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

    no wonder why GSK didn't want the flu division. they knew!

    what did CSL know when purchasing these damaged goods?
     

  2. NIBR quality

    NIBR quality Guest

    Nov 24, 2014
    Novartis Dismisses Employee who Fabricated Data in Research Papers

    By
    Ed Silverman

    A Novartis scientist who engaged in research misconduct has been banned from receiving federal funding for three years and has also been dismissed by the drug maker, a Novartis spokesman tells us.

    Igor Dzhura provided or falsified data that found its way into six research papers, which he has agreed to retract or correct, according to a statement by the Office of Research Integrity at the U.S. Department of Health and Human Services, which reviewed his work. The papers were published while he worked as a biomedical researcher at Vanderbilt University, which also conducted a review. More recently, he worked at the Novartis Institutes for Biomedical Research in Cambridge, Ma.

    “We have learned that Igor Dzhura included papers with fraudulent data in his application for employment at Novartis,” a spokesman for the drug maker tells us. “Falsifying data is not acceptable and we have terminated his employment with the company. We are conducting an internal review to ensure that there was not any scientific misconduct related to his research here.”

    Dzhura could not be reached for comment. We also asked the Vanderbilt Department of Biomedical Engineering and will update you accordingly.

    The half-dozen papers to be retracted were originally published between 2000 and 2005 in several medical journals – Nature Cell Biology, the Journal of Physiology, Circulation and The FASEB Journal, which focuses on biology. And the papers were cited more than 500 times, according to Retraction Watch, a blog that tracks research misconduct. Among the issues cited by ORI: Dzhura created a hierarchy of computer folders containing duplicated and renamed files and also falsified groups of files.
     
  3. Anonymous

    Anonymous Guest

    game changer:

    http://www.reuters.com/article/2014/11/26/us-health-genetherapy-price-idUSKCN0JA1TP20141126?feedType=RSS&feedName=topNews

    (Reuters) - The Western world's first gene therapy drug is set to go on sale in Germany with a 1.1 million euro ($1.4 million) price tag, a new record for a medicine to treat a rare disease.

    The sky-high cost of Glybera, from Dutch biotech firm UniQure (QURE.O) and its unlisted Italian marketing partner Chiesi, shows how single curative therapies to fix faulty genes may upend the conventional pharmaceutical business model.
     
  4. Anonymous

    Anonymous Guest

    Who was leading Vaccines Development at this time?
     
  5. Anonymous

    Anonymous Guest

    the rabbit hole goes deeper.

    here's some trivia:

    who originally led V&D post-Chiron acquisition?
     
  6. Anonymous

    Anonymous Guest

    Jeorg?
     
  7. Anonymous

    Anonymous Guest

    and...?
     
  8. Anonymous

    Anonymous Guest

    have a look at Eric Legangneux' work and you will be surprised what can be found

     
  9. Novartis flu vaccine suspended in Italy after deaths
    By Denise Roland
    2:23PM GMT 28 Nov 2014

    Two batches of a flu vaccine manufactured by Swiss drug giant Novartis have been suspended in Italy following the death of three people shortly after they had received the jab.

    Two women aged 87 and 79 and a 68-year-old man from southern Italy died following jabs of the Fluad vaccine earlier this month. Another man, 92, is seriously ill in hospital.

    Italian health officials stressed that the suspension was a precautionary measure and urged calm, while Novartis said there was no evidence the vaccine shot had caused the deaths.

    The Italian Medicines Agency (AIFA) insisted vaccines were "a precious resource and irreplaceable for the prevention of seasonal flu".

    A Novartis spokesman that a review of the two batches in question had shown they conformed to "all production and quality standards" and that the drug maker was working closely with Italian health officials to carry out further tests.

    The Fluad vaccine was approved in 1997 and more than 65m doses have been distributed to date. The vaccine has a "robust safety history", the spokesman added.

    Fluad is not used in the UK's flu vaccination programme, nor licensed for use in Britain, a spokesman for Public Health England said.

    "There are no implications for the safety of flu vaccines licensed and used in the UK, and we advise people to have the annual influenza vaccine as recommended," he added.

    Novartis is in the process of selling its flu vaccine division to Australian drugmaker CSL. The deal, which valued the business at $275m (£176m), is expected to close in the second half of 2015. The Swiss drugmaker is also offloading the remainder of its vaccines business to Britain’s GlaxoSmithKline, as part of a three-way deal agreed earlier this year.
     
  10. 13th deaths

    13th deaths Guest

    & counting! What a roll !!

    Italy says 13 Novartis flu vaccine deaths
    December 01, 2014 12:15PM

    Swiss pharmaceutical company Novartis AG.
    Thirteen people have died in Italy after being administered a flu vaccine made by Novartis.

    THE number of people who have died in Italy after being administered a flu vaccine made by Swiss pharmaceutical company Novartis has risen to 13.
     
  11. Novartis’s Gilenya Treatment Fails in Trial for Difficult Form of MS

    Result of Phase III Trial for Treatment of Primary Progressive Multiple Sclerosis
    By
    Neil MacLucas
    WSJ Dec. 1, 2014 3:26 a.m. ET

    Novartis said the failure of its Gilenya drug in a phase III trial for treating a difficult form of multiple sclerosis was very disappointing. ENLARGE
    Novartis said the failure of its Gilenya drug in a phase III trial for treating a difficult form of multiple sclerosis was very disappointing. Associated Press
    .
    ZURICH- Novartis AG Monday said a late-stage study showed little difference between its top-selling Gilenya drug and a placebo for treating a difficult form of multiple sclerosis.

    Basel-based Novartis said the Phase III trial of the treatment, which is already approved for treating relapsing multiple sclerosis, failed to show significant difference in disability measures when compared with a placebo used by patients with primary progressive multiple sclerosis.

    Disability measures involve assessments of the level of physical disability, such as upper limb function and walking speed.

    There are presently no approved treatments for primary progressive multiple sclerosis, a disorder of the central nervous system which affects about one in 10 of the 2.3 million sufferers of the disease. The primary progressive form of the disease is distinct from the more common relapsing multiple sclerosis.

    Novartis said the failure of the study “is very disappointing” to sufferers of the disorder, but it is committed to pursuing treatments for patients with multiple sclerosis and other neurological conditions.
     
  12. Novartis and Roche suffer setback in Italian collusion case
    ZURICH Tue Dec 2, 2014 2:00pm EST
    Credit: Reuters/Arnd Wiegmann

    (Reuters) - Swiss drugmaker Novartis said a regional court in Italy had upheld a decision by Italian antitrust authorities which found Novartis and Roche colluded in anti-competitive practices.

    Novartis and Roche, which deny wrongdoing, said on Tuesday they had so far only been verbally informed of the regional administrative tribunal of Lazio's decision and would appeal the verdict.

    The rejection of their appeal is a setback for the two Swiss drugmakers which also face demands for more than a billion euros in damages from the Italian health ministry over the alleged collusion.

    In March, the Italian Competition Authority fined Novartis and Roche 182.5 million euros ($226 million) for colluding to try to impose Novartis' Lucentis as a treatment for a serious eye disease instead of Roche's cheaper Avastin.

    In May, the Italian health ministry said it would seek 1.2 billion euros in damages from the companies.
     
  13. Novartis laying off 200 people in February, after hundreds of job losses this year
    Louis C. Hochman | NJ Advance Media for NJ.com December 09, 2014 at 2:32 PM
    Bloomberg News

    EAST HANOVER — Novartis Pharmaceuticals will lay off about 200 people from its primary care force as it shifts emphasis to cardiovascular disease, the company confirmed to NJ Advance Media Tuesday.

    "We do not take these decisions lightly but do believe they are necessary to ensure we better serve the needs of our patients and customers and position our U.S. General Medicines business for long-term success," the company said in a statement provided by email.

    A notice of the impending layoffs, listed effective Feb. 16 in East Hanover, appeared on state Department of Labor and Workforce Development's website late last week. The company's U.S. headquarters is based in East Hanover.

    In October, Novartis Pharmaceuticals realigned to three units — Cardiovascular and Respiratory, Immunology and Dermatology, and Neuroscience, according to the company.

    As part of that realignment, it created a cardiovascular field force, built in large part from its existing primary care field force, the company said. It sought to retain "as many associates as the business and the geographies could sustain," but not all fit into the new alignment, according to the company.

    In all, Novartis Pharmaceuticals is eliminating 243 positions that won't be part of the cardiovascular field force, though several dozen eliminations were "achieved through vacancy management and other efforts," according to the company.

    Layoffs are nothing new at Novartis. In January, the company said the closure of its plant in Suffern would cost about 200 New Jersey residents their jobs.

    In February, Novartis announced it was laying off 760 employees nationally, including 92 who work in East Hanover.

    And in April, it said it would lay off 215 pharmaceutical development employees in New Jersey, nearly all from its East Hanover headquarters.

    NPC will be offering support for impacted associates including eligibility for severance packages, out-placement services and the opportunity to apply for open positions within the Novartis Group of companies through the end of their employment. Impacted associates have already been notified.

    "We do not take these decisions lightly but do believe they are necessary to ensure we better serve the needs of our patients and customers and position our US General Medicines business for long-term success," the company said in the statement provided Tuesday.
     
  14. Anonymous

    Anonymous Guest

    They need to stop saying that its whats best for "patients and customers" it sounds ridiculous
     
  15. Anonymous

    Anonymous Guest

    True. Not like the cost saving is going to the patient
     
  16. NVS loves to sue, only hates it when it's against them -_-

    HC reserves order on Novartis-Cipla drug dispute
    The dispute is over manufacturing of the drug Indacaterol, used for treatment of chronic obstructive pulmonary disease
    Press Trust of India | New Delhi December 17, 2014 Last Updated at 20:24 IST

    Novartis had moved the high court saying it holds the patents for the Indacaterol maleate salt as well as the manufacturing process for the drug, which is sold in India as an inhalation powder and inhaler under the trademark name of "Onbrez" through its licencee Lupin Ltd since 2010.

    Cipla had this year started manufacture and sale of Indacaterol powder under the name "Unibrez".

    Cipla in its reply filed before the high court argued that the medicine sold by Novartis is too expensive and is sold only to government hospitals and is therefore not easily available to the public.

    It has also given a representation to the Centre to revoke the exclusive patent rights granted to Novartis, claiming that that the pharma firm was not working the patent in India.

    Novartis argued it is not obligated to manufacture the drug in India.
     
  17. More Suing?

    More Suing? Guest

    Big Pharma threatens to sue U.K. fund as officials nix Novartis, Sanofi and Eisai meds
    Pricey treatments from Roche, Pfizer and Amgen also on the potential hit list
    January 8, 2015 | By Tracy Staton

    U.K. officials have decided which drugs to toss off the Cancer Drug Fund (CDF), which pays for drugs rejected by cost-effectiveness gatekeepers. Reportedly, Novartis ($NVS), Sanofi ($SNY) and Eisai treatments are among them.

    Novartis' Afinitor, which the CDF covers for breast, pancreatic and kidney cancer, is likely to get the ax as well. Health officials broke the news in a meeting this week, Pharmafile reports. In a statement to the U.K. publication, the Swiss drugmaker called the NHS' assessment process "unacceptable as it is insufficiently robust and transparent." The cost portion of the evaluation "does not reflect the true value of cancer drugs," Novartis added.

    The CDF, ironically enough, was the U.K.'s answer to outcry over cancer drug rejections by the National Institute for Health and Care Excellence, whose evaluation process is exhaustive and very public. In fact, the agency recently suggested that, if the NHS was planning to review drugs for the cancer fund, then it should use NICE's own processes.

    U.K. officials announced last year that the CDF was running out of money quickly. They expected the fund to overrun its £200 million annual budget ($422 million) by £100 million by the end of the fiscal year. The government promised an additional £160 million infusion over two years, but to avoid tapping out completely, granted the fund power to reassess its drug list.

    "We need to get maximum value for every pound we spend," CDF Chairman Peter Clark said Thursday. "We can no longer sustain a position where we are funding drugs that don't offer sufficient clinical benefit when drugs that will do more for patients are coming on stream."

    Not everyone is outraged at the CDF's decision-making, either. As the BBC points out, some patient advocates and doctors have said the fund itself is a bad idea, because it creates a backup plan for drugmakers that don't want to offer cut-rate prices to NICE. "The drug companies have behaved badly with their pricing and we support the Fund going back to try to reduce costs," said Eric Lowe, chief of Myeloma U.K. (as quoted by the news service).
     
  18. MMM
    KEVIN MCCAFFREY

    JANUARY 12, 2015
    Pfizer challenges Novartis OTC ad claims

    A still from a TV commercial spot for Theraflu - Severe Cold & Flu Relief
    The National Advertising Division (NAD) stated last week that it recommended Novartis remove a claim from an ad for its cough and cold OTC drug Theraflu Multi-Symptom Severe Cold, which alleged that the product “starts to get to work in your body in 5 minutes.” The NAD works as the investigative self-reporting arm of the Better Business Bureau.

    Pfizer challenged Novartis's claim through the NAD on the basis that while acetaminophen—one of the ingredients in Theraflu—is found in the bloodstream within five minutes of administration, this doesn't necessarily mean that the drug starts to work within five minutes. Pfizer, which declined comment, counts Theraflu competitors Dimetapp and Robitussin among its consumer offerings.

    During two TV spots for Novartis's Theraflu, small print accompanied the challenged claim, noting that it “refers to the availability of acetaminophen in the bloodstream,” according to NAD's case documents.Pfizer contends that this addendum may further mislead consumers into thinking that acetaminophen may alleviate a cough or suppress nasal congestion, although acetaminophen is only approved for use as a fever reducer and pain reliever. The drugmaker also asserts that the burden of proof lies with Novartis and that it “must demonstrate that consumers will begin experiencing relief of their severe cold symptoms within 5 minutes.”

    NAD ruled that consumers “could reasonably interpret the stopwatch imagery as either indicating that symptom relief began 5 minutes later (i.e., after drinking Theraflu) or that symptom relief began at 5 minutes and continues to last ‘later on'.”The industry self-regulator also disagreed with Novartis's explanation that “it refers to the presence of acetaminophen in the bloodstream,” rather than the onset of its therapeutic benefits. The NAD noted that this disclosure “contradicts and materially changes the main message that Theraflu ‘starts to get to work in your body in just 5 minutes,” and expressed doubt that “consumers would even understand” what the disclosure meant.

    Novartis spokesperson Julie Masow told MM&M that “while NCH [Novartis Consumer Healthcare] disagrees with the NAD's decision that NCH cannot tout the proven absorption characteristics of its Theraflu Multi-Symptom Severe Cold product, NCH respects the NAD self-regulatory process and will take NAD's guidance into account for future advertising of the product.”
     
  19. & again & again & again & again & again

    Novartis to move work to Lincoln from Puerto Rico plant
    1/16/2015

    Novartis AG said Friday it is closing its manufacturing plant in Puerto Rico as part of a major overhaul of its business and will move some of the work done there to Lincoln.

    The Switzerland-based company said in a statement Friday that the shutdown of its Humacao plant will conclude in early 2019. Some 270 employees will be laid off.