Agency IQ

JUNE 2, 2023

Given the number of approved drugs and biologics on the market that are dispensed on an outpatient basis – and their generic and biosimilar equivalents – the additional workload on FDA’s labeling review staff could be considerable. Some exemptions: Vaccine manufacturers are likely to benefit from the FDA’s proposed rule.

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The Pharma Data

JULY 22, 2021

We believe that this will be further established as we collect more data from the ongoing EMBARK study and the post-marketing confirmatory trial. That was exemplified at its best with the COVID-19 vaccine development. ADUHELM is the first Alzheimer’s treatment approved since 2003.

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The Pharma Data

MARCH 17, 2021

Nally, chief marketing officer, Human Health, will leave the company at the end of March, and Frank Clyburn, chief commercial officer, Human Health, will become president, Human Health and lead all Human Health commercial and marketing for the company. Nally is leaving Merck for a leadership opportunity with another company. “As

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The Pharma Data

MAY 13, 2021

Clients who get results will rave about your skills and nothing beats word of mouth marketing. 2003 ACE Personal Trainer of the Year. ve built a six figure business by providing great service to my clients. This course will help you do that. s a solid investment which will pay for itself in no time. Curb Ivanic, MS, CSCS.

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Codon

NOVEMBER 1, 2024

Such models will, in turn, make it much easier to invent the sorts of platform tools that Amodei asserts “drive >50% of progress in biology,” such as CRISPR and mRNA vaccines, because the creation of these tools ultimately derive from a deeper understanding of how cells work.

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Drug & Device Law

MAY 30, 2022

1981) (applying Virginia law), both of which involved vaccines. In Stanback the prescriber had a similar practice of not warning of a “slight risk,” which led to the same result: [The prescriber] averred that he had not found it necessary and did not make it his practice to advise patients about the risks associated with flu vaccinations.

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Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & A Vaccine Act case similarly held that “parties are expected to put their best case forward in the first instance.” March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v. Wyeth LLC , 562 U.S.

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FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

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Vaccine FDA FDA Approval Production 59

Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.

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