Search Results for: "Other News to Note"
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Pharma: Other News To Note
Ltd., of Osaka, Japan, said the FDA approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopauseBioWorld Today | Wednesday, February 27, 2013 -
Other News To Note
That investment is intended to allow Bone Therapeutics to manufacture lead product Preob, an autologous bone cell therapy product in Phase III testing for osteonecrosis...Viropro Inc., of Washington, and Oncobiologics Inc., of Cranbury, N.J., signed a biosimilar collaboration agreement giving Viropro the rights to manufacture six generic versions of Humira (adalimumab, Abbott), Rituxan (rituximab, Biogen Idec Inc./Genentech Inc.), Avastin (bevacizumab, Genentech Inc.), Herceptin (trastuzumabBioWorld Today | Tuesday, February 26, 2013 -
Pharma: Other News To Note
The FDA expanded the approved use of Stivarga (regorafenib), developed by Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., part of Bayer AG, to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments...With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or is metastatic and no longer responding to Gleevec (imatinib, Novartis AGBioWorld Today | Tuesday, February 26, 2013 -
Other News To Note
In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San Diego facility and certain other cash needs...Cangene plans to advance the program in its pipeline with the goal of developing an immune therapeutic for Alzheimer's targeting the toxic form of amyloid beta that is believed to cause the disease...Exelixis Inc., of South SanBioWorld Today | Monday, February 25, 2013 -
Pharma: Other News To Note
The approval will expand Lupin's range of Suprax dosage forms available to treat approved indications in appropriate patients...Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping coughBioWorld Today | Monday, February 25, 2013 -
Other News To Note
Defibrotide will continue to be available to patients under a named patient program...The goal is to modulate the half-life of the therapy to increase efficacy of treatmentBioWorld Today | Friday, February 22, 2013 -
Pharma: Other News To Note
as a first-line agent or concomitantly with other topical ophthalmic drugs in open-angle glaucoma or ocular hypertension...Sucampo's wholly owned subsidiary, Sucampo Pharma Americas Inc., licensed the commercialization rights to Rescula, a BK channel activator, from R-Tech Ueno in 2009...As part of the transaction, Eisai transferred the new drug application for Targretin to Valeant, which assumed responsibility for pursuing the product's regulatory approval in the U.S. Eisai retained its rights toBioWorld Today | Friday, February 22, 2013 -
Other News To Note
Chelsea also plans to initiate a clinical trial in the fourth quarter, given the potential need to verify Northera's durability of effect in a postmarketing study...18 to close at $1.94, with more than 31 million shares changing hands. (See BioWorld Today, Dec. 6, 2012...Proteologics Ltd., of Rehovot, Israel, and Newcastle Innovation Ltd., the technology transfer company of the University of Newcastle, Australia, entered an exclusive license agreement to develop and commercialize therapeutics forBioWorld Today | Thursday, February 21, 2013 -
Pharma: Other News To Note
Ltd., of Seoul, South Korea, entered an agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates...and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritisBioWorld Today | Thursday, February 21, 2013 -
Pharma: Other News To Note
The approval was based on a liver transplant study showing that Zortress plus reduced tacrolimus led to comparable efficacy and 10mL/min higher renal function as measured by estimated glomerular filtration rate for Zortress compared to standard tacrolimus at 12 monthsBioWorld Today | Wednesday, February 20, 2013 -
Other News To Note
NeurOp is working with Emory to accelerated N-methyl D-aspartate, or NMDA, receptor research in the three-year collaboration...and six other countries under an expanded access program...co-promotion rights for Kineret (anakinra) to Savient Pharmaceuticals Inc., of Bridgewater, N.J. Under the agreement, Sobi will remain responsible for all commercial drug manufacturing, supply, safety and regulatory activities involving Kineret, which is indicated in the U.SBioWorld Today | Wednesday, February 20, 2013 -
Other News To Note
In a pipeline update, Momenta Pharmaceuticals Inc., of Cambridge, Mass., said that it is developing three biosimilar products under its collaboration with Baxter International Inc., of Deerfield, Ill. M923 and M834 are targeted to autoimmune and inflammatory conditions, and M511 is a monoclonal antibody in development for oncology...The company plans to submit an investigational new drug application in 2014 for M923 and may generate a license or milestone payment for M511 and M834 next yearBioWorld Today | Tuesday, February 19, 2013 -
Other News To Note
Oramed Pharmaceuticals Inc., of Jerusalem, said the FDA responded to its investigational new drug (IND) application for oral insulin, requesting a sub study in a controlled inpatient setting...for the treatment of active, mild-to-moderate ulcerative colitis...On Thursday, United's shares (NASDAQ:UTHR) gained $2.29, to close at $56.10BioWorld Today | Friday, February 15, 2013 -
Pharma: Other News To Note
patents relating to Exalgo to sell Actavis' 32-mg product beginning May 15, 2014...16 to $2 per share but did not change previously reported non-GAAP results. (See BioWorld Today, Aug. 22, 2008, and March 10, 2009BioWorld Today | Friday, February 15, 2013 -
Other News To Note
Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...Due to the oversubscription, the closing unit price was set at NIS3.544 per unitBioWorld International | Wednesday, February 13, 2013 -
Other News To Note
According to a joint statement from the two companies the amendment was executed primarily to provide EpiCept with cost-effective operating capital while the merger closing process continues. (See BioWorld Today, Dec. 28, 2012...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents ages 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseasesBioWorld Today | Wednesday, February 13, 2013 -
Pharma: Other News To Note
Reddy expects to settle the offer on Feb. 13, to acquire the remaining shares of OctoPlus under the same terms during a post-closing acceptance period and to terminate the company's listing (Euronext Amsterdam:OCTOBioWorld Today | Wednesday, February 13, 2013 -
Other News To Note
Celgene expects Revlimid to be available to patients late in the second quarter of 2013...Teva opted to make a one-time payment of $880,000 in lieu of future paymentsBioWorld Today | Tuesday, February 12, 2013 -
Pharma: Other News To Note
The complaint alleges that Daiichi Sankyo pays female sales employees less than male employees for performing the same work, promotes or advances female sales employees at a slower rate than male sales employees, treats pregnant employees and working mothers of young children adversely compared to other employees and subjects women to other discriminatory terms and conditions of employmentBioWorld Today | Tuesday, February 12, 2013 -
Other News To Note
That drug is designed to treat acute myeloid leukemia, with potential applications in other hematological and solid tumors...Tranzyme Inc., of Research Triangle Park, N.C., said its board decided to explore and evaluate strategic alternatives, including the possibility of a merger, sale or other form of business combination, or other transaction to maximize value to its stockholdersBioWorld Today | Monday, February 11, 2013
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