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Kathlyn Stone

Kathlyn's Pharma Blog

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Regulators To Study Risk Recall in TV Drug Ads

Saturday May 31, 2014

The FDA is launching a TV content analysis study to determine how viewers comprehend the risk factors contained in direct-to-consumer advertising.

Using an eye tracking device, the study will examine how different elements, including background and audio, affect a viewer's retention of the rapidly uttered risk information included in TV drug ads.

According to the Federal Register announcement, the study asks viewers to watch three ads, including a fake weight-loss drug ad, and then take a quiz to determine risk recall.

FDA Extends Expiration Dates of Some Drugs to Combat Shortages

Saturday May 31, 2014

As the drug shortages pile up, the FDA has been extending the expiration date of certain drugs by up to two years in order to meet patient treatment needs. Of note is the extension of a nerve gas antidote supplied to the U.S. military.

During the past several months the agency has sent numerous alerts to health care providers and emergency responders notifying them that specific lots of DuoDote auto-injectors are approved for use beyond Meridian Medical Technologies' labeled expiration date.

"Due to medical necessity and potential drug shortages, FDA is reviewing data for the potential use of these products beyond their labeled expiration dates," the agency said.

DuoDote auto-injectors (atropine and pralidoxime chloride injection) are primarily used by emergency medical staff to treat nerve agent and insecticide poisoning. Meridian states on its website that it supplies six different drugs, including the nerve gas antidote, to the military.

The FDA said it continues to work with Meridian to resolve its manufacturing issues.

FDA, EU Approve Takeda's Entyvio for Inflammatory Diseases

Friday May 30, 2014
Entyvio screenshot
Entyvio product website, Takeda Pharmaceuticals

The FDA approved Takeda Pharmaceutical's new biologic, Entyvio (vedolizumab), on May 20, 2014, as the newest option for certain chronic inflammatory diseases. Entyvio was approved for ulcerative colitis and Crohn's disease in adults, two fairly common diseases.

Entyvio is delivered intravenously at the start of treatment, at two and six weeks, and then every eight weeks thereafter.

Osaka, Japan-based Takeda's biologic license application submission to the FDA included results from four clinical studies that enrolled 2,700 patients in 30-some countries.

The European Commission approved Entyvio for the same conditions on May 29. The approval gives Takeda access to the 28 European Union member states and a potential market of 2.2 million.

Pfizer Drops AstraZeneca Takeover Bid For Now

Monday May 26, 2014
Pfizer World Headquarters
Pfizer World Headquarters, New York City. Image: Wikimedia

Pfizer has abandoned its troubled attempt to acquire London-based AstraZeneca -- at least for now, according to the company.

Pfizer made the announcement after AstraZeneca's board rejected Pfizer's latest offer of $117 billion (69.4 billion pounds).

The hostile takeover attempt generated lots of controversy for Pfizer.

"We continue to believe that our final proposal was compelling and represented full value for AstraZeneca based on the information that was available to us," said Pfizer CEO Ian Read in a written statement. "As we said from the start, the pursuit of this transaction was a potential enhancement to our existing strategy."

AstraZeneca Chairman Leif Johansson offered his own statement in response to the news: "We welcome the opportunity to continue building on the momentum we have already demonstrated as an independent company."

UK regulations require a three-month cooling-off period before talks can resume.

Study: Improve Adherence Among Illiterate Patients By Adding Pictures to Prescriptions

Saturday May 24, 2014
prescription
Counting out pills for a handwritten prescription. Image: Wikimedia

When hospitals in Lahore, Pakistan, added pictures and symbols to discharge prescriptions patient adherence to the treatment regimen increased significantly, according to a study published in BMJ Quality Improvement Reports.

After researchers with Services Hospital in Lahore analyzed the factors contributing to low adherence to prescriptions obtained at hospital discharge, they found that 48 percent of the hospital's patients were illiterate, and that less than 80% of these patients could comprehend the handwritten discharge prescription, often drafted in English, after they left the hospital. In addition, clinics conducting follow-up with the patients reported a very low level of adherence.

When the hospital's quality improvement team made a new prescription format a available - one with pictures and symbols instead of words - follow-up surveys found that 35% of illiterate patients understood the new prescriptions, compared to 12% when the old handwritten prescriptions were given.

Patients who sought care at the 1000-bed hospital were often from rural villages "many days travel away," according to the authors. They concluded that revising prescriptions to better accommodate impoverished and illiterate patients could be applicable and beneficial to many other areas of the world.

Source: Improving illiterate patients understanding and adherence to discharge medications, BMJ Qual Improv Report 2012;1: doi:10.1136/bmjquality.u496.w167

FDA Issues Another Draft Guideline for Biosimilars

Friday May 23, 2014
Biologic lab
Biologic fermentation laboratory at the Frederick National Laboratory for Cancer Research. The equipment is used to produce Interferon or certain antibiotics, for example. Image: National Cancer Institute

Don't look for biosimilars to hit the U.S. market anytime soon. In mid-May the FDA issued its fifth set of guidelines for biosimilars and will accept comments until August. At that point the agency may either write final rules or issue new draft guidelines.

As it stands now the draft guidelines require generic drug makers to demonstrate that their biosimilar is similar in terms of both pharmacodynamics and pharmacokinetics to the innovator biologic drug. The problem is that the method for testing those measurements are patentable separate from the drug patent, meaning its virtually impossible to demonstrate similarity until the patents expire.

While Europe adopted guidelines for biosimilar manufacturing in 2006, the FDA has yet to issue final regulatory guidelines for companies wanting to market generic-like biologics in the United States.

The guidance also introduces four categories of similarity--not similar, similar, highly similar, and highly similar with fingerprint-like similarity--that will affect the extent to which further study is needed to establish requisite biosimilarity for approval.

The global biosimilars market is estimated to be $20 billion annually.

FDA Draft Guideline: Guidance for Industry -Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

FDA To Study Safety, Efficacy of Generic Metoprolol

Monday May 12, 2014
Pillbox
Wikipedia

In response to the nearly 3,500 adverse events reports it's received over the safety and efficacy of generic metoprolol, a very commonly prescribed treatment for hypertension, the FDA has been seeking researchers to take part in an in-depth study of the extended-release versions of the drug which could launch this fall.

At issue is whether generic versions of the drug are bioequivalent to the brand name version, Toprol XL, developed by AstraZeneca. The FDA said it can't draw any conclusions about the adverse events without gathering more data in a cross-over trial involving patient volunteers.

The issue of generic metoprolol having chemical differences from the branded drug isn't new. Several million bottles of generic metoprolol were recalled in 2008 because they didn't meet specifications.

The complaints were received between 2009 and 2013 and were submitted by both patients and physicians.

Generic metoprolol is sold in the United States by Actavis, Dr. Reddy's Laboratories, Mylan and Wockhardt, among others. Over 40 million prescriptions for generic metoprolol are written in the U.S. each year.

The most commonly cited side effects of the drug are dizziness, hypotension, bradycardia, hypertension, malaise, fatigue and ineffectiveness, according to DrugCite, one of a handful of companies that aggregate and analyze adverse event reports submitted to the FDA.

The top adverse events submitted to the FDA for Metoprolol between 2004 and 2012.

TOP 10 METOPROLOL ADVERSE EVENTS - DrugCite.com

FDA Fast-Tracks Novartis's New Lung Cancer Drug

Wednesday April 30, 2014
Novartis logo Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland.

Novartis has received early approval for its new oncology drug for lung cancer, Zykadia (ceritinib).

The drug is approved for the treatment of late-stage non-small cell lung cancer for patients previously treated with Xalkori (crizotinib).

The approval was based on a trial of 114 anaplastic lymphoma kinase (ALK)-positive lung cancer patients who were prescribed a daily dose of 400 mg (or more) of Zykadia.

According to the FDA's press announcement, Zykadia was approved four months ahead of the goal date for review due to the drug's status as a breakthrough drug.

Genital Mucus a Key to Effective HIV Vaccine?

Wednesday April 30, 2014
Immune cells Illustation: Immune cells and potential HIV targets in the rectal mucosal. Yang, Ochoa, Preza & Anton, 2014

Researchers at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle, USA, suggest in a new PLOS publication that mucosa in the rectal and genital regions -- the locations at which most people contract the HIV infection -- offer the best promise for developing a new HIV vaccine.

Mucosa immunology could conceivably prevent new HIV infections by reducing the spread of the virus through the genital fluids of infected people or by preventing HIV from producing infections in the genital or rectal mucosa of uninfected people, according to the authors.

Reference: Advances in HIV Mucosal Immunology: Challenges and Opportunities. The online publication features four related scientific articles published between September 2013 and February 2014.

Another Indian Generic Drugmaker Hit With US Import Ban

Tuesday April 29, 2014
Sun Pharma logo

A plant operated by Mumbai-based Sun Pharmaceuticals, the country's largest by market value, is the latest to be banned from US markets following an FDA inspection.

In FDA documents obtained by Bloomberg through the Freedom of Information Act, the FDA noted that Sun Pharma employees had falsified test results and that the firm's plant in Karkhadi had serious sanitation issues.

The FDA began expanding its inspection of foreign manufacturers in 2013, particularly in China and India beginning in 2013.

The agency previously banned products from Ranbaxy Laboratories, a Sun Pharma rival. Prior to the bans, Sun had announced plans to purchase Ranbaxy for $3.2 billion. Even temporary loss of access to the world's largest drug market would suggest those plans are now on hold.

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