Pharma News - Chemdiv

FDA Grants Breakthrough Therapy Designation for IPF Treatment

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BI 1015550, a novel investigational therapy for the treatment of patients with idiopathic pulmonary fibros...

GSK Names Consumer Health Venture ‘Haleon’

Drugmaker GlaxoSmithKline (GSK) has rebranded its consumer health care venture, dubbing the unit Haleon from the Old English word “hale,” meaning “in good health,” and the Greek word “leo...

Sanofi, GSK post 58% efficacy in omicron-affected COVID-19 vaccine trial, teeing up race to regulators

Sanofi and GlaxoSmithKline are nearly ready to seek approval for their COVID-19 vaccine.

Orpha Labs AG Announces the Initiation of a Phase III Trial Evaluating ORL-101 for Treatment of Leukocyte Adhesion Deficiency Type II

Orpha Labs AG, a clinical-stage biopharmaceutical company focused on diseases with unmet needs, today announced the initiation of the Phase III trial with ORL-101 in patients with Leukocyte Adhesio...

Discovery of ALS and dementia mechanism points to new treatment strategy

Almost all cases of amyotrophic lateral sclerosis (ALS) and half of frontotemporal dementia (FTD) cases are linked to dysfunction in the protein TDP-43.

Eli Lilly Launches Genetic Medicine and RNA-Focused Facility

Eli Lilly has invested $700 million to launch a Boston, Mass., facility focusing on RNA-based therapeutics and genetic medicines.

Clinical Research Forum Names Top 10 Research Efforts of 2021

The Clinical Research Forum, a nonprofit organization based in Washington, D.C., has unveiled its picks to receive its annual Top 10 Clinical Research Achievement Award, a recognition it gives to r...

FDA Approves Bayer’s Kerendia for Chronic Kidney Disease Associated With Type 2 Diabetes

Bayer’s Kerendia (finerenone) has secured FDA approval for treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes.

Minimally Invasive Epilepsy Treatment EASEE Receives FDA Breakthrough Device Designation

Heidelberg-based Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its EASEE brain stimulator.

GSK, in close race with Pfizer, slams brakes on phase 3 maternal RSV vaccine program over safety signal

GlaxoSmithKline has slammed the brakes on its pivotal maternal respiratory syncytial virus (RSV) vaccine program after a safety assessment, potentially handing an advantage to Pfizer in a close rac...

FDA Grants Immune-Onc’s IO-202 Fast-Track Status for Treating AML

The FDA has granted Fast-Track designation to Immune-Onc Therapeutics’ IO-202, an experimental myeloid checkpoint inhibitor developed for treating patients with relapsed or refractory acute myelo...

Sackler family owners of Purdue Pharma propose up to $6 billion opioid settlement

The Sackler family owners of Purdue Pharma have proposed a new and larger settlement worth up to $6 billion to resolve allegations that the OxyContin maker and its owners contributed to the deadly ...

Pharma News, 2022