The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. J Allergy Clin Immunol.

Trials 40

Trials Production Sales Manufacturing 40

pharmaphorum

FEBRUARY 16, 2022

The 1 January 2021 saw the UK’s regulator, the MHRA, formally join Project Orbis. Project Orbis is a framework for concurrent reviews and approval of promising cancer treatments by regulators in the US, Australia, Canada, Singapore, Switzerland, Brazil and Israel, as well as the MHRA.

Marketing 52

Marketing Life Science Medicine Gene Therapy 52

The Pharma Data

MAY 8, 2021

The Company continues to work with other healthcare authorities and regulators around the world to ensure this information is included in product labels for the Company’s COVID-19 vaccine. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Securities and Exchange Commission Regulation G. It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA.

Sales 40

Sales Production Marketing Cardiology 40

The Pharma Data

NOVEMBER 9, 2020

Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). Lilly is in discussions with global regulators to make bamlanivimab available around the world. The authorization is temporary and does not replace the formal review and approval process.

Antibody 52

Antibody Medicine Manufacturing Trials 52

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

Antibody 40

Antibody Medicine Regulation Trials 40

XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. The TPO receptor agonist regulates blood platelet production by binding to and activating TPO receptors on megakaryocyte cells and inducing signalling cascades that increase platelet production.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world. IMPORTANT SAFETY INFORMATION Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5),

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

MARCH 11, 2021

” Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Trials 40

Trials Antibody Medicine Development 40

The Pharma Data

DECEMBER 2, 2020

Most vaccines take 20 to 30 years to be licensed. To have multiple vaccines licensed within a year of the pathogen being discovered is unprecedented. Regulators must “move as quickly as possible, but not so quickly as to erode confidence,” she continued. Ad hoc members are called on as needed.

Vaccination 52

Vaccination Vaccine Trials Licensing 52