Drug Development

Moderna Appoints Arpa Garay as Chief Commercial Officer

by Samantha McGrail

Moderna recently announced that Arpa Garay will join the company as chief commercial officer, effective May 31, 2022. Garay joins Modera from Merck & Co, where she became an expert in oncology,...

Exploring Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs)

by Alivia Kaylor

Selective serotonin reuptake inhibitors (SSRIs) are a class of antidepressant drugs that treat depression and other mental health conditions by inhibiting the reabsorption of serotonin by neurons in the brain. According to the National...

GSK Enters $1.9B Agreement to Develop Rare Cancer Treatments

by Samantha McGrail

GSK recently entered into a $1.9 billion agreement to acquire biopharmaceutical company Sierra Oncology to treat rare cancers.   Myelofibrosis is a rare blood cancer that causes considerable...

Major Milestones in Medicine, Drug Development in Recorded History

by Alivia Kaylor

Because the past few centuries have witnessed several revolutionary scientific advances, research into the mechanisms responsible for infectious diseases and the development of drugs and vaccines has led to the eradication of...

Sanofi Launches First-in-Pharma Diversity, Equity, Inclusion Board

by Samantha McGrail

Sanofi recently launched its first-in-pharma Diversity, Equity, & Inclusion (DE&I) Board to encourage an inclusive and diverse culture that enables breakthrough innovations.   The...

Sandoz Acquires Drug Delivery Device Company to Boost Pipeline

by Samantha McGrail

Sandoz, a Novartis division, recently acquired a UK-based medical and drug delivery device company, Coalesce Product Development Limited.   Through the terms of the agreement, Sandoz...

Thermo Fisher to Invest $97M to Expand Drug Development Efforts

by Samantha McGrail

Thermo Fisher Scientific will invest $97 million to expand its clinical research operations in Virginia to support the increasing demand for drug development.   Over the next three years,...

How Regulation Stymies Medical Research of Controlled Substances

by Alivia Kaylor

Although there has been increasing public interest in studying scheduled drugs, most scientists are reluctant to conduct studies on Schedule I substances because of unreasonably burdensome rules and regulations enforced by the Drug...

Novo Nordisk Expands Collaboration in Oral Drug Delivery Tech

by Samantha McGrail

Novo Nordisk recently expanded its research collaboration in oral drug delivery technologies with the Massachusetts Institutes of Technology (MIT) and Brigham and Women’s Hospital...

FDA Issues 3 Cancer Clinical Trial Final Guidance Documents

by Samantha McGrail

FDA recently issued three final guidance documents to the industry regarding cancer clinical trials that parallel the goals of President Biden’s effort to renew and rebuild upon his 2016 Cancer...

Understanding the Value, Complexity of Clinical Trials in the US

by Alivia Kaylor

Clinical trials are an integral part of new product discovery and development. These trials (or clinical studies) test and assess potential treatments such as drugs, medical devices, or biologics (vaccines, gene and cellular therapies,...

AstraZeneca, Alexion, Neurimmune to Develop Rare Disease Antibody

by Samantha McGrail

AstraZeneca Rare Disease and Alexion group recently closed a global collaboration and license agreement with Neurimmune AG for the investigational human monoclonal antibody, NI006. NI006 is a...

GSK Introduces Standalone Consumer Healthcare Company, Haleon

by Samantha McGrail

GSK recently announced that the consumer healthcare company from its proposed transaction with Pfizer will be named Haleon. Haleon will be a new world leader in consumer healthcare, offering to bring...

Merck KGaA to Assess Quris AI Platform for Clinical Prediction

by Samantha McGrail

Merck KGaA, Darmstadt, Germany, and Quris recently signed an agreement to assess the Quris BioAI machine learning platform and compare it to traditional in vitro and in vivo approaches. The Quris...

Biogen, Xbrane Develop Preclinical Monoclonal Antibody, Biosimilar

by Samantha McGrail

Biogen and Xbrane Biopharma recently agreed to develop, manufacture, and commercialize a preclinical monoclonal antibody and proposed biosimilar, Xcimzane, referencing Cimzia.  Cimzia is a drug...

Senate Confirms Robert Califf as FDA Commissioner

by Samantha McGrail

The Senate recently confirmed Robert Califf as FDA Commissioner after the Biden administration nominated him in early November, according to multiple outlets. The final vote was 50 to 46, with six GOP...

FDA Issues Draft Guidance for Development of Non-Opioid Analgesics

by Samantha McGrail

The FDA recently issued draft guidance to foster the development of non-addictive alternatives to opioids to manage acute pain and prevent new addiction. The guidance provides recommendations to...

Gilead, ViiV Healthcare Enter $1.25B Settlement Over HIV Drug

by Samantha McGrail

ViiV Healthcare, GSK, and Shionogi recently entered a $1.25-billion settlement over the global patent infringement litigation with Gilead concerning its HIV drug combined with three HIV integrase...

Abbott Implants Dual-Chamber Leadless Pacemaker in Clinical Trial

by Samantha McGrail

Abbott recently announced the world's first implant of a dual-chamber leadless pacemaker system as part of its Aveir DR i2i pivotal clinical trial. The prospective investigational study will...

Biogen to Develop, Commercialize Genentech’s Bispecific Antibody

by Samantha McGrail

Biogen recently exercised its option to participate in the development and commercialization of Genentech’s bispecific antibody, mosunetuzumab. Mosunetuzumab is a CD20xCD3 T-cell engaging...