PHARMACY

Study: Pharmaceutical supply chain could experience more vulnerability

BY Alaric DeArment

NEW YORK Risks of counterfeiting, contamination and intellectual property theft could increase with the globalization of the pharmaceutical supply chain, according to a new report.

Axendia, an analysis firm focused on life sciences and health care, published a study co-sponsored by PricewaterhouseCoopers in which 50% of surveyed pharmaceutical and life sciences executives said they saw imported raw materials as the greatest vulnerability in the supply chain, with 61% saying contaminated and substandard materials would be the top threat in the next five years. As recently as a decade ago, executives considered counterfeiting and diversion small-scale threats, but a growing number consider them major concerns.

According to the report, such emerging economies as China, India, Mexico and Brazil increasingly are becoming attractive markets for drug companies, but the drive to lower costs also means more raw materials are being sourced and more drugs are being manufactured in them, even though outsourcing drug development to companies in other countries carries operational risks.

 

“With manufacturing, sourcing and the sale of medical products expected to increase dramatically in the emerging markets, the geographical expansion of the supply chain will make it more difficult to manage, as well the industry’s changing product mix,” PwC pharmaceutical and life sciences advisory services partner Wynn Bailey said. “In order to meet the demands of globalization, the pharmaceutical supply chain will need to become much more flexible, with different manufacturing routes and distribution channels for the different kinds of products.”

 

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GSK to pay $750 million to settle contamination suit

BY Alaric DeArment

LONDON British drug maker GlaxoSmithKline will pay nearly $1 billion to the U.S. government to settle allegations that it sold contaminated and ineffective products.

 

The company will plead guilty to criminal charges relating to drugs made at a manufacturing plant in Cidra, Puerto Rico, which it closed in 2009, and pay $750 million. In a whistleblower suit filed by a former employee, it was alleged that the company knowingly sold defective supplies of various drugs, including the baby ointment Bactroban (mupirocin) and the antidepressant Paxil (paroxetine).

 

 

“This settlement resolves a significant and long-standing legal issue facing the company,” GSK SVP and head of global litigation P.D. Villarreal said. “We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality.”

 

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Pharmaxis: Bronchitol improved symptoms among CF patients

BY Allison Cerra

BALTIMORE Drug maker Pharmaxis got promising results from an investigative treatment for cystic fibrosis, the company said.

 

Pharmaxis announced results of two six-month phase-3 trials of 643 patients receiving Bronchitol (mannitol), which the company presented last week at the North American Cystic Fibrosis Conference in Baltimore.

 

 

According to study results, patients treated with Bronchitol experienced an average 7.3% improvement in lung function and experienced a “highly significant” improvement compared with patients in the control group.

 

 

“This comprehensive analysis of the pooled results provides an important insight into the overall benefits Bronchitol can provide to patients who are receiving the current best standard of care,” Pharmaxis CEO Alan Robertson said. “The number of exacerbations in the two studies was fairly low, reflecting the aggressive treatment with antibiotics that is now common practice in the clinic.”

 

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