Regeneron Pharmaceuticals Inc. and partner Sanofi SA will launch pivotal studies of the potential blockbuster allergy therapeutic dupilumab (REGN668/SAR231893) by the end of this year on the heels of encouraging phase IIb data showing it helped clear skin lesions in patients with a serious, chronic and hereditary form of eczema called atopic dermatitis (AD). Read More
Board disagreements have delayed the formal completion of the EMA's new policy on access to clinical trial data. The London-based regulatory agency disclosed late Wednesday that it was unable to agree on final wording for the new policy, which had been due to take effect Oct. 1. Read More
BOGOTA, Colombia – A relatively young system to trace pharmaceutical products from manufacturer to patient has put Argentina at the forefront of the global fight against fake drugs. Read More
LONDON – An eight-year study that involved sifting the genome of the malaria parasite has delivered a list of proteins that the parasite cannot do without – as well as determining at what point in the parasite's life cycle each of the proteins is expressed. Read More
A report from real estate firm Jones Lang LaSalle last year listed San Diego as the number two biotech cluster in the U.S. Like any list, that ranking is debatable. Read More
Ocera Therapeutics Inc., of Palo Alto, Calif., priced an underwritten public offering of 4.2 million common shares at $6 apiece for gross proceeds of $25.2 million. Read More
Beike Biotechnology Co. Ltd., of Shenzhen, China, said following the recent Chinese Food and Drug Administration acceptance of its investigational new drug application seeking use of human umbilical cord-derived mesenchymal stem cells to treat lupus, the company anticipates approval to move ahead with the treatment by the end of this year. Read More
Transtech Pharma LLC, of High Point, N.C., said it reached an agreement with the FDA's Division of Neurology Products, under a special protocol assessment process, on the design of a single phase III trial of TTP448 for the treatment of patients with mild Alzheimer's disease. Read More
Roche AG, of Basel, Switzerland, said its member firm, Ventana Medical Systems Inc., entered an agreement with Merck KGaA, of Darmstadt, Germany, to collaborate with Merck's biopharmaceutical division on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana's diagnostic assays. Read More
Novartis AG, of Basel, Switzerland, said the New England Journal of Medicine published the results from two pivotal phase III studies evaluating the interleukin-17A (IL-17A) inhibitor secukinumab, which met all primary and key secondary endpoints in the ERASURE and FIXTURE studies, including Psoriasis Area and Severity Index 75 and 90 and Investigator's Global Assessment modified 2011 0/1 responses. Read More
