Biologics are innovative drugs, biosimilars are copies, and never the twain shall meet. That's the underlying message brand drugmakers sent to the FDA as they urged it to maintain the distinctions between the 351(a) and 351(k) approval paths. Read More
Eli Lilly and Co.'s decision to stop its Phase II study with LY2886721, a beta secretase (BACE) inhibitor as a potential once-daily treatment for slowing Alzheimer's disease (AD), was "sad news, obviously," said Decision Resources analyst Georgiana Kuhlmann. Read More
Polyglutamine stretches in proteins lead to trouble so frequently that there is a whole disease category named after them. The polyglutamine, or polyQ, disorders, of which Huntington's disease is the most famous member, but far from the only one, as "polyglutamine domains have been associated with a lot of pathological conditions," Dartmouth University's Amy Gladfelter told BioWorld Today. Read More
LONDON – "I really hope to create a building where as you walk round the corridors, at the coffee machine and in the cafeteria, that you hear people talking science, that science becomes the language of the place." Read More
SAN DIEGO – At a session at the recent Calbio meeting, biotech executives from multiple companies explained how they got their start-ups off the ground. Be it capital-efficient virtual biotechs, strategic partnerships, venture capital funding or initial public offerings (IPOs), the message was clear: There's more than one way to build a biotech. Read More
• The FDA is investigating two unexplained deaths in patients who received an intramuscular injection of Indianapolis-based Eli Lilly and Co.'s antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). Read More
• Civitas Therapeutics Inc., of Chelsea, Mass., said it received a $1 million grant from the Michael J. Fox Foundation for Parkinson's Research to support a Phase IIb trial of CVT-301, an inhaled formulation of levodopa that is being developed as an adjunct therapy to provide rapid relief from intermittent debilitating motor fluctuations, known as "off" episodes. Read More
• Adamas Pharmaceuticals Inc., of Emeryville, Calif., reported that the company's Phase II/III EASED (Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia) trial of ADS-5102 (Nurelin, amantadine HCl extended release) met the primary endpoint, defined as the reduction in levodopa-induced dyskinesia in Parkinson's patients over eight weeks compared to placebo, as measured by the Unified Dyskinesia Rating Scale. Read More
