Aiming for success in female sexual dysfunction (FSD) after hitting roadblocks with U.S. regulators in erectile dysfunction (ED), Palatin Technologies Inc. is drawing from the $20 million raised last week in equity, along with $10 million in debt, to launch a phase III, 550-patient study that will test bremelanotide (BMT) in an eight-month experiment with an open-label extension phase. Read More
LONDON – Newron Pharmaceuticals Spa has resubmitted its new drug application for Xadago (safinamide) to the FDA exactly five months after receiving a refusal-to-file letter from the agency. The move comes a week after the EMA recommended the Parkinson’s disease treatment for approval, putting the company on course for EU and U.S. launches in 2015. Read More
BOGOTA, Colombia – As of 2015, Argentina will add three vaccines to its already significant immunization schedule. Vaccines for varicella zoster virus (chickenpox), rotaviruses and Neisseria meningitidis will be added to the country´s national immunization program (NIP). Read More
Treatment with histone deacetylase (HDAC) inhibitors can improve the symptoms of Huntington’s disease in a mouse model of the disorder – and can improve their untreated sons’ future symptoms as well, an example of a so-called transgenerational drug effect. Read More
NEW DELHI – India’s attempts to enter a Regional Comprehensive Economic Partnership (RCEP) deal among 16 countries in Asia are likely to have a significant impact on the biopharma industry, but analysts are divided as to what that will be. Read More
Dynavax Technologies Corp., of Berkeley, Calif., said it entered into a credit facility with Hercules Technology Growth Capital, Inc. for up to $40 million of total funding. Read More
Biomarin Pharmaceutical Inc., of San Rafael, Calif., said it has been granted approval in Japan for the registration of Vimizim (elosulfase alfa) for the treatment of patients with mucopolysaccharidosis type IVA, also known as Morquio A syndrome. Read More
Aeterna Zentaris Inc., of Quebec City, reported that an article on final data for the phase I portion of the ongoing phase I/II trial in prostate cancer with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule composed of a synthetic peptide carrier and doxorubicin has been published in the December 2014 issue of Clinical Cancer Research. Read More
