Eli Lilly and Co., of Indianapolis, reported results from its phase III study of Cyramza (ramucirumab) in combination with paclitaxel in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma, showing that the addition of ramucirumab showed a statistically significant improvement in median overall survival, meeting the primary endpoint. Read More
Novo Nordisk A/S, of Bagsvaerd, Denmark, said the European Commission approved Xultophy (ideglira) for the treatment of type 2 diabetes mellitus in adults. The authorization covers all 27 European Union member states. Read More
Heat Biologics Inc., of Durham, N.C., started dosing in its phase II trial of viagenpumatucel-L (HS-110) in patients with non-small-cell lung cancer. HS-110 is Heat's most advanced product candidate in a series of Immune Pan Antigen Cytotoxic Therapy compounds based allogeneic cell lines designed to direct killer T cells to attack cancer. Read More
Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA considers the company's Aug. 29 resubmission of its supplemental new drug application for Xifaxan 550-mg tablets for the proposed indication of irritable bowel syndrome with diarrhea to be complete and assigned an action date of Feb. 28, 2015. Read More
BEIJING – Two Chinese biotech companies are forming an alliance to bring a safer and more effective novel treatment for colorectal, breast and ovarian cancer patients in China. Read More
HONG KONG - Researchers from the Chinese University of Hong Kong (CUHK) have identified a small-molecule compound that dramatically inhibited tumor growth in a mouse model of hepatocellular carcinoma (HCC), representing a promising lead candidate for further investigation as an urgently needed new class of HCC therapy. Read More
Proposed changes in labels for testosterone replacement therapy (TRT) products sent ripples across the space, after the first of a two-day meeting of FDA advisors concluded with a 20-1 vote that the drugs ought only to be used in classic hypogonadism – low testosterone due to testicular or disease of the hypothalamic/pituitary glands. Read More
DUBLIN – Dutch venture capital firm Aglaia has secured $65 million in a first closing of a new oncology fund, which is targeting a final close of $80 million to $100 million. Read More
LONDON – After dealing with the embarrassment of scrapping its tecemotide cancer vaccine just four months after embarking on a third phase III trial, Merck Serono promised no such repetitions as it presented a detailed update on its portfolio and put further flesh on an ambitious biosimilars strategy that will see up to five phase III trials start in 2015 – 2016. Read More
With two more initial public offerings (IPOs) pricing Thursday – a $97.5 million home run by cystic fibrosis player Proqr Therapeutics BV and a $40.2 million infield fly by antibiotics developer Foamix Pharmaceuticals Ltd. – the ups and downs of the IPO market seemed analogous to the set-up for baseball's postseason play. Read More
