DUBLIN – Suppremol GmbH is joining the nascent Baxalta organization in a €200 million (US$221 million) acquisition deal that signals the intentions of the Baxter Bioscience spinout to extend its scientific capabilities and its pipeline into autoimmune disease. Read More
SHANGHAI – A trans-Pacific biotech – with labs in Zhangjiang Hi-tech Park in Shanghai, and offices in Hayward, Calif. – Micurx Pharmaceuticals Inc., has commenced enrollment for its U.S. phase II trial for MRX-1, an antibiotic to combat drug-resistant infections. Read More
The likelihood that the House Appropriations Committee will fully fund the FDA's fiscal 2016 budget request of $4.9 billion looked bleak Wednesday as a subcommittee expressed concerns about the $150 million increase against the backdrop of continuing deficits. Read More
With $22 million in series A fuel and technology licensed from Harvard University, Macrolide Pharmaceuticals Inc. is "blowing out the class" of antibiotics after which the company is named "in a very rapid and efficient manner," CEO and co-founder Lawrence Miller told BioWorld Today. Read More
Aura Biosciences Inc. has secured a $21 million series B round intended to carry its synthetic viral nanoparticle-based therapies into a 24-patient phase I/II ahead of planned pivotal testing for a rare ocular cancer. Read More
LONDON – It is more than two years since Glybera received marketing approval, but finally the first patient is lined up to be treated with the first commercial gene therapy. Read More
HONG KONG – Paving the way for further growth of a $2 billion sector, the CFDA has published final regulatory guidelines for biosimilars. Included are standards for research, development and evaluation. Most importantly, the CFDA also gave clear instruction on the pathway, categorization and application material needed for biosimilar registrations. Read More
As the FDA Vaccines and Related Biological Products Advisory Committee met today to decide which flu strains to include in next year's vaccine, no one would argue that the process worked well last year. Read More
Cyclacel Pharmaceuticals Inc. shares (NASDAQ:CYCC) fell 22.5 percent to $1.10 on Wednesday after the Berkeley Heights, N.J.-based company priced a follow-on offering of 10 million shares of common stock at $1 each, a 29 percent discount to the closing price of $1.42 per share on Tuesday. Read More
Novacyt, of Paris, and Leica Biosystems, of Cambridge, UK, agreed on a deal that gives Leica exclusive distribution in greater China markets of Novacyt's NOVAPrep cytology platform. Read More
Keryx Biopharmaceuticals Inc., of New York, disclosed the publication of Auryxia (ferric citrate) data and expert analyses in two peer-reviewed journals. Read More
To prevent future shortages of drugs containing controlled substances, the Government Accountability Office (GAO) is recommending that the FDA and Drug Enforcement Administration (DEA) develop a better collaborative relationship and agree on what constitutes a shortage. Read More
Bristol-Myers Squibb Co., of New York, said the FDA expanded the approved use of PD-1 inhibitor Opdivo (nivolumab) to treat patients with advanced squamous non-small-cell lung cancer with progression on or after platinum-based chemotherapy. Read More
