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

MAY 5, 2021

The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S. pneumonia and sepsis) occurred more frequently in patients receiving Benlysta; consider pneumococcal vaccination prior to initiation. Immunisation: Do not give live vaccines 30 days before, or concurrently with Benlysta.

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The Pharma Data

MARCH 26, 2021

The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. pneumonia and sepsis) occurred more frequently in patients receiving Benlysta; consider pneumococcal vaccination prior to initiation. About lupus nephritis. Younger children may be at increased risk.

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The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

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Drug Target Review

APRIL 9, 2025

In the fast-moving world of drug discovery and vaccine development, the most transformative breakthroughs often emerge where cutting-edge science meets bold innovation. One such breakthrough comes from Gylden Pharma , a clinical-stage biotech developing T cell-priming vaccines to combat global infectious disease threats.

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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

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

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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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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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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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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