BEIJING – The hot topic at this year's China Bio International 2014 is what type of strategy drugmakers should take to get innovative drugs on the market with China's challenging biologics manufacturing rules. It's clearly a high-stakes gamble, with innovators betting on one of three different horses to get them to the finish line. Read More
Cancer therapy specialist Helsinn Group reported that anamorelin, its once-daily ghrelin receptor agonist for the common wasting disease cachexia significantly increased lean body mass (LBM) compared to placebo in two phase III trials in non-small-cell lung cancer (NSCLC) patients. Read More
DUBLIN – The EMA review of Clinuvel Pharmaceuticals Ltd.'s dossier for Scenesse (afamelanotide 16 mg) in the treatment of erythropoietic protoporphyria (EPP) is the first to incorporate patient feedback under a new pilot program. Read More
LONDON – Blocking signals from immune cells could provide a way to prevent melanoma cells from becoming resistant to the latest highly promising therapies. A new study has shown that the cytokine (chemical messenger) TNF-alpha acts as a growth factor for melanoma cells. Not only that, this cytokine attracts additional immune cells to the tumor, which in turn release more TNF-alpha. Read More
With the current Ebola virus outbreak wreaking havoc in West Africa and generating headlines across the world, it's easy to forget that dozens of other pathogens cause even more illness and death around the world. Read More
The FDA's Office of Prescription Drug Promotion said Friday it is reopening the comment period for the two draft social media guidances published June 17, allowing the public an additional 30 days, beginning Sept. 29, to provide comments. Read More
Coherus Biosciences Inc., of Redwood City, Calif., filed an S-1 for an initial public offering (IPO) to raise up to $86.3 million, though the number of shares and share price have not yet been disclosed. Read More
Aveo Oncology Inc., of Cambridge, Mass., took another step to lower operating costs by terminating the lease agreement on its headquarters facility, reducing its lease obligations by $110 million. The amended agreement calls for a payment of $7.8 million at signing and $7.8 million payable over the subsequent nine months. Read More
Microbiome Therapeutics LLC, of Broomfield, Colo., reported top-line results from a proof-of-concept study testing whether investigational drug NM505, a combination of metformin plus the active ingredients in the firm's lead microbiome modulator, NM504, can improve the tolerability of metformin. Read More
Daiichi Sankyo Co. Ltd., of Tokyo, said it received approval in Japan for anticoagulant Lixiana (edoxaban) for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the treatment and recurrence prevention of venous thromboembolism, deep vein thrombosis and pulmonary thromboembolism. Read More
Researchers from the University of Kentucky at Lexington have shown that autophagy, a process by which cells recycle cellular components they no longer need, is apparently an important process for maintaining pregnancy. Read More
