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. coming to a layoff near you soon

    Novartis AG flags margin increase, higher dividends, cost cuts and strategic acquisitions
    By Reuters | 18 Jun, 2015, 11.51AM IST
    ZURICH: Novartis AG said on Thursday it expects to increase its profit margin this year as it restructures its drug portfolio and cuts costs, as well as generate cash for a higher dividend and smaller, strategic acquisitions.
     

  2. Biosimilar of Novartis' eye drug Lucentis launched in India
    June 19, 2015 | By Eric Palmer

    Novartis' ($NVS) eye drug Lucentis has long had a target on its back from biosimilar makers who would love to get some piece of the $4 billion in annual sales it racks up. Now an Indian drugmaker says it has hit that mark.

    Intas said today that it has launched in India a biosimilar of ranibizumab, the active ingredient in Lucentis, that it will price at a quarter of the cost of Novartis' drug, the Business Standard reported.

    "Intas' Razumab is a 100% 'Made In India' molecule, a feat achieved by the scientists at Intas. With the mission to provide global healthcare at affordable costs, Razumab will be about 25% cheaper than the imported Lucentis in the hand of the patient," Binish Chudgar, vice chairman of the company, said in a statement. "Our objective is to make the treatment available to a wider patient pool, that is as yet denied treatment due to high cost of imported Lucentis."
     
  3. Gleevec Suit

    Gleevec Suit Guest

    More "patients first" leadership

    Hagens Berman: Class Action Alleges Novartis Gleevec Patent Infringement Suit a Sham
    Published: June 24, 2015 11:22 a.m. ET


    Complaint seeks permanent injunctive relief to prevent overcharges and damages, and bring generic Gleevec to market

    BOSTON, Jun 24, 2015 (BUSINESS WIRE) -- A class-action lawsuit filed against Novartis alleges that the pharma company’s patent infringement suit against generic company Sun Pharma was a sham, and seeks a permanent injunction to prevent Novartis or Sun from enforcing the terms of a settlement agreement that, barring relief, will delay the launch of generic Gleevec for months, according to attorneys at Hagens Berman.

    According to Hagens Berman, the suit marks the first time purchasers of prescription drugs have sought injunctive relief to try to prevent antitrust overcharges or damages stemming from delayed launch of generic drugs.

    The lawsuit, filed June 22, 2015 in the U.S. District Court for the district of Massachusetts, seeks to prevent Novartis’ unlawful delay of generic Gleevec (imatinib mesylate), an FDA-approved prescription drug that radically improves the lives of the thousands of patients suffering chronic myeloid leukemia, a cancer of the blood and bone marrow. The drug’s compound patent expires on July 4, 2015, but Novartis unlawfully barred generic maker Sun Pharma from releasing its generic version of Gleevec for at least an additional seven months, according to the suit. Two generic versions of the drug have already been tentatively approved by the FDA.


    “If Novartis played by the rules, a generic version of Gleevec would be available for cancer patients this July, but Novartis wants to illegally reap benefits from of its sham of a patent infringement suit,” said Hagens Berman partner, Thomas M. Sobol. “Gleevec costs about $9,000 a month and has appropriately grossed Novartis more than $13.5 billion in U.S. sales. Now it’s time for it to fairly compete with generics.”

    The suit calls Novartis’ efforts to delay generic Gleevec “patent gamesmanship and frivolous litigation.”

    The suit states that Novartis, “listed invalid follow-on patents in the FDA’s Orange Book, frivolously sued (belatedly) first-inline generic Sun for infringing one of those patents, and extracted from Sun a promise not to launch its generic for seven extra months beyond the compound patent’s expiration in the guise of settling the bogus infringement lawsuit.”

    The suit names two end payers as plaintiffs and has been filed on behalf of a class of all purchasers of Gleevec.

    Concerned purchasers who have paid for Gleevec can find out more about the suit against Novartis. Gleevec purchasers can also contact Hagens Berman’s pharma legal team by calling 617-482-3700 or by emailing Gleevec@hbsslaw.com.
     
  4. CORRUPTION being the operative word


    US authorities are seeking up to $3.3 billion (three billion euros) in fines from Swiss pharmaceutical giant Novartis on allegations it paid kickbacks to boost drug sales, according to a document AFP consulted Wednesday.

    The legal filing made Monday to a New York court by US officials details 126,802 prescriptions for Novartis medication Exjade, and 39,209 for Myfortic submitted by pharmacies for a total $508 million in reimbursements from government health care programs.
    The complaint by US authorities alledges Novartis coaxed pharmacy chains to convince customers to fill or refill relevant prescriptions with Exjade or Myfortic—which respectively lowers blood iron levels and combats the risk of rejection in kidney transplant patients—in exchange for rebates and other advantages.
    The filing notes that Novartis maintains it offered legal rebates to pharmacies it worked with.
    Convinced the arrangement unfairly cost government health programmes millions of dollars in reimbursed drug purchases, US justice officials are seeking three times the amount paid out—or up to $11,000 per prescription.
     
  5. Addios

    Sandoz gives Novartis a boost, but 3 plants still get the boot
    July 22, 2015 | By Eric Palmer

    Novartis's generics business Sandoz provided the key bright spot in an otherwise tough earnings report for the Swiss pharma, with revenues up 10%. But the starring performance did not keep the manufacturing side of Sandoz from getting spanked, with three of its plants now targeted for closing and about 770 jobs lost.
     
  6. anonymous

    anonymous Guest

    Doctors Protest Big Pharma’s Greed As Cancer Drug Costs Soar
    VICTOR JOHNSON on July 26, 2015 at 11:17 pm

    Well over 100 cancer doctors from top cancer hospitals across the United States have issued what the Wall Street Journal‘s Jeanne Whalen referred to in a report as “a harsh rebuke” over the soaring cost of cancer drugs. The group of oncologists, which consisted of 118 cancer experts, produced a series of recommendations which they claim will lead to reduced treatment costs, according to an editorial published July 23 in the journal Mayo Clinic Proceedings. Dr. Ayalew Tefferi, a hematologist at the Mayo Clinic in Rochester, Minnesota, said in a news release that the high cost of cancer drugs is “affecting the care of patients with cancer and our health care system,” HealthDay News reported. Tefferi, who is among those behind the recommendations recently published in the Mayo Clinic Proceedings, went on to explain that while the average U.S. household has a gross income of roughly $52,000 a year, “the out-of-pocket expenses could be as much as $25,000 to $30,000″ more than half their average household income, for an insured patient in need of a cancer drug that costs $120,000 a year. When you consider that cancer will affect one in three individuals over their lifetime, and [with] recent trends in insurance coverage (that) put a heavy financial burden on patients with out-of-pocket expenses, you quickly see that the situation is not sustainable. It’s time for patients and their physicians to call for change.

    Read more at: http://www.immortal.org/13466/doctors-protest-big-pharma-greed-cancer-drug-costs/
     
  7. FDA to revise Novartis' Gilenya label to reflect brain infection risk
    Aug 4 The U.S. Food and Drug Administration said it will update the label of Novartis AG's multiple sclerosis drug, Gilenya, after cases of serious brain infections were linked with its use.

    A case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported with the use of the drug, a first in patients not previously treated with an immunosuppressant for MS or any other condition, the agency said on Tuesday.

    As a result, information about these cases is being added to the oral drug's label, the FDA said.

    PML has long been a concern associated with the long-term use of MS drugs. Sales of Biogen Inc's Tecfidera and Tysabri had been affected by reports of the rare brain infection.

    Caused by a common virus that is harmless for most, PML tends to trouble patients with weakened immune systems, including those taking immunosuppressants.

    The infection causes symptoms such as vision problems, confusion, as well as changes in personality, memory and orientation - potentially culminating in severe disability or death.

    The drug raked in sales of about $700 million in the Swiss drugmaker's latest quarter.
     
  8. FDA to revise Novartis' Gilenya label to reflect brain infection risk
    Aug 4 The U.S. Food and Drug Administration said it will update the label of Novartis AG's multiple sclerosis drug, Gilenya, after cases of serious brain infections were linked with its use.

    A case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported with the use of the drug, a first in patients not previously treated with an immunosuppressant for MS or any other condition, the agency said on Tuesday.

    As a result, information about these cases is being added to the oral drug's label, the FDA said.

    PML has long been a concern associated with the long-term use of MS drugs. Sales of Biogen Inc's Tecfidera and Tysabri had been affected by reports of the rare brain infection.

    Caused by a common virus that is harmless for most, PML tends to trouble patients with weakened immune systems, including those taking immunosuppressants.

    The infection causes symptoms such as vision problems, confusion, as well as changes in personality, memory and orientation - potentially culminating in severe disability or death.

    The drug raked in sales of about $700 million in the Swiss drugmaker's latest quarter.
     
  9. Judge Slams Pretrial ‘Squabbles’ In $3.35B Novartis FCA Suit
    By Jacob Batchelor

    New York (August 4, 2015, 5:44 PM ET) -- The New York federal judge overseeing a $3.35 billion False Claims Act case against Novartis Pharmaceutical Corp. had harsh words Monday for attorneys positioning for the upcoming trial, warning she would not referee their scheduling “squabbles.”
    In a letter, U.S. District Judge Colleen McMahon sternly told both government and Novartis lawyers that she purposely ignored a series of correspondence regarding the number of witnesses to appear at a trial scheduled to begin in November, stating both sides would be on the clock to finish the proceedings before Christmas.

    The judge told attorneys that they had all been over these issues already, and lengthening the trial was not an option.

    “I did not overlook the letters,” she said. “I ignored them. I am not going to referee these sorts of squabbles.”

    Judge McMahon, who will oversee a trial to determine whether Novartis paid illegal kickbacks to pharmacies to recommend iron-reduction drug Exjade and transplant drug Myfortic, will “not be in this hemisphere” come Christmas, according to the letter.

    When she returns from abroad after the Martin Luther King Jr. Day weekend, she must preside over a long, multidefendant criminal trial that “takes precedence over other matters,” she said.

    In short, when time runs out at the trial — currently slated for November and December — each side “will be done.” How attorneys figure out dividing up witness time is their problem, according to the letter.

    “Enjoy the rest of your summer,” she said.
     
  10. anonymous

    anonymous Guest

    Novartis has purchased the full rights to GlaxoSmithKline (GSK)’s ofatumumab, a monoclonal antibody therapy already approved for use in the U.S. to treat chronic lymphocytic leukemia, in a billion-dollar deal. The plan is to develop the drug for multiple sclerosis (MS) and other indications.

    Some analysts expressed skepticism over the drug’s return. Another monoclonal antibody treatment for MS, Roche’s ocrelizumab, is several years ahead of Novartis’s drug. “It fits strategically, but from a timing perspective there’s going to be quite a gap,” Michael Leuchten, an analyst at Barclays Plc in London, told Bloomberg Business.

    “It’s a joke,” Fabian Wenner, an analyst at Kepler Cheuvreux in Zurich, told Bloomberg Business. “Patients either want better convenience than the old drugs or they want better efficacy, and ofatumumab is offering neither of those things. The chances of this being successful in MS and generating any sales are zero in my view.”

    http://www.the-scientist.com/?articles.view/articleNo/43831/title/Novartis-Buys-Rights-to-GSK-MS-Drug-for--1-Billion/
     
  11. eyesee

    eyesee Guest

    Contact Lens Makers Taking Fight Over Price Law to Court
    DENVER — Aug 27, 2015, 5:15 PM ET
    By KRISTEN WYATT Associated Press

    Contact lens makers struggled Thursday to defend their pricing policies in a federal appeals case that could have wide-ranging effects on the $4 billion industry.

    At issue is a Utah law banning minimum prices for contact lenses. The nation's largest contact lens companies asked the 10th Circuit Court of Appeals in Denver Thursday to strike down the measure. They say it was crafted just to help a homegrown discounter, 1 800 Contacts.

    But a three-judge panel grilled the contact lens lawyers about why they don't simply stop doing business in Utah if they insist on price minimums.

    A lawyer for Utah accused the contact lens makers of nationwide price-fixing and said that lens prices would drop as much as 35 percent nationally if the manufacturers dropped price minimums.

    THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP's earlier story is below.

    A legal battle over a hotly contested Utah law banning minimum prices for contact lenses is set to come before a federal appeals court on Thursday.

    The nation's largest contact lens companies are asking the 10th Circuit Court of Appeals in Denver to strike down the measure that could have wide-ranging effects on the $4 billion industry amid an increasingly bitter pricing fight.

    Alcon Laboratories, Johnson & Johnson and Bausch & Lomb call the law a brazen overreach written specifically to help Utah-based discount seller 1-800 Contacts.

    Utah lawmakers deny that. The state's attorney general contends that the contact lens makers that dominate the market are wrongly driving up prices and the law is a legitimate anti-trust measure.

    The manufacturers are appealing a ruling from a federal judge in Utah. After temporarily blocking the law earlier this year, the 10th Circuit allowed the measure to go into effect as the case unfolds.
     
  12. WTF

    WTF Guest

    Sanctions Bid Accuses Novartis Unit Of Dodging Discovery
    By Dani Kass

    New York (August 31, 2015, 8:48 PM ET) -- Counsel for a patient suing aNovartis AG unit after allegedly suffering injuries from a contaminated cancer drug on Friday asked a Florida federal judge to sanction the generic drugmaker, saying they have refused to answer key questions and withheld documents as part of discovery.
    Sandoz Inc. has failed to provide the identities of several people who the plaintiff said are necessary to depose, has blocked access to relevant interrogatories and labeled too many documents as confidential, according to the motions to compel and for sanctions. The company has yet to provide a legal justification for their objections, the plaintiff said.

    “The real reason the defendant has refused to answer interrogatory number three is that the facts contained in the answer will bolster the plaintiff's claims,” the plaintiffs said. “A party, however, cannot refuse to answer an interrogatory simply because the answer is bad for that party’s position.”

    Among the interrogatories that the plaintiff is asking to have answered are the identities of those who helped answer the questions, which Sandoz allegedly said is blocked by attorney-client privilege. The company had said the answers were provided based on conversations with Sandoz employees, according to the motion.

    The plaintiff especially wants the identity of the person who answered questions regarding Sandoz’s decision to discontinue distributing a dosage of the medication in question.

    Sandoz also allegedly gave an overly vague answer to a question over why contaminations may have started occurring, saying that a document speaks for itself, that the information requested comes from a U.S. Food and Drug Administration Employee not under Sandoz’s control and that the company “cannot and will not adopt plaintiffs’ theory of a discussion point made in an internal memorandum,” all of which the plaintiffs say aren't legal justifications.

    Additionally, Sandoz has delivered tens of thousands of pages of discovery documents, most of which were uncategorized, labeled confidential — an abuse of the confidentiality agreement, the plaintiff said — or improperly redacted. The confidential and redacted documents included some that were available online without any such changes, proving they should have been allowed in full, the plaintiff said.

    The company also took months to produce thousands of documents from Ebewe Pharma, who manufacturers the drug in question, saying it needed time to obtain, translate and redact them. However, once those documents were produced, many proved to be from Sandoz, not Ebewe, according to the motion.

    "Either the defendant did not need time to obtain and prepare (i.e., translate and redact) documents to comply with Austrian and European Union law because the documents were in the defendant’s control the entire time, or the Defendant has yet to produce documents from Ebewe that need translation or to be redacted to comply with Austrian and European Union laws," the plaintiff said.

    The plaintiff is asking for their questions to be answered, documents produced properly and monetary sanctions.

    Plaintiff Amy Trahan filed suit against Sandoz in 2013 after taking injections of generic versions of methotrexate to treat her choriocarcinoma, a fast-growing form of cancer that occurs in a woman's uterus. Trahan took the drug in 2010, shortly before the company issued a voluntary recall after discovering glass flakes in some of the vials containing the medication that came as a result of delamination of the glass.

    Trahan says that she suffered injuries because of the contaminated drug, including multiple lung collapses and several strokes, and sued Sandoz for strict liability design defect and negligence, claiming that Sandoz used “substandard glass vials” to package the drug.

    Counsel for the Sandoz did not immediately respond to requests for comment.

    The plaintiff is represented by Howard C. Coker, Charles A. Sorenson and David M. Milton of Coker Schickel Sorenson & Posgay PA.

    Sandoz is represented by Justin B. Aronson, Lori G. Cohen, Sara K. Thompson, Janna Satz Nugent, Prince Njoku, Ritu Kelotra and Sean Jessee of Greenberg Traurig LLP.

    The case is Amy Trahan et al. v. Sandoz Inc., case number 3:13-cv-00350, in the U.S. District Court for the Middle District of Florida.
     
  13. greed

    greed Guest

    Why is Novartis' Copaxone copy lagging? It's all about coverage, analyst explains
    September 11, 2015 | By Carly Helfand

    Typically, the first generics for blockbuster meds get off to a running start. Not so with Novartis' generic of Teva's multiple sclerosis standout Copaxone, though--and Bernstein analyst Ronny Gal thinks he can explain why.

    The Swiss pharma giant's knockoff, dubbed Glatopa, right now has market share of only about 20%--as opposed to the roughly 50% some industry-watchers say it's capable of snagging. And that could be because coverage of the copy is "considerably behind that of Copaxone," he wrote in a Friday note to clients.

    Copaxone reaches the "best available coverage" tier for 59% of covered lives, he pointed out, while Glatopa can only boast that level for 31%. Many payers have kept Teva's original as either preferred or equally accessible thanks to discounting, he noted, and on top of that, Glatopa--likely thanks to its high price--is treated by many plans as a branded product.

    "It appears that the lower penetration is, for the most part, factual and simply reflects current formulary status coverage," Gal wrote. Teva is offering more discount to payers, and those payers are preferring its brand over equally or slightly more expensive Glatopa."

    Novartis' Sandoz unit, though, appears to be taking that tack deliberately. It "can always lower its price and capture share," Gal noted, but right now, it "appears to be interested in building share cautiously in order to protect market price."
     
  14. Gouging

    Gouging Guest

    CANCER
    Americans overpaying hugely for cancer drugs, academic study finds
    Published September 22, 2015
    Reuters

    Americans are paying way over the odds for some modern cancer drugs, with pharmaceutical companies charging up to 600 times what the medicines cost to make, according to an independent academic study.

    The United States also pays more than double the price charged in Europe for these drugs - so-called tyrosine kinase inhibitors (TKIs), a potent class of cancer pills with fewer side effects than chemotherapy.

    The analysis by pharmacologist Andrew Hill of Britain's University of Liverpool, who will present his findings at the Sept. 25-29 European Cancer Congress in Vienna, is likely to fuel a growing storm over U.S. drug costs.

    Democratic presidential candidate Hillary Clinton's declared aim to lower the cost of prescription drugs by ending what her campaign describes as "excessive profiteering" triggered a sell-off in drug stocks this week.

    Hill told Reuters he had shared his work on the cost of producing TKIs with the World Health Organization (WHO), which is keen to add such treatments to its list of medicines deemed essential for a basic healthcare system. WHO officials have used the findings in determining that the drugs can be made at low cost, he said.

    The first such TKI was added to the WHO's latest draft Essential Medicines List earlier this year.


    Several widely-used TKIs are expected to become available as generics within the next five years, as patents expire. Hill calculated that large-scale production could achieve treatment prices in the range of $159 to $4,022 per person a year, against current U.S. prices of around $75,000 to over $100,000.

    "It shows there is a lot of scope for prices to come down," he said. "There has to be some middle ground between the prices that companies are charging, which may not even be cost-effective by the standards set by some healthcare authorities, and the actual production cost."

    RESEARCH COSTS

    Drug companies argue that they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines.

    But the high prices charged for modern drugs is generating increasing push-back from healthcare providers, patients and some doctors.

    Hill used Indian government data on the cost of pharmaceutical ingredients and allowed for a 50-percent profit margin - but no money for investment in research - to work out the costs of producing certain drugs.

    On this basis, he found that Novartis' leukaemia drug Glivec actually cost $159 for a year's treatment, against the $106,000 charged in the United States.

    Roche's Tarceva for lung cancer cost $236, against a U.S. price of $79,000, and Novartis' Tykerb cost $4,000 against a price of $74,000.

    In all these cases the U.S. cost was far above that charged in certain western European countries, where Glivec costs approximately $29,000-35,000, Tarceva $26,000-29,000 and Tykerb around $35,000, Hill reported.

    Roche declined to comment. Novartis said it had no immediate response.

    The issue is not unique to cancer drugs. Earlier this month, for example, Amgen launched its new injectable cholesterol drug Repatha in Europe at around half the U.S. price.

    "Why should the U.S. bear this huge burden cost? It is not as if the GDP of the United States is so much higher than that of European counties, but they just seem to pay these big premiums," Hill said.

    The future pricing of TKIs could also have major implications for developing countries, Hill believes, since mass production could open the way to widespread cancer treatment in the same way that cheap generic drugs helped fight HIV/AIDS.
     
  15. anonymous

    anonymous Guest


    If we manage to shut down "Wall Street", there might be a way out of this me$$.
     
  16. patent axed

    patent axed Guest

    Novartis Sclerosis Drug Patent Gets Axed In AIA Review
    By Y. Peter Kang

    Los Angeles (September 28, 2015, 8:06 PM ET) -- In a rare win for generic-drug makers contesting a branded drug patent, the Patent Trial and Appeal Board ruled Thursday that a patent covering Novartis AG’s multiple sclerosis treatment Gilenya is invalid as obvious, granting challenges made by Torrent Pharmaceuticals Ltd., Mylanand Apotex.
    In making two identical final decisions in the inter partes reviews under the America Invents Act, the board said that the challenged claims of U.S. Patent Number 8,324,283B2 are obvious over prior art.

    “We conclude petitioners have established by a preponderance of the evidence that claims 1-32 of the ‘283 patent are unpatentable,” the board wrote in a 59-page ruling. “We also conclude that patent owners have failed to establish by a preponderance of the evidence that proposed amended claims 33-64 are patentable.”

    The claims for the patent were obvious over prior art referred to as Chiba and Aulton, and the PTAB said a person of ordinary skill in the art would have had a reasonable expectation of success in combining the two teachings.

    “Even when considering the record evidence of objective indicia of nonobviousness, we conclude that petitioners have shown, by a preponderance of the evidence, that each of the challenged claims would have been obvious over the combination of Chiba and Aulton,” it said.

    An oral hearing on the case was held on July 31, according to the decision.

    An attorney for Torrent said the ruling creates a blueprint for other companies wishing to challenge brand-name drugs listed in the U.S. Food and Drug Administration’s so-called Orange Book of approved drugs.

    “While technology companies have historically used the IPR process to successfully challenge patents, it hasn’t been a widely used tool by pharmaceutical companies,” lead counsel Michael Levy of Kenyon & Kenyon said in a statement. “The PTAB's decision sets an excellent example for other pharmaceutical drug companies seeking to challenge Orange Book-listed patents.”

    A spokeswoman for Novartis said they were disappointed with the ruling and are mulling an appeal.
     
  17. anonymous

    anonymous Guest

    Yes
     
  18. Novartis shells out $390M to settle specialty pharmacy kickback claims
    Novartis ($NVS) agreed to pay about $390 million to wrap up federal kickback claims before the $3.3 billion case went to trial. The Justice Department and a number of U.S. states had sought up to $3.4 billion in damages in the case, which zeroed in on the Swiss drugmaker's relationships with specialty pharmacies.

    The settlement, together with other one-time charges, knocked down Novartis' third-quarter net income, which declined to $1.8 billion, a 28% decrease year-over-year in constant currencies.

    According to the feds, Novartis offered special deals to pharmacies to boost prescriptions of its transplant drug Myfortic in a head-to-head competition with Roche's ($RHHBY) CellCept. The drugmaker set up another scheme to increase refills of its iron chelation drug Exjade, the government says.

    One pharmacy, BioScrip, flipped on Novartis last year, agreeing to pay $15 million and detail its financial relationship with the drugmaker to settle the government's claims about Exjade kickbacks. BioScrip said it pushed patients to get Exjade refills in return for more patient referrals and higher rebates. The case had been set for trial Nov. 2, and the settlement still needs final court approval.

    The company says it's not admitting wrongdoing as part of the settlement, and, in fact, continues to use some similar tactics--at least for now--because they're designed to keep patients on their medication regimens.

    [​IMG]
    Novartis CEO Joe Jimenez
    "We're not admitting liability, it's something we just believe we want to put behind us," CEO Joe Jimenez said in announcing the settlement.
     
  19. anonymous

    anonymous Guest

    U.S. FDA warns Novartis on manufacturing violations at 2 India plants
    MUMBAI Oct 28 The U.S. Food and Drug Administration warned Novartis AG last week after the Swiss firm was found in violation of manufacturing practices last year at two of its India drug-making plants, Novartis said.

    The warning, issued to Novartis's generic drugs unit Sandoz on Oct. 22, came after FDA officials inspected its Turbhe and Kalwa sites in western India in August 2014.

    The FDA expressed its concerns to the company last year, and Novartis has been working on addressing them since, it said in a statement disclosing its quarterly results on Tuesday.

    Novartis did not specify details of the warning. The FDA usually posts warning letters on its website a week after issuing them. The letter to Novartis was not posted as of 1000 GMT on Wednesday.

    "Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction," the company said, adding that no supply disruptions were expected.

    The FDA has banned more than 30 drug manufacturing plants in India since 2013, as it ramps up inspections of foreign facilities that supply to the United States. Several of India's largest drugmakers have faced rebukes, hurting the reputation of the industry, an important supplier of cheap generics.
     
  20. Former Novartis chief moved to Monaco: report

    The controversial former chairman and CEO of Novartis has moved to the tax haven Monaco, where he has purchased a luxury duplex apartment valued at around €24 million, a Swiss weekly says.
    Daniel Vasella, 61, resigned in early 2013 from the Basel-based pharmaceutical giant amid an outcry over a 75-million-franc severance package — later cancelled — in return for a promise not to work for a competitor for six years.

    It was later reported that Vasella, upset about the treatment he was getting from Swiss media and politicians, moved to the United States but SonntagsZeitung reported online that the multi-millionaire had instead quietly relocated to Monaco.

    In the Meditterranean principality, free of tax on income and wealth, Vasella acquired a 268-square-metre with a pool on the terrace and wine cellar in a 22-storey building, the newspaper said.

    The apartment enjoys a view of Monaco’s old town, the palace of Prince Albert II and the sea, according to the report.

    It is located in a luxury building with a spa, indoor pool, gym, sauna and steam room.

    SonntagsZeitung computed the value of the apartment based on property prices in Monaco, quoted by real estate agent Savills, of €91,000 per square metre.

    It noted that the cost would be no problem for Vasella, who walked away from Novartis with a share package worth 220 million francs, in addition to options worth 105 million francs.

    Since 2013, the native of Fribourg has also been receiving 250,000 francs a year from Novartis for advisory services, a sum he will continue to get until the end of 2016, regardless of whether he actually provides any services, SonntagsZeitung said.

    Four years ago Vasella transferred ownership of his 700-square-metre villa in Risch in the canton of Zug to his three daughters to ward off a threatened inheritance tax initiative.

    The lakefront property is next to four parcels of land formerly owned by a Novartis subsidiary that has passed into Vasella’s possession.

    He acquired the land after a dispute in which he and Novartis could not agree on the price, a disagreement that was settled by the Zug cantonal court, SonntagsZeitung reported.

    Neither Novartis nor Vasella have revealed the price but reports have put it between 30 million and 40 million francs.

    Vasella has not revealed what he plans to do with the property.