long delayed by a wary FDA, Novartis CEO Daniel Vasella (photo) now says that the diabetes drug Galvus may never be refiled for approval in the U.S. Safety issues arising around liver enzyme levels have twice prompted regulators to pass on approving the DPP-4 inhibitor--allowing Merck to beat it to the market with Januvia.


    Disappointing results for Novartis heart drugs in the treatment of diabetes revealed at ACC meeting
    Article | 15 March 2010
    There was disappointment for Novartis yesterday, when data were presented at the American College of Cardiology annual meeting, held in Atlanta, which showed that potentially new strategies to prevent and treat diabetes and heart disease failed to improve therapy.
    Diovan and Starlix fail in at-risk patients
    Swiss drug major Novartis presented primary data from the NAVIGATOR trial (n=9306),
     

  2. Anonymous

    Anonymous Guest

    Don't forget the velez case and the unpaid overtime case.
     
  3. Anonymous

    Anonymous Guest

    YOU ASKED FOR MORE ? EVEN KIDS ARE NOT IMMUNE !

    JULY 2000
    The law firm of Waters & Kauff has filed a class action lawsuit against Novartis in Texas as "Hernandez, Plaintiff, Individually and on Behalf of all others Similarly Situated v. Ciba Geigy Corporation, U.S.A., Novartis Pharmaceuticals Corporation,

    The lawsuit claims that the Novartis Corporation improperly promoted the use of Ritalin in order to increase its sales. In addition, the lawsuit lists a series of neurological and cardiovascular side effects that the plaintiffs claim Novartis does not accurately relay to its customers.
    plaintiffs' lawyers filed two suits, alleging that the maker of Ritalin, the commonly prescribed attention-deficit treatment, conspired with a psychiatric group to "create" a disease, and later hyped the drug's benefits.
    ADHD has been over-diagnosed, and that Ritalin has been over-prescribed, including among many preschool children. Critics also say the long-term side-effects of Ritalin haven't been adequately studied


    May 27, 1999
    Doan's Pills Must Run Corrective Advertising:
    FTC Ads Claiming Doan's Is Superior In Treating Back Pain Were Unsubstantiated
    The Federal Trade Commission has ordered the makers of Doan's Pills to run ads to correct misbeliefs resulting from their unsubstantiated claim that Doan's Pills are superior to other over-the-counter analgesics for treating back pain. The Order, contained in a Commission opinion announced today, would require advertising and packaging to carry the message, "Although Doan's is an effective pain reliever, there is no evidence that Doan's is more effective than other pain relievers for back pain." The order also would prohibit Novartis Corporation and Novartis Consumer Health, Inc., the marketers of Doan's, from representing that the product is more effective than other over-the-counter products unless they possess and rely upon competent and reliable scientific evidence -- including at least two clinical studies -- to substantiate their claims
     
  4. Anonymous

    Anonymous Guest

    Good point , velez was included OT was not :


    Novartis Sales Reps Win Lawsuit for Overtime Pay
    July 7, 2010By Chelsea Hennessy
    The 2nd Circuit ruled yesterday that Novartis AG's sales representatives merit overtime and are covered by federal wage-and-hour laws under the Fair Labor Standards Act (FLSA). Plaintiffs claimed they were underpaid because they were denied time-and-a-half for each hour worked over 40 hours per week from 2000 to 2007.


    Lagging sales spur Novartis layoffs
    October 18, 2007 — 6:59am ET
    When are skyrocketing earnings bad news? When they're not based on rising drug sales. Novartis posted $6.87 billion in profits, more than triple its results during the third quarter last year, on the strength of large divestments.
    Pharma results were so poor that the company will lay off 1,260 in the U.S. and rearrange its management. Joe Jiminez, who joined the company in April from the private equity firm Blackstone Partners.

    Novartis Cuts 550 Jobs & Shakes Up Management
    5 Comments
    By Ed Silverman // October 20th, 2008 // 7:28 am
    As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010.

    Novartis Flip Flop: Cuts 1,400 Jobs Only Days After Denying Layoffs
    By Jim Edwards | December 1, 2010
    inShare.
    The announcement of 1,400 layoffs at Novartis (NVS) yesterday came just days after the company denied it would do exactly that. The move is the third different and contradictory signal Novartis has given investors and its own employees about its plans to cut jobs, suggesting that CEO Joe Jimenez does not quite have all his internal communications ducks in a row.

    With Sales Up and Costs Down, Novartis CEO Rewards His Staff With Layoff
    By Jim Edwards | November 18, 2010
    inShare.
    Novartis (NVS) CEO Joe Jimenez told investors yesterday that he planned across-the-board cost cuts, which his employees ought to interpret as meaning layoffs, in manufacturing, sales and marketing. It’s something of a surprise because revenues at Novartis are rising (13 percent in Q3 2010),
     
  5. Anonymous

    Anonymous Guest

    PUTTING PATIENTS 1st ALWAYS A PRIORITY AT NOVARTIS !

    Jan. 19, 2006 -- The FDA has approved the "black box" warning prescription eczema drug will carry.

    The FDA announced in March 2005 that Novartis topical eczema drug -- Elidel cream -- would get a "black box" warning about a possible cancer risk. A "black box" warning is the FDA's strongest warning
    An FDA committee had recommended the warning in February 2005. Now, the FDA has approved the warning's content.
    The warning states that there have been reports of cancer (for example, skin and lymphoma) in patients who had been receiving the drug


    FDA Issues Health Advisory Regarding the Safety of Lamisil® Tablets to Treat Fungal Nail Infections
    The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to announce significant safety-related updates to the labeling Of Novartis Lamisil® (terbinafine hydrochloride) tablets. Lamisil® is used to treat nail (onychomycosis), skin and other systemic fungal infections.
    The purpose of today's FDA Public Health Advisory is to alert healthcare professionals to serious risks associated with the use of Lamisil®.
    Lamisil® has been associated with serious liver problems resulting in liver failure and death. As of April 2001, FDA has received and reviewed 16 possible Lamisil®-associated cases of liver failure, including 11 deaths and two liver transplantations
     
  6. Anonymous

    Anonymous Guest

    Novartis , Putting patients 1st , ALWAYS !!!


    CIBA Vision O2 OPTIX contact lens recall
    posted Monday 26th, February 2007
    defect on certain lots of the lenses could potentially harm the eye
    We are taking this action because we have identified that some lenses in these lots did not meet our standards for ion permeability, a material characteristic which contributes to lens movement on the eye.
    these lenses may cause persistent discomfort and/or foreign body irritation, and superficial corneal staining may be observed.



    Sandoz Inc. announced on October 26, 2010 that it is initiating a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials and lots.


    Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly
    Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled
    (Posted by Tom Lamb at DrugInjuryWatch.com)
    In an August 26, 2008 Drug Injury Watch post, "FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility", I reported FDA inspectors found that Sandoz had failed to properly validate its manufacturing process for Metoprolol Succinate ER Tablets (Generic Form Of Toprol

    Sandoz Fentanyl Patch Recall
    June 26, 2009
    If you or a member of your family have utilized the Sandoz fentanyl patch you need to be aware that there has been a recall of this product. Through this article you are provided a general overview of the circumstances and facts surrounding the Sandoz fentanyl patch recall. Armed with this information, you will be in the best possible position to understand your rights and what remedies are available to you incident to the Sandoz fentanyl patch recall.
    The Sandoz fentanyl patch recall was issued as the result of a defect discovered in the product


    Sandoz Inc. Recalls Several Lots of Lorazepam Tablets
    What does this mean?
    This recall for Lorazepam Tablets, USP, 0.5 mg, 1 mg, and 2 mg from Sandoz Inc. was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you take Lorazepam and are concerned, you should speak to your doctor.
    Sandoz Inc. is recalling several lots of Lorazepam Tablets, USP, 0.5 mg, 1 mg, and 2 mg because the lots did not pass the manufacturer's routine tests for quality and expiration dating.
    Lorazepam is used in the treatment of anxiety. Lorazepam is also sold under the brand name Ativan.
    To view the FDA notice about this recall and a complete list of recalled lot numbers, please visit:
    more information here
    Source: FDA
    Publication Date: 2011-01-10
     
  7. Anonymous

    Anonymous Guest

    From: Reuters
    Published March 13, 2008 02:51 PM

    Novartis sued in Calif. over kids' cough medicine
    Drugmakers recall infant cold medicine

    FDA warns against cold drugs for kids under 2
    January 17, 2008 07:06 PM

    LOS ANGELES (Reuters) - A California mother has sued drug maker Novartis AG in what the company believes to be the first proposed class action involving its Triaminic children's cough and cold medicines since overdose fears prompted a recall of the drugs.
    The lawsuit, filed on Tuesday in U.S. District Court in Los Angeles, said several studies have shown deaths and serious injuries linked to over-the-counter children's cold remedies.
    As a result, Novartis "either knew ... or reasonably should have known that their cough and cold products were ineffective and dangerous when used by children under the age of six," the lawsuit said.



    Pfizer sues Novartis over Vfend antifungal patents
    Fri Jan 7, 2011 10:13am EST
    * Novartis' Sandoz unit alleged to infringe two patents
    * Vfend sales $595 mln over nine months
    By Jonathan Stempel

    NEW YORK, Jan 7 (Reuters) - Pfizer Inc (PFE.N) has sued Novartis AG's (NOVN.VX) Sandoz unit, accusing it of infringing its U.S. patents related to the antifungal treatment Vfend.

    Friday's complaint alleges that Sandoz is seeking permission from the U.S. Food and Drug Administration to sell a generic version of Vfend before the expiration of two patents issued in 1994 and 2003, respectively.

    Pfizer said an infringement will cause irreparable injury, according to the complaint filed with the U.S. district court in Wilmington, Delaware. It seeks to block Sandoz from selling any version of Vfend before the patents expire.

    A spokeswoman for Novartis did not immediately return requests for
     
  8. Anonymous

    Anonymous Guest

    As they say , act like an owner .
    Danny V & Jimmy -no layoffs- Jimmynezz certainly do.
    In other words scam what you can , while you can, just like your bosses


    Shareholders lambaste Novartis exec's pay
    February 23, 2011 — 12:15pm ET | By Tracy Staton

    Is Novartis paying Vasella too much?
    Big Pharma execs top highest-paid Swiss list

    Once again, Novartis investors are protesting Daniel Vasella's pay package. More than 38 percent of shareholders at the Swiss drugmaker's annual meeting voted against Vasella's latest compensation arrangement, which includes a $12.2 million one-time retirement payment that one activist shareholder called "scandalous."

    Vasella, who gave up the CEO seat to Joe Jiminez last year and now serves as chairman, has come under fire before for a pay package that's among Switzerland's biggest. As CEO, he was repeatedly paid more than $21 million, the Wall Street Journal notes. According to Swiss shareholder activist Ethos, Vasella earned about 25 million francs in 2010, compared with Novartis' official report of 8 million francs.
     
  9. Anonymous

    Anonymous Guest

    PHARMA's ETHICAL LEADERS & GOOD CORPORATE CITIZENS !!!


    Pension fund sues Alcon, Novartis over deal

    BOSTON (Reuters) - Massachusetts Bricklayers And Masons Trust Funds, a $95 million pension fund based in Massachusetts, sued Alcon Inc ACL.N, Novartis AG (NOVN.VX) and Nestle S.A. (NESN.VX) in connection a deal that the fund claims discriminates against minority shareholders.

    The suit, filed in the United States District Court Southern District of New York on Friday, charges that Swiss drugmaker Novartis is seeking to exploit its status to acquire all the Alcon stock that it does not already own for less than fair value, and for less than the price Novartis is paying Nestle for Alcon shares.
     
  10. Anonymous

    Anonymous Guest

    THINK WHAT'S POSSIBLE !!!

    Bone Drug Zometa’s Risks,

    By Thom Weidlich - May 25, 2011 12:18 PM ET
    ..
    Novartis AG (NOVN), Europe’s second-biggest drugmaker by sales,
    Karlene Hogan sued Novartis in 2006 claiming her late husband, Timothy Hogan, developed jaw death as a result of getting Zometa injections, according to the complaint. Hogan’s case is the fourth to go to trial over Zometa and Aredia, another Novartis bone-strengthening drug.


    Novartis, based in Basel, Switzerland, faces about 700 suits over the two medicines. The Hogan case is the fourth to go to trial. In November, a federal jury in Winston-Salem, North Carolina, ruled that Novartis should pay more than $12.8 million to a North Carolina woman’s family over claims Zometa and Aredia damaged her jaw.

    Other Cases

    In October 2009, a Montana jury ordered Novartis to pay $3.2 million in damages to a cancer patient who made the same claims over the medicines.
     
  11. Anonymous

    Anonymous Guest

    FDA raises safety warning on Novartis iron drug

    NEW YORK | Thu Feb 18, 2010 3:22pm EST

    NEW YORK (Reuters) - A boxed warning highlighting serious safety concerns, including reported deaths, with the use of Novartis AG's Exjade drug to remove excess iron from the blood, has been added to the medicine's label, the U.S. Food and Drug Administration said.

    In a message on its Website, the FDA said the prescribing information for Exjade would now carry a highlighted warning, often called a black box, noting that the drug may cause renal impairment, including kidney failure; hepatic impairment, including liver failure; and gastrointestinal hemorrhage.

    In some reported cases, the agency said, the reactions were fatal.
     
  12. Anonymous

    Anonymous Guest

    Where are the paid corporate stooges to dispute any of this ????
     
  13. Anonymous

    Anonymous Guest

    FDA Panel Votes Down NVS Drug

    By Zacks Investment Research on June 22, 2011 | More Posts By Zacks Investment


    Novartis (NYSE:NVS) received a setback recently when an advisory panel to the US Food and Drug Administration (FDA) recommended against approving its pipeline candidate ACZ885 for the proposed indication.

    Novartis was seeking approval to expand the use of ACZ885 for the treatment of patients suffering from severe gouty arthritis

    LOSERS !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! HAW HAW
     
  14. Anonymous

    Anonymous Guest

    TSK TSK TSK !!!

    FDA Sends Letter to Novartis Regarding Promotional Material for Focalin XR


    SILVER SPRING, Md., Jun 23 2011-- The FDA posted on its website a letter sent to Novartis Pharmaceuticals regarding promotional material for ADHD drug Focalin XR. The letter is below.



    Joyce Pashalides, Sr. Associate Director Regulatory Advertising & Promotional Review, Drug Regulatory Affairs Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936

    Focalin XR® (dexmethylphenidate hydrochloride) Extended-Release Capsules CII MACMIS# 20059

    Dear Ms. Pashalides:

    The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a professional One Point Leave Behind detail aid (FCL-1042739) (detail aid) for Focalin XR® (dexmethylphenidate hydrochloride) Extended-Release Capsules CII (Focalin XR) submitted by Novartis Pharmaceuticals Corporation (Novartis) under cover of Form FDA-2253. The detail aid is false or misleading because it presents unsubstantiated superiority claims for the product. Thus, the detail aid misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21
     
  15. Anonymous

    Anonymous Guest

    THE MORONS DID IT AGAIN !!!! LMFAO !!! COPD is DOA !!!!!!!!!

    UDPATE 1-U.S. FDA approves low dose of Novartis lung drug
    Fri Jul 1, 2011 4:25pm EDT

    * Approves 75 mcg dose of Arcapta Neohaler

    * Novartis hoped for 150 mcg dose approval

    WASHINGTON, July 1 (Reuters) - U.S. health regulators on Friday approved a new lung medicine by Novartis (NOVN.VX), but in a lower dose, creating a roadbump for the Swiss drugmaker in its development of a potentially lucrative new drug.

    In line with its advisory panel's vote in March, the U.S. Food and Drug Administration approved a 75 mcg dose of Arcapta Neohaler, an inhalation powder indacaterol for treating chronic obstructive pulmonary disease (COPD), which is also known as smoker's cough and is the third-leading killer of Americans.

    Indacaterol is a once-a-day, long-acting beta agonist, or LABA, a type of drug used to open airways in patients with asthma or COPD. Other LABAs are taken twice a day.

    Novartis and Glaxo are racing to sell a two-in-one medicine that combines a LABA with long-acting muscarinic antagonist (LAMA) to produce a more effective, convenient therapy.

    For Novartis to develop such drug, it needed approval for a higher 150 mcg dose of Arcapta Neohaler, which is sold as a a single therapy in Europe under the brand name Onbrez Breezhaler and had revenue of $33 million in 2010.

    The 150 microgram dose of Arcapta Neohaler failed to win support from a U.S. advisory panel earlier this year as it urged Food and Drug Administration approval of a 75 microgram dose of the inhaled drug, unconvinced that the higher dose provided any additional benefit.
     
  16. WB#1

    WB#1 Guest

    Good question. These fuckers NEVER admit anything or deny anything. They simply practice their pharmafia motto: OMERTA. Only when they are taken to courts of law or courts of public opinion they respond with their prepaired statements and defences. For that they have their stable of highly paid crooked lawyers and their famous or infamous (depends who is looking at them) BPO.
    For more on this go to regional boards- Canada and see the thread "Why don't they fight back". ps: Do you know what or who is responsible for this? The fact that they are considered innocent till proven guilty, that is who and what.
    Someone will put a stop to this. If not this generation one in the future but it will be done. These fuckers must be stopped and punished for these crimes they think they are entitled to do because the do SOME good with their fucking drugs.
     
  17. Anonymous

    Anonymous Guest

    Novartis screws the Ruskies too !

    Russian police search Novartis,

    MOSCOW, July 5 (Reuters) - Russian police on Tuesday searched the offices of four pharmaceutical companies in Moscow, including Swiss drug maker Novartis AG .

    The website of business daily Vedomosti quoted a police source as saying the searches were carried out as part of an investigation into an alleged carve-up of the market for supplying the state healthcare system with essential drugs by major distributors.

    The government runs a system of subsidised purchases of drugs for low-income citizens. An investigation into the system showed that the bulk of state supply contracts worth over $2 billion went to six distribution firms in 2006-08.

    A Novartis spokeswoman in Moscow confirmed the search took place and said the company was cooperating with the police.
     
  18. Anonymous

    Anonymous Guest

    YET ANOTHER FAILURE

    Novartis Eye Drug Lucentis Fails To Win NICE Support For Diabetic Use In UK

    7/15/2011 12:16 AM

    (RTTNews) - The UK's health-cost watchdog National Institute for Health and Clinical Excellence, or NICE, Friday did not recommend Novartis' eye drug Lucentis, or ranibizumab, for the treatment of diabetic macular oedema, or DMO, stating it was not cost-effective compared to standard laser therapy.
     
  19. Anonymous

    Anonymous Guest

    SLICE & DICE CHAINSAW JOE !!!

    Pharmaceutical firm’s axe falls on 550 jobs in Horsham

    12:30pm Friday 15th July 2011

    By John Keenan, business editor »

    Hundreds of at-risk jobs were finally axed yesterday after pharmaceutical giant Novartis confirmed it was transferring Sussex work abroad.

    The multinational’s Horsham site will be massively scaled back, with 550 posts going
     
  20. Anonymous

    Anonymous Guest

    kind of interesting how posts 18 and 19 just go hand in hand.

    Sorta like peas and carrots!