Pfizer Closes CovX Unit in San Diego
Source Five years after buying the privately held CovX biotech in hopes of bolstering its withering pipeline, Pfizer is now closing the unit as part of ongoing cuts and reorganization in research and development. At the time, the drugmaker touted CovX for its technology platform and preclinical work in metabolic and oncology research (read here). […]
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FDA raises manufacturing concerns at CryoLife
The Food and Drug Administration has raised concerns about manufacturing and management processes at CryoLife Inc. The Kennesaw, Ga.-based company (NYSE: CRY) is an implantable biological medical device and cardiovascular tissue processing company. In the early aughts, CryoLife paid millions of dollars to settle suits involving allegedly contaminated tissue products. In July 2005, CryoLife reached […]
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FDA Issues Warning to Flu Supplement Sellers
U.S. health regulators have sent letters to nine Internet distributors of dietary supplements warning them against making false claims about their products’ ability to fight the flu. The U.S. Food and Drug Administration posted the letters on its website in an effort to steer consumers away from a variety of herbal products that the distributors […]
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Does FDA Regulate REMS Enough?
Source For the past few years, the Risk Evaluation and Mitigation Strategies, or REMS, has been a controversial effort. Designed in the wake of several safety scandals, a REMS program is required when risks are sufficiently worrisome, but there is growing criticism the requirements have become poor substitutes for education. Still worse, a new report […]
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Did DaVita Admit to Fraud When It Sued Whistleblower?
Source File this under ‘What were they thinking?’ Since a fair number of whistleblower cases pop up in the pharmaceutical industry, a recent development concerning a whistleblower and DaVita, the second-largest independent provider of dialysis services in the US, might be of interest. Consider the following… Along with a nurse, a nephrologist and former medical […]
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Device Offers Partial Vision for the Blind
The Food and Drug Administrationon Thursday approved the first treatment to give limited vision to people who are blind, involving a technology called the artificial retina. The device allows people with a certain type of blindness to detect crosswalks on the street, the presence of people or cars, and sometimes even large numbers or letters. […]
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Hospira shares fall after FDA expands import ban
Shares of Hospira Inc. plunged by 8% Thursday after the maker of intravenous pumps said the U.S. Food and Drug Administration had expanded an import ban on several of its products made in a Costa Rica plant. Hospira (US:HSP) shares fell $2.60 to $30.05 at the close, a day after the company, which also makes […]
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FDA Hires New Dep. CDER Director
The Food and Drug Administration made an important new hire today, bringing in someone with deep and practical experience in the development of new drugs to a senior post in the agency’s drug center. As FDA recruits more of its clinical review staff out of the ranks of medical practice and from academic postings, a […]
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FDA To Change Warning Regs Generics
source Last year, the US Supreme Court ruled generic drugmakers are not required to strengthen labeling even when alerted to side effects. The decision came in response to lawsuits by two women who claimed changes could have been made under state law and without FDA approval. They argued generic drugmakers would create uncertainty about safety […]
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Daiichi Sankyo Reps Bring Sex Discrimination Charge
source Yet another drugmaker is being charged with alleged sex discrimination by female employees. The latest instance involves six current and former sales representatives for Daiichi Sankyo, who charge they were subject to discriminatory practices involving pay and promotions, as well as inapproriate conduct in the workplace. The lawsuit, which was filed yesterday in federal […]
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