FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). The Second Circuit’s Interpretation of the AKS and its Mens Rea Element. Background.

Mens Rea 83

Mens Rea Statute Healthcare Manufacturing 83

FDA Law Blog

JUNE 28, 2022

1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or. (2) The relevant CSA provision provides: (a) Unlawful acts. Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally —. (1) 21 U.S.C. §

Mens Rea 98

Mens Rea Court Manufacturing Government 98

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.

Statute 98

Statute Mens Rea Manufacturing Court 98

The IP Law Blog

MARCH 2, 2021

es the threat posed to companies that rely on third-party manufacturers. Considering the importance of Chinese manufacturing to global trade, the Chinese legal system and its evolving trademark enforcement system will likely cause companies to get creative. Romag solidi?es Summary of the Supreme Court’s Opinions.

Manufacturing 52

Manufacturing Mens Rea Contract Tort 52

SCOTUSBlog

FEBRUARY 28, 2022

The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “[e]xcept as authorized by this subchapter.”

Mens Rea 90

Mens Rea Court Government Manufacturing 90