Search Results for: Pharma: Clinical Roundup
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Clinic Roundup
The Phase IIb proof-of-concept program consists of two clinical trials - a six-month trial evaluating PRX-03140 in combination with donepezil and a three-month trial studying PRX-03140 as monotherapy...N30 Pharma, of Boulder, Colo., said it successfully completed Phase I study of N30-201 in patients with mild to moderate asthma, as well as healthy volunteers...After 12 weeks there was overall clinical improvement in 80 percent of subjects, including reduction of erythema and papulesBioWorld Today | Tuesday, May 6, 2008 -
Clinic Roundup
Following the birth of the patient's sibling in December 2007, HPDSCs, along with cord blood, were collected and cryo-preserved and both products were used in the clinical transplant...The transplant is part of a multicenter clinical trial using HPDSCs for patients with a range of disorders including cancers and non-malignancies...PZ-601 was licensed from Osaka, Japan-based Dainippon Sumitomo Pharma Co. LtdBioWorld Today | Monday, May 5, 2008 -
Argos Raises $35.2M in Series C for Cancer and HIV Candidates
Argos, which changed its name in 2004 from Merix Bioscience, has initiated a Phase II clinical trial of AGS-004 in patients with HIV infection...He said his firm also has received a lot of attention from big pharma companies about potential licensing deals for its transplant antirejection product CD83, which currently is being tested in animal studies...There were no fees or other expenses related to the funding.By Donna Young | BioWorld Today | Thursday, April 24, 2008 -
AACR Roundup
Adventrx Pharmaceuticals Inc., of San Diego, said its registrational bioequivalence clinical study of ANX-530 (vinorelbine emulsion) met its primary endpoint and a new drug application will be submitted by the end of the year...Medivation Inc., of San Francisco, presented data from an ongoing Phase I/II clinical trial showing that the company's androgen receptor antagonist, MDV3100, continued to reduce serum levels of prostate-specific antigen in the lowest expanded dose group tested after threeBioWorld Today | Wednesday, April 16, 2008 -
AACR Roundup
Apthera Inc., of Scottsdale, Ariz., presented results from analysis of a randomized safety and efficacy clinical trial studying NeuVax (E75) in the adjuvant treatment of early stage (node-positive and high-risk node-negative), HER2-positive breast cancer, showing patients with low-expressing HER2 tumors experienced decreased breast cancer recurrence and no mortality to date following treatment...Previously disclosed data showed MGCD0103's preliminary antitumor clinical activity in Phase II clinicalBioWorld Today | Tuesday, April 15, 2008 -
$10M Deal: Acusphere Licenses HDDS, Compound to Cephalon
BioAlliance Pharma SA, of Paris, said it entered into an exclusive licensing agreement worth $12 million under which Korea-based Handok Pharmaceuticals will receive commercialization rights in Korea, Taiwan, Singapore and Malaysia for BioAlliance Pharma's muco-adhesive antifungal therapy Loramyc (miconazole Lauriad), which already is approved in Europe, and a Phase III clinical trial has just completed in the U.S. Handok plans to launch Loramyc in 2010By Catherine Hollingsworth | BioWorld Today | Tuesday, April 1, 2008 -
Pieris Pushing Lead Program into Clinic with $38M Series B
In fact, the "majority of the funds" will be devoted to that program, Kueppers told BioWorld Today, with the aim of achieving clinical validation of its Anticalin platform, positioning the firm to attract big pharma partners down the road...SR One, GlaxoSmithKline's independent corporate healthcare venture capital fund, which invested in the company's 2002 Series C round, also participated in the latest financing.By Jennifer Boggs | BioWorld Today | Friday, March 28, 2008 -
Clinic Roundup
Cardiome Pharma Corp., of Vancouver, British Columbia, and partner Astellas Pharma US Inc., of Deerfield, Ill., said data from its first pivotal study of Kynapid (vernakalant hydrochloride) injection was published in Circulation, showing that the trial's primary efficacy analysis demonstrated that 75 of the 145 (51.7 percent) of the Kynapid patients in the short-duration atrial fibrillation group converted to sinus rhythm within 90 minutes of treatment compared to three of the 75 placeboBioWorld Today | Wednesday, March 26, 2008 -
Trius' TR-701 Antibiotic Heading Into Phase II with $30M Series B
That means the San Diego-based firm has been following closely the recent FDA actions in the antibiotic space, with potential competing products, including glycopeptides telavancin (Theravance Inc. and Astellas Pharma US) and dalbavancin, (Pfizer), both getting approvable letters last year, and ceftobiprole, a cephalosporin drug from Basilea Pharmaceutica AG and a unit of Johnson & Johnson, getting its own approvable letter just last week...Much of the agency's reticence has been attributed to theBy Jennifer Boggs | BioWorld Today | Monday, March 24, 2008 -
Alimera Closes $30M Financing, Boosts Stake in Medidur FA
The company said many other systemic compounds for DME will not produce a therapeutic effect in the back of the eye, and those currently under clinical investigation must be injected often due to a lack of long-term release characteristics...Akela Pharma Inc., of Montreal, said it has filed a final short-form prospectus and received a receipt from Canadian regulatory authorities for an offering of up to 7.5 million units, of which 3.75 million units are underwritten and up to 3.75 million units areBy Catherine Hollingsworth | BioWorld Today | Wednesday, March 19, 2008 -
Legislation Would Create Path for Follow-on Biologics Work
Opponents, including the Generic Pharmaceutical Association, have rallied against any legislation that would provide as much as 12 years of data exclusivity, which they have said only protects biotech and pharma profits and keeps lower-cost generics off the market...In her comments to the House, Eshoo said the proposed biosimilars act would provide an abbreviated pathway for approval of biosimilars based in part on the safety and efficacy record of the original biologics, though it would give theBy Jennifer Boggs and Mark McCarty | BioWorld Today | Monday, March 17, 2008 -
Financings Roundup
EyeGate Pharma, of Waltham, Mass., secured $15 million in a Series C venture financing round for two Phase II clinical studies using its EyeGate II delivery system and its formulation of a corticosteroidBioWorld Today | Thursday, March 13, 2008 -
Clinic Roundup
Calistoga Pharmaceuticals Inc., of Seattle, said it has initiated a Phase I clinical trial of CAL-101, an orally available small molecule that inhibits an important intracellular signaling component known as phosphoinositide-3 kinase (PI3K) delta...The primary endpoint is time to last unformed stool, and secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates...UCB Pharma Canada Inc., of Burlington, Ontario, said early data from a Phase IIIb study ofBioWorld Today | Wednesday, March 12, 2008 -
BrainCells' Series B Adds $30M to Advance, Grow CNS Pipeline
Funds primarily will be used to advance the company's pipeline, which includes lead product BCI-540, a compound licensed from Osaka, Japan-based Mitsubishi Pharma Corp...Over the next couple of years, BrainCells anticipates reporting the first clinical results, which will help validate its neurogenesis technology, and also plans to bring in additional assets and continue advancing its pipeline, Shoeneck said...for $200 million. (See BioWorld Today, Dec. 18, 2007, and Feb. 6, 2008.) #kicker123By Jennifer Boggs | BioWorld Today | Tuesday, March 11, 2008 -
Clinic Roundup
LifeCycle Pharma A/S, of Horsholm, Denmark, announced positive top-line results from a Phase II clinical trial for LCP-Tacro in stable kidney transplant patients...NicOx SA, of Sophia Antipolis, France, has begun two large clinical pharmacology studies in the U.SBioWorld Today | Tuesday, March 4, 2008 -
Clinic Roundup
7TM Pharma A/S, of Horsholm, Denmark, reported positive results from two clinical studies of obesity drug TM30339, a drug designed to work via the Y4 receptor to mimic a natural satiety signal from the gastrointestinal tract involved in the regulation of food...At day 10, clinical success was observed in 15 patients (75 percent) receiving Microcyn monotherapy, 16 patients (64 percent) receiving Microcyn plus levofloxacin and 12 patients (57 percent) receiving levofloxacin plus salineBioWorld Today | Thursday, February 28, 2008 -
Clinic Roundup
The clinical trial is a double-blind study that will involve 90 subjects and is expected to be completed by the end of the second quarter...PLx Pharma Inc., of Houston, has initiated a Phase I clinical trial of PL 2100, also known as Aspirin-PC, its oral drug candidate for equivalent label claims for aspirin under a 505(b)(2) regulatory pathBioWorld Today | Wednesday, February 20, 2008 -
Clinic Roundup
The multicenter clinical trial is being conducted in the Republic of Georgia...Surface Logix, of Boston, said results of a Phase IIa clinical trial demonstrated that SLx-4090, a nonsystemically available microsomal triglyceride transfer protein inhibitor, caused clinically significant reductions in postprandial triglycerides and LDL cholesterol and was well tolerated...Tranzyme Pharma, of Research Triangle Park, N.C., said the FDA cleared its investigational new drug application for TZP-102, a secondBioWorld Today | Wednesday, January 30, 2008 -
Seeking to Expand Immune Portfolio, Circassia Adds £11M
closed an oversubscribed second round, adding £11 million (US$21.8 million) for expanding its portfolio of technologies aimed at regulating immune response and to accelerate ongoing clinical development programs in allergy...Kamada, which develops products based on its chromatographic purification technologies, recently concluded Phase I studies of Alpha-1 Antitrypsin, using the eFlow Electronic Nebulizer from PARI Pharma GmbH, in various lung diseases...Shares of Theratechnologies (TSX:TH) closed atBy Jennifer Boggs | BioWorld Today | Wednesday, January 30, 2008 -
Clinic Roundup
The Phase I study of Lipoxen's first product to enter clinical trials is being conducted in 12 healthy volunteers at the Federal State Center of Endocrinology in Moscow...N30 Pharma, of Boulder, Colo., said it successfully completed a Phase I study of N30-201, a compound being investigated to treat reactive and obstructive airway diseases, including cystic fibrosis and asthma...Trion Pharma GmbH, of Munich, Germany, said results of a Phase I trial showed that catumaxomab, a class of trifunctionalBioWorld Today | Tuesday, January 29, 2008
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