Novartis milestones be proud ! Management take a bow !

FUCKING BUNCH OF SLEAZEBALLS >:-o

Novartis removes top Japanese executives for hiding serious potential side effects of leukaemia treatments

Swiss pharmaceutical giant Novartis has removed several Japanese executives after they hid serious potential side effects of leukaemia treatments from regulators.

Novartis's senior executive, David Epstein, apologised on behalf of the Japanese managers and said at a press conference they had "resigned".

"This kind of behaviour is unacceptable and a clear violation of our code of conduct," he said.

"I'd like to once again apologise for Novartis's involvement in the issue."

An independent investigation by Novartis found the Japanese staff had removed evidence that patients in a leukaemia drug trial had severe reactions.

The investigation also found 20 instances of improper activities with Japanese sales staff, who attempted to hide their involvement in the drug study by shredding documents, deleting online files and writing reports for doctors.

This latest scandal comes less than two months after Japanese Novartis executives were alleged to have exaggerated the benefits of a popular blood pressure drug.

 

ANOTHER LEGAL DEFEAT

9th Circ. Allows Expert Testimony In Novartis Jaw Injury Row
By Kira Lerner
New York (April 04, 2014, 4:19 PM ET) -- The Ninth Circuit on Friday overturned a lower court's order barring an expert from testifying that Novartis Pharmaceuticals Corp. bone drugs Aredia and Zometa caused a user to sustain jaw injuries, ruling that the doctor's testimony was not unreliable or irrelevant.

The appeals court panel said that the district court improperly excluded Dr. Richard Jackson’s testimony on the link between plaintiff Linda Messick’s use of bisphosphonates Aredia and Zometa and their development of bisphosphonate-related osteonecrosis of the jaw, according to the order. The panel also reversed

 

Management at Novartis.. That's an Oxymoron

At least the the Senior Management level. Bunch of overpaid, worthless idiots. They do not contribute one thing to the bottom line. Like to sit around and push out management objectives to all their reports. Novartis was so "high and mighty" when some of the other pharma companies were penalized. I personally remember individuals in the Legal and Regulatory bragging about they had never had those issues. First off that is BS and wonder how they feel about it now. Like I said there is NO Senior Leadership at Novartis. It turned into a company more concerned with how they looked to customers and investors than a true research/development and commercialization organization. They are more interested in diversity and making sure they meet quotas ( not sales quotas) than selling anything. Watched them promote people who should have been fired and would have been anywhere else. Only way they survive over the long haul is through consolidation or merger. Pathetic.

 

EPSTINE JIMENEZ & REINGOLD REPLIED "HUH? WHAT? DUH "
MASOW said " WE GOTS THIS CODE OF CONDUCT TESTS ON THAT IPAD & STUFF"

French antitrust watchdog probes Roche and Novartis over eye drug
Thu Apr 10, 2014 6:57am EDT

By Andrew Callus and Caroline Copley

PARIS/ZURICH, April 10 (Reuters) - France's competition authority is investigating drugmakers Roche and Novartis on suspicion they were involved in anti-competitive practices in relation to eye disease treatments, the companies said on Thursday.

This is the second time in as many months that the Swiss drugmakers have faced regulatory scrutiny over treatments for wet age-related macular degeneration (AMD)- a leading cause of blindness among the elderly.

In March, Italy's antitrust authority alleged the firms had colluded to prevent doctors prescribing Roche's cancer drug Avastin for AMD in favour of the more expensive drug Lucentis marketed by both Roche and Novartis. It fined the companies 182.5 million euros ($254.2 million).

A statement on the French authority's website said it had conducted "search and confiscation" operations on April 8 in relation to treatments for wet AMD, but it did not name the companies involved.

Spokeswomen for both Roche and Novartis confirmed the French authorities had started an investigation regarding treatments for the eye condition and said they would cooperate fully.

 

Raid confirmed....

PARIS—Competition authorities raided the French offices of Roche Holding AG ROG.VX -0.04% and Novartis AG NOVN.VX +0.95% earlier this week, part of an investigation into alleged price fixing of an eye treatment.

In a statement, the French Competition Authority said investigators had confiscated material related to treatments of age-related macular degeneration on Tuesday. The authority said the raids were conducted because of suspicion the companies, which it didn't name, had violated French antitrust law.

A spokeswoman for the authority declined to provide further details.

Separately, Roche and Novartis, both based in Basel, Switzerland, confirmed Thursday that authorities had visited their French offices in relation to the sale of Lucentis, a jointly marketed eye drug that treats macular degeneration, and Roche's Avastin, a cheaper cancer drug that some doctors use to treat the same disease.

Both companies said they would cooperate with the French authorities.

The French investigation follows a separate investigation by the Italian antitrust authority, which fined the companies more than €90 million ($123.6 million) each in March. Italian officials said the companies had colluded to channel demand toward Lucentis, which was developed by a Roche unit but is sold by both companies, pushing up costs for the health-care system. The companies denied the allegations and said they would fight them.

In its statement Thursday, Roche said it has no agreement with Novartis to restrict competition. It also said the two drugs address different diseases.

"Avastin and Lucentis are two different drugs and were developed for different therapeutic purposes," Roche said.

Lucentis and Avastin work in a similar manner, which has encouraged some doctors in Europe, the U.S. and elsewhere to prescribe Avastin for eye diseases because it is significantly less expensive.

In France, Lucentis costs €895.57 ($1,241.26) per injection, about 50 times more expensive than Avastin. Patients often require up to three injections a month.

Lucentis, which was developed by Roche's Genentech unit, is administered by injection in the eye. It is specifically designed to treat wet age-related macular degeneration, a disease that often causes severe vision loss in the elderly.

Roche sells the drug in the U.S., where it generated 1.69 billion Swiss francs ($1.9 billion) in revenue in last year. Novartis sells it in the rest of the world, where it generated $2.38 billion in sales.

Avastin is Roche's second-best-selling treatment with around 6.25 billion francs in sales last year.

Novartis owns roughly one-third of Roche's shares, despite the two companies competing in many markets.

 

Why don't you go and talk to Dr Donald Johns. He should know all the details.

 

MIAMI — Two Florida doctors who received the nation’s highest Medicare reimbursements in 2012 are both major contributors to Democratic Party causes

Topping the list is Dr. Salomon E. Melgen, 59, an ophthalmologist from North Palm Beach, Fla., who received $21 million in Medicare reimbursements in 2012 alone. The doctor billed a bulk of his reimbursements for Lucentis, a medication used to treat macular degeneration made by a company that pays generous rebates to its doctors.

Dr. Melgen appeared on investigators’ radar when a Medicare contractor noticed that he, a single practitioner, was billing for Lucentis at a significantly higher rate than his peers, Justice Department lawyers wrote in response to a suit the doctor filed against the Health and Human Services Department.

Each vial of the medication comes with up to four times the amount that a patient requires. Investigators said the doctor was using one vial to treat three or four patients, and billing as if he had purchased a new vial each time. The doctor would be reimbursed $6,000 to $8,000 for a vial that cost him $2,000.

The investigation concluded that in 2007 and 2008 alone, he overbilled by $9 million, which he was forced to pay back.

 

‘Yolanda’ hero Dario Raagas fights for his life vs giant drug firm Novartis
by Danny Petilla
Philippine Daily Inquirer
4:40 am | Saturday, April 12th, 2014

As a first responder during Supertyphoon “Yolanda,” Dario Raagas helped save lives. Now, the leukemia-stricken firefighter is fighting to save his own.

But his fight for survival has also meant battling pharmaceutical giant Novartis and its Manila subsidiary Novartis Healthcare Philippines (NHP), which he claims is denying him access to a life-saving drug after using him in clinical trials for one of its antileukemia medication.

“I was their guinea pig for almost eight years, now they don’t want me anymore,” Raagas, 43, said, adding that Novartis is asking him to pay P30,000 a month for Tasigna (generic name: Nilotinib), an expensive cancer-fighting drug used for treating chronic myelogenous leukemia (CML) that Raagas has been afflicted with since he was 30.

People afflicted with CML have a compromised ability to ward off diseases because their bone marrow produces abnormal levels of white blood cells.

Raagas said he participated since 2004 in what he described as clinical trials for Novartis’ other leukemia-fighting drug, Glivec (generic name: Imatinib), under its Glivec International Patient Assistance Program (Gipap).

Based on the website of Max Foundation, Novartis’ partner in the program, Gipap was designed “to provide Glivec free of cost to eligible patients in developing countries who meet specific medical and socioeconomic guidelines.”

Under Gipap, Raagas could access Glivec for free starting in 2004. Glivec was approved for leukemia treatment by the US Food and Drug Administration in 2001.

When his body became resistant to Glivec, Raagas’ doctors told him to try Tasigna, a change that, however, came with a hefty price tag.

P30K monthly

“I almost fainted when I received the e-mail [saying] Novartis was going to charge me P30,000 a month to use Tasigna,” Raagas said.

The billing came when Novartis broadened the Gipap program in 2008 under its Novartis Oncology Access (NOA) program.

According to the Novartis website, NOA “is a sustainable access solution through which Novartis shares the cost of its medicines with government healthcare systems, charities and other payers, or directly with patients without healthcare coverage who are unable to pay for the full cost of their medication.”

(The Inquirer called the NHP head office in Makati City to get the company’s side, but our calls were not returned. Again at press time on Friday, the Inquirer attempted to get a comment from Christine Liwanag, Novartis Philippines corporate affairs and market access director, but to no avail. Calls were not returned and she did not reply to a text message sent by the Inquirer.)

“Don’t they want me to eat anymore, buy my basic needs and provide for my wife?” asked the 17-year veteran firefighter who earns close to P30,000 a month, including benefits.

“His prognosis is not good, and he knows it. I hope he gets the help he needs,” said hematologist Dr. Gemma Udtujan, Raagas’ doctor since 2000 when he was diagnosed with CML.

‘Accelerated stage’

Udtujan, the only known specialist in blood diseases for adults in Leyte and Samar provinces, told Raagas that his leukemia was now in the “accelerated stage” (similar to stage 4 for cancer), making him prone to bleeding inside and outside his body.

Raagas, who, despite his condition, volunteered to go on duty on Nov. 7 as Supertyphoon “Yolanda” was threatening Eastern Visayas, was rushed to Divine Word University Hospital here on March 31 after he complained of severe body aches.

But because he could not afford Novartis’ leukemia-fighting drugs Glivec and Tasigna, Raagas had to take the cheaper Hydroxyurea (generic name: Litalir) whose side effects included darkening of skin and nails.

Medical problems seem to stalk the Raagas family. His brother Danilo died of cancer at age 27 in 1993. His mother Purificacion died of a stroke in June last year at age 75. The family also lost to Yolanda its ancestral house in Barangay Buri in Palo town, 12 kilometers south of this city.

Corporate citizenship

Raagas has questioned Novartis’ claims of corporate citizenship in countries where it does business like the Philippines.

“Are they here to help their patients or are they here for profit?” he asked.

Raagas’ 17 coworkers at the Bureau of Fire Protection (BFP) office in Palo, Leyte, immediately threw their support behind their embattled colleague.

“He manned the fort during and after Yolanda despite his delicate condition. That does not make him less of a hero,” said Insp. Agustin Ballo, fire marshal of Palo BFP.

Ballo and his staff have been scouring local blood banks, looking for possible donors of Raagas’ rare blood type, AB positive. Raagas has also appealed for help from Philippine Red Cross chair Richard Gordon, for easier access to the local blood bank’s supply, and to his boss, Interior Secretary Mar Roxas.

“I don’t want him to die; we want to explore all our options as long as it does not destroy us financially,” said Raagas’ wife, Marilou, who took a 100-km bus ride to Ormoc City to buy her husband’s other medication on Monday.

“I hope Mr. Thomas Weigold (NHP president and program director in Manila) is listening and will help us,” she added.

Novartis was once named one of Fortune magazine’s most admired companies, a turnaround from its widely criticized refusal in June 2009 to provide free vaccines to counter a flu epidemic in Third World countries, saying donor countries should foot the cost.

Novartis is cited as the second biggest drug company in the world, with 133,000 employees in 140 countries. In 2012, the drug giant reported worldwide net sales of $56.7 billion.

Its Philippine website said it raised a $1.5-million calamity fund to provide medicine and vaccines to Yolanda-affected communities. Its Filipino employees also raised a P330,000 donation for the victims and survivors of the supertyphoon.

 

Novartis to lay off 215 NJ support staff employees
Alexi Friedman/The Star-Ledger By Alexi Friedman/The Star-Ledger
April 15, 2014 at 6:30 AM, updated April 15, 2014 at 9:04 AM

Novartis Pharmaceuticals said it will lay off 215 support staff employees who work in New Jersey, part of a company-wide reorganization announced in January.

EAST HANOVER — Novartis will lay off 215 support staff employees in New Jersey, nearly all from its East Hanover headquarters, the company said Monday.

The job cuts come two months after Novartis Pharmaceuticals shed 92 employees who work in New Jersey, among the more than 750 sales and support staffers nationwide to lose their jobs.

Both actions are related to the drugmaker's company-wide reorganization announced in January, which it has said is aimed at supporting the launch of new products this year.

In the latest round of cuts, another 20 support staffers will lose their jobs at other locations throughout the country, Novartis said.

Affected workers will be offered severance packages and job placement assistance, according to Novartis, whose world headquarters is in Switzerland.

The company filed a required notice with the state Department of Labor about the New Jersey cuts, saying workers would be affected as of June 30.

 

It's just incomprehensible that a company can be trashed in less than 5 years. Management should be fined. I'm sure the govt. would love some additional revenue from evil corporate America. How DO these guys sleep at night?

 

The chickens are all coming home to roost. The trashing actually commenced around 2001. The guys have no trouble sleeping and almost always fall up. Gross huh?

 

Litigation round-up
Cooley LLP
Sarah K. diFrancesca
USA

March 14 2014

Investigations

In addition to the two complaints filed against Novartis on April 23 and April 26, 2013, including the complaint related to BioScrip discussed in ”Settlements” above, the DOJ has filed a third complaint alleging that Novartis paid kickbacks to CVS and other specialty pharmacies to induce them to recommend that patients order Novartis drugs Exjade, Gleevec, Tasigna, TOBI and Myfortic.

 

The Novartis-Glaxo-Lilly Swap’s Downside: Less Research

By Peter Waldman April 22, 2014

The asset shuffling announced today by three of the world’s biggest pharmaceutical companies makes sense at a time when drugmakers, facing a declining number of patent protections and soaring development costs, want to focus on their most profitable product lines. But consolidation could bode ill for the rest of us in two ways: Less competition may mean less spending on research to cure disease, and even higher drug prices.

In the three-company deal, Novartis (NVS) will buy GlaxoSmithKline’s (GSK) cancer drugs for as much as $16 billion and sell most of its vaccine division to Glaxo for $7.1 billion. Glaxo and Novartis will form a consumer-health joint venture, and Eli Lilly (LLY), for its part, will purchase Novartis’s animal-health unit for $5.4 billion. The trio is swapping assets “so that each can specialize in what they’re good at and make it even more profitable,” Ori Hershkovitz, a managing partner at Sphera Funds Management in Tel Aviv, told my colleague Oliver Staley.


By narrowing their focus, however, the companies will inevitably pare R&D spending and decrease scientific and market competition for the next health breakthroughs, says John LaMattina, who spent 30 years as a research scientist at Pfizer (PFE), the last three of them as its chief of global R&D. Since leaving the company in 2008, LaMattina says he’s watched Pfizer slash its R&D almost in half—after acquiring Wyeth Pharmaceuticals in 2009—as other drug companies have made similar cuts after mergers. “You will no doubt have fewer people doing cancer research and one fewer competitor in the oncology field” after Novartis swallows up Glaxo’s cancer unit, says LaMattina, a senior partner at PureTech Ventures in Boston.

Academic studies show that innovation clearly declines after drug companies merge, but may revive later, says Ken Getz at the Tufts Center for the Study of Drug Development. A recent Tufts Center study found cycle times for drug development and regulatory approval increase by nine months at companies after a merger, “a pretty substantial amount,” Getz says. An older study, however, shows researchers “hit a groove” again and their productivity recovers about three years after a merger.

Mergers can push up prices because competition declines, says John Hoadley of Georgetown University’s Health Policy Institute. When there are multiple drugs to treat the same disease, manufacturers negotiate more favorable rates, he says. “To the extent that choices are reduced, there’s less incentive to negotiate on price.”

Drug-company consolidation also hampers access in poor countries, says Tahir Amin, co-founder of the nonprofit group Initiative for Medicines, Access & Knowledge in New York. The race to develop and market antiretroviral drugs to combat HIV infection was instrumental in bringing costs down for sufferers in Africa and elsewhere in the developing world, he says. “If only a few companies can shape the market, it’s left to the few to decide what public health looks like.”

 

MATCH MADE IN HEAVEN !!!!!!!!!!!!

GSK under growing pressure from UK authorities, lawyers warn

Legal experts warn recent developments will have drawn more scrutiny from the Serious Fraud Office

By Denise Roland

9:00PM BST 21 Apr 2014

British drug giant GlaxoSmithKline will come under more pressure from prosecutors in the UK and US after admitting that it is investigating bribery allegations in several countries, legal experts have said.

The drug maker has, within the last two weeks, been forced to admit it is looking into bribery allegations in four countries: Poland, Iraq, Jordan and Lebanon.

These admissions come months after the company became embroiled in a major bribery scandal in China, where it was accused of funnelling as much as £320m to doctors and government officials to boost sales. GSK has said it is co-operating with the Beijing authorities’ investigation.

If the allegations are successfully prosecuted abroad, GSK may also have breached the UK’s powerful bribery laws. Britain’s Bribery Act, which counts failure of a company to prevent bribery as an offence, can be applied to domestic companies operating abroad and foreign companies with a presence in the UK.

Reuben Guttman, a director of US law firm Grant & Eisenhofer, said GSK could also be vulnerable to prosecution under America’s anti-corruption laws.

“GSK is a company that trades on our exchanges; a determination that it had engaged in bribery of foreign officials would have implications under the US Foreign Corrupt Practices Act,” he said.

“This means GSK could be subject to monetary penalties in the US and claims could be brought by the SEC or the Justice Department,” Mr Guttman added, pointing out that in the past “sanctions have been in the millions of dollars”.

Nathan Peacey, regulatory partner at law firm Bond Dickinson, said Britain’s Serious Fraud Office was likely to be considering action against the drug maker.

“The SFO is keen to create the impression that they have a number of ongoing investigations and that we can expect to see prosecutions in the not too distant future,” he said.

Mr Peacey said that if GSK was charged by the SFO, the most likely outcome would be a deferred prosecution arrangement (DPA), a new sentencing option which holds back prosecution as long as the company agrees to take certain measures to address any issues. DPAs were introduced in February as an alternative to prosecution, which under the Bribery Act could involve a ban from public contracts.

“The public interest in prosecuting and debarring GSK, one of the UK’s flagship companies, from selling medicines to hospitals the world over has got to be very questionable. If it turned out there were grounds to prosecute, GSK should surely be a prime candidate for a deferred prosecution agreement,” said Barry Vitou, corporate crime partner at law firm Pinsent Masons.

The SFO has not yet launched an investigation into GSK, a necessary prerequisite to charging the company, and will neither confirm nor deny its interest in the drug maker. However Glaxo has said it is in contact with both the SFO and the Department of Justice (DoJ) in the US “as appropriate”, and legal experts believe the authorities have been following the case with interest.

“The reality is that to all intents and purposes GSK is subject to regulatory scrutiny already. GSK is firmly in the cross hairs of the SFO and DoJ,” said Mr Vitou.

“Against this backdrop, a formal SFO investigation is more form over substance at this point. Whether or not GSK is a potential target for prosecution will, of course, be dependent on the actual conduct and not newspaper stories,” he added.

GSK has insisted that it does not have a systemic bribery problem, and that any wrongdoing it has unearthed was by rogue salesmen working outside the company’s control processes.

The company has also pointed out that the number of cases of sales and marketing misconduct it faces are “very similar to those reported by other companies in our sector”.

Legal experts, however, have said recent media attention on Glaxo could nonetheless make it more vulnerable to scrutiny from prosecutors.

“The problem GSK has is that it is a business under the spotlight. In that context, it [the news flow] is extremely unhelpful,” said Mr Vitou.

Mr Peacey added that the growing list of countries where GSK is investigating alleged bribery “makes it feel like it will be harder for them to demonstrate a single isolated incident”.

 

indeed. it's obvious that gsk sees more value as well as the solution to their current predicament in the novartis otc/vaccines business dna regarding values and behaviors.

 

If they are looking to Vaccines to inject some ethics into their culture then that explains why they were stupid enough to pay more than $7B for this shit hole - they are just stupid.

 

Spanish Consumers Ask Watchdog To Probe Roche, Novartis

By Melissa Lipman
New York (April 24, 2014, 3:38 PM ET) -- A Spanish consumer group on Thursday asked the country's antitrust watchdog to investigate claims that Hoffmann-La Roche Ltd. and Novartis AG conspired to keep patients from using a cheaper macular degeneration drug in favor of their more expensive Lucentis product.

La Organizacion de Consumidores y Usuarios, known as OCU, filed a formal complaint with Spain's Comision Nacional de los Mercados y la Competencia, asking the competition enforcer to look at the same conduct that has led to an antitrust probe in France and $250 million fine in Italy.

 

Lack of antitrust enforcement creating frenzy of mergers
Posted: Monday, April 28, 2014 11:00 am

The lack of antitrust enforcement within the Obama administration is becoming more and more apparent.

The Comcast/Times Warner merger clearly indicates that both of those companies — and they are well-connected to the Obama administration — have no fear of an antitrust action by the Department of Justice, led by Attorney General Eric Holder.

A new wave of mergers seems to be pending. Big pharmaceutical companies, probably taking notice of Holder’s inactivity on the antitrust front, are announcing deals that could further increase prices for pharmaceuticals and have a detrimental effect on competition.

The recent announcement of a $50 billion takeover battle for the maker of Botox and a multibillion dollar asset swap between Novartis and GlaxoSmithKline have “intensified the deals frenzy that is ripping the pharmaceuticals industry,” according to The Financial Times.

Deals announced within the past few days bring the total of global pharmaceutical mergers this year to approximately $140 billion.

GlaxoSmithKline has an agreement to sell its portfolio of cancer drugs to Novartis for $14.5 billion. Correspondingly, Novartis has agreed to sell most of its group vaccines unit to GSK for $7.1 billion. Additionally, they will combine their consumer health businesses in a joint venture that will be controlled by the English group.

Novartis will go on to sell its animal health business to Eli Lilly of the United States for $5.4 billion.

Bill Ackman, the hedge fund “genius” who almost destroyed J.C. Penney Co., is attempting to gain control of Allergan, the maker of Botox.

And Pfizer has made an offer to take over AstraZeneca in the biggest pharmaceutical deal ever made.

All this activity is a clear indication that antitrust laws are being flouted. These groups, realizing the Obama administration’s lack of zeal in enforcing the laws, are paying scant attention to the antitrust regulations.

Ultimately, if these deals go through the consumer will suffer. Prices will increase for their products and scarcities will be claimed.

These deals must be watched closely. Obama supporters should recognize that the Times Warner/Comcast deal, if approved, may be opening a floodgate.

 

Bloomberg News

Roche, Novartis Eye-Drug Collusion Allegations Studied by EU
By Aoife White May 06, 2014

The European Union’s antitrust chief said regulators are “gathering information” on whether Roche Holding AG (ROG) and Novartis AG (NOVN) colluded to prevent the use of Roche’s cancer drug Avastin to treat an eye disease.

The European Commission “will assess whether further action is needed in this area,” said Joaquin Almunia, the EU’s antitrust chief, in response to a question from an EU lawmaker dated yesterday. He declined to comment further on the “precise content of its current investigative activities.” The EU hasn’t opened a formal probe of the companies.

Roche and Novartis were fined 182.5 million euros ($254.4 million) by Italy for blocking sales of Avastin in favor of a more expensive drug, Lucentis, that the two companies market jointly for an eye malady known as wet age-related macular degeneration. Their actions cost Italy’s health system more than 45 million euros in 2012, the country’s antitrust authority said. Novartis is appealing the decision.

Italy’s conclusions aren’t “an indication of the existence, or not, of similar behavior in other member states,” Almunia said. The Italian case is “factually and legally, closely related to the Italian regulatory framework.”

Roche and Novartis described Avastin as “more dangerous” than Lucentis to sway doctors and health services, the Italian authority said in March. Italy only recently approved off-label use of a medicine where doctors may use a drug approved for one condition to treat another. This would allow them prescribe Avastin as an eye treatment.

‘No Agreement’

Antoine Colombani, a spokesman for Almunia, declined to comment beyond Almunia’s response. He said in March that the Italian case was “very specific due to the local regulation concerning off-label use. Avastin doesn’t have EU-wide approval as an eye drug.

‘‘Roche confirms there is no agreement between Roche and Novartis that restricts competition,’’ Nicolas Dunant, a spokesman for the company, said in an e-mail. Novartis hasn’t been informed of any investigation into alleged anti-competitive practices between itself and Roche in relation to Lucentis and Avastin, Anja von Treskow, a spokeswoman for the company, said in an e-mail.

France is also probing Roche and Novartis and last month raided companies it didn’t name to seek evidence. Almunia said the EU was in close contact with France and other national competition authorities.

The European Consumer Organisation, a consumer advocacy group known as BEUC, has asked the EU to investigate, saying it is unacceptable that ‘‘unethical tactics” by the companies have blocked sales of a cheaper alternative treatment.

“This case undoubtedly requires an EU-wide investigation as both medicines have been approved” by the European regulator and “are available in most EU member states,” Ilaria Passarani, Senior Health Policy Officer at BEUC, said in an e-mail. “Consumers have the right to access cheaper medicines.”

Care Costs

European authorities are monitoring drug prices more closely as governments face ballooning health-care costs because of an aging population and as the number of patients suffering from chronic diseases such as diabetes rises.

A study in 2010 found that Avastin worked as well as Lucentis in treating the disease. Roche hasn’t sought regulatory approval for the use of Avastin in the eye malady and has fought efforts in the U.S. to expand the use of the drug for that purpose.

 

Drugmaker Novartis fails to report side effects linked to Tasigna
May 9, 2014

Novartis Pharma K.K. failed to inform the government of at least 10 suspected cases of serious side effects involving its Tasigna leukemia drug, it was learned Friday.

The Health, Labor and Welfare Ministry has opened an investigation into whether the Novartis unit broke the pharmaceutical affairs law, sources said.

The Japanese unit of Swiss drug giant Novartis AG conducted a questionnaire with doctors between April 2013 and January this year to collect information on some 3,000 patients who use Tasigna, according to the company and other sources.

The questionnaire revealed some 30 suspected cases of serious side effects, with at least 10 of these subject to a duty to report stipulated by the law, the sources said.

But Novartis left the Tasigna cases unreported — until recently, the sources said. Sales representatives were aware of the side effect data produced by the questionnaire but did not report it to the corporate department in charge of the matter, according to the sources.

Two similar cases also came to light in connection with a scandal over the drugmaker’s inappropriate involvement in clinical trials.