Any notion that sponsor Amylin Pharmaceuticals LLC, a wholly owned subsidiary of Bristol-Myers Squibb Co. (BMS), might receive limited support from the FDA during the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting evaluating its biologics license application (BLA) for metreleptin (recombinant methionyl human leptin) was quashed early Wednesday morning. Read More
The FDA’s Allergenic Products Advisory Committee will issue a recommendation on Stallergenes SA’s Oralair grass allergy tablet, a therapy that’s well established in Europe, for first-time approval in the U.S. market. Until now, the FDA has only approved subcutaneous therapies involving allergen extracts. Stallergenes is seeking approval for Oralair to treat allergic rhinitis or conjunctivitis in patients 5 years of age and older. Read More
LONDON – “It always seems impossible until it’s done.” This typically insightful comment by Nelson Mandela was invoked as a call for action by health ministers, science ministers, researchers, voluntary organizations, the Organisation for Economic Co-operation and Development (OECD) countries and the WHO, at the First G8 Dementia summit in London Wednesday. Read More
Hopes raised just over a month ago by encouraging interim Phase IIb data with aldoxorubicin (aldox) in soft-tissue sarcomas (STS) were met and then some by Cytrx Corp., which disclosed top-line results that show an 80 percent to 100 percent improvement in progression-free survival (PFS) with the compound. Read More
A new spending framework constructed by congressional budget negotiators would provide some relief from across-the-board sequestration cuts, but it does nothing to protect FDA and Patent and Trademark Office (PTO) user fees from those cuts. Read More
Engineered T cells are probably the most promising therapy that regularly sends its recipients to the intensive care unit. Their toxicity is due to two separate issues: on-target/off-tumor activity and cytokine release syndrome, or cytokine storm. Now, scientists have found a way to reduce on-target/off-tumor activity. Indirectly, their method may also help reduce the cytokine storm. Read More
Ario Pharma Ltd., of Cambridge, UK, has spun out from Xention Pharma Ltd., a specialist ion channel R&D company, to develop new approaches to treat respiratory disease. Read More
Receptos Inc., of San Diego, said that Ono Pharmaceuticals Co. Ltd., of Osaka, Japan. has elected to amend and expand their existing collaboration agreement to include transfer to Ono of the Receptos G-protein-coupled receptor (GPCR) technology platform, a high resolution protein crystal structure determination technology, which enables rational drug design for the GPCR therapeutic target class. Read More
Kamada Ltd., of Ness Ziona, Israel, completed the pivotal Phase II/III trial in Europe and Canada of the company’s inhaled alpha-1 antitrypsin therapy for the treatment of alpha-1 antitrypsin deficiency (inherited emphysema). Read More
Iroko Pharmaceuticals LLC, of Philadelphia, said its affiliate, Iroko Pharmaceuticals Inc., has signed licensing agreements with Algorithm SAL and PT Pratapa Nirmala (Fahrenheit), under which the two companies will obtain the exclusive rights to market and sell pain drug Zorvolex (diclofenac) capsules to countries in the Middle East, North Africa and Indonesia, respectively. Read More
