The FDA user fee bill passed a Senate committee vote with a hefty 21-2 margin without a provision for drug reimportation, but the bill does include an amendment that would require that clinical trials both broaden access and enroll a body of patients that reflects the populations that would receive that therapeutic product. Read More

It used to be that going public was a reason for biotechnology company executives to pop the champagne corks. In years past the goal was to achieve a public listing as quickly as possible in order to first obtain an infusion of cash for product development and then, as a public entity, be in a position to readily access further capital in follow-on offerings. While that goal still remains embedded in the business plans of biotechs, the financial climate that exists today has reduced the urgency for private companies to join the public ranks, and "going public" has become in many ways just another financing event. Read More

The first large-scale analysis of noncoding genome regions in pancreatic cancer samples has both implicated new players in pancreatic cancer and given insights into how known culprits exert their effects. Read More

TAIPEI, Taiwan – Aslan Pharmaceuticals Pte. Ltd., a Singapore-based company focused on the development of treatments for prevalent tumor types in Asia, is conducting a competitive auction and public offer of common shares for its initial listing on the Taipei Exchange (TPEx). Read More

The FDA revised the boxed warning for fluoroquinolone antibacterials for systemic use, added a new warning for the drugs and updated other parts of the label, including the patient medication guide. Read More

Scancell Holdings plc, of Nottingham, U.K., said it plans a placing of new ordinary shares in the company with existing and new institutional and professional investors to raise up to £5 million (US$6.43 million). Read More

Rhythm Pharmaceuticals Inc., of Boston, said the FDA expanded a previously granted breakthrough therapy designation for setmelanotide, the company's melanocortin-4 (MC4) receptor agonist, to include the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway, which includes both pro-opiomelanocortin (POMC) and leptin receptor deficiency obesity. Read More

Orphazyme ApS, of Copenhagen, said it completed enrollment for its lead program testing molecular chaperone candidate arimoclomol vs. placebo in patients with Niemann-Pick type C disease, when it is administered in addition to the patient's current prescribed best standard of care. Read More