BioSpace.com News

Teva Pharmaceutical Industries Limited Victim of Product Tampering - Report

Thu, 13 Jun 2013 12:00:00 AM GMT

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Regulators in France have reported the first findings of an investigation into Teva Pharmceutical after some zopiclone sleeping pills were found in packs of the diuretic furosemide.The country's National...

"Suspicious" Death in France After Teva Pharmaceutical Industries Limited Medicine Alert

Tue, 11 Jun 2013 12:00:00 AM GMT

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French police are investigating the death of a 92-year-old man as "suspicious" after he was given medicine that may have been wrongly labelled as a diuretic drug, a police representative said on Sunday.The...

GlaxoSmithKline Probes Allegedly Fraudulent Data in Study Written by Employees

Tue, 11 Jun 2013 12:00:00 AM GMT

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In the latest instance in which a global drugmaker has become embroiled in a scandal over published study results, GlaxoSmithKline is investigating whether a paper that appeared in Nature Medicine three years...

GlaxoSmithKline's Avandia Vote Ends an Era of Drug Safety Scandals

Mon, 10 Jun 2013 12:00:00 AM GMT

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Avandia, once the most-used diabetes pill on the planet, was all but finished. After concerns emerged that it might cause heart attacks, the Food and Drug Administration in 2010 put severe restrictions on Avandia...

Apollo Pharmacy Halts Sale of Ranbaxy Laboratories Drugs

Mon, 10 Jun 2013 12:00:00 AM GMT

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Apollo Pharmacy, the country's largest branded drug retail network with over 1,500 outlets, has temporarily suspended sale of medicines manufactured by Ranbaxy Laboratories. It has also stopped further procurement...

Another Novartis AG Manufacturing Facility Gets an FDA Lashing

Thu, 06 Jun 2013 12:00:00 AM GMT

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Novartis employees may take ceo Joe Jimenez seriously when he insists that quality matters (remember this?), but the FDA is not taking him at his word. Once again, the agency has issued the drugmaker a warning...

Johnson & Johnson Recalls 32 Million Boxes of Contraceptives From 43 Countries

Wed, 05 Jun 2013 12:00:00 AM GMT

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Even as Johnson & Johnson labors to crawl out from under a mountain of product recalls, the health care giant continues to yank medicines and devices on a regular basis. The latest example involves the Cilest...

FDA Raises Safety Concerns at Hospira, Inc. Plant in India

Thu, 30 May 2013 12:00:00 AM GMT

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Hospira Inc said it received a warning letter from the U.S. Food and Drug Administration raising concerns about contamination of drugs manufactured at its facility in India. The letter followed an October inspection...

Fresenius Kabi AG Voluntarily Recalls One Lot of Magnesium Sulfate Injection

Tue, 28 May 2013 12:00:00 AM GMT

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Fresenius Kabi USA Initiates Voluntary Recall of Single Lot of Magnesium Sulfate

LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi USA announced today it has initiated...

Those Johnson & Johnson Recalls Keep on Coming: Tylenol Bottles Yanked From Brazil

Thu, 23 May 2013 12:00:00 AM GMT

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Despite assorted efforts to get its corporate house in order, Johnson & Johnson simply cannot escape manufacturing problems. The latest escapade has occurred in Brazil, where more than 3.3 million bottles of...

Takeda Pharmaceutical Co. Ltd. Recalls Batch of Anemia Therapy Rienso in Switzerland After Patient Death

Wed, 22 May 2013 12:00:00 AM GMT

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Amag Pharmaceuticals Inc said its marketing partner in Switzerland, Takeda Pharmaceutical Co Ltd, is recalling a batch of Amag's anemia drug, Rienso, because of a death and several cases of hypersensitivity...

Johnson & Johnson Licence Revoked Over Baby Powder Concerns

Mon, 06 May 2013 12:00:00 AM GMT

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Health officials have revoked Johnson & Johnson's license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder...

Johnson & Johnson Halts Tylenol Production in South Korea Over Mishap

Mon, 06 May 2013 12:00:00 AM GMT

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Johnson & Johnson may have a new image campaign to help consumers, investors and physicians overlook the cascade of recalls and scandals (see this), but such promotional efforts are no substitute for improved...

Takeda Pharmaceutical Co. Ltd. Penalized Over Quality Failure

Mon, 22 Apr 2013 12:00:00 AM GMT

Takeda Pharmaceutical has been penalised by its local trade organisation over the quality failings that led to the recall of an injectable dietary supplement product. The Osaka Pharmaceutical Manufacturers Association (OPMA) has suspended Takeda's activities as chair of the good manufacturing practice (GMP) committee, and vice-chair of the pharmaceutical laws and regulations committee for six months...

GlaxoSmithKline's Avandia Gets Second Look at Heart Risk by U.S.

Fri, 12 Apr 2013 12:00:00 AM GMT

GlaxoSmithKline Plc (GSK)s Avandia, the best-selling diabetes pill that was pulled off the market in Europe and tightly restricted in the U.S. because of its heart risks, will undergo another regulatory review. The U.S. Food and Drug Administration plans a June meeting to discuss a re-analysis of a 2009 study, known as Record, that found Avandia more than doubled the risk of heart failure, without...

Dr. Reddy's Laboratories, Inc. and Glenmark Pharmaceuticals Recall Drugs in U.S. Over Odors

Tue, 19 Mar 2013 12:00:00 AM GMT

Dr Reddys Laboratories has recalled its anti-depression drug Citalopram from the US market, following complaints of a strong odour. Mumbai-based Glenmark Pharmaceuticals too recalled its allergy and asthma drug in February, after reports that some batches of bottle containing the Montelukast sodium tablets were emitting an odour. Dr Reddys generates more than 50 per cent of its revenues from the...

Salmon Hormone Sold by Novartis AG, Upsher-Smith Laboratories and More May Contain Too Much Cancer Risk

Tue, 05 Mar 2013 12:00:00 AM GMT

A salmon hormone used to treat post- menopausal osteoporosis may not reduce bone fractures enough to outweigh the drugs cancer risks, U.S. regulators said. Three studies on oral, injectable and nasal calcitonin- salmon formulations sold by Novartis AG (NOVN), Upsher-Smith Laboratories Inc. and other companies showed unreliable or disappointing results, Food and Drug Administration staff said today...

Affymax, Inc. Plunges After Recall of Omontys Due to Deaths

Wed, 27 Feb 2013 12:00:00 AM GMT

PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (AFFY) and Takeda Pharmaceutical Company Limited (Takeda) today have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been...

Ranbaxy Laboratories Slams Consumers for Seeking Lipitor Recall

Mon, 25 Feb 2013 12:00:00 AM GMT

Last November, Ranbaxy Laboratories recalled more than three dozen lots of generic Lipitor because some contained tiny glass particles and the generic drugmaker then halted all production of the cholesterol pill. Not surprisingly, the move prompted lawsuits, even though the FDA indicated the likelihood of patient harm appeared to be extremely low. But several consumers are asking a federal judge...

FDA Issues Another Warning on Fake Version of Roche's Avastin

Fri, 08 Feb 2013 12:00:00 AM GMT

The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung...

Novo Nordisk A/S: Previously Announced FDA Warning Letter Published

Tue, 05 Feb 2013 12:00:00 AM GMT

BAGSVAERD, DENMARK--(Marketwire - February 05, 2013) -

Company announcement No 10 / 2013:http://hugin.info/2013/R/1675578/545854.pdf

This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained...

France Suspends Sales of Bayer AG's Acne Pill Diane 35 After Deaths

Thu, 31 Jan 2013 12:00:00 AM GMT

France's health regulator ANSM said on Wednesday it would suspend sales of Bayer acne pill Diane 35 and its generic versions, all also used as a contraceptive, after four deaths over the past 25 years were linked to its use. About 315,000 women used Diane 35 or its generic version in France last year. Bayer officials were not immediately available to comment on the suspension of the drug, which is...

FDA Warns of Liver Injury Risk With Otsuka America Pharmaceutical, Inc.'s Tolvaptan

Fri, 25 Jan 2013 12:00:00 AM GMT

January 25, 2013 -- AUDIENCE: Gastroenterology, Nephrology, Pharmacy

ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed...

GlaxoSmithKline's High-Dose Zofran Pulled From Market

Fri, 07 Dec 2012 12:00:00 AM GMT

The 32-mg, single IV dose of ondansetron hydrochloride no longer will be marketed because of the potential for serious cardiac risks, according to the FDA. Ondansetron hydrochloride (Zofran, GlaxoSmithKline) has been used to prevent chemotherapy-induced nausea and vomiting. The FDA issued a drug safety communication in June urging clinicians to stop using the 32-mg, single IV dose due to the risk for...

Aurobindo Pharma Drug Recalled in the U.S.

Thu, 29 Nov 2012 12:00:00 AM GMT

On Friday, Ranbaxy Laboratories voluntarily recalled a few batches of generic Lipitor from the US market. But the Gurgaon-based company is not the only Indian drugmaker to voluntarily recall drugs from the US market this year. An enforcement report brought out by the US Food and Drugs Administration (FDA) on November 14 shows Hyderabad-based Aurobindo Pharma voluntarily recalled a batch of Zolpidem...

Ranbaxy Laboratories Recall Brings Back Painful Memories

Tue, 27 Nov 2012 12:00:00 AM GMT

Memories of Ranbaxy Laboratories Ltds long-drawn effort to end compliance-related issues with the US Food and Drug Administration (FDA) at some of its plants appear to be still fresh in investors minds. The company is complying with the terms of a consent decree signed with the US regulator to settle these issues and a formal closure is still awaited. But, something else grabbed investor attention...

GlaxoSmithKline Pulls Vaccine Batch in Canada Over Contamination Concerns

Wed, 07 Nov 2012 12:00:00 AM GMT

GSK has withdrawn another lot of its Infanrix Hexa vaccine over concerns about potential microbial contamination.

FDA: No Increased Bleeding Risk for Boehringer Ingelheim GmbH's Pradaxa

Fri, 02 Nov 2012 12:00:00 AM GMT

The risk of serious bleeding among new users of Pradaxa, a blood-clot preventer made by Germany's Boehringer Ingelheim, appeared to be no higher than in patients on the widely used standard blood thinner warfarin, U.S. regulators said.

The announcement Friday by the U.S. Food and Drug Administration may allay some safety concerns about Pradaxa, a pill developed by the privately held drugmaker...

Precautionary Holds on Novartis AG' Influenza Vaccines Lifted in Canada, Switzerland

Thu, 01 Nov 2012 12:00:00 AM GMT

Canadian and Swiss health authorities lifted a ban on Novartis's flu vaccines on Wednesday after the drugmaker showed they posed no risk to safety.

Italy last week banned the sale of four anti-influenza vaccines produced by Novartis pending tests for possible side effects after small particles were found in some of the injections.

France Halts Sale of Novartis AG Flu Vaccine, Germany Orders Recall

Fri, 26 Oct 2012 12:00:00 AM GMT

Novartis | Jobs at Novartis Pharmaceuticals

France said it was halting sales of an influenza vaccine made by Swiss drugmaker

Italy Bans Four Novartis AG Flu Vaccines Amid Side-Effects Probe

Thu, 25 Oct 2012 12:00:00 AM GMT

Novartis Pharmaceuticals Corporation | Jobs at Novartis Pharmaceuticals Corporation

The Italian health ministry said on Wednesday that it had imposed an...

European Medicines Agency Probes Roche for Reporting Failures

Thu, 25 Oct 2012 12:00:00 AM GMT

Three months after the European Medicines Agency found that Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths, the agency is now initiating what its calls an infringement procedure at the request of the European Commission. The move means that Roche faces financial penalties if the EMA finds violations of pharmacovigilance...

UK Says Sanofi (France), Merck & Co., Inc. Recall Some Typhoid Vaccine Batches

Tue, 09 Oct 2012 12:00:00 AM GMT

Sanofi Pasteur MSD, the vaccine joint venture of Sanofi and Merck & Co, has recalled some batches of its typhoid vaccine because of concerns about effectiveness, Britain's drug regulator said on Monday. The decision to recall 16 batches of Typhim Vi follows filling problems in the manufacturing process, according to the Medicines and Healthcare Products Regulatory Agency.

FDA: Teva Pharmaceutical Industries Limited Antidepressant is Ineffective

Tue, 09 Oct 2012 12:00:00 AM GMT

White Plains, NY (PRWEB) October 04, 2012 -- Are all generic drugs therapeutically equivalent to their brand name counterparts? Until yesterday, the FDA, and many others, adamantly said they were. In an unprecedented move Wednesday afternoon, the FDA admitted that a generic version of the popular antidepressant Wellbutrin XL 300 mg, marketed since 2006 as Budeprion XL 300 mg by Teva Pharmaceuticals...

FDA Warns of Burns From OTC Pain and Muscle Relievers Including Johnson & Johnson's Bengay and Sanofi (France)'s Icy Hot

Mon, 17 Sep 2012 12:00:00 AM GMT

Over-the-counter muscle and joint pain relievers may cause chemical burns in rare cases, U.S. health regulators warned on Thursday. Products that contain menthol, methyl salicylate, or capsaicin including major brands such as Johnson & Johnson's Bengay, Sanofi's Icy Hot, Capzasin and Flexall, and Rohto Pharmaceutical Co's Mentholatum were found to cause first- to third-degree burns. "These products...

Sanofi (France) Recalls Nine Lots of Kidney Transplant Rejection Drug

Tue, 28 Aug 2012 12:00:00 AM GMT

The U.S. health regulator said Sanofi's rare disease division, Genzyme, voluntarily recalled nine lots of its drug Thymoglobulin, which treats transplant rejection in kidney transplant patients. The recall was initiated on Aug. 2 when one lot of the drug failed a periodic stability test, a study to check the shelf life of a drug within specified conditions. "Genzyme has not identified any new safety...

European Medicines Agency Agency Recalls Pacira Pharmaceuticals, Inc. Drug on Contamination Worries

Mon, 27 Aug 2012 12:00:00 AM GMT

The European Medicines Agency said on Friday it had recommended cancer drug DepoCyte be recalled in Europe, where suitable alternative treatments are available, due to sterility concerns at a U.S. plant operated by Pacira Pharmaceuticals. A recent inspection carried out jointly by France and Britain at Pacira's manufacturing site in San Diego identified a number of manufacturing deficiencies related...

Health Canada: GlaxoSmithKline Issues Warning on Pulmonary Arterial Hypertension Drug

Mon, 16 Jul 2012 12:00:00 AM GMT

GlaxoSmithKline has written to doctors telling them not to use lung drug Volibris in patients with idiopathic pulmonary fibrosis, Canadian regulator Health Canada said on Thursday. Volibris is the Canadian and European brand name for Gilead Sciences' Letairis, which British group GSK sells outside the United States. The drug is approved to treat pulmonary arterial hypertension, a rare and potentially...

Pfizer Inc. Recalls Robitussin Product Due to Label Errors

Thu, 12 Jul 2012 12:00:00 AM GMT

Pharmaceutical company Pfizer is voluntarily recalling its cough syrup medicine due to errors in its labeling, the Food and Drug Administration (FDA) said in its advisory. The FDA said Pfizer Consumer Healthcare informed its office of the recall of its Robitussin DM product, which contains Dextromethorphan HBr 15 mg and Guaifenessin 100 mg per 5 mL due to labeling error. "The continuous distribution...

Roche Ignores 80,000 Cases of Possible Adverse Drug Reactions

Tue, 03 Jul 2012 12:00:00 AM GMT

The European Medicines Agency said on Thursday it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions. The issue relates to medicines from across the Roche product range that were part of a financial reimbursement system in the United States. Roche is the world's largest maker of cancer medicines...

Novartis AG Recalls Introvale Birth Control Pills Over Packaging Flaw

Fri, 08 Jun 2012 12:00:00 AM GMT

The U.S. Food and Drug Administration said Wednesday that a Novartis AG (NVS, NOVN.VX) unit is recalling a three-month birth-control regimen sold in the U.S. because of a packing error. The recall involves a birth-control pill called Introvale that is marketed by Sandoz. The product contains 84 active pills that are peach colored and seven inactive pills in week 13 that are white. FDA said the recall...

FDA Warns Consumers About Fake Versions of Teva Pharmaceutical Industries Limited's Adderall

Wed, 30 May 2012 12:00:00 AM GMT

A fake version of Teva Pharmaceutical's Adderall, a drug for children and teenagers with chronic sleepiness and attention-deficit hyperactivity disorder, is for sale on rogue websites, the Food and Drug Administration (FDA) warned Tuesday. The counterfeits, which mimic 30-milligram pills that have been in short supply, could pose a health risk to patients because they are made from ingredients used...

Allergy Therapeutics plc: Notification of Voluntary Product Recall of Anapen?? by

Wed, 23 May 2012 12:00:00 AM GMT

May 23, 2012 -- Allergy Therapeutics plc (AIM: AGY), the fully integrated specialty pharmaceutical company, announces that it has been notified by Lincoln Medical Limited, the producer of Anapen (adrenaline for injection), that they are undertaking a voluntary drug recall for all unexpired units of Anapen in the UK, as a precautionary measure. Allergy Therapeutics has distribution rights for Anapen...

FDA Says Unsure if Novartis AG MS Pill Caused Deaths

Tue, 15 May 2012 12:00:00 AM GMT

The U.S. Food and Drug Administration said it could not conclude that Novartis AG's multiple sclerosis pill Gilenya was related to unexplained deaths of patients, but it remains concerned about the cardiovascular effects of the drug after the first dose. In recent months, doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person...

FDA Voices Caution About Popular Bone Drugs, Including Novartis AG's Reclast

Fri, 11 May 2012 12:00:00 AM GMT

In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution about long-term use of the drugs, but fell short of issuing specific recommendations. The F.D.A. review, published in The New England Journal of Medicine online on Wednesday, was prompted by a growing debate over how...

Lethal Injection Drug from Naari AG Held by Nebraska is Recalled

Thu, 10 May 2012 12:00:00 AM GMT

A Swiss pharmaceutical company has issued a voluntary recall of a lethal injection drug held by Nebraska, but state officials said Wednesday they won't return the drug and the U.S. Food and Drug Administration says it won't enforce the company's decision. Naari AG asked Nebraska officials to quarantine its supply of sodium thiopental and return it to the company or the FDA. The company said in a recall...

FDA Issues Warning Over Fentanyl Patches; Makers Include Mylan Inc. and Watson Pharmaceuticals, Inc.

Mon, 23 Apr 2012 12:00:00 AM GMT

(Reuters) - U.S. health officials warned on Thursday about the sometimes deadly effect of overexposure to fentanyl painkiller patches, particularly for small children, saying at least 10 people have died and 12 hospitalized in the last 15 years.

n a safety alert, the U.S. Food and Drug Administration said a majority of the 26 cases of accidental exposure to fentanyl observed since 1997 involved...

Novo Nordisk A/S Warns FDA of Biosimilar Concerns

Thu, 19 Apr 2012 12:00:00 AM GMT

Novo Nordisk urged FDA to define biosimilars as products that are as similar as scientifically possible to their reference products, at least through sharing the same amino acid sequence, without exception, as their reference products. The company cited FDAs emphasis on the importance the 3-D structures of proteins play in their biological functions and the ability of post-translational modifications...

Sun Pharmaceutical Industries Ltd Recalls 1,55,000 Eye Solution Bottles From US

Fri, 30 Mar 2012 12:00:00 AM GMT

Sun Pharmaceuticals, India's most valuable drug company, is recalling 1,55,000 bottles of an eye solution from the US after impurities were discovered in the medicine, the US Food and Drug Administration said. Another Indian drugmaker, Cipla, is also withdrawing two drugs made for its foreign partners for similar reasons.

GlaxoSmithKline Recalls Drug Made at Troubled Novartis AG Plant

Tue, 28 Feb 2012 12:00:00 AM GMT

GlaxoSmithKline has recalled 394,230 bottles of its DynaCirc CR hypertension drug from the U.S. market after the manufacturer, Novartis, reported inconsistent packaging practices. The generic drug is manufactured at a Novartis plant in Lincoln, Nebraska. Glaxo said in a statement that it has received no reports of adverse events nor any complaints of contamination or tablet mix-ups in batches of the...

FDA Issues Import Alerts for 22 Chinese Heparin Suppliers

Fri, 24 Feb 2012 12:00:00 AM GMT

The Food and Drug Administration said Wednesday it found 14 additional Chinese companies supplied contaminated raw material to make heparin, a widely used blood thinner. The companies supplied the materials in 2008, when the FDA found a link between contaminated heparin marketed by Baxter International Inc. to some Chinese suppliers of the active ingredient used in heparin. The contamination was linked...

Novartis AG to Add Warnings to Rasilez Blood-Pressure Drug

Mon, 20 Feb 2012 12:00:00 AM GMT

Novartis AG (NOVN) said it will add a warning to the label for its blood-pressure drug Rasilez in Europe to comply with a request from regulators. Novartis is changing the product information for Rasilez, sold in the U.S. as Tekturna, to say that the drug should not be used to treat patients with diabetes or kidney problems who are taking certain other medicines, the Basel, Switzerland-based company...

Sanofi (France)'s Genzyme Corporation Recalls 9,380 Vials of Fludara Leukemia Drug Made at Ben Venue Laboratories Plant

Mon, 20 Feb 2012 12:00:00 AM GMT

Sanofi, Frances biggest drugmaker, recalled 9,380 vials of the leukemia medicine Fludara because of a lack of assurance of sterility, U.S. regulators said. Genzyme, a unit of Paris-based Sanofi, notified customers of the recall of the intravenous drug on Jan. 31 and Feb. 1, the Food and Drug Administration said today in an enforcement report on its website. The nationwide recall was prompted by...

Roche Warns of Counterfeit Avastin in the U.S.

Thu, 16 Feb 2012 12:00:00 AM GMT

The maker of the widely prescribed cancer drug Avastin is warning doctors and patients about counterfeit vials of the product that have been distributed in the U.S. Roche's Genentech unit said Tuesday that the fake products do not contain the key ingredient in Avastin, which is used to treat cancers of the colon, lung, kidney and brain. The drug is a huge money-maker for Roche, generating about $...

Teva Pharmaceutical Industries Limited's Cephalon, Inc. Recalls Treanda Leukemia Drug Due to Glass Fragments

Tue, 31 Jan 2012 12:00:00 AM GMT

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) US subsidiary Cephalon has recalled a lot of its Treanda leukemia drug, because glass fragments were found in one of the vials. The US Food and Drug Administration (FDA) said in a statement that Cephalon distributed the Treanda lot TB30111 to wholesalers and distributors between March 22 and October 5, 2011, and notified those recipients...

Novartis AG Unit to Take $120 Million Charge on Recall, Initiates Precautionary Recall of 4 OTC Brands

Tue, 10 Jan 2012 12:00:00 AM GMT

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...

FDA Further Restricts Use of Sanofi (France)'s Multaq

Wed, 21 Dec 2011 12:00:00 AM GMT

Federal health officials said Monday they have added new safety warnings to the heart rhythm drug Multaq, after a company study by Sanofi linked the tablet to higher rates of heart attack, stroke and death in a subset of patients.The boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition...

Novartis AG: Patient Died After Starting Gilenya

Thu, 15 Dec 2011 12:00:00 AM GMT

Novartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease. Whether Gilenya played a role in the patients death cant be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported...

Bayer AG Concealed Yasmin's Clot Risk, Former FDA Chief Says

Wed, 07 Dec 2011 12:00:00 AM GMT

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said. David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didnt include an analysis that demonstrated an increase in the U...

Naari AG Wants Nebraska to Return Lethal Injection Drug

Wed, 30 Nov 2011 12:00:00 AM GMT

A Swiss pharmaceutical company is asking Nebraska officials to return a drug the state plans to use to execute death row inmates. Earlier this month, the Nebraska Department of Correctional Services announced that it had obtained a new supply of sodium thiopental, one of three drugs needed to carry out executions by lethal injection, from Swiss company Naari AG. The drug is no longer manufactured in...

EU Recalls Cancer Meds Made by Boehringer Ingelheim Corporation Unit

Mon, 28 Nov 2011 12:00:00 AM GMT

The manufacturing problems engulfing the troubled Boehringer Ingelheim unit have just grown worse. The European Medicines Agency has just issued a precautionary recall for the remaining batches of three cancer meds - Busilvex, Velcade and Vidaza - that were manufactured at its Ben Venue Laborartories facility in Ohio. And no new patients are to be treated with yet another med, Doxil. The move comes...

Boehringer Ingelheim Corporation Says About 260 Deaths Related to Pradaxa

Wed, 16 Nov 2011 12:00:00 AM GMT

Boehringer Ingelheim said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa so far, adding that the risk of death was still below the rate that emerged in the clinical trial that led to the drug's approval. In early November, the German drugmaker had said that 50 reported deaths were a "reasonable order of magnitude". The company on Saturday confirmed in a...

FDA Cites Blood-Clot Risk Tied to Bayer AG Birth-Control Pills

Mon, 31 Oct 2011 12:00:00 AM GMT

U.S. regulators warned there may be an increased risk of blood clots connected with birth-control pills made by Bayer AG, and said the issue will be further evaluated in a meeting with advisers in December. Women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low- estrogen pills, the Food and Drug Administration said in a report released...

Eli Lilly and Company to Withdraw Xigris From Market Worldwide

Wed, 26 Oct 2011 12:00:00 AM GMT

OTTAWA, ONTARIO, Oct 25, 2011 (MARKETWIRE via COMTEX) -- Health Canada is informing Canadians that it is working with Eli Lilly Canada, Inc. to withdraw the drug Xigris (drotrecogin alfa) from the Canadian market, in light of the company's decision to withdraw Xigris from the market worldwide.

Xigris is used solely in hospital intensive care units to treat patients at a high risk of death...

Ranbaxy Laboratories Recalls Three Drugs From UK Market

Mon, 17 Oct 2011 12:00:00 AM GMT

The British arm of Ranbaxy Labs is in the process of recalling three drugs from the UK market. The drug firm has been asked by the UK drug regulator Medicines and Healthcare products Regulatory Agency to withdraw one batch each of antiviral drug Aciclovir, anti-fungal drug Fluconazole and analgesic Oldaram (Tramadol) from the market. The recall happened as the drugmaker violated stipulated safety...

Bristol-Myers Squibb Company's Sprycel May Increase Hypertension Risk, FDA Says

Wed, 12 Oct 2011 12:00:00 AM GMT

Bristol-Myers Squibb Co. (BMY)s leukemia drug Sprycel may increase the risk of a rare condition that causes high blood pressure in the lungs arteries, U.S. regulators said today. Health-care providers should evaluate patients for signs of underlying cardiopulmonary disease before starting Sprycel, chemically known as dasatinib, and during treatment. If abnormally high blood pressure known as pulmonary...

CSL Limited Denies Report of New Manufacturing Warnings from FDA

Thu, 29 Sep 2011 12:00:00 AM GMT

Australia's biggest drug company CSL is trying to dampen the effect of criticisms made by the US Food and Drug Administration (FDA) of its manufacturing operations. The details of the FDA's criticisms have been obtained by News Limited newspapers under a Freedom of Information request, based on two years' worth of audit reports. Among the FDA's criticisms are concerns about a "multitude of manufacturing...

VA Halts Roche's Avastin for Eye Disease; Rival Regeneron Pharmaceuticals, Inc.'s Stock Surges

Fri, 23 Sep 2011 12:00:00 AM GMT

The U.S. Department of Veterans Affairs said it has stopped using Roche's Avastin to treat a sight-robbing eye disease as it looks into reports of increased risk of infection. Roche's Lucentis is specifically approved to treat wet age-related macular degeneration -- the leading cause of blindness in the elderly. But its multibillion-dollar a year cancer drug Avastin, which works in a similar manner...

EU Agency Calls for Restrictions on Sanofi (France)'s Multaq

Fri, 23 Sep 2011 12:00:00 AM GMT

Risks of liver, cardiovascular or lung issues stemming from Sanofi's Multaq irregular heart beat drug mean its use should be restricted, Europe's drug regulator said on Thursday following a safety review. The decision could raise further pressure on Sanofi to speed up the replenishment of a drug pipeline which has been drastically diminished after a top-to-bottom review. Following a monthly meeting...

GlaxoSmithKline Anti-Nausea Drug Linked to Arrhthymias

Mon, 19 Sep 2011 12:00:00 AM GMT

U.S. health regulators said they are reviewing the safety of GlaxoSmithKline's anti-nausea drug Zofran to ascertain whether there is a potential risk of abnormal heart rhythm. The drug may increase the risk of developing abnormal changes in the electric activity of the heart, leading to a potentially fatal heart rhythm, the U.S. Food and Drug Administration said in a statement. GSK will be required...

GlaxoSmithKline Stops Tykerb Arm of Breast-Cancer Trial

Tue, 13 Sep 2011 12:00:00 AM GMT

LONDON (MarketWatch) -- GlaxoSmithKline PLC /quotes/zigman/146635/quotes/nls/gsk GSK -1.83% Friday said it will stop administering breast cancer drug Tykerb alone to patients in a clinical trial, after an independent committee decided the medicine would probably produce worse results than Roche Holding AG's (ROG.VX) rival product Herceptin.

The three arms of the late-stage trial in which...

Boehringer Ingelheim Corporation's Pradaxa Causes a Side Effect Flap in New Zealand

Mon, 12 Sep 2011 12:00:00 AM GMT

Three months after New Zealands pharmaceutical management agency agreed to place the new Pradaxa bloodthinner on its formuarly, the Boehringer Ingelheim drug is being linked to two deaths and reports of dozens of elderly patients suffering bleeds. And some doctors say the Pharmac agency may have put lives at risk by funding Pradaxa before more was known about managing side effects. At the time Pharmac...

Roche Avastin Injections Linked to Blindness

Thu, 01 Sep 2011 12:00:00 AM GMT

Repackaged injections of the cancer drug Avastin, also known as bevacizumab, have caused a cluster of serious eye infections in the Miami, Florida area, the U.S. Food and Drug Administration said on Wednesday. The Florida Department of Health notified the FDA of Streptococcus endophthalmitis infections in three clinics following injections given through the eye of repackaged Avastin, manufactured by...

U.K. Warns of Package Mix-Up Between AstraZeneca PLC's Seroquel XL and Reckitt Benckiser Plc's Nurofen Plus

Fri, 26 Aug 2011 12:00:00 AM GMT

British regulators issued a safety alert on Thursday after discovering packs of the over-the-counter painkiller Nurofen Plus containing the anti-psychotic drug Seroquel XL. The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert, potentially affecting thousands of packs, after receiving reports of rogue Seroquel XL tablets in three different batches of Nurofen Plus. The two...

Deaths Prompt Revisions in Japanese Precautions for Boehringer Ingelheim Corporation's Prazaxa

Tue, 16 Aug 2011 12:00:00 AM GMT

Boehringer Ingelheim has strengthened the safety warnings and use precautions for its novel anticoagulant Prazaxa (dabigatran etexilate) in Japan following the deaths of five patients receiving the product. The oral direct thrombin inhibitor, marketed as Pradaxa elsewhere, was the first in the...

Dr. Reddy's Laboratories, Inc. Recalls Contaminated Simvastatin in the US

Mon, 15 Aug 2011 12:00:00 AM GMT

Dr Reddy's Laboratories has initiated a recall of certain strengths of its cholesterol-lowering drug, simvastatin, in the US following concerns over 'chemical contamination' of the product. The ongoing Class II recall involves the 10mg, 40mg and 80mg strengths and the company's investigations have...

FDA OKs Stronger Warning for Takeda Pharmaceutical Co. Ltd.'s Diabetes Drug Pioglitazone

Tue, 09 Aug 2011 12:00:00 AM GMT

The FDA has approve updated drug labels for pioglitazone-containing medicines to include a safety warning that the use of pioglitazone for more than 1 year may be associated with an increased risk for bladder cancer. According to the new drug label, health care professionals should: Not use pioglitazone in patients with active bladder cancer. Use pioglitazone with caution in patients with a prior history...

FDA Issues Alerts on Sanofi (France)'s Heart Drug Multaq

Fri, 22 Jul 2011 12:00:00 AM GMT

American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms. The Food and Drug Administration said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug. The alerts provided the first details of a 3,000-patient...

European Medicines Evaluation Agency Warns About Takeda Pharmaceutical Co. Ltd.'s Actos, Backs Pfizer Inc.'s Champix, Restricts GlaxoSmithKline's Pandemrix

Fri, 22 Jul 2011 12:00:00 AM GMT

Europe's regulator has given its support to continued use of Takeda's diabetes pill Actos but has recommended new contraindications and warnings be added to the label regarding a "small increased risk of bladder cancer". Last month, France and Germany suspended use of Actos (pioglitazone) and Competact (pioglitazone/metformin) following new data from a retrospective study which appears to indicate...

Hong Kong Orders Recall of GlaxoSmithKline Children's Drug

Tue, 19 Jul 2011 12:00:00 AM GMT

Hong Kong has ordered pharmaceutical giant GlaxoSmithKline to recall an antibiotic used to treat infections in children which contained chemical additives, and warned it may sue the drugmaker. The health department on Monday said tests revealed the British firm's Augmentin antibiotic tablet contained several plasticisers, including diisodecyl phthalate (DIDP), raising "quality concerns." But the department...