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Regardless of the reason (greed, carelessness, incompetence, etc.) that Chinese heparin became tainted, the end result will be increased scrutiny on imported raw materials and other ingredients, not only from China, but from all 3rd World suppliers. How the FDA and other regulatory agencies actually...
The 3-month reduction in HbA1c demonstrated by AGI-1067 is promising, but I still have many questions regarding the design and outcomes. There are many existing therapies that lower A1c - many have undesireable side effects like weight gain or hepatotoxicity.
The news that Cubist's Cubicin has been contaminated with 2-mercaptobenzothiazole (MBT) has caused great concern for patients. It appears that the MBT has leeched out of the Cardinal Health ReadyMED drug pumps that are used for delivering Cubicin. Regardless of who is at fault, everyone involved (Cubist,...
The pharmaceutical industry continues to lay its collective head on the chopping block by pushing drugs like Vytorin that demonstrate at best marginal activity. Insurers have a fiduciary duty to push back against the poor judgement of drugmakers who take advantage of confusion and DTC advertising to...
While disappointing for patients and caregivers, Pfizer's loss of a late-stage treatment for melanoma casts an even darker shadow on the ability of pharmaceutical and biotech companies to successfully bring new treatments to market. Coupled with other recent Phase 3 failures, this latest outcome points...
The purchase of Bentley Pharmaceuticals is significant in two ways, it will assist TEVA to file for Paragraph IV filings, thereby being first to market and improved supply chain distribution in Europe.
Overseas manufacturing controls for both APIs and finished drug products will need to be improved and the FDA will closely monitor compliance in an increased fashion.
Drug regulation itself is not likely to change, but more inspections and more thorough review of DMFs and information submitted in...
The article shows Wyeth as having a pattern of attrition of it's staff, or outright letting people go with severance agreements. It appears they are doing all they can to appease the shareholders. The loss of a product to TEVA is another sore for Wyeth.