• Clinigen Healthcare, of Burton-on-Trent, UK, the pharmaceutical products division of Clinigen Group, said its supplemental new drug application for Foscavir (foscarnet sodium) in HIV/AIDS-related cytomegalovirus infections and herpes was approved by the FDA. Read More
• Dendreon Corp., of Seattle, reported a wider-than-expected loss for the first quarter, though revenues of $82 million for sales of prostate cancer vaccine Provenge (sipuleucel-T) fell in line with expecations. The net loss was $103.9 million, or 70 cents per share, compared to analyst estimates of a 63-cents-per-share loss. Dendreon said there was increased demand for Provenge, with 128 new infusion sites added in the first quarter. Read More
• Advaxis Inc., of Princeton, N.J., said two patients have been enrolled into a Phase I/II study sponsored by Cancer Research UK to test immunotherapy candidate ADXS-HPV for the treatment of human papillomavirus (HPV)-positive head and neck cancer. Read More
• Nuvo Research Inc., of Mississauga, Ontario, said partner Galderma Laboratories L.P., an affiliate of Galderma SA, of Levallois-Perret, France, responded to a complete response letter from the FDA for Pliaglis (lidocaine and tetracaine cream). Read More
WASHINGTON – A subcommittee of the House Energy and Commerce (E&C) Committee needed little time to agree to the manager's mark for the House version of FDA user fee legislation, amending the draft with only a technical fix offered by the subcommittee chairman. Read More
LONDON – Intercell AG is raising €40 million (US$52 million) in debt and equity as it continues work to repair the damage wreaked by the clinical failure of vaccines against traveler's diarrhea and Staphylococcus aureus. Read More
After a first career in cancer, the mTOR kinase is a fairly recent addition to the list of longevity proteins – that is, proteins whose activation or inhibition can affect mammalian life span. Read More
Briefing documents released in advance of Thursday's meeting of the FDA's Endocrinological and Metabolic Drugs Advisory Committee (EMDAC) suggested Arena Pharmaceuticals Inc. may have allayed many of the agency's concerns about the safety of its weight loss drug Lorqess (lorcaserin). Read More
In a bit of a déjà vu, the FDA's Arthritis Advisory Committee (AAC) once again overwhelmingly rejected a sponsor's quest to expand the label of its IL-1 blocker to include the prevention of gout flares. Read More
• H. Lundbeck A/S, of Copenhagen, Denmark, and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported data showing significant improvements in overall symptoms of depression in elderly patients taking Lu AA21004, with patients taking 5 mg of the multimodal depression drug showing a significantly greater (p = 0.0011) improvement on the primary efficacy endpoint of HAM-D24 total score vs. placebo at week eight. Read More
