Chimerix Inc. and Omthera Pharmaceuticals Inc. have joined eight other biotechs with initial public offerings (IPO) filed and pending. IPO activity has been light in 2013 thus far, with just two companies pricing their first offerings. Once the ultimate aspirational goal for a start-up, the IPO has become almost an option of last resort in a public market that has run hot and cold on biotech for quite some time. Read More
Beginning next week, the U.S. patent system will be in step with the rest of the world. But to keep pace, the Patent and Trademark Office (PTO) and industry will have to manage a steep learning curve as the nation switches from first-to-invent patent claims to a globally accepted first-to-file system. Read More
Bolstering its news in January, when the firm disclosed that the intravenous antiplatelet cangrelor had proven strong in a Phase III trial as compared to oral clopidogrel, The Medicine Co.'s scientific team offered specifics over the weekend at the American College of Cardiology Scientific Session in San Francisco. Read More
AbbVie Inc. and InterMune Inc. could derail the European Medicines Agency's (EMA) carefully timetabled introduction of a new data transparency regime on Jan. 1, 2014 by seeking court injunctions preventing the disclosure of clinical trial data for their respective principal products, Humira (adalimumab) and Esbriet (perfidenone). Read More
LONDON – It was money galore for UK biotech on Monday as the government Biomedical Catalyst fund announced its second round of grants, with 51 companies bagging a total of £47.2 million (US$70.2 million). Read More
Shares of Aeterna Zentaris dropped 22.5 percent Monday after a data safety monitoring board (DSMB) said it was unlikely a Phase III study testing PI3/Akt inhibitor perifosine in multiple myeloma would hit its endpoints. Read More
NeuroVive Pharmaceutical AB extended its drug pipeline by picking up a series of polyketide-based preclinical cyclophilin inhibitors from Biotica Technology Ltd., a UK pioneer of polyketide engineering, which is currently in administration. Read More
• Resverlogix Corp., of Calgary, Alberta, said it entered an amended and restated loan agreement with Citibank NA, increasing the loan from $25 million to $38.8 million. The loan is secured by an irrevocable $38.8 million standby letter of credit arranged by Eastern Capital Ltd., and the firm issued an additional 728,640 share purchase warrants to Eastern in connection with the loan increase. Read More
• Celtic Therapeutics Management LLLP, of New York, changed its name to Auven Therapeutics Management LLLP to overcome confusion related to other Celtic entities. Read More
• Gilead Sciences Inc., of Foster City, Calif., said data from the double-blind, placebo-controlled, parallel Phase IV TERISA (Type II Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study showed that adding ranolazine (Ranexa) to background anti-anginal therapy in chronic angina patients with Type II diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background anti-anginal therapy. Read More
• Moberg Derma AB, of Stockholm, Sweden, said it is discontinuing the development of Limtop, a formulation of imiquimod, in actinic keratosis. Read More
• Pfizer Inc., of New York, said the REMINDER trial of Inspra (eplerenone) showed statistically significant risk reductions in the primary composite efficacy endpoint, defined as time to first event of cardiovascular mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) = 40 percent after one month or an elevation of BNP/NT-proBNP after one month. Read More