Today's Top Stories
Risk evaluation and mitigation strategies--mandated measures to ensure the safe use of certain drugs--may be driving changes in drug distribution.
Using so-called restricted distribution as a REMS component, manufacturers are bypassing traditional distributors and shipping to patients or otherwise minimizing the number of handoffs between factory and home. Overnight delivery services--especially those using package tracking technologies--are being called up.
Jazz Pharmaceuticals used a restricted distribution technique in its REMS program for the narcolepsy treatment, Xyrem. The drug is a diversion risk because it is prone to abuse. The Xyrem REMS program includes a restricted distribution network: a central pharmacy that ships drugs directly to the patient, reports Securing Pharma.
And Biogen Idec, responding to a serious side effect associated with its multiple sclerosis treatment Tysabri, restricts the drug's distribution network as one REMS element; a physician certification program and patient registry are additional elements.
The FDA issued draft guidance on REMS last fall, as we reported.
- see the article
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Read more about: REMS
Balancing atop the profitability/flexibility high wire familiar to most contract manufacturers, Lonza has ditched spreadsheet scheduling in favor of a simulation-based system. Goals were to increase throughput in the company's near-capacity 275,000-square-foot Portsmouth, NH, facility, home to some 200 assets that can be scheduled. Batches and runs comprise as many as 500 activities; six runs can be on-board simultaneously.
The company spent 18 months working with process-optimization solutions provider Aspen Technology and is now using a scheduling system that simulates the timing links between production activities and warns the scheduler of potential issues. The scheduling simulation uses a target, the ideal or preferred timing for one activity relative to another, as its staring point.
Lonza reports in PharmaManufacturing that it has cut batch cycle time to less than five days from seven while boosting production output by 20 percent. And it did so without additional scheduling headcount.
- here's the article
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Read more about: contract manufacturing, Lonza
Anti-malaria drugs in use in Sub-Saharan Africa are often of substandard quality, according to research conducted by the US Pharmacopeial for an U.S. humanitarian assistance agency. The poor-quality drugs--artemisinin-based combination therapy products and sulfadoxine-pyrimethamine products--suffer from several shortcomings, among them insufficient levels of API and impurities. Some, of course, are counterfeits.
USP researchers find that 26 percent to 44 percent of the anti-malarials tested in Uganda, Senegal and Madagascar didn't make the grade. The study examined about 500 samples collected from public and regulated sectors as well as "informal markets," according to an announcement. The researchers find that the ACT products most often fail purity tests while the SP products most often fail dissolution tests. Quality problems appear to originate at the source, say researchers.
Researchers used a two-step test method to evaluate the drugs: An on-site initial screen using Global Pharma Health Fund's portable Minilab--a mobile unit for quick quality checks and counterfeit detection--and full-scale QC confirmatory testing of about 40 percent of the samples at USP facilities.
The substandard drugs may contribute to the growth of a virulent drug-resistant strain of malaria.
- here's the announcement
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Read more about: quality, counterfeit
ChemNutra, a pet food supplier, and principals Sally and Steve Miller are paying $35,000 in fines after pleading guilty to misdemeanor violations of the Food, Drug and Cosmetic Act. The fines follow the melamine-contaminated pet food case dating back to 2006 that led to the sickening and deaths of dogs and cats.
"A company can face criminal liability if it was part of a chain of commerce that led to the distribution of a misbranded or adulterated product," says Robert Becerra of the Miami law firm Fuerst Humphrey Ittlemen PL. Becerra provided representation in the case.
"Under the Food, Drug and Cosmetic Act, a company can have no knowledge of the adulteration or misbranding of the product but still be held criminally liable, as was the case here," he says.
ChemNutra sold the contaminated gluten to U.S. pet food manufacturers. The gluten was mixed into their products.
Former ChemNutra CEO Steve Miller says there was never any criminal knowledge or intent on the company's part, and "the U.S. government realized that very early on. We used the best safety procedures in the industry at the time. We were caught up in the fraud perpetrated by an unscrupulous Chinese manufacturer."
The Justice Department maintains the company should have known about the activities of the Chinese manufacturer and partners to evade inspection of the gluten by Chinese authorities. "We believe that was impossible to know," says Miller.
- here's the press release
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Read more about: FDA regulation, Chinese Suppliers, ChemNutra
The Canadian government is holding out hope for construction of an HIV vaccine manufacturing facility with the Gates Foundation, but the Winnipeg-based International Centre for Infectious Diseases will not be part of the plan. The ICID bid has been rejected, despite earlier signs it was the likely winner.
ICID chief executive Heather Medwick is awaiting details, following "some general comments" from the Public Health Agency of Canada last week on why the bid failed.
The facility was to house the Canadian HIV Vaccine Initiative, a $139-million collaboration between Ottawa and the Bill and Melinda Gates Foundation. The plant was to be used by researchers worldwide as a non-profit location to manufacture HIV vaccine candidates for clinical trials.
Medwick says she was told the facility itself could still be built. The project is now "being assessed," and the Gates Foundation is working with the health agency toward an announcement in the next few months. A local press report speculates that the Liberal Party candidacy of Medwick's ICID predecessor, Terry Duguid, has been an impediment to the ICID bid.
- here's the article
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Read more about: vaccine manufacturing, Canada, Bill and Melinda Gates Foundation
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