Search Results for: Other News to Note
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Other News To Note
In other news, Orexo said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013...The endpoint is to demonstrate safety and tolerability and provide data on surrogate efficacy and mechanism of actionBioWorld International | Wednesday, November 21, 2012 -
European Launch Imminent After CHMP OK for Lixisenatide
Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia...Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects...Other safety issues, according to the EMA, including hypoglycemia when Lyxumia wasBy Cormac Sheridan | BioWorld International | Wednesday, November 21, 2012 -
Other News To Note
Ironwood plans to initiate Phase I studies in healthy volunteers to assess the pharmacokinetics of IW-2143...Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune Pharmaceuticals Inc. – focused on developing antibody therapeutics and other targeted drugsBioWorld International | Wednesday, November 14, 2012 -
Other News To Note
In addition to active involvement in the development of the monoclonal antibody, AET BioTech will provide additional investment in the biosimilar based on committed long-term financing and will oversee future commercialization of the product...IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...The FDA is not obligated to follow the advice of its advisory panelsBioWorld International | Wednesday, November 7, 2012 -
Other News To Note
In other news, Cellectis said it signed two exclusive license agreements with Iowa State University granting the firm worldwide rights to inventions related to TAL effector-nucleases (TALENs) and monomeric TALENsBioWorld International | Wednesday, October 31, 2012 -
Other News To Note
for turoctocog alfa, a third-generation recombinant coagulation Factor VIII intended for prevention and treatment of bleeding with people with hemophilia A. In other news, Novo Nordisk said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Tresiba and Ryzodeg for the treatment of diabetes mellitus in adults...In other news, Prolor said data from a Phase II trial of its long-acting human growth hormone, hGH-CTP, in growth hormone-deficient adults will beBioWorld International | Wednesday, October 24, 2012 -
Other News To Note
In other news, Almirall reported data from the MOVE 2 study supporting the use of Sativex, an endocannabinoid modulator, to reduce symptoms of moderate to severe spasticity due to multiple sclerosisBioWorld International | Wednesday, October 17, 2012 -
Other News To Note
Patients were randomized to three dose groups of intravenously administered ALX-0061 (1mg/kg every 4 weeks, 3mg/kg every 4 weeks and 6mg/kg every 8 weeks) or to placebo...The study aims to establish the efficacy of the drug as a maintenance therapy in patients whose disease has not progressed after a first-line docetaxel-based chemotherapy...Tasquinimod is believed to have a pleiotropic mode of action that includes immunomodulatory, anti-angiogenic and antimetastatic activityBioWorld International | Wednesday, October 10, 2012 -
Other Financings Of Public Biotechnology Companies: September 2012
note and W $3 CorMedix made an initial closing of a private placement of $3M in stock units consisting of a one-year $1,000 aggregate principal amount 9% senior convertible note at 35 cents per note and a five-year warrant to purchase 2,500 shares of common stock 9/27/12 EpiCept Corp. (Tarrytown, N.Y.) Warrant exercise 8.1W $0.8 EpiCept received $800,000, reducing the exercise price from 20 cents and 17 cents to 10 cents for all warrants immediately exercised 9/26/12 Imprimis Pharmaceuticals IncBioWorld Insight | Monday, October 8, 2012 -
Other News To Note
In other news, BioLineRx said results from the Phase II EAGLE trial of BL-1020, an oral GABA-enhanced antipsychotic, published in the Journal of Clinical Psychiatry, showed that the drug was safe and effective in improving schizophrenia, in addition to improving cognitive impairment associated with the disease...In other news, Evotec and Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said they inked an advisory agreement for support in the development and partnering of Aspireo's SomatoprimBioWorld International | Wednesday, October 3, 2012 -
Obesity Drugs: 'Useful Tools' With Lifestyle Modification
This is certainly good news for a nation that is trying to cope with an obesity epidemic that numbers well over 60 million American adults being obese...Reimbursement Likely In addition to overcoming regulatory hurdles in Europe, the other major challenge obesity drugs face to finding general acceptance relates to reimbursementBy Peter Winter | BioWorld Insight | Monday, October 1, 2012 -
Other News To Note
In other news, Ablynx said it and partner Merck Serono, a division of Darmstadt, Germany-based Merck KGgA, advanced Nanobody candidate ALX-0751 into preclinical development in cancer...In other news, Boehringer and Eli Lilly and Co., of Indianapolis, said they received a positive opinion from the European Committee for Medicinal Products for Human Use for DPP-4 inhibitor Trajenta (linagliptin) in combination with insulin in adults with Type II diabetes...are soliciting consents from note holders forBioWorld International | Wednesday, September 26, 2012 -
Other News To Note
In other news, 3SBio said its special committee of independent directors has retained Cleary Gottlieb Steen & Hamilton LLP, of New York, as the committee's legal counsel...In other news, Boehringer said it started an open-label U.S...The objectives are to decrease or stabilize the number of blood-circulating CLL cells and to delay the onset of other signs of progression, such as swelling of lymph nodes, which then requires immunochemotherapy treatmentBioWorld International | Wednesday, September 19, 2012 -
Pluristem Raising $32M Publicly As PLX Pipeline Gains Attention
The news sent shares (NASDAQ:PSTI) down 15 percent Thursday, though they stabilized somewhat Friday, closing at $3.83, down 2 cents...In addition to the CLI and IC indications, the company has said it plans to move into Phase II testing of PLX cells in Buerger's disease and muscle injuryBy Jennifer Boggs | BioWorld International | Wednesday, September 19, 2012 -
Other News To Note
In other news, BioLineRx said BL-7010, an oral candidate in celiac disease and gluten sensitivity, was found to be safe and well tolerated in preclinical studies presented at the Better Life for Coeliacs 2012 Conference in Helsinki, Finland...Due to the close relationship among Family B GPCRs, which have proven intractable to small-molecule chemistry, insights from the CRF structure will allow structural models to be generated for the entire family, Heptares saidBioWorld International | Wednesday, September 12, 2012 -
Other News To Note
Medgenics Inc., of Misgav, Israel, said Israeli regulators approved two Phase I/II trials to assess the safety and efficacy of Infradure, a subcutaneous autologous tissue implant developed to continuously produce interferon-alpha, in patients with hepatitis C. One study will evaluate previously untreated patients with genotypes 1 and 3, while the other trial will study genotype 1 patents who have relapsed after initially responding to prior treatments...In other news, the FDA approved AfinitorBioWorld International | Wednesday, September 5, 2012 -
Other News To Note
Glenmark Pharmaceuticals Ltd., of Mumbai, India, said the International Centre for Dispute Resolution ruled in Glenmark's favor on the arbitration claim filed in August 2011 against Napo Pharmaceuticals Inc., of San Francisco, seeking, among other things, a ruling that Glenmark's exclusive rights to develop, commercialize and distribute Crofelemer in 140 countries for treatment of diarrheal diseases includes the exclusive rights to distribute through relief agencies in those countries and anBioWorld International | Wednesday, August 29, 2012 -
Gilead's Much-Awaited Quad Gets Timely FDA Nod in HIV
In addition to its Quad application, Gilead also is seeking approval of elvitegravir as a drug in its own right...In addition to promising data from its all-oral, interferon-free regimen, Gilead has benefited from disappointing news from competing programs at BMS and Idenix Pharmaceuticals IncBio Perspectives | Tuesday, August 28, 2012 -
Other News To Note
Zushima spray is designed to relieve pain and topical swelling, joint pain due to rheumatic conditions and helps improve blood circulation near affected areas...CRT said that CTx-0294886 could be used to treat other cancers, including a subset of acute myeloid leukemia (AML) patients with mutations in FLT3, a receptor tyrosine kinase involved in controlling the growth and development of several blood cancers, including AML...The study is designed to enroll up to 64 patients, who will receive 28 daysBioWorld International | Wednesday, August 22, 2012 -
Other News To Note
Rosetta plans to use the proceeds to fund its general corporate operations...Sun Pharmaceutical Industries Ltd., of Mumbai, India, will acquire Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., for $39.50 in cash per share paid to shareholders other than Sun Pharma and its affiliates, which currently own about 66 percent of outstanding ordinary shares and 100 percent of founders sharesBioWorld International | Wednesday, August 15, 2012
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