Zymewire

FEBRUARY 8, 2024

Skip to a topic Axonis' journey and purpose The impact of the economic client on emerging biopharma The place of Artificial Intelligence in drug development & discovery Working with NASA Relationships with CROs, CDMOs, and other service providers What made you want to start Axonis? sending neurons to space.

Competition 52

Competition Leads Patients Marketing 52

Clarivate

OCTOBER 7, 2021

Based on the KEYNOTE-716 data, it is anticipated that Keytruda will gain a label expansion in this patient setting, with FDA priority review status and a PDUFA date set for December 2021. This novel antibody-drug conjugate (ADC)ADC faces much competition, should it be approved. Abstract LBA52. Abstract 944P.

Patients 91

Patients Safety Marketing Physicians 91

Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

Manufacturing 59

Manufacturing Pharmaceutical Biopharma FDA 59

Pharmaceutical Technology

JANUARY 15, 2023

FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Baxter Biopharma Solutions, Fareva SA, BSP Pharmaceuticals SpA, and Takeda Pharmaceuticals are manufacturing the parenteral portion of the ADC. Source: GlobalData Pharmaceutical Intelligence Center.

Manufacturing 52

Manufacturing Pharmaceutical FDA Pharma 52

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study.

FDA 52

FDA Food and Drug Administration Patients Marketing 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. FDA decisions In December 2022, the FDA expanded the label for Novo Nordisk’s Wegovy (semaglutide), to include its use as an anti-obesity drug in adolescents with an initial body mass index over a certain threshold.

Manufacturing 52

Manufacturing Pharmaceutical Pharma FDA 52