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Annaliesa Anderson, Ph.D., Will Lead Pfizer’s Vaccine Research & Development 

The Pharma Data

Dr. Anderson joined Pfizer via Wyeth in 2007. Dr. Anderson earned her doctorate in Biological Sciences at the University of Warwick in the field of microbial ecology and then completed two post-doctoral fellowships.

Vaccine 40
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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products. Overall, 2022 phenylephrine retail sales reached $1.8

Science 40
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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.

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The Battle for Better Air

Codon

Heat and Filtration In 1844 in Florida, John Gorrie, a young doctor, was treating an endless stream of yellow fever patients. While air conditioning has some immediate, obvious health benefits, like fewer cases of heatstroke, we now know it can help with mental health , cognition , and … stock market returns.

Disease 87
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Making a “Miracle” HIV Medicine

Codon

Doctors began prescribing combinations of three or more antiretrovirals in 1995, making it unlikely that a mutant HIV strain resistant to one drug could evade the others. The painkiller rofecoxib , for example, was licensed before doctors discovered it increased the risk of cardiovascular disease.) In Peru, that number is 6,300.

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Removal, Severance & Rule 21

Drug & Device Law

May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. Defendant] does not deny that it, the doctor, and the hospital are potential joint tortfeasors. . . . 30, 2007) (“joinder of the malpractice claim. . . Zimmer, Inc.