Prima Biomed Ltd., of Sydney, reported that multiple jurisdictions have approved its amended CAN-004 protocol, including regulators in Latvia, Lithuania, Bulgaria, Ukraine and Belarus. Read More
Amag Pharmaceuticals Inc., of Waltham, Mass., reported net U.S. Feraheme (ferumoxytol) sales of $71.4 million in 2013 in the FDA-approved indication of treating iron deficiency anemia (IDA) in chronic kidney disease (CKD). Read More
Grant & Eisenhofer PA said it is representing a whistleblower in a false claims lawsuit unsealed Thursday against Celgene Corp., of Summit, N.J., alleging off-label marketing of Thalomid (thalidomide) and Revlimid (lenalidomide) to cancer patients and payment of kickbacks to physicians for prescribing the medications. Read More
Alcobra Ltd. didn’t set out to address attention deficit hyperactivity disorder (ADHD), an indication with a number of approved drugs – including Ritalin (methylphenidate, Novartis AG), Concerta (a different formulation of methylphenidate, Johnson & Johnson) and Adderall XR (d-amphetamine, Shire plc) – as well as spectacular failures. Instead, the company was formed in 2008 by several Israeli entrepreneurs to pursue a drug that would induce rapid sobriety for social drinkers by quickly reducing blood alcohol levels – thus, the mashup of “alcohol” and “sobriety” in its name. Read More
Researchers have shown that in two animal models of autism, it was possible to prevent autism symptoms from developing in offspring by treating their mothers with the diuretic drug Bumex (bumetanide, Roche AG) before and during delivery. Conversely, blocking oxytocin signaling in mothers during delivery could lead to autism-like neuronal activity and behavior in their offspring. Read More
A culturing process designed to determine the growth and biological characteristics of the resulting cell population is enough to render stem cells a drug subject to FDA manufacturing and labeling regulations, a federal appellate court said this week in a ruling upholding a permanent injunction against Regenerative Sciences LLC’s Regenexx-C, a stem cell product used as an alternative to surgery for various orthopedic conditions and diseases. Read More
Topical Botox developer Revance Therapeutics Inc. priced its initial public offering (IPO) at the top of the projected range, sold more shares than expected and came out of the gate strong, with the stock (NASDAQ:RVNC) closing Thursday at $26.85, up $10.85, or 67.8 percent. Read More
Abbvie Inc., of North Chicago, said it is investing about $320 million to establish operations in Singapore for small-molecule and biologics active drug substance manufacturing. Read More
