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FDA Approves Oriahnn

Approvals, Clinical Studies, FDA, FDA/Regulatory, Menstrual Bleeding, Uterine Fibroids

AbbVie won a first-of-its-kind approval for a non-surgical treatment aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.

June 1, 2020/by Andrew Humphreys

Lilly and AbCellera Dose First Patients with COVID-19 Antibody

Antibodies, Clinical Trials, Collaborations, Coronavirus Disease (COVID-19) Pandemic, Coronavirus Disease 2019 (COVID-19), Dosing, R&D

Eli Lilly and AbCellera dosed the first patients in a Phase I study of a potential antibody treatment for COVID-19.

June 1, 2020/by Andrew Humphreys

ASCO 2020 Highlights

American Society of Clinical Oncology (ASCO), Analysis, Androgen Deprivation Therapy (ADT), CAR-T Therapy, Clinical Data, Clinical Trials, Gastrointestinal Stromal Tumors, High-Risk Myelodysplastic Syndrome (MDS), Leukemia, Metastatic non-small cell lung cancer, Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC), PD-1/PD-L1 inhibitors, R&D, Relapse/Refractory Multiple Myeloma, T-Cells, Triple Negative Breast Cancer (TNBC)

The American Society of Clinical Oncology (ASCO) 2020 meeting was held virtually this year due to the COVID-19 pandemic and included hundreds of abstracts, posters and presentations.

June 1, 2020/by Andrew Humphreys

U.S. awards new contract for potential COVID-19 vaccine

"Operation Warp Speed" Initiative, Biomedical Advanced Research and Development Authority (BARDA), Business, COVID-19 Vaccines, Department of Health and Human Services (HHS), Manufacturing, U.S. government

The U.S. government entered into a $628 million contract with drugmaker Emergent BioSolutions to boost manufacturing capacity for a potential COVID-19 vaccine.

June 1, 2020/by Andrew Humphreys

FDA approval for Brilinta, EU recommendation for Lynparza

Approvals, BRCA mutation, Blockbusters, Committee for Medicinal Products for Human Use (CHMP), Coronavirus Vaccines, European Medicines Agency, FDA, FDA/Regulatory, Heart Attacks, Metastatic pancreatic cancer, New Indications, Product Pipeline, Shares, Strokes

Britain’s AstraZeneca clinched expanded regulatory backing for two medications, including one for the blockbuster cancer treatment Lynparza, in a development pipeline that now includes a possible coronavirus vaccine.

June 1, 2020/by Andrew Humphreys

AstraZeneca’s heart drug gets FDA nod

Approvals, Aspirin, Blockbusters, Clinical Trials, Coronary Artery Disease (CAD), FDA, FDA/Regulatory, Heart Attacks, Stroke

The U.S. Food and Drug Administration approved AstraZeneca Plc’ drug for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

June 1, 2020/by Andrew Humphreys