The U.S. Food and Drug Administration (FDA) recently announced a significant move to gradually phase out animal testing while developing monoclonal antibody therapies and other drug candidates. This groundbreaking initiative aims to promote public health by introducing safer, more effective treatments, reducing animal experimentation, lowering research and development (R&D) costs, and potentially reducing drug prices.… Continue reading Understanding the FDA’s Ambitious Plan to Eliminate Animal Testing in Drug Development
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo (aztreonam-avibactam)—a novel antibiotic therapy developed in partnership with Pfizer—to treat complicated intra-abdominal infections (cIAI), including those caused by multidrug-resistant Gram-negative bacteria. This approval makes Emblaveo the first and only monobactam/beta-lactamase inhibitor combination therapy authorized for this indication, marking a significant advancement… Continue reading FDA Approves AbbVie & Pfizer’s Emblaveo for cIAI Amid Rising AMR Concerns
Eli Lilly has entered into a groundbreaking collaboration with Alchemab Therapeutics, utilizing Alchemab’s cutting-edge antibody discovery platform to transform therapeutic options for amyotrophic lateral sclerosis (ALS). This innovative platform identifies antibodies associated with resilience by analyzing patient samples from individuals exhibiting unusually slow rates of disease progression. As part of the partnership, Alchemab will contribute… Continue reading Eli Lilly Partners with Alchemab Therapeutics to Revolutionize ALS Therapies
The FDA’s recent approval of Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug Victoza, a once-daily GLP-1 receptor agonist injection, is a significant milestone. This drug, indicated for glycemic control in patients aged 10 years and above with type 2 diabetes, serves as an adjunct to diet and exercise. Over 38 million Americans are… Continue reading FDA Approves Hikma’s Generic Version of GLP-1 Diabetes Drug Victoza
On August 26, the U.S. Food and Drug Administration (FDA) approved Insulet’s SmartAdjust technology for managing type 2 diabetes in patients aged 18 and above. Earlier, this interoperable automated glycemic controller software was authorized for treating type 1 diabetes in individuals two years and older. The SmartAdjust technology automatically regulates insulin delivery by integrating an… Continue reading FDA Approves First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes
Bengaluru-based biopharmaceutical company Biocon has inked a pact with Brazil-based Biomm SA to commercialize its diabetes treatment in the Latin American nation. As per the MoU, Biocon will focus on developing, manufacturing, and supplying Semaglutide (generic: Ozempic)—a drug used to improve glycemic control in adults with type-2 diabetes. Meanwhile, Biomm will be in charge of… Continue reading Biocon, Biomm: Diabetes Drug Licensing Deal for Brazil
Shoppers Drug Mart Inc. is taking significant steps toward its commitment to reducing plastic waste with the launch of the “Quo Beauty Cosmetics Free Recycling Program”. The Canadian retail pharmacy chain has collaborated with TerraCycle® to initiate the revolutionary program, enabling customers to donate US$1 to the Shoppers Foundation for Women’s Health™ for each pound… Continue reading Shoppers Drug Mart partners with TerraCycle® for cosmetics recycling
On March 19, the FDA granted approval to Orchard Therapeutics’ gene-edited cell therapy atidarsagene autotemcel (now branded as Lenmeldy in the U.S.) for treating children with metachromatic leukodystrophy (MLD). It is the first gene therapy for children suffering from this rare hereditary disorder to be approved in the United States. The disease is estimated to… Continue reading USFDA approves Orchard Therapeutics’ gene therapy for childhood MLD
Breye Therapeutics ApS (Breye), a leading clinical-stage biopharma company headquartered in Denmark, has initiated a phase 1b/2a clinical trial to check the safety, side effects, and dosage of danegaptide, administered orally, in patients with diabetic macular edema (DME). The company is committed to developing novel, oral ophthalmology drugs for millions of patients suffering from deteriorating… Continue reading Breye Therapeutics: Oral Danegaptide in DME Trial
Summary: There has been a ceaseless development in gene modification strategy beginning from restriction endonucleases, transgenic breeding, and RNAi advances to the currently engineered endonucleases. Over the last few decades, Gene editing took a new turn with the discovery of CRISPR and its variant Cas9. CRISPR not only gave a new image to gene editing… Continue reading In-depth Analysis- CRISPR/Cas9 Technology
