Novartis milestones be proud ! Management take a bow !
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Novartis ordered to face U.S. lawsuit over doctor kickbacks
By Jonathan Stempel
NEW YORK, Sept 30 Tue Sep 30, 2014 1:24pm EDT
(Reuters) - A federal judge said Novartis AG must face a U.S. government lawsuit accusing the Swiss drugmaker of paying multimillion-dollar kickbacks, including a $9,750 dinner for three at a Japanese restaurant, to induce doctors to prescribe its drugs.
U.S. District Judge Paul Gardephe in Manhattan on Tuesday let the government pursue its entire lawsuit, brought under the federal False Claims Act. He also said New York can pursue most of its state law claims in a related lawsuit.
Julie Masow, a Novartis spokeswoman, said the Basel-based company is reviewing Gardephe's 90-page decision, and will continue to defend itself against the allegations.
The federal government's lawsuit is one of two it filed in April 2013 against Novartis, seeking triple damages over alleged kickbacks to doctors.
Authorities claim that Novartis caused Medicare and Medicaid to pay millions of dollars in reimbursements from 2002 to 2011 based on kickback-tainted claims for drugs such as Lotrel and Valturna to treat hypertension, and the diabetes drug Starlix.
They said these resulted from the East Hanover, New Jersey-based Novartis Pharmaceuticals Corp unit having lavished hefty speaking fees on doctors to appear at thousands of sham programs that were merely "social occasions," where little work got done.
Authorities said Novartis also feted some doctors at high-end restaurants such as the Japanese restaurant Nobu in Dallas, Smith & Wollensky in Washington, D.C. and the three Michelin-starred L20 in Chicago, while others dined at the lower-end Hooters.
Novartis allegedly spent over $65 million and conducted more than 38,000 speaker programs for Lotrel, Valturna and Starlix alone over a decade. One doctor was allegedly paid to speak at his own office eight times.
"The pleadings explain in detail why the speaker events were shams and how they served as a vehicle for kickbacks," Gardephe wrote. "Novartis has cited no case demonstrating that the government entities' pleading of particular false claims is deficient."
Masow said Novartis is committed to "high standards of ethical business conduct," and that speaker programs "can help educate other healthcare providers about the appropriate use of medicines so they can make informed prescribing decisions."
In the other Novartis case, U.S. District Judge Colleen McMahon in August let the government pursue most claims over reimbursements for Myfortic and Exjade, respectively used by patients with kidney transplants and patients who get blood transfusions.
The Lotrel, Valturna and Starlix case was originally brought in January 2011 by former Novartis sales representative Oswald Bilotta. On Tuesday, Gardephe let Bilotta pursue part of his own lawsuit, which raises additional claims.
A spokeswoman for U.S. Attorney Preet Bharara in Manhattan declined to comment. A spokesman for New York Attorney General Eric Schneiderman was not immediately available for comment. Eric Young, Bilotta's lawyer, said his client is pleased his case will continue.
The federal government often joins False Claims Act lawsuits that it believes have greater merit. Whistleblowers share in damages that are recovered.
The case is U.S. ex rel. Bilotta v. Novartis Pharmaceuticals Corp, U.S. District Court, Southern District of New York, No. 11-00071. (Reporting by Jonathan Stempel in New York; Additional reporting by Karen Freifeld; Editing by David Gregorio)
By Jonathan Stempel
NEW YORK, Sept 30 Tue Sep 30, 2014 1:24pm EDT
(Reuters) - A federal judge said Novartis AG must face a U.S. government lawsuit accusing the Swiss drugmaker of paying multimillion-dollar kickbacks, including a $9,750 dinner for three at a Japanese restaurant, to induce doctors to prescribe its drugs.
U.S. District Judge Paul Gardephe in Manhattan on Tuesday let the government pursue its entire lawsuit, brought under the federal False Claims Act. He also said New York can pursue most of its state law claims in a related lawsuit.
Julie Masow, a Novartis spokeswoman, said the Basel-based company is reviewing Gardephe's 90-page decision, and will continue to defend itself against the allegations.
The federal government's lawsuit is one of two it filed in April 2013 against Novartis, seeking triple damages over alleged kickbacks to doctors.
Authorities claim that Novartis caused Medicare and Medicaid to pay millions of dollars in reimbursements from 2002 to 2011 based on kickback-tainted claims for drugs such as Lotrel and Valturna to treat hypertension, and the diabetes drug Starlix.
They said these resulted from the East Hanover, New Jersey-based Novartis Pharmaceuticals Corp unit having lavished hefty speaking fees on doctors to appear at thousands of sham programs that were merely "social occasions," where little work got done.
Authorities said Novartis also feted some doctors at high-end restaurants such as the Japanese restaurant Nobu in Dallas, Smith & Wollensky in Washington, D.C. and the three Michelin-starred L20 in Chicago, while others dined at the lower-end Hooters.
Novartis allegedly spent over $65 million and conducted more than 38,000 speaker programs for Lotrel, Valturna and Starlix alone over a decade. One doctor was allegedly paid to speak at his own office eight times.
"The pleadings explain in detail why the speaker events were shams and how they served as a vehicle for kickbacks," Gardephe wrote. "Novartis has cited no case demonstrating that the government entities' pleading of particular false claims is deficient."
Masow said Novartis is committed to "high standards of ethical business conduct," and that speaker programs "can help educate other healthcare providers about the appropriate use of medicines so they can make informed prescribing decisions."
In the other Novartis case, U.S. District Judge Colleen McMahon in August let the government pursue most claims over reimbursements for Myfortic and Exjade, respectively used by patients with kidney transplants and patients who get blood transfusions.
The Lotrel, Valturna and Starlix case was originally brought in January 2011 by former Novartis sales representative Oswald Bilotta. On Tuesday, Gardephe let Bilotta pursue part of his own lawsuit, which raises additional claims.
A spokeswoman for U.S. Attorney Preet Bharara in Manhattan declined to comment. A spokesman for New York Attorney General Eric Schneiderman was not immediately available for comment. Eric Young, Bilotta's lawyer, said his client is pleased his case will continue.
The federal government often joins False Claims Act lawsuits that it believes have greater merit. Whistleblowers share in damages that are recovered.
The case is U.S. ex rel. Bilotta v. Novartis Pharmaceuticals Corp, U.S. District Court, Southern District of New York, No. 11-00071. (Reporting by Jonathan Stempel in New York; Additional reporting by Karen Freifeld; Editing by David Gregorio)
Novartis' FCA Suit Discovery Request Slammed By States
By Khadijah M. Britton
New York (September 30, 2014, 5:57 PM ET) -- California, New York, New Jersey and eight other states on Monday challenged Novartis Pharmaceutical Corp.’s bid for information on their medication adherence programs, saying the information is irrelevant to a whistleblower suit accusing Novartis of paying kickbacks to pharmacies.
In their opposition to Novartis’ Sept. 9 motion to compel further discovery, the states accused Novartis of making an overbroad and burdensome request and improperly trying to divert attention from its own actions by revealing that the government behaves similarly, which wouldn't be a defense
By Khadijah M. Britton
New York (September 30, 2014, 5:57 PM ET) -- California, New York, New Jersey and eight other states on Monday challenged Novartis Pharmaceutical Corp.’s bid for information on their medication adherence programs, saying the information is irrelevant to a whistleblower suit accusing Novartis of paying kickbacks to pharmacies.
In their opposition to Novartis’ Sept. 9 motion to compel further discovery, the states accused Novartis of making an overbroad and burdensome request and improperly trying to divert attention from its own actions by revealing that the government behaves similarly, which wouldn't be a defense
Kyodo News International October 1, 2014 10:37am
Novartis reports 3,878 suspected cases of drug side effects
Novartis Pharma K.K. said Wednesday that it suspects a total of 3,878 cases of severe side effects related to drugs sold by the company after discovering documents on around 10,000 cases were left unattended.
To examine the causal relationships between the drugs and possible side effects, the Japanese sales arm of Swiss pharmaceutical giant Novartis will conduct a detailed investigation into doctors who diagnosed patients and submit further reports to Japan's health ministry, it said.
The Ministry of Health, Labor and Welfare, which was informed of the cases of suspected side effects on Tuesday, said it will consider its response after seeing the additional reports.
Of the 3,878 cases, 1,934 were related to Glivec and 813 involved Tasigna, both used to treat chronic myelocytic leukemia.
"We deeply apologize for causing great worry to patients and trouble to medical experts because of a delay in reporting side effects, which is extremely important for a pharmaceutical company," Novartis said in a statement.
In June, Novartis said it had left documents regarding suspected side effects unattended, mainly because employees in charge of sales did not share the information with the department for safety management.
The pharmaceutical affairs law requires pharmaceutical companies to report information on severe side effects to the government within a certain period of time.
==Kyodo
Copyright 2014 Kyodo News International.
Novartis reports 3,878 suspected cases of drug side effects
Novartis Pharma K.K. said Wednesday that it suspects a total of 3,878 cases of severe side effects related to drugs sold by the company after discovering documents on around 10,000 cases were left unattended.
To examine the causal relationships between the drugs and possible side effects, the Japanese sales arm of Swiss pharmaceutical giant Novartis will conduct a detailed investigation into doctors who diagnosed patients and submit further reports to Japan's health ministry, it said.
The Ministry of Health, Labor and Welfare, which was informed of the cases of suspected side effects on Tuesday, said it will consider its response after seeing the additional reports.
Of the 3,878 cases, 1,934 were related to Glivec and 813 involved Tasigna, both used to treat chronic myelocytic leukemia.
"We deeply apologize for causing great worry to patients and trouble to medical experts because of a delay in reporting side effects, which is extremely important for a pharmaceutical company," Novartis said in a statement.
In June, Novartis said it had left documents regarding suspected side effects unattended, mainly because employees in charge of sales did not share the information with the department for safety management.
The pharmaceutical affairs law requires pharmaceutical companies to report information on severe side effects to the government within a certain period of time.
==Kyodo
Copyright 2014 Kyodo News International.
http://www.cbsnews.com/news/the-cost-of-cancer-drugs/
"Gleevec is the top selling drug for industry giant Novartis, bringing in more than $4 billion a year in sales. $35 billion since the drug came to market. There are now several other drugs like it. So, you'd think with the competition, the price of Gleevec would have come down.
Dr. Hagop Kantarjian: And yet, the price of the drug tripled from $28,000 a year in 2001 to $92,000 a year in 2012.
"They are making prices unreasonable, unsustainable and, in my opinion, immoral."
Lesley Stahl: Are you saying that the drug companies are raising the prices on their older drugs.
Dr. Hagop Kantarjian: That's correct.
Lesley Stahl: Not just the new ones. So, you have a new drug that might come out at a $100,000, but they are also saying the old drugs have to come up to that price, too?
Dr. Hagop Kantarjian: Exactly. They are making prices unreasonable, unsustainable and, in my opinion, immoral."
"Gleevec is the top selling drug for industry giant Novartis, bringing in more than $4 billion a year in sales. $35 billion since the drug came to market. There are now several other drugs like it. So, you'd think with the competition, the price of Gleevec would have come down.
Dr. Hagop Kantarjian: And yet, the price of the drug tripled from $28,000 a year in 2001 to $92,000 a year in 2012.
"They are making prices unreasonable, unsustainable and, in my opinion, immoral."
Lesley Stahl: Are you saying that the drug companies are raising the prices on their older drugs.
Dr. Hagop Kantarjian: That's correct.
Lesley Stahl: Not just the new ones. So, you have a new drug that might come out at a $100,000, but they are also saying the old drugs have to come up to that price, too?
Dr. Hagop Kantarjian: Exactly. They are making prices unreasonable, unsustainable and, in my opinion, immoral."
Pays well to quadruple the price of the decade old drug the NIC & Leukemia Society Funded!!!
Shareholder group critical as Roche and Novartis chiefs top Swiss pay table
ZURICH Wed Oct 8, 2014 8:25am EDT
(Reuters) - The bosses of drugmakers Roche (ROG.VX) and Novartis (NOVN.VX) both earned more than 13 million Swiss francs ($13.6 million) last year, according to a study published on Wednesday, 18 months after the Swiss voted for some of the world's strictest controls on executive pay.
The pay packets of Roche CEO Severin Schwan and Novartis counterpart Joe Jimenez topped the list of Switzerland's best-paid managers and prompted criticism from shareholder group Ethos, which conducted the study.
"Double-digit sums are difficult to accept in Switzerland," Ethos director Dominique Biedermann told reporters. "When Mr Schwan and Mr Jimenez earn 13 million in a good year, but not a record year, what will they earn in a record year?"
Shareholder group critical as Roche and Novartis chiefs top Swiss pay table
ZURICH Wed Oct 8, 2014 8:25am EDT
(Reuters) - The bosses of drugmakers Roche (ROG.VX) and Novartis (NOVN.VX) both earned more than 13 million Swiss francs ($13.6 million) last year, according to a study published on Wednesday, 18 months after the Swiss voted for some of the world's strictest controls on executive pay.
The pay packets of Roche CEO Severin Schwan and Novartis counterpart Joe Jimenez topped the list of Switzerland's best-paid managers and prompted criticism from shareholder group Ethos, which conducted the study.
"Double-digit sums are difficult to accept in Switzerland," Ethos director Dominique Biedermann told reporters. "When Mr Schwan and Mr Jimenez earn 13 million in a good year, but not a record year, what will they earn in a record year?"
Headhunting Firm Accuses Novartis Of $578K Breach
By Martin Bricketto
New York (October 08, 2014, 3:40 PM ET) -- A headhunting firm has slapped a Novartis AG unit with a breach-of-contract suit of more than $578,000 in New Jersey state court, claiming the pharmaceutical giant has avoided paying the company for its help filling various executive positions.
East Hanover, New Jersey-based Global Source & Search Consultants Inc. contends in its Oct. 3 complaint against Novartis Consumer Health Inc. OTC in Morris County Superior Court that its client has failed to pay up for services involving posts for regional head for quality assurance and compliance
By Martin Bricketto
New York (October 08, 2014, 3:40 PM ET) -- A headhunting firm has slapped a Novartis AG unit with a breach-of-contract suit of more than $578,000 in New Jersey state court, claiming the pharmaceutical giant has avoided paying the company for its help filling various executive positions.
East Hanover, New Jersey-based Global Source & Search Consultants Inc. contends in its Oct. 3 complaint against Novartis Consumer Health Inc. OTC in Morris County Superior Court that its client has failed to pay up for services involving posts for regional head for quality assurance and compliance
Screwing & corrupting yet another country's healthcare system
Novartis employee pleaded guilty in Polish bribery case
ZURICH Thu Oct 9, 2014 5:19pm BST
Credit: Reuters/Danish Siddiqui
An executive at a pharmaceutical company in Poland who pleaded guilty in a bribery case involving improper payment, works for Novartis (NOVN.VX), the Swiss drugmaker said on Thursday.
Poland's anti-corruption bureau said on Tuesday two women had appeared in court in a case in which a health fund official was given a tourist trip worth more than $1,000 (620.67 pounds) in exchange for backing the sale of a particular drug.
Both defendants pleaded guilty as part of a fast-track system that avoids a full trial. Sentencing has not yet been handed down.
The Basel-based Novartis confirmed that one of the two women was an employee who had been put on leave. It said the action taken by the Polish authorities did not involve the company.
"Novartis can confirm that an employee was recently interviewed by authorities in Poland in connection with an ongoing enquiry," the drugmaker said in an emailed statement.
"It should be noted that the enquiry relates to the individual and that the company is not a part of this enquiry," it said, adding it would be inappropriate to comment further out of respect for the privacy of those concerned and because it was a matter for the authorities.
The incident is the latest in a string of bribery cases that are embarrassing the pharmaceutical industry.
Novartis employee pleaded guilty in Polish bribery case
ZURICH Thu Oct 9, 2014 5:19pm BST
Credit: Reuters/Danish Siddiqui
An executive at a pharmaceutical company in Poland who pleaded guilty in a bribery case involving improper payment, works for Novartis (NOVN.VX), the Swiss drugmaker said on Thursday.
Poland's anti-corruption bureau said on Tuesday two women had appeared in court in a case in which a health fund official was given a tourist trip worth more than $1,000 (620.67 pounds) in exchange for backing the sale of a particular drug.
Both defendants pleaded guilty as part of a fast-track system that avoids a full trial. Sentencing has not yet been handed down.
The Basel-based Novartis confirmed that one of the two women was an employee who had been put on leave. It said the action taken by the Polish authorities did not involve the company.
"Novartis can confirm that an employee was recently interviewed by authorities in Poland in connection with an ongoing enquiry," the drugmaker said in an emailed statement.
"It should be noted that the enquiry relates to the individual and that the company is not a part of this enquiry," it said, adding it would be inappropriate to comment further out of respect for the privacy of those concerned and because it was a matter for the authorities.
The incident is the latest in a string of bribery cases that are embarrassing the pharmaceutical industry.
More Countries More Scandals More Scams
NPPA slaps Rs 300-crore penalty on Novartis
Sends notice for overcharging; company moves court
Sushmi Dey | New Delhi October 13, 2014 Last Updated at 00:58 IST
The National Pharmaceutical Pricing Authority (NPPA) has imposed a fine of around Rs 300 crore on Swiss multinational drug company Novartis for overcharging consumers on sale of Voveran, its best-selling painkiller medicine.
The drug pricing regulator also served a showcause notice on the company, asking to explain within two weeks why action should not be taken against it for overcharging, a source in the know of the development, who did not wish to be named, told Business Standard.
Novartis' analgesic brand, Voveran, is based on diclofenac, a component that is under the government's direct price control. According to IMS Health annual data, Voveran, with annual sales of about Rs 225 crore, was among the top 10 brands in the domestic drug retail market as of April this year.
PAIN FOR THE DRUG
• Voveran, Novartis’ analgesic brand, is based on diclofenac, a component under the government’s direct price control
• According to IMS Health annual data, with annual sales of about Rs 225 crore, Voveran was among the top 10 brands in the domestic drug retail market as of April this year
• A strip of 15 Voveran SR 100 mg tablets currently costs Rs 102, while one of 50 mg comes for Rs 74
When contacted, a spokesperson for Novartis confirmed the company had received a notice from NPPA. "However the basis of the demand itself has been challenged by us before the Delhi High Court. Since the matter is sub judice, we are unable to comment further," she said.
The new drug price control order, implemented in May last year, brought 348 medicines under price control. The prices of these were capped at an average of the prices of all drugs with more than one per cent market share in their respective segments.
However, Novartis, Cipla and GlaxoSmithKline had approached the court in July last year to protest against provisions of the new order, which required them to replace within 45 days their stocks in the market with new ones mentioning revised prices.
According to a trade source, a strip of 15 Voveran SR 100 mg tablets currently costs Rs 102, while one of 50 mg comes for Rs 74.
Voveran's market share is believed to have dipped since the new pricing regime came into force. The IMS data show the value growth of the drug has fallen 14.5 per cent from last year.
Industry analysts say Voveran faced a sharp cut after the new price control order as it was one of the more expensive brands in the segment and had a huge market share.
Recently, a Delhi High Court Bench of judges B D Ahmed and Vibhu Bakhru said representatives of pharma companies should hold a meeting with NPPA and the government to settle the matter. "You hold a meeting with the director of NPPA and come back in October. We expect the meeting to take place and be concluded before the next date of hearing (October 30). You should try to resolve the issue once and for ever. We are also tired of hearing it," the court said while hearing a bunch of petitions moved by drug makers challenging the government's new drug pricing order.
NPPA slaps Rs 300-crore penalty on Novartis
Sends notice for overcharging; company moves court
Sushmi Dey | New Delhi October 13, 2014 Last Updated at 00:58 IST
The National Pharmaceutical Pricing Authority (NPPA) has imposed a fine of around Rs 300 crore on Swiss multinational drug company Novartis for overcharging consumers on sale of Voveran, its best-selling painkiller medicine.
The drug pricing regulator also served a showcause notice on the company, asking to explain within two weeks why action should not be taken against it for overcharging, a source in the know of the development, who did not wish to be named, told Business Standard.
Novartis' analgesic brand, Voveran, is based on diclofenac, a component that is under the government's direct price control. According to IMS Health annual data, Voveran, with annual sales of about Rs 225 crore, was among the top 10 brands in the domestic drug retail market as of April this year.
PAIN FOR THE DRUG
• Voveran, Novartis’ analgesic brand, is based on diclofenac, a component under the government’s direct price control
• According to IMS Health annual data, with annual sales of about Rs 225 crore, Voveran was among the top 10 brands in the domestic drug retail market as of April this year
• A strip of 15 Voveran SR 100 mg tablets currently costs Rs 102, while one of 50 mg comes for Rs 74
When contacted, a spokesperson for Novartis confirmed the company had received a notice from NPPA. "However the basis of the demand itself has been challenged by us before the Delhi High Court. Since the matter is sub judice, we are unable to comment further," she said.
The new drug price control order, implemented in May last year, brought 348 medicines under price control. The prices of these were capped at an average of the prices of all drugs with more than one per cent market share in their respective segments.
However, Novartis, Cipla and GlaxoSmithKline had approached the court in July last year to protest against provisions of the new order, which required them to replace within 45 days their stocks in the market with new ones mentioning revised prices.
According to a trade source, a strip of 15 Voveran SR 100 mg tablets currently costs Rs 102, while one of 50 mg comes for Rs 74.
Voveran's market share is believed to have dipped since the new pricing regime came into force. The IMS data show the value growth of the drug has fallen 14.5 per cent from last year.
Industry analysts say Voveran faced a sharp cut after the new price control order as it was one of the more expensive brands in the segment and had a huge market share.
Recently, a Delhi High Court Bench of judges B D Ahmed and Vibhu Bakhru said representatives of pharma companies should hold a meeting with NPPA and the government to settle the matter. "You hold a meeting with the director of NPPA and come back in October. We expect the meeting to take place and be concluded before the next date of hearing (October 30). You should try to resolve the issue once and for ever. We are also tired of hearing it," the court said while hearing a bunch of petitions moved by drug makers challenging the government's new drug pricing order.
we should sell trading our drugs at cost or giving it away for free.
the world would be so much a better place.
p.s.
your concepts are just as abstract as mine.
as it all is.
the world would be so much a better place.
p.s.
your concepts are just as abstract as mine.
as it all is.
Screw Cancer patients that can't afford this forEvergreened drug. NVS runs to the government since apparently they can't compete in a free market environment
Novartis Drags DRL to Court over Gleevec
By ENS Economic Bureau
Published: 21st October 2014 06:00 AM
HYDERABAD: Basel-headquartered Novartis Pharmaceuticals Corporation and Novartis AG dragged city-based Dr Reddy's Laboratories Ltd (DRL) and its US subsidiary Dr Reddy's Laboratories Inc to the US court over alleged patent infringement.
As per Novartis' petition filed on October, 8 at the District Court of Delaware, DRL infringed its patents pertaining to Novartis’ anti-cancer drug — Gleevec. Originally, patent was issued to inventors Jurg Zimmermann in May, 2005 and Novartis was an exclusive licensee. It was reissued in January, 2013 to Jurg, which was also exlusively licensed to Novartis.
“DRL’s commercial manufacture, use, offer to sell or sale of its Imatinib Mesylate ANDA Tablets, prior to the expiration of the ’051 Patent and the RE932 Patent, would constitute infringement of the ’051 Patent and the RE932 Patent under 35 U.S.C. § 271,” Novartis said.
In a letter dated August 27, 2014, DRL notified Novartis that it had submitted ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer to sell or sale of capsules containing 400 mg of imatinib mesylate, imatinib mesylate capsules, EQ 400 mg Base.
Novartis claims that the effective date of any FDA approval for DRL to make, use or sell its 400 mg Imatinib Mesylate ANDA capsules be no earlier than the date on which last-expiring its patents, including any associated regulatory exclusivities.
The petition also seeks a judgement awarding Novartis damages resulting from such infringement and if DRL engages in the commercial production, use or sale of the drug prior to patent enpiry.
Novartis Drags DRL to Court over Gleevec
By ENS Economic Bureau
Published: 21st October 2014 06:00 AM
HYDERABAD: Basel-headquartered Novartis Pharmaceuticals Corporation and Novartis AG dragged city-based Dr Reddy's Laboratories Ltd (DRL) and its US subsidiary Dr Reddy's Laboratories Inc to the US court over alleged patent infringement.
As per Novartis' petition filed on October, 8 at the District Court of Delaware, DRL infringed its patents pertaining to Novartis’ anti-cancer drug — Gleevec. Originally, patent was issued to inventors Jurg Zimmermann in May, 2005 and Novartis was an exclusive licensee. It was reissued in January, 2013 to Jurg, which was also exlusively licensed to Novartis.
“DRL’s commercial manufacture, use, offer to sell or sale of its Imatinib Mesylate ANDA Tablets, prior to the expiration of the ’051 Patent and the RE932 Patent, would constitute infringement of the ’051 Patent and the RE932 Patent under 35 U.S.C. § 271,” Novartis said.
In a letter dated August 27, 2014, DRL notified Novartis that it had submitted ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer to sell or sale of capsules containing 400 mg of imatinib mesylate, imatinib mesylate capsules, EQ 400 mg Base.
Novartis claims that the effective date of any FDA approval for DRL to make, use or sell its 400 mg Imatinib Mesylate ANDA capsules be no earlier than the date on which last-expiring its patents, including any associated regulatory exclusivities.
The petition also seeks a judgement awarding Novartis damages resulting from such infringement and if DRL engages in the commercial production, use or sale of the drug prior to patent enpiry.
They always know how to put the beatdown on Novartis 
http://www.reuters.com/article/2014/10/30/us-cipla-novartis-patent-idUSKBN0IJ0U420141030
http://www.reuters.com/article/2014/10/30/us-cipla-novartis-patent-idUSKBN0IJ0U420141030
WSJ
11:14 am ET
Oct 30, 2014
Did Novartis Make a Ham-Handed Move to Promote an Antibiotic for Pigs?
By
Ed Silverman
—Associated Press
Last summer, Novartis NOVN.VX +0.92% changed details on a website for its Denagard antibiotic after a coalition of consumer groups complained to the FDA that the drug maker was promoting the treatment for uses that were never approved by the agency. Specifically, Keep Antibiotics Working was concerned that Novartis was promoting the antibiotic for use in helping food-producing livestock gain weight.
Why? This type of use contributes to antibiotic resistance among humans, which was noted in a recent report by the President’s Council of Advisors on Science and Technology. The issue has gained traction, especially after the U.S. Centers for Disease Control and Prevention blamed antibiotic resistance for at least 2 million illnesses and 23,000 deaths annually in the U.S. alone.
In response, the FDA has been working with drug makers in hopes of convincing food producers to use antibiotics only for preventing or treating disease, not promoting weight gain. But the FDA plan relies on voluntary compliance that doesn’t begin until 2016, and consumer groups worry that some food producers will, meanwhile, continue unchecked use of antibiotics.
And so Keep Antibiotics Working is monitoring Novartis and, in fact, has again complained to the FDA. In a letter sent this week to Mike Taylor, the FDA Deputy Commissioner for Foods and Veterinary Medicine, the coalition says the drug maker has restored some of the earlier language to the Denagard website that suggests the antibiotic can be used to promote animal growth.
Denagard is used to control dysentery and treat pneumonia and intestinal infections in swine. But the coalition complains that certain information appears to emphasize weight gain, which makes the animals better suited for increased food production. In doing so, the coalition believes Novartis is promoting the antibiotic for an unapproved use and undermines a commitment to the FDA program.
“Despite FDA statements that the agency understands our concerns about this type of promotion and repeated FDA statements that growth promotion uses will be illegal after a company removes a production claims from the label, Novartis continues to promote the growth benefits of (Denagard) … and has even reversed changes made after we first raised the issue,” the group writes.
For instance, the Denagard website last April included a prominent promotional message to food producers: “Control Disease and Improve Grow-Finish Performance,” a phrase that refers to bolstering weight gain. KAW says this message was removed last June after the group complained to FDA officials, but the coalition maintains that the language recently reappeared.
The coalition also contends that studies Novartis cites on the website do not provide any evidence that “performance gains,” or increased weight, are derived from the therapeutic indications for which the antibiotic is approved. The coalition also maintains that related promotional materials make claims that are “misleading” because they are not supported by evidence.
“Why say you’re doing something about antibiotic resistance when the company’s marketing for the product still says growth promotion is a benefit?” says Steven Roach, the food safety program director at Food Animal Concerns Trust, one of the groups in the coalition. “Yes, this label was already changed, but the marketing is what we’re concerned about.”
For its part, Novartis insists the antibiotic is not promoted off-label or as a growth promoter. A spokesman sent us a statement saying the drug maker promotes all products according to approved labels and that the Denagard website was updated on May 23 “in an effort to reduce or eliminate any misinterpretation by non-professional audiences on the product’s uses and benefits.
“The U.S. Denagard website clearly explains that Denagard is used therapeutically and that the animal performance benefits derived from the use of Denagard result from a reduction in disease associated with stressful periods that are directly related to higher disease levels throughout a pig herd.” There was no specific comment regarding any recent revisions to the website.
As for the FDA, an agency spokeswoman sent this: “We continue to engage with the Keep Antibiotics Working coalition and other stakeholders on this and other antimicrobial resistance issues, and we understand the concern that drug manufacturers may promote extra-label production uses for products approved only for therapeutic use, thereby undermining the spirit and intent” of a recent FDA guidance.
She adds that the FDA intends to “look for ways to reinforce the importance of the principles of judicious and appropriate use, including engaging animal drug manufacturers on the appropriate use of promotional materials. We are in the early stages of implementing this strategy. Important issues will arise along the way and we are committed to addressing them.”
11:14 am ET
Oct 30, 2014
Did Novartis Make a Ham-Handed Move to Promote an Antibiotic for Pigs?
By
Ed Silverman
—Associated Press
Last summer, Novartis NOVN.VX +0.92% changed details on a website for its Denagard antibiotic after a coalition of consumer groups complained to the FDA that the drug maker was promoting the treatment for uses that were never approved by the agency. Specifically, Keep Antibiotics Working was concerned that Novartis was promoting the antibiotic for use in helping food-producing livestock gain weight.
Why? This type of use contributes to antibiotic resistance among humans, which was noted in a recent report by the President’s Council of Advisors on Science and Technology. The issue has gained traction, especially after the U.S. Centers for Disease Control and Prevention blamed antibiotic resistance for at least 2 million illnesses and 23,000 deaths annually in the U.S. alone.
In response, the FDA has been working with drug makers in hopes of convincing food producers to use antibiotics only for preventing or treating disease, not promoting weight gain. But the FDA plan relies on voluntary compliance that doesn’t begin until 2016, and consumer groups worry that some food producers will, meanwhile, continue unchecked use of antibiotics.
And so Keep Antibiotics Working is monitoring Novartis and, in fact, has again complained to the FDA. In a letter sent this week to Mike Taylor, the FDA Deputy Commissioner for Foods and Veterinary Medicine, the coalition says the drug maker has restored some of the earlier language to the Denagard website that suggests the antibiotic can be used to promote animal growth.
Denagard is used to control dysentery and treat pneumonia and intestinal infections in swine. But the coalition complains that certain information appears to emphasize weight gain, which makes the animals better suited for increased food production. In doing so, the coalition believes Novartis is promoting the antibiotic for an unapproved use and undermines a commitment to the FDA program.
“Despite FDA statements that the agency understands our concerns about this type of promotion and repeated FDA statements that growth promotion uses will be illegal after a company removes a production claims from the label, Novartis continues to promote the growth benefits of (Denagard) … and has even reversed changes made after we first raised the issue,” the group writes.
For instance, the Denagard website last April included a prominent promotional message to food producers: “Control Disease and Improve Grow-Finish Performance,” a phrase that refers to bolstering weight gain. KAW says this message was removed last June after the group complained to FDA officials, but the coalition maintains that the language recently reappeared.
The coalition also contends that studies Novartis cites on the website do not provide any evidence that “performance gains,” or increased weight, are derived from the therapeutic indications for which the antibiotic is approved. The coalition also maintains that related promotional materials make claims that are “misleading” because they are not supported by evidence.
“Why say you’re doing something about antibiotic resistance when the company’s marketing for the product still says growth promotion is a benefit?” says Steven Roach, the food safety program director at Food Animal Concerns Trust, one of the groups in the coalition. “Yes, this label was already changed, but the marketing is what we’re concerned about.”
For its part, Novartis insists the antibiotic is not promoted off-label or as a growth promoter. A spokesman sent us a statement saying the drug maker promotes all products according to approved labels and that the Denagard website was updated on May 23 “in an effort to reduce or eliminate any misinterpretation by non-professional audiences on the product’s uses and benefits.
“The U.S. Denagard website clearly explains that Denagard is used therapeutically and that the animal performance benefits derived from the use of Denagard result from a reduction in disease associated with stressful periods that are directly related to higher disease levels throughout a pig herd.” There was no specific comment regarding any recent revisions to the website.
As for the FDA, an agency spokeswoman sent this: “We continue to engage with the Keep Antibiotics Working coalition and other stakeholders on this and other antimicrobial resistance issues, and we understand the concern that drug manufacturers may promote extra-label production uses for products approved only for therapeutic use, thereby undermining the spirit and intent” of a recent FDA guidance.
She adds that the FDA intends to “look for ways to reinforce the importance of the principles of judicious and appropriate use, including engaging animal drug manufacturers on the appropriate use of promotional materials. We are in the early stages of implementing this strategy. Important issues will arise along the way and we are committed to addressing them.”
Continuously raising the price of its cancer drugs so people have to chose between Novartis drugs or food! Bastards!!!!!!!!!!!
again.....
FDA advisers spurn Novartis' blood cancer drug, putting approval in doubt
November 6, 2014 | By Damian Garde
Novartis' ($NVS) new multiple myeloma treatment is too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the cancer drug next year.
The FDA's Oncologic Drugs Advisory Committee voted 5-2 against the drug, called panobinostat, noting its demonstrable benefits for patients with blood cancer but ultimately concluding that its side effects were too severe to warrant approval. In its pivotal trial, Novartis' treatment helped extend progression-free survival (PFS) by 3.9 months compared to placebo, but not without serious safety concerns. Seven percent of patients in the panobinostat arm died from non-cancer complications compared to just 3.5% in other group, alarming toxicity that outweighed the drug's benefit, panelists said.
The agency is not obligated to follow the committee's advice, though it most often does. Regulators are expected to hand down a final decision on the drug next month.
FDA advisers spurn Novartis' blood cancer drug, putting approval in doubt
November 6, 2014 | By Damian Garde
Novartis' ($NVS) new multiple myeloma treatment is too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the cancer drug next year.
The FDA's Oncologic Drugs Advisory Committee voted 5-2 against the drug, called panobinostat, noting its demonstrable benefits for patients with blood cancer but ultimately concluding that its side effects were too severe to warrant approval. In its pivotal trial, Novartis' treatment helped extend progression-free survival (PFS) by 3.9 months compared to placebo, but not without serious safety concerns. Seven percent of patients in the panobinostat arm died from non-cancer complications compared to just 3.5% in other group, alarming toxicity that outweighed the drug's benefit, panelists said.
The agency is not obligated to follow the committee's advice, though it most often does. Regulators are expected to hand down a final decision on the drug next month.
"Croatia admitted it has tested Novartis vaccines on Croatian kids for years. As a result, many Croatian kids developed mental deficiencies and all sorts of diseases. In fact, the Croatian Government admitted its doctors are receiving bonuses from Novartis for each vaccine administered on patients. "
http://macedoniaonline.eu/content/view/24176/2/
http://macedoniaonline.eu/content/view/24176/2/
FiercePharma reported that Novartis filed a special Iran Notice with the SEC indicating that its Alcon eye care unit, which is based in Texas, is being investigated. The feds are looking at whether it violated sanctions against sales to Iran and other pariah nations. The company said a "grand-jury subpoena" asked for documents dating back to 2005. The company told the WSJ that it is cooperating but had nothing more to say. - See more at: http://www.policymed.com/2013/07/su...oehringer-ingelheim.html#sthash.Ceg5MAJ3.dpuf
whoever had been promoting and was directly involved in these tactics should be fired immediately, if they are still around.
whoever hired and supervised the aforementioned people should be counseled immediately, if they are still around.
JR needs to deliver a personal message immediately to the entire company's associates on our new values and behaviors, if he genuinely cares about the integrity of our company and the people who put in a day's work just to earn a modest income while trying to honestly help care and cure the human race.
ffs.
LEAD.