DUBLIN – Bidding to become the second European firm to win a gene therapy approval, Glaxosmithkline plc filed a marketing authorization application (MAA) with the EMA for GSK2696273, a treatment for severe combined immunodeficiency syndrome associated with adenosine deaminase deficiency (ADA-SCID) in patients for whom bone marrow transplants are not possible. Read More
Launched in 2012, Symbiomix Therapeutics LLC sped quickly from baby steps to a full sprint in advancing its single asset, SYM-1219, for the treatment of bacterial vaginosis (BV). Read More
SAN FRANCISCO – With international dealmaking often a key element of the biopharma asset development adventure, the path to success in Japan took center stage during the first day of Allicense, an annual pilgrimage for the industry's top business development pros. Read More
SHANGHAI – China may not be known for innovation, but Generon Corp. Ltd.'s founders decided 12 years ago they were not going to let that stop them from developing a potentially first-in-class biologic: F-652, a recombinant protein containing human interleukin 22 (IL-22). Read More
LONDON – The pharmaceutical industry has weighed in with its views of the antimicrobial resistance crisis, describing how difficult it is to develop new products and calling for changes in pricing and reimbursement to guarantee a return on investment. Read More
BOGOTA, Colombia – After three public hearings in July, October and February, Brazil's health surveillance agency, Anvisa, updated its clinical trial regulations. Read More
Amag Pharmaceuticals Inc., of Waltham, Mass., reported first quarter revenues of $89.5 million, compared with $20.8 million in the first quarter of 2014, primarily due to an increase of 85 percent in sales of Makena (hydroxyprogesterone caproate) over the period, to $55.5 million. Read More
Aldeyra Therapeutics Inc., of Lexington, Mass., launched a follow-on public offering of 3 million common shares and said it expects to grant underwriters a 30-day option to purchase up to 450,000 additional shares, which were not yet priced. Read More
Eleven Biotherapeutics Inc., of Cambridge, Mass., presented preclinical data on EBI-031, its protein therapeutic IL-6 inhibitor for diabetic macular edema, at the Association for Research in Vision and Ophthalmology meeting in Denver. Read More
Pernix Therapeutics Holdings Inc., of Morristown, N.J., said it completed a human pharmacokinetic equivalence study with ZX007, an abuse-deterrent tablet formulation of hydrocodone bitartrate. Read More
Teva Pharmaceutical Industries Ltd., of Jerusalem, said it completed the acquisition of Auspex Pharmaceuticals Inc., of La Jolla, Calif., in a roughly $3.2 billion deal that gives Teva rights to Auspex's orphan drug pipeline, including lead compound SD-809 (deutetrabenazine) for the potential treatment of chorea associated with Huntington's disease, tardive dyskinesia and Tourette syndrome. Read More
Abbvie Inc., of North Chicago, reported results at the Association for Research in Vision and Ophthalmology meeting in Denver from VISUAL I, a phase III study investigating the efficacy and safety of Humira (adalimumab) in adult patients with active non-infectious intermediate, posterior, or panuveitis who still experienced intraocular inflammation while on systemic corticosteroid therapy. Read More
