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.
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.
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.
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.
Novavax Inc., of Gaithersburg, Md., reported that research from a preclinical study of its Nanoflu influenza vaccine candidate has been published in Vaccine.
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.
Mabvax Therapeutics Holdings Inc., of San Diego, said it closed its securities purchase agreements with investors providing for the registered sale of approximately $1.31 million of shares of series J convertible preferred stock, representing approximately 2,386.36 shares at a purchase price of $550 per share.
Alliance Foundation Trials LLC, of Boston, New York-based Pfizer Inc., and six international cancer research groups have launched Patina, a randomized, open-label, phase III study of the cyclin-dependent kinase 4/6 inhibitor Ibrance (palbociclib).
Wave Life Sciences Ltd., of Cambridge Mass., said an article describing how to produce antisense oligonucleotide (ASO) therapeutics with high stereochemical purity was published in Nature Biotechnology.
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