Bluebird Bio Inc. reported that new data from an ongoing phase I trial of its gene therapy, Lentiglobin, in sickle cell disease suggests that changes made to the study protocol and to manufacturing of the therapy are improving engraftment of the gene-modified stem cells. After trading as high as $161.84, company shares (NASDAQ:BLUE) ended the day Wednesday at $142.95, up $3.85, as the company detailed its third-quarter earnings and previewed clinical data it plans to present at the American Society of Hematology (ASH) meeting next month. Read More
PERTH, Australia – Novartis AG's recent tender offer to acquire radiopharmaceuticals specialist Advanced Accelerator Applications SA (AAA) for $3.9 billion could bode well for Aussie radiopharma company Telix Pharmaceuticals Ltd., which announced its IPO to raise A$50 million (US$38.4 million) on the Australian Securities Exchange. Read More
Bolstered hours earlier by FDA approval of the oral small-molecule Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib), Astrazeneca plc and its biologics research and development arm, Medimmune, quietly posted a miss for the phase III STRATOS 2 and TROPOS trials of tralokinumab, an anti-interleukin-13 (IL-13) immunoglobulin (IGE)-G4 monoclonal antibody, in severe, uncontrolled asthma. Read More
In oncology, there is a saying that "the tissue is the issue," meaning that to determine the best way to deal with a tumor, you need to biopsy it – and that such biopsies can be difficult to obtain. Read More
HONG KONG – In a pivotal phase III study, Tokyo-based Daiichi Sankyo Co. Ltd.'s pexidartinib met its primary endpoint of tumor response, measured by size reduction, in patients with symptomatic tenosynovial giant cell tumor (TGCT). Read More
Pelago Bioscience AB, of Solna, Sweden, was awarded a SEK3.6 million (US$428,000) Swelife grant to use its CETSA technique to identify new oncology biomarkers to help select the best treatments for childhood leukemia. Read More
Concerned about unintended consequences, two U.S. senators are asking the Centers for Medicare & Medicaid Services (CMS) to exclude coverage of Medicare Part B drugs from its payment adjustments to the Merit-based Incentive Payment System (MIPS). Read More
Intercept Pharmaceuticals Inc., of New York, recorded $40.9 million in worldwide net sales of Ocaliva (obeticholic acid), including a change in estimate related to deferred revenue with a net effect of a one-time increase of $4.1 million in net revenue for the third quarter. Read More
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif., said it closed its underwritten public offering of 2.13 million shares of its common stock that included the exercise in full of the underwriter's option to purchase up to 278,212 shares, at $10 each. The offering resulted in net proceeds to the company of approximately $19.5 million. Read More
Moleculin Biotech Inc., of Houston, said responses to the FDA's requests for additional information relating to a physician-sponsored IND to study WP-1066, a STAT3 inhibitor, in brain tumors has been submitted. The planned phase I study is expected to study WP-1066 in patients with glioblastoma or melanoma. Read More
