Shares of Puma Biotechnology Inc. (NYSE:PBYI) rose 20.3 percent Friday on word that the company has submitted an FDA new drug application (NDA) for its lead candidate, neratinib, along with updated data showing that the drug's absolute invasive disease-free survival (DFS) benefit remained steady over time during a phase III study including the company's initial intent-to-treat (ITT) population, women with early stage HER2-positive breast cancer previously treated with Herceptin (trastuzumab, Roche AG). Read More
Sciclone Pharmaceuticals Inc. has wound down a strategic review process after having spoken with a number of potential buyers, deciding instead to remain a publicly listed company. The company said the board did not receive a bid that reflected a premium to the company's trading price. Sciclone plans to continue with growth plans for its China-focused commercial business. Read More
LONDON – Work starts Monday on drawing up a life sciences transition program that the industry intends to present to government on Sept. 6 as a blueprint for negotiating the U.K.'s exit from the EU on favorable terms for the sector. Read More
HONG KONG – Japan's Chugai Pharmaceutical Co. Ltd. has licensed rights to its treatment for skin diseases to the company's Swiss partner, Galderma Pharma SA. The global agreement gives Lausanne-based Galderma rights to antibody nemolizumab, or CIM331. Read More
HONG KONG – Looking to continue morphing from a maker of active pharmaceutical ingredients (APIs) to a key biologic drug developer and manufacturer, Zhejiang Hisun Pharmaceutical Co. Ltd. has bought the rights to a targeted therapy for epithelioma in China from U.S. biotech company Nascent Biotech Inc. Read More
TAIPEI, Taiwan – At BioBusiness Asia 2016, a two-day conference and part of the four-day BioTaiwan festival, sessions on drug development models and global partnering strategies showcased several Taiwanese companies that have succeeded by adopting strategies tailor-made for Taiwan conditions. Read More
Heat Biologics Inc., of Durham, N.C., initiated and hours later suspended a public offering of its common shares, which was not priced. The company said it had received and was exploring alternative options. Read More
Eisai Ltd., of Hatfield, U.K., said the EMA's Committee for Medicinal Products for Human Use issued a positive opinion for Kisplyx (lenvatinib) in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior VEGF-targeted therapy. The opinion was issued following the evaluation of results from a pivotal phase II trial, which show lenvatinib plus everolimus significantly extended progression-free survival in patients with unresectable advanced RCC vs. everolimus alone. Read More
Merck & Co. Inc., of Kenilworth, N.J., said 48 weeks of treatment with 1,200 mg of raltegravir, delivered as 2 x 600 mg once daily, was statistically noninferior (88.9 percent, 472/531) to the marketed formulation of the drug, branded Isentress, dosed at 400 mg twice-daily (88.3 percent, 235/266), in both cases as combination therapy with Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences Inc.) in previously untreated adults with HIV-1 infection. Read More
