Companies - May 20, 2015
FDA Investigating Type 2 Diabetes Drugs
The U.S. Food and Drug Administration (FDA) is investigating diabetes drugs used to treat Type 2 diabetes made by Johnson & Johnson, AstraZeneca PLC and Eli Lilly and Company after 20 cases of ketoacidosis that required hospitalization were reported, according to BioSpace.com. Sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes may lead to […]
Drug Development Pharma - April 22, 2015
More Good News for Kidney Transplant Drug
Trials of once-daily Envarsus® XR, an investigational drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose in African-American patients is sufficient for therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus, according to Veloxis. Veloxis is seeking an order requiring the FDA to […]
Drug Development Pharma - April 9, 2015
FDA Accepts Novo Resubmission
The US Food and Drug Administration (FDA) has accepted for review Novo Nordisk’s Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data, according to the company. This team has prepared the interim analysis […]
Clinical Trials - March 30, 2015
Clanotech Drug Gets FDA Orphan Label
Clanotech AB’s candidate drug CLT-28643 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for prevention of scarring after glaucoma surgery. The European Medicines Agency (EMA) previously granted an orphan drug designation pertaining to the EU. The orphan drug designation is expected to significantly shorten future market approval processes and reinforce […]
Clinical Trials - March 27, 2015
Novo to Resubmit Drugs to FDA
Novo Nordisk has decided to resubmit the prespecified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications (NDAs) of Tresiba® and Ryzodeg® to the US Food and Drug Administration (FDA). The resubmission is expected to take place within the next month, according to the company. The cardiovascular outcomes trial for […]
Business article - March 2, 2015
SEC: Keep up With Compliance, Disclosures
Shoring up compliance and disclosure procedures is the best way for pharmaceutical companies to avoid brushes with regulatory agencies, according to the U.S. Securities and Exchange Commission (SEC). Andrew Ceresney, the SEC’s top enforcement director, delivered the message to attendees at the recent Annual Pharmaceutical Compliance Congress. Companies need to accurately report their dealings with […]
