Lonza Group Ltd., of Basel, Switzerland, and South San Francisco-based Denali Therapeutics Inc. announced an exclusive strategic partnership on Denali's biologic pipeline products for neurodegenerative diseases. The agreement covers all stages of the development and manufacturing, the partners said. The deal gives Denali access to Lonza's cell-line development using the GS Xceed Gene Expression System to process development and manufacturing at facilities in Slough, U.K., and Hayward, Calif. Read More
The FDA released additional draft and revised draft product-specific guidances, which provide recommendations on, among other things, the design of bioequivalence studies to support ANDAs. The document is set for publication in the Feb. 9 issue of the Federal Register. The agency also released a guidance on microbiology data for antibiotics, aimed at assisting sponsors in the development, analysis and presentation of microbiology data during antibacterial drug development. Read More
Alexion Pharmaceuticals Inc., of New Haven, Conn., reported fourth-quarter revenues totaling $909.7 million, beating consensus estimates of $880.6 million. For the full year, revenues totaled $3.551 billion. On a GAAP basis, diluted earnings per share (EPS) for the quarter was 13 cents per share, while EPS for the full year was $1.97 per share. Read More
Adverum Biotechnologies Inc., of Menlo Park, Calif., priced its public offering of about 8.9 million shares at $6.75 per share for gross proceeds of about $60 million. The gene therapy company granted underwriters a 30-day option to purchase up to an additional 1.3 million shares. Cowen and Piper Jaffray & Co. are acting as joint book-running managers, while Raymond James & Associates Inc. is acting as lead manager for the offering, set to close on or about Feb. 9. Shares of Adverum (NASDAQ:ADVM) closed Thursday at $7.50, up 40 cents. Read More
The first high-performance plasma biomarkers for Alzheimer's disease (AD) have been validated in an international collaborative study, which was reported in the Jan. 31, 2018, edition of Nature. Read More
Rani Therapeutics Inc., the San Jose, Calif.-based developer of a pill designed to replace injectable drugs for chronic disease, has raised $53 million to invest in manufacturing and preparation for clinical trials expected to begin within 12 months. Read More
The mystery started last June. That's when Novartis AG disclosed top-line results from the tests that pitted its VEGF-A ligand inhibitor, brolucizumab (RTH-258), in neovascular age-related macular degeneration (AMD) against Regeneron Pharmaceuticals Inc.'s flagship product, Eylea (aflibercept). Read More
Nearly halfway into fiscal 2018, U.S. Senate leadership has agreed to a bipartisan budget deal that puts the horse in front of the spending cart by setting new caps for defense and other discretionary government spending for this year and 2019. Read More
Tyme Technologies Inc., of San Francisco, reported data at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco from an ongoing phase II trial of SM-88 in patients with nonmetastatic, biochemical-recurrent prostate cancer. Data from 13 evaluable patients showed that 92 percent (12/13) have maintained radiographic progression-free survival (rPFS) with a median of 12 months since documented biochemical recurrence, and 10 months since starting SM-88 treatment. Read More
