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Clinic Roundup
The study showed a good safety profile, with no drug-related serious adverse events to dateBioWorld Today | Wednesday, June 19, 2013 -
Other News To Note
The safety profile of CT-P13, a biosimilar candidate to Rituxan, also was comparable to the approved drug...Galapagos said the short-term efficacy and favorable safety profile supported the potential of JAK1 inhibition for RA treatment and confirmed results of its previous proof-of-concept studyBioWorld International | Wednesday, June 19, 2013 -
Biotech Yields Another in Bumper Crop of IPOs
Onconova has accumulated data from more than 850 patients with advanced, heavily pretreated solid tumors and hematological cancers in ongoing and completed trials of rigosertib, demonstrating a good safety profile for the drugBio Perspectives | Tuesday, June 18, 2013 -
Biotech Yields Another in Bumper Crop of IPOs
Onconova has accumulated data from more than 850 patients with advanced, heavily pretreated solid tumors and hematological cancers in ongoing and completed trials of rigosertib, demonstrating a good safety profile for the drugBy Marie Powers | BioWorld Today | Tuesday, June 18, 2013 -
Pharma Clinical & FDA Action Update: May 2013
safety profile consistent with previous studies 5/22/13 Baxter International Inc. (Deerfield, Ill.) Gamma-globulin Immunoglobulin Alzheimer's disease Phase III data showed it did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities 5/8/13 Bayer Healthcare Pharmaceuticals Inc. (Berkeley, Calif.) and Onyx Pharmaceuticals Inc. (South San Francisco) Stivarga Regorafenib Metastatic gastrointestinal stromal tumor FDA approved it 5/16/13 BoehringerBioWorld Insight | Monday, June 17, 2013 -
Clinic Roundup
The safety profile of CT-P13, a biosimilar candidate to Rituxan, also was comparable to the approved drug...Galapagos said the short-term efficacy and favorable safety profile supported the potential of JAK1 inhibition for RA treatment and confirmed results of its previous proof-of-concept studyBioWorld Today | Friday, June 14, 2013 -
Clinic Roundup
Ablynx NV, of Ghent, Belgium, will make an oral and poster presentation for arthritis candidate, ALX-0061, at the Annual European Congress of Rheumatology in Madrid, Spain, showing a strong efficacy and safety profile for the drug in a Phase II studyBioWorld Today | Thursday, June 13, 2013 -
Other News To Note
DiaPep277 was well tolerated with a good safety profile, similar to that observed in DIA-AID 1, and no drug-related serious adverse events were reportedBioWorld International | Wednesday, June 12, 2013 -
Clinic Roundup
DiaPep277 was well tolerated with a good safety profile, similar to that observed in DIA-AID 1 , and no drug-related serious adverse events were reportedBioWorld Today | Thursday, June 6, 2013 -
Other News To Note
3SBio Inc., of Shenyang, China, said it completed its merger with Decade Sunshine Ltd., an exempted company with limited liability incorporated under the laws of the Cayman Islands. The firm also requested that trading of its American depositary shares on Nasdaq be suspended, while it works to delist its registered securities. Addex Therapeutics SA, of Geneva, completed a previously announced restructuring, and Bharatt Chowrir stepped down effectively immediately as CEO and as director ofBioWorld International | Wednesday, June 5, 2013 -
Clinic Roundup
No safety concerns relating to any of the aforementioned products have been identified in any preclinical and clinical data generated to date and there is no reason to believe that the favorable safety profile of the products will be affectedBioWorld Today | Tuesday, June 4, 2013 -
ASCO Roundup
AbbVie Inc., of Chicago, reported results from a Phase I study of ABT-199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and relapsed/refractory non-Hodgkin's lymphoma (NHL). The Phase I, open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the pharmacokinetics of ABT-199 inBioWorld Today | Tuesday, June 4, 2013 -
Oncothyreon, Array Team Up On Small-Molecule HER2 Drug
Square said ARRY-380 also showed a "highly competitive" safety profile with minimal gastrointestinal or skin-related eventsBy Catherine Shaffer | BioWorld Today | Friday, May 31, 2013 -
Enlivex Harnessing Apoptosis as a New Approach in GVHD
Enlivex uses fully mature cells to induce apoptosis, improving the safety profile, with no risk of differentiation into malignant cellsBy Marie Powers | BioWorld Today | Thursday, May 30, 2013 -
Other News To Note
AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studiesBioWorld International | Wednesday, May 29, 2013 -
Prosensa Leads More Biotechs into IPO Parade
The compound showed a favorable safety profileBy Marie Powers | BioWorld Today | Wednesday, May 29, 2013 -
Other News To Note
The fusion molecule directs a targeted interferon alpha mediated cytotoxic effect on lymphoma cells leading to dramatically improved efficacy and safety profiles in preclinical studiesBioWorld Today | Thursday, May 23, 2013 -
Clinic Roundup
Taken together, the three studies demonstrated that AE37 is meeting or exceeding all expectations for generating a specific, robust and long-lived immune response while maintaining a favorable safety profile, the company saidBioWorld Today | Thursday, May 23, 2013 -
Post-Ampligen FDA Workshop Leads to CFS Guidance Pledge
The safety profile, considered by itself, suggested approval for the drug was merited, the committee decided by an 8-5 ballot, but that was not sufficient to save AmpligenBy Randy Osborne | BioWorld Today | Wednesday, May 22, 2013 -
Pharma: Clinic Roundup
AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studiesBioWorld Today | Wednesday, May 22, 2013
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