Roche Holding AG issued a vote of confidence in partner Ionis Pharmaceuticals Inc. by tapping the Carlsbad, Calif.-based company for a second alliance, focused on the treatment of complement-mediated diseases. The companies will collaborate on the development of IONIS-FB-LRx, targeting factor B (FB), in a broad range of diseases, beginning with geographic atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD). Read More
U.S. biosimilar competition for cancer drug Rituxan is just a step away, after the FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously Wednesday to recommend approval of Celltrion Inc.'s CT-P10. Read More
As if to highlight the need for speed in the midstage race in alopecia areata (AA, or hair loss in patches), Wayne, Pa.-based Aclaris Therapeutics Inc. in July gained fast track status from the FDA for the phase II topical JAK1/3 inhibitor ATI-502. Read More
HONG KONG – Chinese biotech firm Origimed Co. Ltd., of Shanghai, is taking part in building China's first cancer big data platform with two oncology organizations to gather genetic data of the Chinese population. That will give doctors more precise information to diagnose cancer and customize treatment. Read More
Wyss Institute researchers have shown that gold nanoparticles can help extend the half-life of investigational cytokine interleukin 4 (IL-4), which is known to boost anti-inflammatory activity but degrades too quickly when injected alone to produce the desired effect. Read More
Briefing documents released ahead of Friday's meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) suggest Acelrx Pharmaceuticals Inc. might have better luck the second time around with its sublingual 30-mcg tablet version of sufentanil given by way of a non-invasive, single-dose applicator. Read More
Beigene, Ltd., of Beijing, said China's State Medical Insurance Administration has included Vidaza (azacitidine for injection) on its national reimbursement drug list. The nucleoside metabolic inhibitor was approved in China for patients with intermediate-2/high-risk myelodysplastic syndrome, acute myeloid leukemia with 20 percent to 30 percent bone marrow blasts and chronic myelomonocyte leukemia. It is marketed in China under an exclusive license from Celgene Corp., of Summit, N.J. Read More
Audentes Therapeutics Inc., of San Francisco, said it intends to offer $150 million of its common stock in an underwritten public offering and also grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its common stock. Read More
President Donald Trump has signed into law bills S. 2553 and S. 2554 banning the insurance gag clauses that have kept pharmacists from letting patients know that paying out of pocket might be cheaper than their copay for a prescription drug. Read More
