Back in July, it looked like Transcept Pharmaceutical Inc.'s insomnia drug Intermezzo (zolpidem tartrate) was down for the count. The company, aiming to provide the first treatment specifically for middle-of-the-night waking, had just gotten a surprise second complete response letter (CRL), despite conducting the FDA-requested next-day highway driving study. Read More
Big pharma and biotech start-ups have embarked on a federated mission to explore the expansive chemical space between small molecules and biologics to seek out new therapies that will boldly go where no drugs have gone before. Read More
Combination treatment with Bactericidal/Permeability-Increasing protein (BPI) and an antibiotic that is the veterinary equivalent of Cipro (ciprofloxacin, Bayer AG) – was able to save three-quarters of mice subjected to radiation levels that almost unfailingly killed their untreated cousins. Read More
Inspiration Biopharmaceuticals Inc. initiated patient enrollment in the second of two pivotal studies of the company's OBI-1 Accur8 Phase III hemophilia program. Read More
BioWorld's offices were closed Thurday, Nov. 24, and Friday, Nov. 25, in observance of the Thanksgiving Day holiday in the U.S. No issues were published those days. Read More
• Radius Health Inc., of Cambridge, Mass., closed a second tranche of a three-tranche financing worth $91 million total. The second close includes $21.4 million in equity financing by current investors and $6.25 million in debt financing. Proceeds will fund the ongoing Phase III trial of BA058 for osteoporosis. Read More
• Cipher Pharmaceuticals Inc., of Mississauga, Ontario, submitted an amendment to its pending new drug application to the FDA for cip-isotretinoin, which is in development for the treatment of acne. The amendment includes additional clinical information requested by the FDA. Acceptance by the FDA as a complete response will trigger a $1 million milestone payment from Cipher's marketing partner. Read More
• Neuralstem Inc., of Rockville, Md., dosed its first patient in a trial of a stem cell therapy in the cervical region of the spine in an ongoing safety trial in amyotrophic lateral sclerosis. The previous 12 patients in the study received stem cell transplants in the lumbar region of the spine, but patient 13 received the transplant in the gray matter of the cervical region. Read More
The innate immune system has two competing jobs. On one hand, it tries to limit the replication of viruses and bacteria. But on the other, it has to make sure there is enough antigen around to get the adaptive immune system going. Read More
