Pharma News - Chemdiv

Viatris unloads biosimilar business to partner Biocon for $3.3B

Viatris is leaving the biosimilar field just months after winning the landmark FDA approval for the first interchangeable biosimilar product.

Eli Lilly, Boehringer Ingelheim's Jardiance clinches heart failure edge with FDA nod for wider label

With one heart failure nod already in the books, Eli Lilly and Boehringer Ingelheim’s diabetes blockbuster Jardiance (Empagliflozin) just racked up another key approval—opening the door to a mu...

Health Canada Approves Plant-Based COVID-19 Vaccine

Health Canada has approved Medicago’s Covifenz COVID-19 two-dose vaccine, the first authorized vaccine that uses plant-based proteins.

Contract Research Organization Draws FDA Warning Letter for GLP Violations

Massachusetts-based Toxikon Corp., a Labcorp subsidiary, has received an FDA warning letter for good laboratory practice (GLP) violations, including multiple observations of inaccurately recorded ...

Scientists discover new approach to fighting antibiotic resistance

A new approach to fighting antibiotic resistance could help to prevent diseases by making bacteria vulnerable to treatment again.

Repurposing FDA-approved drugs may help combat COVID-19

Several FDA-approved drugs—including for type 2 diabetes, hepatitis C and HIV—significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new r...

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.