Cornerstone Pharmaceuticals Inc., of Cranbury, N.J., said that, following a successful end-of-phase I type B meetings with the FDA, the company has a clear clinical and regulatory path forward to conduct pivotal trials of its lead compound, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. Read More

Heat Biologics Inc., of Durham, N.C., said it priced an underwritten public offering of 5 million shares of its common stock at $0.80 each with gross proceeds expected to be $4 million. Read More

A new task force will explore how drug regulators in the European Economic Area (EEA) can use big data to support research, innovation and drug development to benefit human and animal health. Read More

SINGAPORE – Asia has all the building blocks necessary to be at the vanguard of drug innovation, so what is stopping it from being on an equal footing with mature markets such as the U.S. and Europe? Industry experts at the 2017 BioPharma Asia Convention in Singapore pointed to the need for a change in the region's mindset toward innovation. Read More

All the congressional rhetoric about escalating U.S. drug prices, all the inquiries into abuses of the system and all the public complaints are coalescing into a unified cry for the U.S. government to do something to bring down the cost of drugs. Read More

The "five star general" of cancer genomics and discoverer of a number of key oncogenes has now confirmed that two-thirds of cancer-causing mutations are the result of random errors which occur when normal cells divide. Read More

SAN FRANCISCO – While the medical device industry remains true to its roots, seeking to improve the duration and quality of lives across many conditions, the $371 billion industry is increasingly seeking ways to push beyond incremental innovation, Jefferies LLC managing director Raj Denhoy told attendees at the Cooley Medical Technology Growth Conference on Thursday. Read More

The delay in reporting data from the phase II trial by Ultragenyx Pharmaceutical Inc. with UX007 (triheptanoin, or trihep) in glucose transporter type-1 deficiency syndrome (Glut1 DS) patients with seizures may have tipped some investors that mixed results lay ahead with the compound, but Raymond James analyst Christopher Raymond said that, "with the Glut1 DS filing strategy still dependent on the pivotal phase III movement-disorder study, we do not see [the latest] data meaningfully changing trihep's opportunity in Glut1 DS." Read More

Galectin Therapeutics Inc., of Norcross, Ga., (NASDAQ:GALT) said trading will be halted in GALTW and GALTU at close of business on March 23, due to the expiration, on March 28, 2017, of certain publicly traded warrants that were issued in March 2012. Read More