Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. No dosage adjustment is needed in patients with mild renal impairment.

Research 112

Research Vaccine Vaccination Drugs 112

The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?

HR 52

HR Antibody FDA Approval Development 52

XTalks

MAY 2, 2024

The Prescription Drug User Fee Act (PDUFA) date is the deadline that the FDA sets for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. Alexion, AstraZeneca Rare Disease is serving as a licensing partner of BridgeBio’s affiliate, Eidos Therapeutics, Inc.,

Drugs 52

Drugs FDA Approval Sales Vaccine 52

The Pharma Data

APRIL 8, 2021

for baricitinib plus SoC versus SoC; hazard ratio [HR]: 0.52; 95% CI: 0.33, 0.80; nominal p-value=0.0065). Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19.

FDA Approval 52

FDA Approval HR Trials Medicine 52

The Pharma Data

JULY 29, 2021

Data supporting the initial EUA included the primary endpoint of median time to recovery, which was seven days for baricitinib plus remdesivir compared to eight days for placebo plus remdesivir (HR: 1.15; 95% CI: 1.00, 1.31; p=0.047). Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.

HR 52

HR Licensing Licensing FDA Approval 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). The list price of Stelara was stated to be $25,497.12

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmaceutical Technology

MARCH 6, 2023

New data for TopAlliance Biosciences/ Coherus Biosciences’ anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with chemotherapy suggest that it can become the next standard of care in the frontline setting. months for the chemotherapy arm (hazard ratio [HR]: 0.52). At a median follow-up of 22.1 months versus 8.2

HR 130

HR FDA Approval Licensing Licensing 130

The Pharma Data

APRIL 26, 2022

AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 0.93; p=0.0035).4

Immune Response 52

Immune Response Trials Protein Antibody 52

The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). However, polyps have a strong tendency to reoccur often leading to repeat surgery. About mepolizumab.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; If approved, TicoVac would be the first vaccine in the U.S.

Vaccine 40

Vaccine Vaccination Production Sales 40

XTalks

NOVEMBER 26, 2024

on these sales under an exclusive licensing agreement that allows Janssen to develop, produce and market daratumumab. In Phase III clinical trials, Ibrance demonstrated significant benefits as a first-line treatment for adults with HR-positive, HER2-negative metastatic breast cancer, showing strong progression-free survival data.

Sales 105

Sales FDA Approval Drugs Marketing 105