Avanir Pharmaceuticals Inc. announced that the Food and Drug Administration will allow it to speed research on a newer version of its drug Nuedexta. The company said the FDA's decision could reduce the cost of developing the drug and allow it to win marketing approval sooner.
Naurex Inc. has begun patient dosing in a Phase 1 trial of its novel, orally active agent NRX-1074. The trial is a randomized, placebo-controlled, ascending dose study that will assess the safety and pharmacokinetics of NRX-1074 in normal volunteers.
Generic drugmaker Impax Laboratories Inc. said it eliminated 110 jobs, or about 10% of its workforce, partly because of delays in approval of an important product. Impax said most of the cuts were made at its manufacturing facility in Hayward, where 176 employees worked at the end of 2012.
Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration will conduct an accelerated review of their lipid disorder drug metreleptin. The companies want to market metreleptin for metabolic disorders associated with rare forms of a condition called lipodystrophy.
There have been significant advancements in needle-free injection technology, which aim to increase adoption of self-injectable therapies and adherence. Patients often lack the confidence to self-inject or are put off by the complexity, impacting their ability to incorporate these therapies into their lifestyle.
Johnson & Johnson is conducting a voluntary recall of millions of oral contraceptive packages in 43 countries outside the U.S., but says there's a "very low" risk that the flawed tablets could cause unplanned pregnancies. The recall includes all 179 lots of the contraceptive Cilest.
The Gram-negative bacterium E. coli is the workhorse of molecular biology, regularly used as the first choice host for DNA cloning, small-scale protein expression, and large-scale protein production for FDA approved biologics.
Abacalab’s Protocol Labacus App for iPad, Android tablet or laptop that helps technicians, scientists, clinicians, and others working on the move. The Protocol Labacus provides an overview of the steps in a procedure and detailed instructions for each step.
Rigel Pharmaceuticals Inc. said partner AstraZeneca will not seek regulatory approval for the potential rheumatoid arthritis treatment fostamatinib. AstraZeneca is returning the compound's rights to Rigel, which said it will take a couple months to figure out the next step for the potential drug.
The Medicines Co. plans to buy ProFibrix BV in a deal that hinges on late-stage study results for a topical powder that ProFibrix is developing to stop bleeding during or after surgery. Medicines Co. said it will review the results and if satisfied, will purchase all outstanding shares of the company.
Scientists at the National Institutes of Health have discovered that a gene called BACH2 may play a central role in the development of diverse allergic and autoimmune diseases, such as multiple sclerosis, asthma, Crohn's disease, celiac disease, and type-1 diabetes.
The PRONOUNCE trial compared an Alimta, carboplatin doublet regimen to a paclitaxel, carboplatin and bevacizumab triplet regimen. The study did not achieve its primary superiority endpoint of improved progression-free survival without grade four adverse events.
Merck presented preliminary results from an ongoing Phase 1b expansion study evaluating the safety and efficacy of lambrolizumab, Merck’s investigational antibody therapy targeting PD-1, in patients with advanced (inoperable and metastatic) melanoma.
The long-standing mystery behind dormant disseminated breast tumor cells and what activates them after years and even decades of latency may have been solved. Researchers have identified the microenvironment surrounding microvasculature as a niche where dormant cancer cells reside.
A former blockbuster diabetes pill which was subjected to major safety restrictions in 2010 may not be as risky as once thought. The Food and Drug Administration is reviewing a new interpretation of the key study of Avandia's heart attack risks, which suggests the drug is as safe as older diabetes drugs.