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Prime-boost malaria vaccine regimen provides sterile protection: Vical

Vical Incorporated announced today that a prime-boost malaria vaccine regimen provided sterile protection, with no disease symptoms and no detectable malaria parasites, in 4 of 15 vaccinated volunteers a full 28 days after challenge with multiple infected-mosquito bites.

27 Apr 2010

UK MHRA authorizes Presidio Pharmaceuticals to initiate Phase 1 clinical trial of PPI-461 for HCV

Presidio Pharmaceuticals, Inc. announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the initiation of a Phase 1 first-in-human clinical trial of PPI-461, an orally administered NS5A inhibitor for the treatment of hepatitis C virus (HCV). The Phase 1 clinical trial will be conducted in healthy volunteers.

27 Apr 2010

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, has received a grant of US$500,000 for its on-going Phase II clinical trial of DIABECELL in New Zealand from the Juvenile Diabetes Research Foundation International, a world leader in setting the agenda for diabetes research and the largest charitable funder and advocate for research in type 1 diabetes.

27 Apr 2010

Evotec to receive EUR 1.5M from German BMBF for advancing H3 receptor antagonist programme

Evotec AG today announced that it will receive funding of up to EUR 1.5 million from the German Federal Ministry of Education and Research (BMBF) to advance its H3 receptor antagonist programme into the clinic.

27 Apr 2010

Patient preference study results of Kristalose to be presented at 2010 Digestive Disease Week meeting

Cumberland Pharmaceuticals Inc. today announced that results from a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, will be presented at the 2010 Digestive Disease Week meeting in New Orleans.

27 Apr 2010

Phase 2b clinical study initiated to evaluate GI safety of LT-NS001

Logical Therapeutics, Inc., a Waltham, Mass.-based biotechnology company announced today the initiation of a Phase 2b clinical study to evaluate the gastrointestinal safety of its investigational drug LT-NS001 (naproxen etemesil). The study will compare the cumulative rate of gastric ulcers vs. Naprosyn after 12 weeks of treatment.

27 Apr 2010

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.

27 Apr 2010

OSI Pharmaceuticals completes enrollment in Phase III clinical trial of Tarceva

OSI Pharmaceuticals, Inc. announced today that it has completed enrollment in the RADIANT study, a Phase III clinical trial testing Tarceva (erlotinib) as an adjuvant therapy in patients with Stage IB-IIIA non-small cell lung cancer who have undergone surgery and have EGFR-positive tumors.

26 Apr 2010

First patient enrolled in Phase II clinical trial of E10030 for treatment of wet age-related AMD

Ophthotech Corp., a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, today announced that the first patient has been enrolled in its Phase II randomized, controlled clinical trial of E10030, an anti-PDGF aptamer, in combination with Lucentis® for the treatment of wet age-related macular degeneration (AMD).

26 Apr 2010

Phase 1/2 clinical trial of TRC105 therapy initiated for patients with castrate-resistant prostate cancer

TRACON Pharmaceuticals, a biotechnology company that develops targeted therapies for oncology and ophthalmology, announced today that the National Cancer Institute has initiated a Phase 1/2 clinical trial of TRC105 therapy for patients with castrate-resistant prostate cancer.

26 Apr 2010

Pevion Biotech to present positive results of PEV4 RSV vaccine candidate at Vaccine Innovation Meeting

Pevion Biotech, the Swiss vaccine company, today announced that it has successfully completed the preclinical safety and efficacy studies of its RSV vaccine candidate PEV4. The vaccine candidate is a modern subunit vaccine candidate against respiratory syncytial virus (RSV), which is based on a recombinant RSV-F protein formulated with Pevion Biotech's proprietary and market-validated virosome technology platform.

26 Apr 2010

Recent business progress at Penwest Pharmaceuticals

Penwest Pharmaceuticals Co. today sent a letter to its shareholders to provide an update on the Company's recent progress and on corporate governance developments.

24 Apr 2010

Study finds AFREZZA comparable to standard of care insulin therapy

Pulmonary function test results (PFTs) in patients treated with AFREZZATM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy, according to data presented today at the American Association of Clinical Endocrinologists 19th Annual Meeting (Poster #267).

24 Apr 2010

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

Yesterday, The Lancet published online the results of the first study comparing the once-daily human GLP-1 analog, Victoza (liraglutide [rDNA] injection) with a DPP-4 inhibitor, Januvia. The 26-week trial showed that Victoza produced significantly greater reductions in A1C, fasting plasma glucose, and body weight than Januvia, with similar or better overall treatment satisfaction.

24 Apr 2010

Urigen Pharmaceuticals requests FDA meeting for advancing URG101 clinical program

Urigen Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that it has filed a request for an FDA meeting to advance the URG101 clinical program and mutually agreed with Oceana Therapeutics, Inc. to terminate their Consulting Agreement effective immediately.

24 Apr 2010

AFFiRiS' AD02 Alzheimer's vaccine candidate in phase II clinical testing

AFFiRiS AG's clinical Alzheimer's vaccine candidate AD02 has already progressed to phase II clinical testing. It may therefore be possible to confirm the efficacy of the vaccine as early as during 2012. Indeed the start of this efficacy study comes only five months after the completion of the corresponding phase I study. The company is active in several disease areas and is currently developing a total of twelve prospective products in all stages of the development pipeline up to clinical phase II.

24 Apr 2010

Oncolytics Biotech completes Phase I enrollment in Phase I/II trial of REOLYSIN for recurrent malignant gliomas

Oncolytics Biotech Inc. announced today that it has completed Phase I patient enrollment in its Phase I/II clinical trial to investigate the use of REOLYSIN(R) for patients with recurrent malignant gliomas (REO 007). The principal investigator is Dr. James Markert, Division Director of Neurosurgery, and Professor, Neurosurgery and Physiology, the University of Alabama at Birmingham.

23 Apr 2010

Geron scientists highlight importance of telomerase inhibitor, GRN163L at AACR 2010

Geron Corporation today announced five presentations by Geron scientists and collaborators on the company's telomerase inhibitor, imetelstat sodium, including the drug's activity against cancer stem cells, at the 101st American Association for Cancer Research annual meeting held in Washington D.C.

23 Apr 2010

Affymax institutes quiet period in connection with Hematide Phase 3 result analysis

Affymax, Inc. today announced that it has instituted a quiet period to curtail discussions with the investor community and the media in connection with the analysis of Phase 3 results for the investigational drug, Hematide, in four clinical trials (PEARL 1, PEARL 2, EMERALD 1 and EMERALD 2) which evaluated Hematide for the treatment of anemia in chronic renal failure patients.

23 Apr 2010

Amira Pharmaceuticals granted UK patent covering novel small molecule inhibitors of DP2 receptor

Amira Pharmaceuticals, Inc. today announced that the U.K. Intellectual Property Office has granted it patent number GB2460597 titled "N,N-Disubstituted aminoalkylBiPhenyl Antagonists OF Prostaglandin d2 RECEPTORS."

23 Apr 2010

Drug Trial News

Prime-boost malaria vaccine regimen provides sterile protection: Vical

UK MHRA authorizes Presidio Pharmaceuticals to initiate Phase 1 clinical trial of PPI-461 for HCV

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

Evotec to receive EUR 1.5M from German BMBF for advancing H3 receptor antagonist programme

Patient preference study results of Kristalose to be presented at 2010 Digestive Disease Week meeting

Phase 2b clinical study initiated to evaluate GI safety of LT-NS001

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

OSI Pharmaceuticals completes enrollment in Phase III clinical trial of Tarceva

First patient enrolled in Phase II clinical trial of E10030 for treatment of wet age-related AMD

Phase 1/2 clinical trial of TRC105 therapy initiated for patients with castrate-resistant prostate cancer

Pevion Biotech to present positive results of PEV4 RSV vaccine candidate at Vaccine Innovation Meeting

Recent business progress at Penwest Pharmaceuticals

Study finds AFREZZA comparable to standard of care insulin therapy

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

Urigen Pharmaceuticals requests FDA meeting for advancing URG101 clinical program

AFFiRiS' AD02 Alzheimer's vaccine candidate in phase II clinical testing

Oncolytics Biotech completes Phase I enrollment in Phase I/II trial of REOLYSIN for recurrent malignant gliomas

Geron scientists highlight importance of telomerase inhibitor, GRN163L at AACR 2010

Affymax institutes quiet period in connection with Hematide Phase 3 result analysis

Amira Pharmaceuticals granted UK patent covering novel small molecule inhibitors of DP2 receptor

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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