Last month, the FDA's Center for Drug Evaluation and Research issued a draft guidance on the development of drugs in early stage Alzheimer's disease (AD). Intended as a conversation starter, the draft lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment into clinical trials.
Sirtris Inc., which moved like a shot from its formation in 2004 to a $720 million buyout by GlaxoSmithKline (GSK) plc in 2008, is losing its research facility in Cambridge, Mass., but not its name or mission to develop sirtuins, a family of seven enzymes believed to modulate the aging process.
Astellas Pharma Inc. dropped the hammer on Ambit Biosciences Corp., ending its collaboration on the joint development and commercialization of FMS-like tyrosine kinase-3 (FLT3) inhibitors, including lead program quizartinib (formerly AC220), effective Sept. 3.
One month after gaining FDA approval for Ravicti (glycerol phenylbutyrate) in the chronic management of certain urea cycle disorders (UCDs), orphan disease specialist Hyperion Therapeutics Inc. upsized a public offering of about 2.9 million shares of common stock, priced at $20.75, seeking to raise $59.7 million.
Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of treatment options. That void is all the more frustrating because epilepsy remains a debilitating condition for reasons beyond the clinical manifestations, often resulting in chronic unemployment or underemployment, social isolation and poor socioeconomic status. It's no surprise, then, that the prospect of a new treatment for people with medically refractory epilepsy would be greeted with great enthusiasm. As an adjunct...
Privately held Immunomic Therapeutics Inc. (ITI) worked quietly for five years to advance its LAMP-vax technology, based on lysosomal associated membrane protein (LAMP), a ubiquitous glycoprotein found on 80 percent of the surface area of lysosomal membranes.
Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of treatment options. That void is all the more frustrating because epilepsy remains a debilitating condition for reasons beyond the clinical manifestations, often resulting in chronic unemployment or underemployment, social isolation and poor socioeconomic status. It's no surprise, then, that the prospect of a new treatment for people with medically refractory epilepsy would be greeted with great enthusiasm. As an adjunct...
Privately held Concert Pharmaceuticals Inc. struck another business development high note, inking an exclusive license agreement that provides Jazz Pharmaceuticals plc with global rights to develop and commercialize deuterium-modified sodium oxybate (D-SXB) compounds, including C-10323, aimed at narcolepsy.
The Senate added its stamp of approval to H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), agreeing by unanimous vote to reauthorize the Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield. The move followed strong bipartisan support for the bill in the House, which passed its version in January by a 395-29 vote.
Eschewing the landscape of failures in central nervous system disorders, privately held EnVivo Pharmaceuticals Inc. showed moxie by initiating a Phase III program for lead compound EVP-6124, an alpha-7 agonist, in the lead indication of schizophrenia.
