The antibiotic dalbavancin’s long road to approval seems likely to end near the end of next May, now that Durata Therapeutics Inc. has submitted the new drug application (NDA) for the drug targeting acute bacterial skin and skin structure infections caused by gram-positive microorganisms, including the hospital scourge known as MRSA: methicillin-resistant Staphylococcus aureus. Read More
SHANGHAI – The venture capital arm of Eli Lilly and Co. plans to invest in a small but rapidly growing biotech company with a strong pipeline to push forward the development of a third-generation whooping cough vaccine. Read More
Following calls to improve supervision over clinical trials, China has launched a new online registration platform that should help improve transparency and the quality of the growing number of trials done in the country. Read More
Inotek Pharmaceuticals Corp., of Lexington, Mass., plans to apply $21 million in proceeds from a venture financing and $7 million in venture debt financing to advance its A1 subtype adenosine mimetic for glaucoma and ocular hypertension. The funds will allow it to begin a Phase II study of trabodenoson in combination with latanoprost in late 2013. Read More
Rebiotix Inc. has sprinted from concept to clinical application in less than two years in pursuit of treatment for gastrointestinal diseases, such as recurring Clostridium difficile infection (CDI), using the human microbiome – the collective genomes of the human microbiota. Read More
Figuring out the contribution of any gene to complex disorders is a murky fishing expedition, done in waters muddied by the interaction of the gene in question with other genes and environmental influences. As a result, identifying genetic contributions to complex disorders has been slow going even when very large groups have been sequenced. Read More
• Anida Pharma Inc., of Cambridge, Mass., said it was awarded funding from the Michael J. Fox Foundation for Parkinson’s Research to conduct preclinical research using its lead compound for neurodegenerative diseases, Neuroprotectin D1, an endogenous DHA-derived lipid mediator that regulates circuits of resolution. Read More
• Bioheart Inc., of Sunrise, Fla., reported preliminary data from its Phase I ANGEL trial, showing at the three-month time point that patients are demonstrating an average improvement in exercise capacity or a six-minute walk test of 47 meters. Read More
• Mylan Inc., of Pittsburgh, and Agila Specialities Global Pte. Ltd., of Bangalore, India, have had conditions on Mylan’s proposed acquisition of Agila imposed by the Federal Trade Commission (FTC), which is requiring the firms to divest 11 generic injectable drugs prior to the acquisition. Read More
If practical obstacles can be overcome, induced pluripotent stem (iPS) cells could turn into a source for autologous cells for transplant. One of those practical obstacles is that immune responses may develop to even autologous iPS cells, at least in mice. Read More
