The batch was only distributed to and sold in Switzerland, and the recall is limited to the specific batch and to Switzerland...The companies will collaborate to advance the potential companion diagnostic, originally developed by Lilly
The Cell Therapy Catapult, which focuses on the development of the UK cell therapy industry, said it will work with London-based GlaxoSmithKline plc to explore potential collaborations in a range of areas relevant to the development of cell therapies, from research projects to technical and regulatory strategy
In addition to the stock investment, Aradigm may receive up to $25 million in development milestones, along with tiered royalties...Baxter said it will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014...Other data demonstrated that pharmacological inhibition of Usp14 by the company's small-molecule inhibitors stimulated degradation of the proteins in cell, neuron and brain slice models, suggesting the compounds' potential in a number of
The company plans to move ASM-024 into a Phase II trial in COPD later this year...His contributions to the field of oncology include more than 20 compounds brought into development, including the recently approved anticancer drugs Xalkori (crizotinib) and Inlyta (axitinib), discovered at Pfizer where O'Connor served as the global research therapeutic area head for oncology...Relmada is seeking to move LevoCap through approval using the 505(b)(2) pathway. (See BioWorld Today, Aug. 24, 2012
In addition to RA and Crohn's, the pharma may develop GLPG0634 in psoriasis, irritable bowel syndrome and lupus, mirroring the path by which the label on its blockbuster Humira (adalimumab) was expanded beyond RA. (See BioWorld Today, March 1, 2012, and Jan. 3, 2013...SciClone agreed to make additional payments of $10 million if Zensun receives approval of Neucardin by subcutaneous infusion, and further indications and improved product forms could result in additional payments...Prior to the
Fenofibrate Tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B, and to increase high-density lipoprotein cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia
GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...In other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation in tumor cells of RNA
Prior to the approval of Nymalize, nimodipine was available only in gel capsule form...The company expects to complete the trial in the first half of 2014. (See BioWorld Today, Dec. 20, 2012...distribution rights to the drug, a next-generation micellar diblock co-polymeric paclitaxel formulation, from Samyang
Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease...Valeant Pharmaceuticals International Inc., of Laval, Quebec, has provided additional information related to the proposal to continue
We note that an acquisition of Warner could potentially offer a tax strategy as Warner has a lower tax rate...Regeneron waived its right to opt in on canakinumab and, instead, is entitled to sales royalties
rights to market Pertzye (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis...The board is recommending that shareholders approve the arrangement resolution, which is intended, among other goals, to improve Mirati's ability to attract funding in the larger U.S
Merck expects the review for this BLA, as well as a BLA for its Timothy grass pollen (Phleum pretense) sublingual allergy immunotherapy tablet, to be completed in the first half of 2014
To date, 130 laboratory-confirmed cases of human infection with the H7N9 virus, resulting in 31 deaths, have been reported to the World Health Organization...To date the company is known for its biodegradable and low toxicity DNA and RNA delivery reagents for cell-based research and therapeutics
In other news, Addex said dipraglurant demonstrated dose-dependent mGlu5 receptor occupancy in a nonhuman primate positron emission tomography study, showing the correlation between the plasma concentration of dipraglurant and occupancy of dipraglurant on mGlu5 receptors in the brain...The goal is to validate emerging epigenetic targets for oncology indications and to demonstrate the eligibility of selected target families for drug formalations
GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...The technology is being developed to aid in understanding the biology critical to cardiac tissue engineering, for applications in regenerative cell therapy for heart disease and for predictive use in vitro assays for drug rescue and development
Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer...In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients
Sagent expects to close the transaction over the next several months...Addition of Vaxfectin to the influenza vaccines substantially increased both antibody and T-cell responses compared with nonadjuvanted vaccines in mice and guinea pigs, according to Vical
The batch was only distributed to and sold in Switzerland, and the recall is limited to the specific batch and to Switzerland...The companies will collaborate to advance the potential companion diagnostic, originally developed by Lilly