If lawmakers, industry and payers need any more motivation to reform the complex drug supply chain in the U.S., they have only to look at some of the potentially game-changing technologies coming down the pike. Read More
DUBLIN – Shares in Ablynx NV dropped 18 percent Thursday morning on news that Abbvie Inc. decided not to trigger an option to take forward vobarilizumab in rheumatoid arthritis (RA). Vobarilizumab, an interleukin-6 receptor (IL-6R) inhibitor, recently demonstrated solid efficacy in a phase IIb head-to-head monotherapy trial against Actemra (tocilizumab, Roche Holding AG) and in a phase IIb combination trial with methotrexate. Read More
What one analyst characterized as a "weird" placebo response in one patient was enough to skew the results for Rigel Pharmaceuticals Inc.'s second of two double-blind studies in its FIT phase III program with fostamatinib, an oral spleen tyrosine kinase inhibitor, in adults with chronic/persistent immune thrombocytopenia (ITP). Read More
Theravance Biopharma Inc. and Mylan NV reported that revefenacin, a nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), met the primary endpoints in twin phase III studies, demonstrating statistically significant improvements from baseline over placebo in trough forced expiratory volume in one second (FEV1) after 12 weeks of dosing for each of two doses studied. Read More
While the FDA and industry are gung-ho about the commitments they fine-tuned for the second rendition of the biosimilar user fee agreement (BsUFA), patient advocacy groups and health care providers aren't so happy with some of the measures, especially the proposed delays in guidance on interchangeability, naming and labeling. Read More
LONDON – With pressure on drug pricing on the rise, Jim Greenwood, president of the U.S. Biotechnology Innovation Organization (BIO) was defending the industry's position in the U.K. yesterday, attending the Oxford University Union to debate the motion, "Big pharma prioritizes profit over patients." Read More
Puma Biotechnology Inc., of Los Angeles, priced an underwritten public offering of 3.75 million common shares at $40 apiece, a discount of 6.3 percent to the previous day's closing price of $42.75, seeking to raise $150 million. Read More
Vaxil Bio Ltd., of Toronto, said it R&D arm, Vaxil Biotherapeutics Israel and Rehovot, Israel-based Hadassah Medical Center have signed an agreement to work together on the company's immunotherapy platform, including its lead product, Immucin (MUC-1 peptide vaccine). Read More
Applied Genetic Technologies Corp., of Gainesville, Fla., said it filed an IND to conduct a phase I/II trial of its gene therapy candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene. Read More
