JBAshtin

FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee

Fri, 24 May 2013 17:33:00 +0000

The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.

FDA allows marketing of first A1c test labeled for diagnosing diabetes

Thu, 23 May 2013 19:14:00 +0000

Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use.

FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

Sat, 18 May 2013 18:32:00 +0000

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.

FDA seeks preliminary injunction against New York fish manufacturer

Fri, 17 May 2013 17:38:00 +0000

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.

FDA approves Simponi to treat ulcerative colitis

Wed, 15 May 2013 20:00:00 +0000

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

FDA approves new drug for advanced prostate cancer

Wed, 15 May 2013 14:28:00 +0000

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients

Tue, 14 May 2013 19:09:00 +0000

On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer

Tue, 14 May 2013 19:33:00 +0000

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).

FDA releases new tool to help prevent intentional food contamination

Mon, 13 May 2013 18:49:00 +0000

The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.

FDA warns consumers about potential health risk with Juices Incorporated juice products

Fri, 10 May 2013 15:59:00 +0000

The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.

FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease

Fri, 10 May 2013 15:10:00 +0000

The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.

FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop

Wed, 08 May 2013 17:34:00 +0000

The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

FDA issues proposal to increase consumer awareness of tanning bed risks

Mon, 06 May 2013 18:38:00 +0000

Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.

FDA warns pregnant women to not use certain migraine prevention medicines

Mon, 06 May 2013 17:20:00 +0000

The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older

Tue, 30 Apr 2013 21:16:00 +0000

The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.

FDA approves Procysbi for rare genetic condition

Tue, 30 Apr 2013 16:14:00 +0000

The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.

FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding

Mon, 29 Apr 2013 21:56:00 +0000

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool

Wed, 24 Apr 2013 17:00:00 +0000

The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.

FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy

Sun, 21 Apr 2013 14:35:00 +0000

Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.

FDA approves abuse-deterrent labeling for reformulated OxyContin

Tue, 16 Apr 2013 20:30:00 +0000

The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).

AbbVie takes some heat for raising price of Niaspan after studies panned it

Fri, 24 May 2013 15:42:57 +0000

When studies of AbbVie's chloesterol drug Niaspan raised questions about its effectiveness, analysts suggested it would lose its blockbuster status. But in the face of falling sales, AbbVie's former parent Abbott Laboratories simply raised the price.

FDA responds to one small piece of Avandia criticism

Fri, 24 May 2013 15:39:28 +0000

Novartis apologizes over Diovan study as probe shows employee involvement in trials

Fri, 24 May 2013 14:45:00 +0000

Novartis' blood pressure Diovan is on the wane as its expects generics next quarter to begin eating at its blockbuster status. But even as it comes under attack by generics, so does its reputation, as a probe by Novartis reveals that not everything in its trials in Japan followed accepted protocol.

Former Carl Icahn proxy brawler Alex Denner joins fight against Vivus board

Fri, 24 May 2013 13:50:39 +0000

A Vivus shareholder who wants to stack the drugmaker's board with a more aggressive slate of directors has brought in one of the champions of this kind of shareholder brawl. Alex Denner, who gained his experience in proxy fights as the head of Carl Icahn's healthcare investments, has been invited to the battle by investor First Manhattan Co.

J&J plans 25 line extensions in next four years

Fri, 24 May 2013 12:39:29 +0000

Johnson & Johnson executives were touting the company's pipeline yesterday, drawing attention to the 10 new applications it expects to file in the next four years--some with blockbuster potential. But some analysts said what shouldn't be lost in the mix is that it also is planning 25 significant line extensions by 2017.

BRIC markets turning out to be tougher to mine than expected

Fri, 24 May 2013 11:31:55 +0000

Western drugmakers headed into the BRIC countries to provide the kind of volume growth they couldn't scare up elsewhere. But it is not turning out exactly as planned. India has expanded price controls.

FDA ban could cost India's Wockhardt $100 million

Thu, 23 May 2013 15:51:24 +0000

An FDA import ban can be costly, and India's Wockhardt says the import alert it is now under could slice $100 million out of its revenues.

Ranbaxy said to be eyeing major cuts to sales force, mainly in U.S.

Thu, 23 May 2013 15:45:47 +0000

The company is considering cutting back its field force of about 14,600 by as much as one-third, the sources said.

Why is the FDA holding Avandia hearings? Agency critic has ideas

Thu, 23 May 2013 15:38:27 +0000

Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under tight rein in the U.S. Now, the FDA is revisiting the issue, and Nissen himself has issues with that.

Merck, Lilly, Pfizer top $1B doc-payments list

Thu, 23 May 2013 14:54:08 +0000

Drugmakers forked over more than $1 billion to doctors last year, significantly more than reported in 2011. And that's only the amounts we know about. According to a new data analysis by PharmaShine, reported in the Financial Times, that figure only includes the 12 leading drugmakers that actually disclose physician payments.

Forest Labs CEO to step aside at year's end after decades at the helm

Thu, 23 May 2013 14:07:23 +0000

Forest Laboratories will have a new CEO when 2014 dawns. Longtime chief Howard Solomon will step out of that role on Dec. 31, with plans to stick around as chairman till next year's annual meeting, and as a director for some time after that. In the meantime, Forest's search committee is hunting for a replacement, aiming to name someone before year's end.

Daiichi accuses Ranbaxy shareholders of hiding info before buyout

Thu, 23 May 2013 11:57:16 +0000

Ranbaxy Laboratories' FDA woes may soon be over now that the drugmaker has forked over a $500 million settlement to the federal government. It seems owner Daiichi Sankyo's Ranbaxy woes, however, are anything but. The Japanese company now believes former Ranbaxy shareholders withheld key info when negotiating to sell Daiichi its majority stake in the Indian drugmaker.

Billionaires snap up former Merck Serono HQ for Geneva biotech hotspot

Wed, 22 May 2013 15:42:06 +0000

Two Swiss billionaires--Ernesto Bertarelli and Hansjörg Wyss--have joined forces to buy out the former Merck Serono facility in Geneva.

Specialty drugs to rocket upward by 67% by 2015

Wed, 22 May 2013 14:35:15 +0000

Drugmakers know that specialty products are where it's at these days. A recent IMS Institute report showed the U.S. drug market shrinking for the first time last year. But spending on specialty drugs posted double-digit increases. Almost 20%, according to a recent Express Scripts report, in fact.

Boehringer Ingelheim handed FDA warning letter

Wed, 22 May 2013 14:22:43 +0000

Boehringer Ingelheim, whose contract manufacturing facility in Bedford, Ohio, has been at the heart of huge drug disruptions in the U.S., is now feeling the sting of FDA inspectors at a key plant in Europe.

Amag pulls anemia drug batch after Swiss patient dies

Wed, 22 May 2013 14:17:47 +0000

Amag Pharmaceuticals and partner Takeda have run into a snag in Switzerland. Japan-based Takeda is recalling a batch of Amag's anemia drug Feraheme, sold as Rienso in the Swiss market, after several reports of hypersensitivity reactions, one of them fatal.

Pfizer offers share exchange to grant Zoetis its freedom

Wed, 22 May 2013 13:48:42 +0000

Pfizer is cutting the apron strings at Zoetis. Just months after its highly successful IPO, in which Pfizer sold off a 20% stake, the animal health business is set to become fully independent. Pfizer is offering a stock swap to its shareholders, who can exchange $100 in Pfizer shares for roughly $107 worth of Zoetis stock.

Merck to buy $5B in stock from Goldman Sachs in jump-start for repurchase plan

Wed, 22 May 2013 12:33:05 +0000

Generic competition, sales woes and R&D disappointments have put revenue on the decline and Merck in hot water, with the pharma giant earlier this month promising to buy back as much as $15 billion in shares. And yesterday, the company started in on a big chunk of that buyback, inking a deal to buy $5 billion of its own shares from Goldman Sachs.

Vermont passes assisted-suicide law, with drug-dispensing safeguards

Tue, 21 May 2013 15:52:24 +0000

The law includes safeguards, including requirements that terminally ill patients ask for the requisite drugs three times before they're actually dispensed.

Impax calls on former Teva, Watson execs to confront FDA issues

Tue, 21 May 2013 15:52:20 +0000

Having failed so far to get its extended-release Parkinson's drug Rytary to market, Impax Laboratories ($IPXL) is turning to asking three big-name specialists what it should do.

How Well Does Your Doctor Communicate with You?

Fri, 22 Mar 2013 16:12:43 +0000

Patients' complaints about doctors are finally being taken seriously, as poor communication is increasingly understood to be at the root of many of health care’s failures—and a leading culprit in rising costs. Research shows that when doctors don’t listen to patients, they miss important health cues and misdiagnose illness. Meanwhile, patients who don’t understand what their doctors say fail to follow their regimens, leading to preventable hospitalizations, complications and poor outcomes.

How Companies Can Foster Healthy Employees

Fri, 08 Feb 2013 17:16:29 +0000

Many employers offer wellness programs to contain their health-care costs—and perhaps also improve morale and productivity.

Vote: Do You Want to Know What’s in Your Genes?

Mon, 04 Feb 2013 16:16:59 +0000

For healthy people, is there a compelling reason to know if your genes make you susceptible to a specific disease or condition? Or are there some things you’re better off not knowing?

How Often for Mammograms?

Mon, 04 Feb 2013 16:14:29 +0000

Changing recommendations for when women should get mammograms have created conflict and confusion. Not only do recommendations from different sources vary, but some have moved in opposite directions.

News from the Health Blog

Wed, 14 Nov 2012 18:53:54 +0000

We're updating the Health Blog infrequently. Please consider bookmarking the Journal's Health and Wellness page, for daily updates on health news and analysis.

Vote: Should men get PSA tests to screen for prostate cancer?

Mon, 10 Sep 2012 18:51:24 +0000

Prostate cancer hits one in six American men in their lifetimes, though in most cases it progresses so slowly that it would never cause problems. PSA tests can give an early warning of prostate cancer. But PSA tests also give many false alarms, prompting more than one million unnecessary biopsies every year.

Vote: Are ADHD Medications Overprescribed?

Mon, 10 Sep 2012 18:04:50 +0000

The number of children being treated with prescription medication for attention deficit hyperactivity disorder has soared in recent years. Some doctors, parents and child advocates have become concerned that many children are taking medication unnecessarily. What do you think?

One Woman’s Drug-Resistant TB, Echoing Around the World

Sun, 09 Sep 2012 02:44:34 +0000

: Chiara Goia for The Wall Street; Rahima Sheikh's yearslong effort to beat tuberculosis left her, in the end, all but untreatable. She displays scans in the Mumbai slum she shared with her husband and daughter.

By Geeta Anand This weekend's Wall Street Journal has the story of Rahima Sheikh, one of India's first documented cases of tuberculosis that is resistant to virtually all the medicines approved to treat it. Over the past six years, Mrs. Sheikh, 40 years old, mortgaged her family's rice fields, spent her father's and brother's life savings, and crisscrossed India in search of a cure for tuberculosis. But instead of getting healthier, Mrs. Sheikh grew increasingly resistant to medication with each failed treatment. Her six-year journey to all-but-incurable TB exposes a blind spot in an Indian medical bureaucracy that, for decades, neglected to implement widespread testing or treatment for drug-resistant strains.

Should Medicare’s Eligibility Age Be Raised?

Thu, 06 Sep 2012 18:18:01 +0000

With tens of millions of baby boomers heading into retirement, Medicare’s long-term financial prognosis is grim. One proposed solution is to raise the eligibility age gradually to 67 from 65. What do you think?

A.M. Vitals: Democrats Ready Response on Medicare

Fri, 31 Aug 2012 12:16:09 +0000

Also: Bristol-Myers recalls more than 31,000 vials of the brain-tumor drug carmustine; a study links rosacea to a form of bacteria that lives in a type of skin mite; and researchers find the balance between the benefits of omega-3 oils and mercury in fish isn't clear.