Krystal Biotech Inc., a company developing gene therapies for rare skin disorders, has filed to raise up to $34.5 million in an IPO. Its two preclinical programs, KB-103 for dystrophic epidermolysis bullosa (DEB) and KB-104 for Netherton syndrome, employ an engineered viral vector based on herpes simplex virus 1 and skin-optimized gene transfer. Read More
Intra-Cellular Therapies Inc. vice president Kimberly Vanover told BioWorld that the company "should have everything we need" to file an NDA for lumateperone, also known as ITI-007, in the middle of next year, and the company's shares (NASDAQ:ITCI) closed Wednesday at $14.39, up $3.12, or 27.7 percent, on word that the FDA found adequate the company's responses to a request for more information regarding toxicology experiments in dogs. Read More
The holdup on an interoperable, electronic, serialized, track-and-trace system that will have a global reach for prescription drugs sold in the U.S. market is much more basic than supply and demand. It's a matter of settling on a vision of what that system should look like in the face of ever-evolving technology. Read More
HONG KONG – China's drug authority is upscaling the Marketing Authorization Holder (MAH) mechanism pilot, which is seen as a boon for drug innovation in the country. The CFDA released another notice regarding the pilot MAH mechanism in the country which clarified details on the responsibilities of the authorization holders and license transferring. Read More
A new confidentiality commitment signed by the European Commission, the EMA and the FDA allows the U.S. agency to share nonpublic and commercially confidential information with EU regulators. Read More
Cel-Sci Corp., of Vienna, Va., said it entered a definitive agreement with institutional investors for an offering of shares of common stock with gross proceeds of approximately $3.5 million in a registered direct offering. Read More
Novavax Inc., of Gaithersburg, Md., reported that research from a preclinical study of its Nanoflu influenza vaccine candidate has been published in Vaccine. Read More
Celldex Therapeutics Inc., of Hampton, N.J., completed patient enrollment in its phase IIb METRIC trial testing glembatumumab vedotin, an antibody-drug conjugate that targets gpNMB, compared to Xeloda (capecitabine, Roche AG) in 327 patients with metastatic triple negative breast cancer that overexpress gpNMB. Read More
