Merck Gets Sued by PETA Over Shareholder Proposal
For the second consecutive year, the People for the Ethical Treatment of Animals has filed a lawsuit against Merck over a shareholder proposal that the animal-rights group wants included in the annual proxy statement. At issue is a proposed requirement that the drugmaker disclose its use of animal testing in all research. Specifically, PETA wants […]
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FDA Crack Down on Cargo Thefts
Source: Pharmalot As last month drew to a close, the FDA issued a new standard operating procedure for dealing with cargo thefts, yet another point in the pharmaceutical supply chain that has generated concern. In recent years, hijacked trucks and spectacular break-ins have highlighted an area of weakness that has prompted drugmakers to energize an […]
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FDA bans Ontario firm from shipping products to U.S.
An Ontario company that makes cosmetics and over-the-counter drugs has been banned by the U.S. Food and Drug Administration from shipping its wares to U.S. dollar stores until it cleans up its alleged shoddy manufacturing practices. The FDA accused Mississauga-based Pax-All Manufacturing Inc. in a letter last month of failing to perform adequate product testing, […]
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FDA: Tobacco Companies Must Report Levels of Dangerous Chemicals In Products
Tobacco companies will be required to report the levels of dangerous chemicals found in cigarettes, chew and other related products, marking the first time the industry will be required by law to specify the quantities of dangerous chemicals found in tobacco.The requirement stems from new preliminary guidelines released last Friday by the U.S. Food and […]
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Poor Quality of Cancer Studies Alarm Industry
Source: Pharmalot Ever wonder why some oncology research never becomes a clinical success? Two cancer researchers were curious and so they reviewed 53 so-called landmark papers, which were published in leading journals and emanated from reputable laboratories. What did they find? An overall poor quality of published preclinical data, and 47 papers – or 89 […]
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Provenge Researcher Threatened for Questioning Company Studies
Source: Pharmalot Yet another controversy surrounding the Provenge prostate cancer vaccine has emerged. The latest involves Marie Huber, a former hedge fund manager who recently co-authored a medical study that questioned the benefit of the medicine and, as a result, has received threatening remarks on investor message boards. Why? Her thesis is that the studies […]
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FDA Plans a New Review of Metal-on-Metal Hip Implants
FDA responded to mounting concerns about the safety of metal-on-metal hip implants on Thursday, saying it would subject the devices to a two-day expert review that could lead to new standards. The F.D.A. announced an advisory panel for June 27-28 that will gather input from scientists, researchers, patients and medical practitioners to help regulators decide […]
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FDA: Tobacco Companies Must Report Chemicals
Tobacco companies will be required to report the levels of dangerous chemicals found in cigarettes, chew and other products under the latest rules designed to tighten regulation of the tobacco industry. The preliminary guidance issued Friday by the Food and Drug Administration marks the first time tobacco makers would be required to report quantities of […]
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Congress Writing New Bill To Speed Drug Approvals
Source: Pharmalot Yet another effort has been devised by some members of Congress to jumpstart the FDA approval process. The latest initiative is a bi-partisan bill that is called the Advancing Breakthrough Therapies for Patients Act, which would require the agency to hasten the development and review of breakthrough drugs. What is a breakthrough drug? […]
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Stem Cell Company Receives Raft of Warnings From FDA
Source: Pharmalot From its offices on the east side of Manhattan, IntelliCell BioSciences makes what ceo Steve Victor likes to call a soup – physicians remove fat from their patients and send this to IntelliCell, which has the fat removed and returns the remaining cells to the doctors, who can administer these to their patients […]
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