Camargo

DECEMBER 9, 2020

House of Representatives passed the “ Fairness in Orphan Drug Exclusivity Act ” to require proof from biopharma companies introducing improved versions of orphan drugs that they do not expect to recoup R&D costs through US sales in 12 years. GDUFA has changed this picture, at least for complex drug products.

Development 140

Development Production Drugs FDA Approval 140

Pharma in Brief

AUGUST 9, 2021

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. On-site Evaluations.

Regulation 98

Regulation Drugs Manufacturing Production 98

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. However, stakeholders should be aware that the leaked review contains no such analysis. They said: “This assertion raises some difficult questions.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Major Policy Initiatives. (a) a) COVID-19.

Regulation 52

Regulation Manufacturing Medicine Drugs 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. If retail sales were the sole indicator that the US economy is recovering, the country would have something to cheer about. According to the Commerce Department, retail sales rose 7.5 Canada now has over 115,000 confirmed cases and almost 9,000 deaths.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92