Spun out of Verus Pharmaceuticals Inc. in 2008 to focus on developing oral budesonide suspension (OBS) for eosinophilic esophagitis (EoE) in children and adults, Meritage Pharma Inc. has brought the compound to the brink of phase III and found a buyer in Shire plc, which is paying $70 million up front plus development and regulatory milestone rewards as high as $175 million to acquire the company. Read More
Novartis AG salvaged a win, gaining conditional FDA approval for Farydak (panobinostat), the first histone deacetylase inhibitor (HDAC) approved to treat patients with multiple myeloma (MM), despite an advisory committee's concerns that the drug's benefit could outweigh its risks in certain contexts. Read More
Ipsen SA plucked Canbex Therapeutics Ltd. in its prime, gaining an exclusive option to purchase the small University College London (UCL) spin-off and forestall a potential competitor to its Dysport (abobotulinumtoxin A) franchise to treat spasticity across a range of neuromuscular conditions. Read More
A class of experimental therapeutics that is being tested in both cancer and wound healing indications may have found another home. Researchers from Karyopharm Therapeutics Inc. and collaborators at the Mount Sinai School of Medicine have reported that treatment with a class of drugs they have termed Selective Inhibitors of Nuclear Export, or SINE compounds, slowed down disease progression in mouse models of multiple sclerosis and axonal damage. Read More
DUBLIN – Prexton Therapeutics SA, an early stage CNS drug developer spun out of the Merck Serono arm of Merck KGaA, raised €8.7 million (US$10 million) to move a metabotropic glutamate receptor 4 (mGluR4) agonist development program into clinical trials in Parkinson's disease. Read More
Despite fourth quarter and full-year financial results that topped analyst expectations, Alkermes plc saw shares (NASDAQ:ALKS) slide Tuesday after the company halted development of pain candidate ALKS 7106 following disappointing phase I results. Read More
HONG KONG – China surpassed the U.S. and Japan in 2013 to become the No. 1 patent-filing country in the world with more than 600,000 applications in 2013. A significant chunk of that activity was in the general pharmaceutical space, with more than 20,000 patents filed. Read More
SHANGHAI – China has seen a massive rise in patent filings over the last seven years, with the number of published patents growing an average of 16 percent annually. Read More
With an eye toward greater inclusion, the FDA is seeking comments on specific diseases where significant outcome differences may be anticipated for racial or ethnic subgroups and the differences can be addressed through regulatory science research. Read More
Inotek Pharmaceuticals Corp., of Lexington, Mass., said it closed its IPO of 6.7 million shares priced at $6 apiece for aggregate proceeds of $40 million. Read More
Insys Therapeutics Inc., of Phoenix, signed an exclusive sublicense with Gold Coast Therapeutics Inc., of Illinois, to develop a combination of cromolyn sodium and cetirizine (Zyrtec, Johnson & Johnson) as a new chemical entity to treat patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said it inked an agreement with the Medicines Patent Pool (MPP) to license its pediatric formulations of raltegravir for use in treating HIV-1 infection in infants and children, ages 4 weeks to younger than 12 years, in developing countries. Read More
Biotime Inc., of Alameda, Calif., said the first patient was successfully treated in a pivotal trial in Europe assessing the efficacy of Renevia for the treatment of HIV-associated lipoatrophy, a disorder characterized by abnormal loss of body fat from under the skin that occurs in almost half of the approximately 3 million people on antiretroviral therapy in the U.S. and Europe. Read More
Teva Pharmaceutical Industries Ltd., of Jerusalem, said The Lancet Respiratory Medicine has published data from two replicate 52-week phase III global studies on its investigational anti-interleukin-5 (IL-5) monoclonal antibody, reslizumab. Read More
