BOSTON – When the Biotechnology Industry Organization's (BIO) annual international convention opened in Boston five years ago, the industry was basking in all its pre-recession glory, with plenty of money flowing into both new and existing ventures – some said too much – and one of the biggest concerns heading into the BIO meeting was whether lawmakers would quit locking horns and finally pass PDUFA IV. Read More
Valeant Pharmaceuticals Inc. continued its specialty pharma shopping spree with an agreement to acquire oral health firm OraPharma Inc. for $312 million with up to $114 million in additional milestones. Read More
One of the disappointments of targeted cancer therapies has been that their promise of low toxicity has not been borne out. At the American Society of Clinical Oncology conference earlier this month, Geoffrey Shapiro of the Dana-Farber Cancer Institute told BioWorld Today that "alopecia" – hair loss – "and bone marrow toxicity have been replaced by diarrhea and rash" as the dose-limiting banes of therapeutic development. Read More
WASHINGTON – Reconciliation of the House and Senate versions of the PDUFA package could turn into a battle pitting brand drugmakers against generics as both sides fight for a little more market time. Read More
The cost of doing biopharma business in Brazil, Russia, India and China, as well as other emerging and underdeveloped markets, could come with a significant trade-off if the budding compulsory licensing trend gains traction. And, at the moment, there's not much brand makers can do about it. Read More
• Oxygen Biotherapeutics Inc., of Morrisville, N.C., said it entered agreements with institutional investors to amend the terms of its $7.5 million offering of registered shares of Series A convertible preferred stock and registered warrants to purchase shares. Read More
• Questcor Pharmaceuticals Inc., of Anaheim, Calif., said its initial commercialization plans for rheumatology drug H.P. Acthar Gel (repository corticotropin injection) include the creation of a 12-member sales force, plus a national sales director and two regional sales managers. Read More
• Kenta Biotech, of Zurich-Schlieren, Switzerland, reported that the first patient was enrolled in a Phase I/II trial with KBSA301, a fully human antibody for the treatment of severe pneumonia caused by S. aureus. The trial will involve 44 patients suffering from severe pneumonia caused by S. aureus admitted into intensive care units around Europe. They will receive a single dose of KBSA301, or placebo, in addition to standard antibiotic therapy. Read More
• Meda AB, of Goteborg, Sweden, reported that Edluar has received registration approval in Europe, via the decentralization process, to treat sleep disorders. National registration processes will follow in each country, with the first launches expected early next year. Read More
• Bristol-Myers Squibb Co., of New York, reported six-year follow-up results from a Phase III trial of Sprycel (dasatinib) in Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia adult patients resistant or intolerant to Glivec (imatinib, Novartis AG), demonstrating a progression-free survival rate of 49.3 percent and an overall survival rate of 71 percent for patients receiving dasatinib, with 6 percent of patients progressing to accelerated or blast phase of the study at six years of follow-up. Read More
