Researchers from the University of California at Los Angeles, the University of Southern California and Harvard University have used large-scale sequencing of prostate risk cancer genes to estimate that 42 percent of prostate cancer risk is due to rare variants. Read More
Aptose Biosciences Inc., of San Diego, said the FDA placed a clinical hold on the phase Ib trial of APTO-253 in patients with hematologic cancers, following the company's voluntary suspension of dosing in the study. Read More
Newron Pharmaceuticals SpA, of Milan, Italy, said it completed a private placement of 209,364 shares with an undisclosed U.S.-based biotechnology and health care specialist fund for gross proceeds of $5.4 million. The subscription price was CHF25.60 (US$25.12) per share. Under the agreement, the fund holds an option to subscribe to another 209,364 newly issued shares no later than June 30, 2016. Newron said proceeds will accelerate the advancement of the planned pivotal trial with sarizotan to treat patients with Rett syndrome. The transaction is expected to close by Nov. 25. Piper Jaffray acted as exclusive financial advisor. Read More
Genmab A/S, of Copenhagen, Denmark, said it achieved a $45 million milestone in its Darzalex (daratumumab) collaboration with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. Read More
The FDA Friday gave a faster-than-expected nod to Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib), an oral proteasome inhibitor expected to eventually replace blockbuster Velcade (bortezomib), which is set to lose patent protection later this decade. Read More
HONG KONG – The Malaysian government is setting a five-year data protection structure for biologics in the country under the terms of the Trans-Pacific Partnership (TPP). That could mean more expensive drugs for the people and better protection for drugmakers. Read More
As Biomarin Pharmaceutical Inc. unveiled a data analysis comparing the efficacy of Kyndrisa (drisapersen) in similar patients across three randomized studies, the FDA let fly with briefing documents for Tuesday's meeting of the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee (adcom). Read More
Plans to launch the first biosimilar of Enbrel (etanercept, Amgen Inc.) in Europe are taking a big step forward with receipt by Samsung Bioepis Co. Ltd. of a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). Read More
LONDON – The UK is to apply real world evidence to decisions on whether to allow routine commissioning of expensive cancer drugs, providing a fast track to companies that offer lower prices and collect data on patient benefit for the first two years a product is on the market. Read More
Runaway drug pricing, deductible tricks by health insurance providers to dodge payouts, and the importance of developing new therapies as weighed against what patients can afford – such topics and more were taken up during a day-long forum sponsored by the Department of Health and Human Services (HHS). Read More
To skeptics, looking for cancer drugs by screening cell lines is the equivalent of searching for your lost wallet under a street lamp. The types of cells that can be cultured, the argument goes, are different in critical ways from those that can't, and any knowledge gleaned from them is likely to lead drug developers down a primrose path that ends in clinical failure. Read More
