An increased risk of diabetic ketoacidosis (DKA), a safety concern that wasn't understood or considered important five years ago, was largely responsible for the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) 8-8 vote Thursday on recommending approval of Zynquista, a dual SGLT1 and SGLT2 inhibitor, as an adjunct to insulin in treating type 1 diabetes (T1D). Read More
Baltimore-based Agenebio Inc. has enrolled the first patient in a phase III trial of a drug for amnestic mild cognitive impairment (MCI) due to Alzheimer's disease (AD). The medicine, an experimental once-daily, extended-release formulation of the common epilepsy medication levetiracetam, is called AGB-101. It targets the reduction of neuronal overactivity in the hippocampus, thought to drive downstream pathology and memory impairment. The trial, called Hope4MCI, is supported in part by $16 million in grant money from the NIH. Read More
When he took the position about a year ago, CEO Joe Turgeon of Spectrum Pharmaceuticals Inc. saw "right off the bat, when I met with my senior staff" that the company needed to change, he told BioWorld. "We had these important products, but they were small niche products, and we were classified as a specialty pharma company." Read More
HONG KONG – The Indian Ministry of Chemicals and Fertilizers has exempted foreign makers of new drugs patented under India's Patents Act 1970 (39 of 1970) from price regulation for five years. Read More
Isofol Medical AB, a small Swedish company founded a decade ago, is seeking to improve the standard of care (SOC) for metastatic colorectal cancer (mCRC), an oncology indication that receives far less attention than metastatic forms of more prevalent breast, prostate and lung cancers, said CEO Anders Rabbe. The Gothenburg-based company disclosed results from the open-label extension of its phase I/IIa study of folate receptor antagonist arfolitixorin (Modufolin) in individuals with mCRC that underpin a phase III effort that was initiated last month. Read More
Proteus Digital Health Inc. is rolling out digital oncology medicine with an eye to improving adherence and, therefore, patient outcomes. The Redwood City, Calif.-based company developed the system in partnership with Fairview Ventures, an innovation-focused arm of Minneapolis-based Fairview Health Services, and the University of Minnesota to develop the user experience and work flow for digital medicines to treat colorectal cancer. Read More
Pain Therapeutics Inc., of Austin, Texas, is collaborating with the University of Texas, Austin to establish proof of concept around "a well-known, and undisclosed, drug of abuse." The collaboration is unrelated to Remoxy ER (oxycodone), the company said. In November, Pain Therapeutics petitioned the FDA regarding an August complete response letter (CRL) for Remoxy, one of four CRLs the candidate has drawn to date. Read More
The FDA posted a final guidance, "Coordinated Development of Antimicrobial Susceptibility Test Devices," aimed at minimizing the time between the approval of new antimicrobial drugs and clearance of antimicrobial susceptibility tests used to determine the potential effectiveness of those drugs and to provide recommendations to drug- and device makers on how to work together to facilitate timely clearance. Read More
Correvio Pharma Corp., of Vancouver, British Columbia, said it completed its at-the-market offering of 4.3 million common shares at an average price of $2.71 each, resulting in net proceeds of approximately $11.5 million. The proceeds provide it with sufficient capital to operate its business through the submission and FDA review of the new drug application filing for heart drug Brinavess (vernakalant hydrochloride). Read More
