Word leaked out late last week of China's rejection of a patent application by Gilead Sciences Inc. related to the blockbuster hepatitis C virus (HCV) drug, Sovaldi (sofosbuvir), putting a damper – at least for now – on the company's scheme to introduce one of its top-selling drugs into the world's most populous country.
Clementia Pharmaceuticals Inc. completed a $60 million mezzanine financing round to support continued development of its lead compound, palovarotene (formerly Clm-001), to treat fibrodysplasia ossificans progressiva (FOP).
Nearly a decade after The Medicines Co. (MDCO) began to enroll patients in the first phase III trial of cangrelor, the antiplatelet therapy gained FDA approval late Monday to prevent blood clots in patients undergoing percutaneous coronary intervention or angioplasty, provided they were not previously treated with a P2Y12 inhibitor or receiving a glycoprotein IIb/IIIa inhibitor.
Although the sprawling exhibit hall at the BIO International Convention sometimes seems like an indoor advertising showcase for big pharma, it also serves as an essential meeting point for smaller companies seeking to expand their networks or attract that critical initial partner. Pity the poor exhibitor stuck in a back corner who has to compete with floor to ceiling exhibits featuring gourmet delicacies, live entertainment, celebrities and visiting dignitaries.
PHILADELPHIA – Provenge (sipuleucel-T), the prostate cancer immunotherapy developed by Dendreon Inc., was a topic of conversation at several sessions at the BIO International Convention, and not in a good way.
PHILADELPHIA – For decades, young biotechs have circled the so-called "Valley of Death," trying not to fall into the funding chasm that can occur during the period between discovery and clinical proof of concept – the critical milestone when most venture capital (VC) firms are willing to get on board.
As Redhill Biopharma Ltd. suggested it might move the needle on treating Helicobacter pylori (H. pylori) bacterial infection, the company's shares (NASDAQ:RDHL) sizzled, as well, hitting an historic high of $22.22 before closing Monday at $19.07 for a gain of $2.61, or 15.9 percent.
The roller-coaster ride that is Aveo Oncology Inc. took another dip Friday when the Cambridge, Mass.-based company reported written feedback from the FDA on the development of a biomarker that would help predict the response of patients with colorectal cancer (CRC) to tivozanib (tivo) compared with Avastin (bevacizumab, Roche AG).
Four years after its launch, Xtuit Pharmaceuticals Inc. came out of virtual mode with a $22 million series A that should suffice to advance its lead candidates in oncology and liver fibrosis through human proof-of-concept studies.
After a long first day of debating the merits of low-density lipoprotein cholesterol (LDL-C) as a surrogate endpoint for cardiovascular (CV) risk before endorsing Praluent (alirocumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in general genetic heterozygous high-risk populations and higher risk secondary populations, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reconvened Wednesday to review what many analysts predicted might be a more bruising battle in the protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor class.
