Sunday, February 23, 2020

Sunday, February 23, 2020

Latest News

ELI LILLY AND COMPANY: US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes

Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) is a once-daily therapy combining three well-established treatments in one pill

U.S. FDA: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.

U.S. FDA: Statement on quality issues with certain Cardinal Health surgical gowns and packs

FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions

ABBOTT: Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson's Disease

Abbott's Infinity™ DBS is the first FDA approved directional Deep Brain Stimulation (DBS) system to allow targeting of a specific area of the brain that is critical to motor functions

U.S. FDA: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ).

U.S. FDA: FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers

U.S. Food and Drug Administration is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.

ARUVANT: Receives Orphan Drug Designation for ARU-1801 for the Treatment of Sickle Cell Disease

ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and β-thalassemia

INHIBITOR THERAPEUTICS: Receives prostate cancer IND Clearance from FDA

SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer

OBI PHARMA: Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

Second Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate in combination with a validated payload (MMAE) and the antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.

U.S. FDA: FDA approves first treatment for thyroid eye disease

U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).

TENNOR THERAPEUTICS: Received FDA Orphan Drug Designation

TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.

MERCK: LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

LYNPARZA Reduced the Risk of Disease Progression or Death by 47% Compared to Placebo in Patients Whose Disease Had Not Progressed On at Least 16 Weeks of a First-Line Platinum-Based Chemotherapy Regimen. Only PARP Inhibitor Approved in Germline BRCA-mutated Advanced Pancreatic Cancer

SEATTLE GENETICS: Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Submission Based on Positive Pivotal HER2CLIMB Trial Results Recently Presented at the 2019 San Antonio Breast Cancer Symposium and Published in the New England Journal of Medicine

OBI PHARMA: Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

First Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate targeting Globo H, a glycolipid antigen found on multiple tumor types

U.S. FDA: FDA approves first generics of Eliquis

U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

U.S. FDA: FDA approves new treatment for adults with migraine

The U.S. Food and Drug Administration approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.

EISAI INC.: U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients

Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients

U.S. FDA: FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

FDA Health News