Camargo

DECEMBER 9, 2020

Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. Practically, this act (which still must be considered by the Senate) will mainly apply to orphan drugs granted exclusivity prior to 2017.

Development 140

Development Production Drugs FDA Approval 140

Pharmacy Checkers

MAY 22, 2020

The Januvia package reads “Formulated in UK.” The Januvia package also states “Sitagliptin (active ingred.) There are many thousands of drugs approved for the U.S. market, so maybe some do disclose this information, but most do not. But Metformin is an off patent, widely-manufactured generic drug.

Manufacturing 98

Manufacturing Drugs Generic Drugs Branding 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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. On-site Evaluations.

Regulation 98

Regulation Drugs Manufacturing Production 98

Pharma in Brief

JANUARY 9, 2022

In 2020, the FC struck down the new price calculation contained in the amendments but upheld the other impugned amendments. The proposed amendments contain fee changes including the introduction of an excess claim fee for applications with over 20 claims. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

Regulation 52

Regulation Manufacturing Medicine Drugs 52

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. It contains the antiviral medications nirmatrelvir and ritonavir.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. And stimulus packages continue.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92