The Pharma Data

AUGUST 3, 2021

end-stage renal disease (ESRD) bundled payment system, dialysis clinics rapidly implemented new treatment protocols, switching patients from Parsabiv to generic oral cinacalcet. LUMAKRAS received accelerated approval based on overall response rate and duration of response. With Parsabiv’s inclusion in the U.S. In May, the U.S.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering 85

Engineering Vaccine Production RNA 85

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations 40

Regulations FDA Science Production 40

Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. Hamilton , 372 S.W.3d

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59