Novartis milestones be proud ! Management take a bow !

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GEESH YOU NEED TO HIRE A FULL TIME BLOGGER TO CHRONICAL ALL OF NOVARTIS FAILURES !

UPDATE: Novartis Stops Key Trial Of Potential Blockbuster

DECEMBER 20, 2011, 5:37 A.M. ET.UPDATE: Novartis Stops Key Trial Of Potential Blockbuster .
-- Termination of study is a major blow for Novartis
-- Company had high hopes in organ-protection benefits of Rasilez
-- Warns Rasilez sales will take a hit
-- Rasilez so far hasn't been profitable
-- Analysts surprised by findings of high unwanted side effects
-- Analysts expect cuts in US sales force

Of DOW JONES NEWSWIRES
ZURICH (Dow Jones)--Novartis AG (NVS) was dealt a major blow Tuesday when it was forced to halt development of its high-blood pressure treatment Rasilez for wider use, due to unwanted side ...


-- Termination of study is a major blow for Novartis

-- Company had high hopes in organ-protection benefits of Rasilez

-- Warns Rasilez sales will take a hit

-- Rasilez so far hasn't been profitable

-- Analysts surprised by findings of high unwanted side effects

-- Analysts expect cuts in US sales force

ZURICH (Dow Jones)--Novartis AG (NVS) was dealt a major blow Tuesday when it was forced to halt development of its high-blood pressure treatment Rasilez for wider use, due to unwanted side ...
 






Novartis to halt some sales of high blood pressure drug

Boston Business Journal by Julie M. Donnelly, Reporter
Date: Tuesday, December 20, 2011, 3:03pm EST - Last Modified: Tuesday, December 20, 2011, 4:43pm EST..

Julie M. DonnellyReporter - Boston Business JournalEmail
Novartis has decided to halt sales of its approved high-blood pressure drug Rasilez, also called Tekturna, withdrawing the drug when used in combination with an ACE-inhibitor or ARB, due to side effects including non-fatal stroke, renal complications, hyperkalemia and hypotension. The side effects were discovered in a large, late-stage trial designed to gain approval for wider use, a spokeswoman told the Boston Business Journal today.

Novartis' decision to pull Rasilez, would not impact their operations in Massachusetts.

BECAUSE YOU KNOW , THEY NEED THE GEHRY/LIN PALACE TO CELEBRATE !
 






FDA joins probe into Gilenya patient's sudden death

Read more: FDA joins probe into Gilenya patient's sudden death - FiercePharma http://www.fiercepharma.com/story/fda-joins-probe-gilenya-patients-sudden-death/2011-

FDA is now investigating the death of a multiple sclerosis patient who'd just taken Gilenya for the first time. The agency joins Novartis ($NVS) in probing the 59-year-old patient's death within 24 hours of starting treatment. The patient had been monitored for 6 hours after that first dose, as required by Gilenya's label, without any apparent ill effects.

As InPharm points out, Gilenya has been tagged with some serious potential side effects, including a slowed heart rate after the initial dose. Patients whose heart rate slows often don't have symptoms, but they can experience dizziness, fatigue, and palpitations
 






Novartis News
The Swiss pharma company Novartis ranks in the top 10 of pharma companies,

It also owns the generic giant Sandoz.

"Unlike its competitor, GlaxoSmithKline, Novartis did not offer free flu vaccines during the H1N1 flu epidemic."

NICE ! Way to put patients first ! but hey at least frank ghery & maya lin got paid !!
 






LIKE A BROKEN RECORD

Novartis Drug Failures Prompt Sales, Profit Alerts
Dec. 20 2011 (Bloomberg) --
Novartis AG said drugs in late-stage development for depression and hypertension failed in studies, prompting warnings about earnings and sales forecasts.
The bad results emerged at the same time,
 






WHERE ARE YOU BOARD OF DIRECTORS ? HOW MANY BILLIONS MUST THESE EXECUTIVES SQUANDER ?

Novartis' Own Study Puts Tekturna On Its Death Bed
by: Jon Crowley January 3, 2012

When Novartis (NVS) commissioned its own study to determine if Tekturna could help patients with severe renal disease due to Type 2 diabetes it was hoping the results would bolster Tekturna's underwhelming sales. However, the study might lead to Novartis abandoning the drug altogether.

Novartis hoped that this study would build some momentum behind Tekturna sales to offset the lost sales of Diovan. Diovan, which will be facing generic competition in 2012, currently is Novartis' best selling medication. Since Tekturna represents less than 2% of Novartis total sales and the drug wasn't very profitable, its failure should not have a negative impact on earnings.

The study mostly represents a failure to increase future profits through Tekturna sales. This once promising drug might be sold to another drug company or possibly be abandoned all together.
 






Anonymous said:
Novartis News
The Swiss pharma company Novartis ranks in the top 10 of pharma companies,

It also owns the generic giant Sandoz.

"Unlike its competitor, GlaxoSmithKline, Novartis did not offer free flu vaccines during the H1N1 flu epidemic."

NICE ! Way to put patients first ! but hey at least frank ghery & maya lin got paid !!
Click to expand...

Not surprised. During the hight of SARS crisis in Canada, where they had the original patient, Novartis was the LAST pharma company to order sales reps off territory work. This even in the very area the hospital where the original patient was treated and few doctors got sick along with a couple who visited their doughter. That couple died later. One of the really insane local managers was urging reps to go and see 10-15 doctors per day. His reasoning was that since all other cos are not out there Novartis reps should take the advantage of free for all. The doctors did not think that was OK and only when reps reported doctors' objections to Novartis' reps going from one office to anther and potentially spreading the SARS, the management relented and ordered a break. Of course, this evil company was the first one to order the reps back, at least two weeks before others did.
For anyone who believes this co would not sell a drug with known (to insiders) dangerous side effects, I have a bridge to sell you.
The sadest part is that this was one of the best and honorable companies in the world before the Novartis brand too over in earnest. You see the result of that. Yes we are all (un)proud!
 






Anonymous said:
FDA cites violations at three Novartis plants
Tue Dec 6, 2011 3:14pm EST

(Reuters) - Drug regulators cited Novartis AG for "significant violations" of manufacturing regulations at its three generic drug plants in the United States and Canada, several of which were repeat offenses.

U.S. Food and Drug Administration investigators found a lack of proper procedures to ensure the drugs' sterility and correct composition. They also found inadequate cleaning at one of the plants, FDA said in a warning letter posted on Tuesday.

http://www.reuters.com/article/2011...ations-three-novartis-p-idUSTRE7B529N20111206
Click to expand...

OOPS! WE DID IT AGAIN! LINCOLN NEBRASKA PLANT CLOSED! OUCH, I HAVE A HEADACHE, I NEED SOME EXCEDRIN!


http://www.pharmalot.com/2012/01/novartis-suspends-production-at-a-key-plant/
 






NOVARTIS INEPT MANAGEMENT STRIKES AGAIN

Novartis unit to take $120 million charge on recall
Reuters – 1/9/2011 19 hrs ago.
ZURICH (Reuters) - Novartis's consumer health unit will take a $120 million hit in the fourth quarter after the Swiss drugmaker decided to voluntarily recall some products in the United States and move to improve quality standards at manufacturing sites.

Novartis said in a statement on Sunday that operations and shipments had been temporarily stopped at the Novartis Consumer Health (NCH) Lincoln, Nebraska facility, to accelerate improvements at the site.

"NCH will take a one-time charge currently estimated at $120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln facility," Novartis said in the statement.

The group is recalling all lots of select bottle packaging configurations from retailers of Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier, in the United States.

Novartis said there had not been any adverse events reported and that the U.S. Food and Drug Administration (FDA) was aware of the recall.

The products are being recalled due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out.
 


















Novartis recall hints at regulatory snowball
January 9, 2012 — 8:52pm ET | By George Miller

Uh-oh. Novartis (NVS) is recalling some OTC drugs made at a Nebraska plant that was recently shut down for maintenance and upgrades. The voluntary recall is one thing. But the recall's timing, so close to that of the voluntary plant shutdown, which occurred so close to a warning letter citing three of the drugmaker's other plants in North America (in Colorado, North Carolina and Canada), may imply the kind of systemic trouble that consent decrees are made of.

There are notable examples in which the FDA has pulled the court card. Ranbaxy, Johnson & Johnson, McNeil and Genzyme. In Ranbaxy's case, a product import ban substitutes for the plant shutdown.

In an announcement made Sunday, Novartis said its consumer health unit (NCH) is conducting the recall while Novartis Group "strengthens quality standards across all manufacturing sites." Recalled products are OTC heavyweights Excedrin, Bufferin and NoDoz, in addition to Gas-X.

"Hundreds of complaints" of broken and chipped pills are behind the recall, The Associated Press reports, as well as "inconsistent bottle packaging that could cause pills to be mixed up." Candidates for mix-ups with the recalled drugs are opioids Percocet, Endocet, Opana and Zydone, which are sold by Endo Pharmaceuticals ($ENDP), AP said.

AP reports the recall encompasses a combined 1,645 lots.

Novartis didn't state a time frame in its Nebraska remediation announcement. That's probably wise. The typical follow-on step in the poor-inspection/plant-shutdown/product-recall scenario is an announcement extending the remediation timeline.
 






Novartis Issues Recall and Suspends Operations at US Facility
Jan 12 , 2012

By: Rich Whitworth
ePT--the Electronic Newsletter of Pharmaceutical Technology

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention. According to a media release, the recall follows consumer complaints of chipped or broken pills and inconsistent bottle packaging line clearance practices that could lead to stray tablets, capsules, or caplets from other Novartis products. US consumers have been advised to either destroy or return unused product identified in the recall. No related adverse events have been reported.

Operations at the Lincoln, Nebraska, facility have been temporarily suspended to facilitate necessary planned improvements, with production gradually resuming in agreement with FDA. However, a timescale for a return to full operational capacity has not been established. Shipments from the site have also been halted.

Joseph Jimenez, CEO of Novartis, said in the press release, “The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines.”

UH YEAH OK JOE , WHATEVER YOU SAY ASSWIPE KETCHUP BOY
GARBAGE IN GARBAGE OUT = NOVARTIS
 






Is there any way that we as stockholders, can initiate a class action lawsuit against the "leadership" at Novartis. Any organization that has this level of incompetence needs to be held accountable for this sheer irresponsible leadership.
The other question the begs to be answered is: Why did Vasella sell such a substantial percentage of his stock holdings right before the Aliskiren announcement????
 






The Novartis Job Merry-go-round

Novartis to cut nearly 2,000 U.S. jobs

By Aaron Smith@CNNMoneyJanuary 13, 2012: 7:18 AM ET

NEW YORK (CNNMoney) -- The Swiss drugmaker Novartis is cutting nearly 2,000 jobs in the United States, anticipating the impending loss of patent protection on its blockbuster drug Diovan.

Novartis (NVS) said it is reducing its "field force" by 1,630 positions and cutting an additional 330 jobs at its headquarters. Though the company did not specify where exactly these job cuts would take place, its U.S. headquarters is in East Hanover, N.J., and it also has facilities in Massachusetts and California.


Diovan, a blood pressure medication, is the company's top products, bringing in more than $6 billion in revenue in 2010, the most recent year for sales data.

But Diovan will lose its patent protection in September 2012. When that happens, it will open the market for generic production by competing drugmakers such as Teva Pharmaceutics (TEVA) in Israel and Barr Pharmaceuticals in New Jersey, which will cause the price of the drug to plummet.

That's great news for patients with cardiovascular problems, but bad news for Novartis. The company has an ample supply of billion-dollar blockbusters, but none of them come close to Diovan.

After Diovan, the Basel-based drugmaker's top-selling medications are the cancer drugs Gleevec and Glivec, with nearly $4.3 billion in 2010 sales. Novartis has three other billion-dollar blockbusters, including Lucentis, a treatment for vision loss, at $1.5 billion in 2010, as well as the cancer drugs Zometa, also at $1.5 billion, and Femara, at nearly $1.4 billion.

Novartis is reacting to a failed study, announced in December, involving the drugs Rasilez and Tekturna for diabetics. The failure of the late-stage "altitude" study dried up another potential sources of sales for Novartis.

The job cuts will take place in the second quarter, the company said.
 






Anonymous said:
Is there any way that we as stockholders, can initiate a class action lawsuit against the "leadership" at Novartis. Any organization that has this level of incompetence needs to be held accountable for this sheer irresponsible leadership.
The other question the begs to be answered is: Why did Vasella sell such a substantial percentage of his stock holdings right before the Aliskiren announcement????
Click to expand...

Not a bad idea but think about it , all the execs already took their tens/hundreds of millions
 






The worst part. The executives still reap huge rewards and compensation for deplorable acts and lack of vision. They ride off into the sunset wealthy while the rest wait in the unemployment line.

Who said life was fair?
 






KILLING PATIENTS 1 at a TIME

Bloomberg

Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths
January 20, 2012, 12:27 PM EST

By Simeon Bennett

Jan. 20 (Bloomberg) -- European and U.S. regulators are reviewing Novartis AG’s Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months.

The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it’s also reviewing data on the medicine
 






Drug giant Novartis under investigation following patient deaths

By Tim Sandle
Jan 23, 2012 - 6 hours ago in Health

The pharmaceutical company Novartis is under investigation by the European Union following the deaths of 11 patients who took the drug Gilenya.

Novartis AG, the Swiss manufacturer of the multiple sclerosis drug, is subjected to a European wide investigation after at least 11 patients taking the medicine died (as announced by several media outlets and by the Multiple Schlerosis Resource Center). The drug which was taken goes under the brand name Gilenya. The drug is relatively new and was only licensed last year in the European Union (the drug was approved for use in the USA in 2010).
The deaths of the patients have led regulators to be concerned that Gilenya may trigger heart problems, especially after patients have taken their first dose. One patient reportedly died within 24 hours of taking the drug. In November 2011, a patient died in the USA in an event that may have been related to the drug or for other reasons. This remains the subject of an FDA investigation.
The investigation into the ill-health effects and into Novartis is being undertaken by the European Medicines Agency (EMA), which has similar status to the U.S. Food and Drug Administration (FDA). The EMA is expected to conclude its investigation in March. In addition to the European concerns, Fox News have reported that the FDA are also conducting their own data analysis and will make an announcement about the use of Gilenya in the near future.
Neither agency is stating, at this stage, that Gilenya is the cause and the investigations are continuing. The announcement, according to the San Francisco Chronicle, led to a steep fall in the Novartis share price. Gilenya is an expensive drug, with MS News estimating that a year’s supply for a patient would cost $48,000.
Bloomberg Business Week quotes from a statement from Novartis, which runs: “The role of Gilenya in the reported cardiovascular events has not been fully established and the cause of this patient’s death is still unexplained. Novartis continues to believe that Gilenya provides an important health benefit.”
In the meantime the drug has not been withdrawn. Gilenya is taken by some 30,000 patients worldwide. In light of the reported incidents the EMA has advised medical staff to increase the monitoring of patients. When the drug was released, medicines agencies were aware that there was a risk of slow heart rate, or bradycardia. The requirement for monitoring is also likely to become a recommendation in the product insert, which accompanies the medicine.
This recent situation follows on from further problems relating to Novartis. Earlier this year, the Digital Journal reported on concerns about quality control at Novartis after powerful prescription pain drugs and common over-the-counter medications, like Excedrin and Gas-X, made at a Novartis manufacturing plant became mixed-up. A further Digital Journal report also indicated that chipped and broken pills and inconsistent bottle packaging clearance practices had led to consumers potentially taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient.
These reports indicate that, despite twenty-first century technology, quality control errors can have serious consequences for patients and consumers of medicines.
 






Novartis Q4 profit halves to $1.2B on charges
By FRANK JORDANS, Associated Press – 31 minutes ago
DAVOS, Switzerland (AP) — Swiss drug maker Novartis AG reported a 47 percent drop in its fourth-quarter net profit Wednesday, citing a slate of exceptional costs from the ending of clinical trials to manufacturing problems and layoffs.

The Basel-based company said its net profit reached $1.21 billion in the fourth quarter, compared with $2.32 billion in the same period in 2010. Sales rose four percent to $14.78 billion in the Oct.-Dec. period.

"We experienced some disappointments in the fourth quarter, with Tekturna/Rasilez and with the need to improve our quality standards at some manufacturing sites," Chief Executive Joseph Jimenez said in a statement.

Novartis recently halted a clinical trial into wider uses of the hypertension drug Tekturna, which is known as Rasilez outside the United States, after it was found to cause increased complications in patients already taking other common hypertension drugs.

The company said it took an exceptional charge of $900 million in the fourth quarter as a result of the trial ending.

Two other experimental drugs were also dropped, leading to one-off charges of $160 million in the fourth quarter.

Manufacturing problems led the company to recall several over-the-counter drugs from the U.S. market earlier this month. The company closed the Lincoln, Nebraska, facility where the products were manufactured and took a charge of $115 million for the temporary production halt.

Novartis said it would also book charges of $288 million for over 2,000 job cuts announced last year. Many of those were in the United States, where the company expects to see a sharp dip in sales with the expiry of another hypertension drug, Diovan.

"I am quite bullish on the future growth prospects for the company once we get Diovan out of the base," said Jimenez.

In a conference call, Jimenez told reporters that he didn't expect any further job cuts in 2012 "unless conditions change." <- ( LOOKY LOOKY !!!!!!!)

The results were in line with analyst expectations, but shares fell 2.5 percent to 50.70 Swiss francs ($54.58) on the Zurich exchange as traders focused on the company's cautious outlook for 2012.

"We consider the current results to be very strong, but the outlook particularly for 2012 will likely disappoint investors," Zuercher Kantonalbank said in an analyst note.

Jimenez said his company supported a European medicines agency investigation into its multiple sclerosis drug Gilenya, following the death of one patient.

Gilenya contributed $494 million to sales results last year.

"We are confident that Gilenya will continue to be a growth driver," said Jimenez.
(BWAHAHAHAHAHAHAHAHAHAHAHAHAHA)

For the full year 2011, Novartis reported a net profit of $9.25 billion, down seven percent from $9.97 billion the previous year.
 






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