FDA cites violations at three Novartis plants

2011-12-06T12:30:32Z

(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.

Reuters) - The government urged the Supreme Court to rule in favor of a generic drugmaker in a case over how companies can fight brand-name rivals to get cheaper drugs to market.

The nation's top court on Monday heard arguments about whether the generics company, Reuters) - Regulators and drugmakers need to find ways to make more clinical data openly available, since vital knowledge about fighting disease is often locked away in confidential databases, the head of the U.S. drugs watchdog said on Monday.

Food and Drug Administration

FDA warns Mylan on Puerto Rico plant violations

2011-11-22T08:00:24Z

(Reuters) - U.S. drug regulators found "significant violations" of manufacturing regulations at Mylan Inc's Caguas, Puerto Rico, facility, according to a letter posted on Tuesday.

A NEW ORLEANS (Reuters) - The American Medical Association threw its support behind government efforts to ensure the supply of lifesaving medicines but stopped short of recommending financial penalties against drug companies.

The influential...

FDA spurns Merck contraceptive, glaucoma drug

2011-11-09T13:00:20Z

(Reuters) - The Food and Drug Administration has declined to approve an oral contraceptive and a glaucoma treatment being developed by Merck & Co Inc, but the drugmaker did not disclose details of the agency's concerns.

Merck already sells both products in some overseas markets. The contraceptive, cal...

Petition demands US label genetically engineered food

2011-10-04T19:30:55Z

Supporters and producers of organic foods petitioned the US government Tuesday for mandatory labeling of genetically engineered foods, and encouraged consumers to go online and join the cause.

The 21 petitioners want the Food and Drug Administration (FDA) to use the full power of the law to ensure that consumers know when they are buying food made with genetically modified ingredien...

U.S. FDA guidance on biosimilars may be imminent

2011-09-23T14:00:10Z

NEW YORK (Reuters) - The U.S. Food and Drug Administration appears to be on the verge of issuing long-awaiting guidelines for the development of generic versions of complex biotechnology medicines.

The FDA still plans to release the guidance by the end of the year but the agency's top drug official,

Fear in US as drug shortages mount

2011-09-04T15:30:10Z

Shortages of vital drugs, particularly cancer-fighting medication, have raised concerns in the United States, where regulators often have to race to try to find replacements.

A recent report by the Food and Drug Administration (FDA) found that the number of important treatments that are difficult or impossible to find nearly ...

FDA finds drug research firm faked samples, documents

2011-07-27T13:00:53Z

WASHINGTON (Reuters) - Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.

The Food and Drug Administration said on Tuesday two 2010 ins...

FDA finds U.S. drug research firm faked documents

2011-07-26T16:00:25Z

The Food and Drug Administr...

Pfizer will suspend U.S. sales of poultry drug

2011-06-08T14:00:20Z

WASHINGTON (Reuters) - Pfizer Inc has agreed to suspend U.S. sales of a popular poultry drug after a study found the drug increased levels of a carcinogen in chickens, U.S. health officials said on Wednesday.

A study from the Food and Drug Administra...

Drug firms go online to test and sell medicines

2011-06-08T05:00:12Z

LONDON (Reuters) - Prompted by the soaring cost of developing and marketing their medicines, drug companies are embracing the Internet in a bid to drive down costs.

The hope is that digital tools will not only make them more efficient, but also smarter and nimbler.

Pfizer, the world's biggest drugmaker, is pushing the e...

Junior explorer jumps on potash resource projection

2011-05-16T19:30:13Z

This as a drug delivery stock popped on a new submission to the FDA Monday

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Stockhouse Canadian Small and Micro-cap Stock Report for Monday, May 16, 2011

India's Ranbaxy shares fall on US penalty threat

2011-05-05T06:30:33Z

Shares in India's largest drugmaker Ranbaxy Laboratories fell by nearly nine percent on Thursday on reports it may have to pay over $1 billion to resolve ongoing regulatory issues in the United States.

Ranbaxy, a unit of Japan's

Special report: When the drugs don't work

2011-03-31T02:30:33Z

LONDON (Reuters) - David Livermore is in a race against evolution. In his north London lab, he holds up an evil-smelling culture plate smeared with bacteria. This creamy-yellow growth is the enemy: a new strain of germs resistant to the most powerful antibiotics yet devised by humankind.

Out on t...

Amylin, Lilly diabetes drug falls short of Novo's

2011-03-03T06:00:17Z

NEW YORK (Reuters) - A long-awaited experimental diabetes medicine from Eli Lilly & Co and Amylin Pharmaceuticals Inc failed to match up to Novo Nordisk A/S

FDA: Stomach acid drugs can lower magnesium

2011-03-02T11:30:24Z

WASHINGTON (Reuters) - Prescription ulcer drugs such as AstraZeneca Plc's blockbuster, Nexium, will carry a new warning that long-term use may cause low magnesium levels, U.S. health officials said on Wednesday.

Low ma...

U.S. seeks more data on Protalix drug; shares sink

2011-02-25T08:00:12Z

WASHINGTON (Reuters) - Health regulators want more data on Protalix Biotherapeutics Inc and Pfizer Inc's experimental drug for Gaucher disease before deciding whether to approve the therapy for patients with the rare geneti...

FDA wants more data on Pfizer-Protalix drug

2011-02-25T06:00:06Z

CHICAGO (Reuters) - U.S. health regulators have asked for additional data to support Pfizer Inc's and Protalix Biotherapeutics Inc's new drug application for taliglucerase alfa, a treatment for Gau...

FDA cites Sanofi over drug side effect reporting

2011-02-22T08:00:10Z

WASHINGTON (Reuters) - The Food and Drug Administration warned Sanofi-Aventis SA's U.S. unit for failing to tell the agency about reports of possible serious side effects in a timely manner.

In a January 28 letter ...

Obama budget targets brand name medicines

2011-02-15T07:00:15Z

WASHINGTON (Reuters) - Big pharmaceutical companies could face increased competition from generic drugmakers under two proposals put forth by the Obama administration on Monday despite earlier savings extracted from drugmakers as part of last year's healthcare law.

President Barack Obama, as part of his 2012 budget proposal...

Drugmakers could take hit under Obama budget

2011-02-14T08:30:21Z

WASHINGTON (Reuters) - The Obama administration is turning to the pharmaceutical industry to squeeze out more savings to help reduce the deficit and cover other health initiatives such as the implementation of last year's healthcare overhaul.

In his fiscal 2012 budget proposal released on Monday, President Barack Obama took...

MannKind says FDA rejects Afrezza diabetes device

2011-01-19T14:31:12Z

BOSTON (Reuters) - MannKind Corp said on Wednesday that U.S. regulators have rejected Afrezza, its experimental device to treat diabetes, and will require two new clinical trials before approving the product.

MannKind's shares fell 7.3 percent to $9.11 before being halted pending the news.

Afrezza is a...

FDA to review growth hormone safety, follows EU

2010-12-22T15:31:40Z

WASHINGTON (Reuters) - U.S. health officials are taking a closer look at recombinant human growth hormone products made by Pfizer, Novartis and other drugmakers to see whether they increase the risk of death.

The move comes on the heels of a Frenc...

FDA warns Tessalon cough capsules a risk to kids

2010-12-14T17:00:46Z

FDA warns Forest Laboratories' Tessalon cough capsules look like candy, pose risk to kids

The U.S. Food and Drug Administration says that Tessalon liquid cough capsules should be kept in child-proof containers because they look like candy ...

Valeant says Chairman Bill Wells has resigned

2010-12-13T06:30:24Z

Valeant Pharmaceuticals International Inc. said Monday that Chairman Bill Wells resigned from the board to pursue other interests.

The change comes as Valeant deals with setbacks for two of its most advanced drug candidates.

The Canadian drugmaker said board member Robert Ingram has been named a...

Supreme Court to decide generic drug labeling issue

2010-12-10T17:00:20Z

WASHINGTON (Reuters) - The U.S. Supreme Court said on Friday that it would decide whether generic drug companies could be sued under state law over allegations they failed to provide adequate label warnings about potential side effects.

The nation's highest court will consider whether federal law preempted such ...

AstraZeneca cancer drug carries toxic risks: FDA

2010-11-30T19:30:57Z

An experimental drug developed by AstraZeneca to treat a rare form of thyroid cancer carries "substantial toxicity" risks, the US Food and Drug Administration warned Tuesday.

Thirty-one percent of patients taking the drug, vandetanib, experienced serious side effects compared to 13 percent who did when taking a placebo.

Side...

Despite Abbott Labs Suit, Impax Labs Moves Ahead With Generic Simcor Drug

2010-11-29T14:50:13Z

...

How do I Estimate the Cost of New Drug Development?

2010-11-30T12:38:21Z

...

A.M. Vitals: FDA Extends Merck KGaA’s Cladribine Review

2010-11-29T15:01:29Z

...

U.K. Foods Standards Agency Says Cloned Meat, Milk is Safe

2010-11-29T14:54:01Z

...

FDA Approves Lilly's Axiron

2010-11-29T14:50:08Z

...

CNS Therapeutics Gets FDA Nod

2010-11-29T14:35:13Z

...

Drug Development Spotlight: The mTOR's New Clothes?

2010-11-29T14:50:00Z

...

FDA pulls Darvon painkiller due to safety risks

2010-11-19T08:31:02Z

FDA says maker of Darvon painkiller will withdrawal drug after evidence of deadly heart risks

The maker of the painkiller Darvon is pulling the drug off the market under pressure from public health officials who say it causes dangerous heart rhythms.

The Food and Drug Administration says the drugmaker Xanodyne will ...

Amgen bone drug OK'd for use in cancer patients

2010-11-18T18:30:20Z

FDA expands approval of Amgen bone-strengthening drug to cancer patients with solid tumors

Biotech drugmaker Amgen says federal health regulators approved its bone-strengthening drug for preventing fractures and skeletal-problems in patients with advanced cancer.

The Food and Drug Administration cleared the ...

Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of Benlysta for Systemic Lupus Erythematosus

2010-11-29T14:35:08Z

...

Morphine Sulfate Solution Approved

2010-11-29T14:46:00Z

...

A.M. Vitals: Xerox and Other Tech Firms Aiming for Insurance Exchange Contracts

2010-11-29T15:01:27Z

...

Clinical Data, Inc. Announces Issuance of New U.S. Patent for Vilazodone

2010-11-29T14:35:07Z

...

Getting Big by Going Small

2010-11-29T14:50:55Z

...

FDA More Cautious About Drug Safety

2010-11-29T14:35:06Z

...

Trimethobenzamide

2010-11-30T13:49:25Z

...

Omeprazole

2010-11-30T13:48:27Z

...

Cloned Food

2010-11-30T13:50:08Z

...

Cloning

2010-11-30T13:50:08Z

...

Pharming (genetics)

2010-11-30T13:48:35Z

...

Telavancin

2010-11-30T13:49:16Z

...

Forest Labs Is Green With Cash (FRX, PFE, AMGN, BIIB, GSK)

2010-11-29T14:43:55Z

...

Adulteration

2010-11-29T14:42:40Z

...

Vivus Diet Drug Denied

2010-11-29T14:40:24Z

...

Review Says Momenta's Aid Taints FDA's OK of Heparin

2010-11-29T14:35:01Z

...

Ex-Glaxo Attorney Charged With Obstruction

2010-11-29T14:35:01Z

...

6 Companies With Upcoming FDA Decisions and Bullish Options Sentiment

2010-11-29T14:49:12Z

...

Can Investors Warm To Warner Chilcott?

2010-11-29T14:43:41Z

...

A.M. Vitals: Sanofi (Again) Presses Genzyme to Talk

2010-11-29T15:01:27Z

...

What is cloned beef?

2010-11-29T15:48:13Z

...

How have campaign contributions and lobbying efforts influenced policy on an issue you care about?

2010-11-29T15:41:57Z

...

Heparin Recall and Litigation

2010-11-29T14:47:04Z

...

3 Upcoming FDA Decisions to Watch Closely

2010-11-29T14:49:09Z

...

The future of pharmaceutical manufacturing and research

2010-11-29T15:20:55Z

...

Gatifloxacin

2010-11-30T13:10:01Z

...

Do drugs really have an expiration date or is this a marketing ploy

2010-11-29T15:20:54Z

...

The future of pharmaceutical research

2010-11-29T15:20:54Z

...

Gepirone

2010-11-30T13:10:01Z

...

Does poor nutrition and junk foods lead to pharmaceutical profits

2010-11-29T15:20:17Z

...

Investing in health care stocks

2010-11-29T15:36:21Z

...

Tylenol recall: FDA investigates hundreds of serious Tylenol side effects

2010-11-29T15:20:53Z

...

The case against cloning animals for human consumption

2010-11-29T15:40:39Z

...

Escitalopram

2010-11-30T13:09:50Z

...

Questioning the safety of our food to health

2010-11-29T15:20:13Z

...

Drug Identification Regulations

2010-11-29T14:35:39Z

...

PhRMA Statement on the FDA Approving Biosimilars

2010-11-05T06:44:32Z

...

Drug Shortages Cause Big Concerns

2010-11-29T14:29:01Z

...

Medco, Amgen Weigh in On Biosimilars at FDA Meeting

2010-11-03T18:01:54Z

...

FDA approves kidney cancer drug to treat brain tumors

2010-11-02T07:00:27Z

Everolimus, which is marketed under the name Afinitor by Swiss pharmaceutical giant Novartis, was approved to treat tumors caused by the genetic condition tuberous sclerosis that cannot be resolved with surgery, the US Food and Drug Administrati...

Why the FDA Keeps Saying 'No' to Diet Pills

2010-11-29T14:48:45Z

...

Pozen CEO Discusses Q3 2010 Results - Earnings Call Transcript

2010-11-29T14:48:34Z

...

AMAG Pharmaceuticals Announces Financial Results for the Third Quarter Ended September 30, 2010 and a Restructuring Plan to Reduce Operating Expenses

2010-11-03T17:51:22Z

...

Should drug companies be regulated more than they are now

2010-11-29T15:05:23Z

...

Orphan drugs increase options for those with rare disease

2010-11-29T15:04:15Z

...

Bristol-Myers: FDA wants factory's problems fixed

2010-10-26T10:30:35Z

Bristol-Myers: FDA finds problems at Puerto Rico plant; could delay approval of new drugs

U.S. regulators have cited drugmaker Bristol-Myers Squibb Co. for multiple deficiencies at its Puerto Rico manufacturing plant, including glass particles in drug vials and possible contamination of sterile drug products.

Does FDA have jurisdiction over physicians' promotional efforts?

2010-10-26T10:10:11Z

...

Medication and You.

2010-11-03T09:40:11Z

...

DNA FREE Event and Magnetic Products Information

2010-11-03T01:45:49Z

...

ADHD and Medication: An Evidence-Based Review

2010-11-03T09:38:50Z

...

Weight Loss Drug Approval Could Mean Big Gains For Orexigen Therapeutics

2010-11-02T12:29:17Z

...

Amylin Says FDA Wants More Testing On Bydureon

2010-11-02T12:40:27Z

...

Good News Keeps Coming for Amgen With Aranesp Vote

2010-11-02T12:15:31Z

...

Jazz Feels No Pain Following FDA Rejection

2010-11-02T12:15:31Z

...

Risk management, drug safety raise challenges for sponsors and healthcare providers

2010-11-02T13:57:17Z

...

The Truth About Big Pharma : Exposing Evil Pharmaceutical Companies

2010-11-02T21:52:45Z

...

Novartis Halts Development of Two Drugs: Biotech's Latest Tribulations

2010-10-12T15:49:01Z

...

Approval of Questcor's Athcar Drawing Near

2010-10-12T15:49:05Z

...

Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato Loxapine) NDA

2010-10-11T22:15:06Z

...

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia

2010-10-11T22:15:11Z

...

FDA holds up approval of Alexza's anti-psychotic drug

2010-10-11T12:00:08Z

BANGALORE (Reuters) - U.S. health regulators declined to approve Alexza Pharmaceuticals Inc's drug to treat agitation in patients with schizophrenia or bipolar disorder, potentially delaying approval of its lead drug by more than a year, ...

Star Scientific-Smokeless Tobacco

2011-01-04T12:31:04Z

FILE - In this Sept. 28, 2010 file photo, smokeless tobacco products, including Ariva, are displayed in Richmond, Va. Tobacco maker Star Scientific Inc. says it has developed a moist smokeless tobacco with lower levels of cancer-causing chemicals than any other tobacco product now on the market. Star Scientific says the "modified-risk" label that the

FDA Obesity Treatments

2010-12-03T21:31:29Z

In this product photograph provided by Allergan, Inc., the LAP-BAND System is displayed. An FDA panel will vote whether to recommend expanding the use of a stomach shrinking band currently approved just for the morbidly obese. (AP Photo/Allergan, Inc.) NO SALES

Sen. Tom Harkin, D-Iowa, speaks to reporters in Des Moines, Iowa. The Food and Drug Administration would have to step up inspections of food processors under legislation the Senate is expected to pass this week. The bill, which...

Novartis Settlement

2010-09-30T12:45:34Z

U.S. Attorney Zane David Memeger, from left, speaks as Nicholas DiGiulio from the Department of Health and Human Services and Thomas Doyle from the Food and Drug Administra...

Abortion Pill 10 Years

2010-09-26T21:30:31Z

FILE - In this Jan. 11, 1995 file photo, inventor of the RU-486 abortion-inducing drug, Professor Emile-Etienne Beaulieu, holds the pills in Paris. Ten years ago, on Sept. 28, 2000, after long and bitter debate, the Food and Drug Administration approved use of the abortion pill by American wom...

News on Food And Drug Administration

Amgen, Watson to collaborate on cancer biosimilars

FDA cites violations at three Novartis plants

FDA warns Mylan on Puerto Rico plant violations

FDA spurns Merck contraceptive, glaucoma drug

Petition demands US label genetically engineered food

U.S. FDA guidance on biosimilars may be imminent

Fear in US as drug shortages mount

FDA finds drug research firm faked samples, documents

FDA finds U.S. drug research firm faked documents

Pfizer will suspend U.S. sales of poultry drug

Drug firms go online to test and sell medicines

Junior explorer jumps on potash resource projection

India's Ranbaxy shares fall on US penalty threat

Special report: When the drugs don't work

Amylin, Lilly diabetes drug falls short of Novo's

FDA: Stomach acid drugs can lower magnesium

U.S. seeks more data on Protalix drug; shares sink

FDA wants more data on Pfizer-Protalix drug

FDA cites Sanofi over drug side effect reporting

Obama budget targets brand name medicines

Drugmakers could take hit under Obama budget

MannKind says FDA rejects Afrezza diabetes device

FDA to review growth hormone safety, follows EU

FDA warns Tessalon cough capsules a risk to kids

Valeant says Chairman Bill Wells has resigned

Supreme Court to decide generic drug labeling issue

AstraZeneca cancer drug carries toxic risks: FDA

Despite Abbott Labs Suit, Impax Labs Moves Ahead With Generic Simcor Drug

How do I Estimate the Cost of New Drug Development?

A.M. Vitals: FDA Extends Merck KGaA’s Cladribine Review

U.K. Foods Standards Agency Says Cloned Meat, Milk is Safe

FDA Approves Lilly's Axiron

CNS Therapeutics Gets FDA Nod

Drug Development Spotlight: The mTOR's New Clothes?

FDA pulls Darvon painkiller due to safety risks

Amgen bone drug OK'd for use in cancer patients

Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of Benlysta for Systemic Lupus Erythematosus

Morphine Sulfate Solution Approved

A.M. Vitals: Xerox and Other Tech Firms Aiming for Insurance Exchange Contracts

Clinical Data, Inc. Announces Issuance of New U.S. Patent for Vilazodone

Getting Big by Going Small

FDA More Cautious About Drug Safety

Trimethobenzamide

Omeprazole

Cloned Food

Cloning

Pharming (genetics)

Telavancin

Forest Labs Is Green With Cash (FRX, PFE, AMGN, BIIB, GSK)

Adulteration

Vivus Diet Drug Denied

Review Says Momenta's Aid Taints FDA's OK of Heparin

Ex-Glaxo Attorney Charged With Obstruction

6 Companies With Upcoming FDA Decisions and Bullish Options Sentiment

Can Investors Warm To Warner Chilcott?

A.M. Vitals: Sanofi (Again) Presses Genzyme to Talk

What is cloned beef?

How have campaign contributions and lobbying efforts influenced policy on an issue you care about?

Heparin Recall and Litigation

3 Upcoming FDA Decisions to Watch Closely

The future of pharmaceutical manufacturing and research

Gatifloxacin

Do drugs really have an expiration date or is this a marketing ploy

The future of pharmaceutical research

Gepirone

Does poor nutrition and junk foods lead to pharmaceutical profits

Investing in health care stocks

Tylenol recall: FDA investigates hundreds of serious Tylenol side effects

The case against cloning animals for human consumption

Escitalopram

Questioning the safety of our food to health

Drug Identification Regulations

PhRMA Statement on the FDA Approving Biosimilars

Drug Shortages Cause Big Concerns

Medco, Amgen Weigh in On Biosimilars at FDA Meeting

FDA approves kidney cancer drug to treat brain tumors

Why the FDA Keeps Saying 'No' to Diet Pills

Pozen CEO Discusses Q3 2010 Results - Earnings Call Transcript

AMAG Pharmaceuticals Announces Financial Results for the Third Quarter Ended September 30, 2010 and a Restructuring Plan to Reduce Operating Expenses