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Specific influenza immunization strategies for RA patients may be required for future flu pandemics

A Brazilian hospital-based study assessed responses to flu vaccines in 340 RA patients in regular follow-up compared to 234 healthy patients.

26 May 2011

iBioLaunch Platform successfully expresses hookworm-derived molecule for potential vaccine

iBio, Inc. today announced that its proprietary iBioLaunch Platform successfully expressed the hookworm-derived molecule known as NaAPR1M-74, which will be evaluated as a potential vaccine candidate for human hookworm disease.

26 May 2011

Pharmasset, Bristol-Myers Squibb initiate PSI-7977 plus BMS-790052 combination Phase 2a trial in HCV

Pharmasset, Inc. announced today the initiation of a Phase 2a trial investigating the combination of Pharmasset's PSI-7977, a nucleotide polymerase inhibitor, and BMS-790052, Bristol-Myers Squibb Company's NS5A replication complex inhibitor, for the treatment of chronic hepatitis C.

26 May 2011

BioCryst presents positive data from two BCX4208 Phase 2 studies in gout at EULAR 2011

BioCryst Pharmaceuticals, Inc. presented positive data from its two completed, randomized, double-blind, placebo-controlled Phase 2 studies of BCX4208 in patients with gout at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism in London, U.K.

26 May 2011

ImmunoGen's clinical data on IMGN901 and SAR3419 to be presented at ASCO 2011

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced that favorable clinical data on two ImmunoGen-created TAP compounds - IMGN901 and SAR3419 - are being presented at the ASCO 2011 Annual Meeting taking place in Chicago, IL, June 4-8, 2011.

26 May 2011

Mayoly-Spindler, ProteaBio complete MS1819 Phase I/IIA trial in malabsorption syndrome

ProteaBio Europe SAS, announced today that the company, in partnership with Mayoly-Spindler, has successfully completed a Phase I/IIA human clinical trial for their MS1819 recombinant Lipase.

26 May 2011

Boehringer Ingelheim's new afatinib-cetuximab phase Ib data in NSCLC presented at ASCO 2011

Boehringer Ingelheim Pharmaceuticals, Inc. will present new phase Ib data at the 2011 American Society of Clinical Oncology annual meeting in Chicago that indicates combining its investigational therapy afatinib with cetuximab at the maximum tested dose controlled disease in all (n=22) treated epidermal growth factor receptor (EGFR)-mutation positive patients with non-small cell lung cancer who developed acquired resistance to treatment with a reversible EGFR tyrosine kinase inhibitor.

26 May 2011

NWBT accelerates addition of clinical sites for new enrollment into ongoing GBM brain cancer trial

Northwest Biotherapeutics today announced that it has accelerated the addition of clinical trial sites, exceeding its projections for the doubling of such sites across the U.S. this calendar quarter, for enrollment of new patients into the Company's ongoing 240-patient randomized, double blind, placebo controlled clinical trial of DCVax immune therapy for Glioblastoma multiforme, the most lethal form of brain cancer.

26 May 2011

Lytix Biopharma completes two LTX-109 Phase I/IIa studies in MRSA, Gram+ skin infections

The Norwegian pharmaceutical company Lytix Biopharma today announces the successful completion of two Phase I/IIa studies with the topical antimicrobial drug Lytixar - one for nasal decolonisation of MRSA / MSSA bacteria and one for treatment of Gram+ skin infections.

26 May 2011

Tofacitinib safe and effective for patients with rheumatoid arthritis

Results of a Phase III study presented today at the EULAR 2011 Annual Congress show that at 6 months, 58.3 percent of patients who had previously not responded to treatment with DMARDs, achieved ACR20 response when treated with the novel oral Janus kinase inhibitor tofacitinib at 10mg BID compared to 31.2 percent in the placebo group. Significant improvements were also observed in the 5 mg BID dose.

26 May 2011

Ardea reports additional results from lesinurad-allopurinol Phase 2b study in hyperuricemia, gout

Ardea Biosciences, Inc. announced that additional positive clinical and preclinical results from its development program of lesinurad, the Company's lead product candidate for the treatment of hyperuricemia and gout, were presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism in London, UK.

26 May 2011

NEJM publishes ZYTIGA plus prednisone Phase 3 trial data in metastatic castration-resistant prostate cancer

A study titled "Abiraterone and Increased Survival in Metastatic Prostate Cancer," published in the May 26 issue of NEJM, found that patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel showed a significant improvement in overall survival when treated with ZYTIGA plus prednisone compared to patients treated with prednisone plus placebo.

26 May 2011

PolyMedix presents new pre-clinical data on antimicrobial compounds at two scientific meetings

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced today that new pre-clinical data for its novel, defensin-mimetic antimicrobial compounds was recently presented at two prestigious scientific meetings, including the American Society of Microbiology.

25 May 2011

Derma Sciences announces results of DSC127 Phase 2 trial in diabetic foot ulcers at 24-weeks

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced that in the follow-up portion of its Phase 2 clinical trial in patients with diabetic foot ulcers, the percentage of patients treated with the therapeutic dose of DSC127 with complete healing at 24 weeks following trial enrollment was 73% in the intent-to-treat population and 85% in the per-protocol population, a difference of 27 and 33 percentage points, respectively, compared with patients treated with placebo/standard of care.

25 May 2011

Pathway receives FDA approval to commence PWT33597 Phase 1 study in advanced solid tumors

Pathway Therapeutics, Inc., a company developing novel therapeutics that target the PI3K and mTOR pathways, today announced that the FDA has accepted an IND filing for PWT33597, which allows Pathway to commence Phase 1 clinical testing.

25 May 2011

Avanafil phase 3 trial in ED following radical prostatectomy meets primary endpoints

VIVUS, Inc. today announced positive results from a phase 3, placebo-controlled clinical trial of the investigational drug avanafil for the treatment of erectile dysfunction in patients following a radical prostatectomy.

25 May 2011

New findings from STELARA psoriasis clinical trial to be presented at 22nd World Congress of Dermatology

New findings to be presented from pooled analyses of the STELARA psoriasis clinical development program showed that the safety profile of STELARA and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment.

25 May 2011

Oral and injected steroids appear to be equally effective for sudden hearing loss

A relatively new treatment for sudden hearing loss that involves injecting steroids into the middle ear appears to work just as well as the current standard of oral steroids, a study by researchers at Johns Hopkins and other institutions suggests.

25 May 2011

CRT, Cancer Research UK and Centella partner to launch clinical development of CEN-209

Cancer Research UK and Cancer Research Technology - the charity's development and commercialisation arm - have partnered with Centella Therapeutics, Inc. of Palo Alto, California, to develop, manufacture and trial a promising new drug, CEN-209 in cancer patients with solid tumours.

25 May 2011

Two Novartis ACZ885 Phase III trial data in severe gouty arthritis to be presented at EULAR 2011

Novartis announced results of two pivotal Phase III trials in patients with severe gouty arthritis, showing that ACZ885 provided superior pain relief and reduced the risk of suffering new attacks by up to 68% compared to an injectable steroid used to treat gouty arthritis attacks.

25 May 2011

Drug Trial News

Specific influenza immunization strategies for RA patients may be required for future flu pandemics

iBioLaunch Platform successfully expresses hookworm-derived molecule for potential vaccine

Pharmasset, Bristol-Myers Squibb initiate PSI-7977 plus BMS-790052 combination Phase 2a trial in HCV

BioCryst presents positive data from two BCX4208 Phase 2 studies in gout at EULAR 2011

ImmunoGen's clinical data on IMGN901 and SAR3419 to be presented at ASCO 2011

Mayoly-Spindler, ProteaBio complete MS1819 Phase I/IIA trial in malabsorption syndrome

Boehringer Ingelheim's new afatinib-cetuximab phase Ib data in NSCLC presented at ASCO 2011

NWBT accelerates addition of clinical sites for new enrollment into ongoing GBM brain cancer trial

Lytix Biopharma completes two LTX-109 Phase I/IIa studies in MRSA, Gram+ skin infections

Tofacitinib safe and effective for patients with rheumatoid arthritis

Ardea reports additional results from lesinurad-allopurinol Phase 2b study in hyperuricemia, gout

NEJM publishes ZYTIGA plus prednisone Phase 3 trial data in metastatic castration-resistant prostate cancer

PolyMedix presents new pre-clinical data on antimicrobial compounds at two scientific meetings

Derma Sciences announces results of DSC127 Phase 2 trial in diabetic foot ulcers at 24-weeks

Pathway receives FDA approval to commence PWT33597 Phase 1 study in advanced solid tumors

Avanafil phase 3 trial in ED following radical prostatectomy meets primary endpoints

New findings from STELARA psoriasis clinical trial to be presented at 22nd World Congress of Dermatology

Oral and injected steroids appear to be equally effective for sudden hearing loss

CRT, Cancer Research UK and Centella partner to launch clinical development of CEN-209

Two Novartis ACZ885 Phase III trial data in severe gouty arthritis to be presented at EULAR 2011

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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