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Independent investigator begins pump trial of Biodel's two ultra-rapid human insulin formulations

Biodel Inc. announced today that an independent investigator initiated a pump trial of Biodel's two ultra-rapid-acting formulations of recombinant human insulin.

10 May 2011

Tetraphase presents TP-434, TP-2758 antibiotics study data against pathogens at ECCMID

Tetraphase Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on next-generation antibiotics, announced today that it is presenting new results of several studies designed to support the continued advancement of its lead antibiotic, TP-434, a potent new broad-spectrum intravenous antibiotic with oral stepdown potential effective against difficult-to-treat and multidrug-resistant pathogens.

10 May 2011

biocrea and Pfizer jointly presented details on novel PDE10 inhibitors

biocrea, a biopharmaceutical company focusing on novel treatments for disorders of the central nervous system (CNS), today reported details on the design and synthesis of novel, brain-penetrating phosphodiesterase-10 (PDE10) inhibitors developed in collaboration with Pfizer Inc. (NYSE: PFE). The data were featured in joint presentations1 with Pfizer at the recent 241st ACS National Meeting & Exposition, an event organized by the American Chemical Society (ACS).

10 May 2011

Bayer's regorafenib granted FDA Fast Track designation for treatment of GIST

Bayer HealthCare Pharmaceuticals Inc. announced today that its investigational compound regorafenib (BAY 73-4506) has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite at least imatinib and sunitinib as prior treatments.

10 May 2011

Treatment with estrogen-lowering drugs shrinks tumors and reduces mastectomy rates in breast cancer patients

In the first large trial of its kind in the United States, researchers have shown that estrogen-lowering drugs can shrink tumors and reduce mastectomy rates for patients with stage 2 or 3 breast cancer.

10 May 2011

Pfizer presents SA3Ag staphylococcal vaccine Phase 1 trial data at ECCMID/ICC

Inhibitex, Inc., announced today that Pfizer Inc. presented safety and immunogenicity data from a Phase 1 double-blind randomized placebo controlled study in 408 healthy volunteers of a novel three antigen Staphylococcus aureus investigational vaccine at the 21st European Congress of Clinical Microbiology and Infectious Diseases and 27th International Congress of Chemotherapy in Milan, Italy.

10 May 2011

MGH, Duke University and Angion Biomedica partner to develop novel therapeutics for ischemic stroke

Angion Biomedica Corp. announced today the establishment of an alliance with Duke University and Massachusetts General Hospital to pursue advanced development and clinical studies of its lead therapeutics for treatment of ischemic stroke.

10 May 2011

OncoGenex first quarter revenue decreases to $1.2 million

OncoGenex Pharmaceuticals, Inc. today announced its first quarter financial results and provided an update on current events and activities.

10 May 2011

Kowa presents three K-115 study results against glaucoma at ARVO 2011

Kowa Company Ltd, today announced the results of two clinical studies and a non-clinical study of a drug candidate for glaucoma and ocular hypertension.

10 May 2011

Nexvax2- coeliac disease vaccine shows promising results in Phase I clinical trial

The world's first potential vaccine for coeliac disease has shown promising results for treating coeliac disease in a Phase I clinical trial and is expected to move to Phase II trials within the next year.

10 May 2011

Acceleron presents RAP-661 preclinical data in osteopenic mice at international meeting

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, presented preclinical data highlighting the significant anabolic bone effects in normal and osteopenic mice of RAP-661.

10 May 2011

Abbott, Sucampo present lubiprostone phase 3 trial data in Japanese CIC at DDW 2011

Sucampo Pharmaceuticals, Inc. and Abbott today reported data from a phase 3 clinical efficacy trial in 124 Japanese chronic idiopathic constipation patients as well as from a phase 3 long-term safety trial in an additional 209 Japanese CIC patients.

10 May 2011

Uganda: First vaccination for GMZ2 malaria vaccine trial

Today, the EDCTP-funded GMZ2 consortium starts volunteer enrolment for the phase IIb clinical trial of the candidate malaria vaccine GMZ2 in Uganda. This is the third trial site to initiate volunteer recruitment for this multi-country study. Vaccination is already underway at trial sites in Gabon (November 2010) and Burkina Faso (April 2011). The Uganda site is in the peri-urban area of Iganga/Mayuge, at the Iganga Hospital. Akin to most areas in Uganda, malaria is one of the major health problems in this district. A team from Makerere University (Kampala) is conducting the trial.

9 May 2011

New GARDASIL data against Human Papillomavirus presented at EUROGIN conference

A real-world study evaluating the safety of GARDASIL among 189,629 females in California found no serious adverse events related to vaccination, no safety signals for any health event resulting in an emergency room visit or hospitalization and no safety signals associated with pre-specified autoimmune conditions or pregnancy outcomes.

9 May 2011

GTx reports net loss of $2.6 million for first quarter 2011

GTx, Inc. today provided a company update and reported financial results for the first quarter of 2011.

9 May 2011

EMA agrees to Swedish Orphan Biovitrum, Biogen Idec's pediatric rFIXFc trial in hemophilia

Biogen Idec and Swedish Orphan Biovitrum today announced that the European Medicines Agency's Pediatric Committee has adopted an opinion agreeing to the pediatric investigational plan for the companies' long-lasting, fully-recombinant Factor IX Fc fusion protein.

9 May 2011

Inovio reports VGX-3100 Phase I study data in cervical dysplasia and cancer

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, has reported data demonstrating long-term durability of immune responses induced by VGX-3100, its investigational DNA vaccine for treating cervical dysplasia and cancer caused by human papillomavirus.

9 May 2011

Diamyd Medical announces European Phase III study results in type 1 diabetes

Diamyd Medical reports that results from its European Phase III study with the antigen-based therapy Diamyd did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, as measured by meal stimulated C-peptide, in newly diagnosed type 1 diabetes patients.

9 May 2011

Cempra to present solithromycin Phase 1 study data at ECCMID/ICC meeting

Cempra Pharmaceuticals, a developer of differentiated antibiotics, today announced an oral presentation showing that intravenous (IV) solithromycin demonstrates excellent tolerability and a favorable pharmacokinetic profile at IV doses up to 800 mg.

7 May 2011

Millennium presents VELCADE Phase III trial data in multiple myeloma at IMW meeting

Millennium: The Takeda Oncology Company today reported the presentation of results of a randomized Phase III trial that investigated the effect of consolidation with single-agent VELCADE for Injection in newly diagnosed multiple myeloma patients after autologous stem cell transplant.

7 May 2011

Drug Trial News

Independent investigator begins pump trial of Biodel's two ultra-rapid human insulin formulations

Tetraphase presents TP-434, TP-2758 antibiotics study data against pathogens at ECCMID

biocrea and Pfizer jointly presented details on novel PDE10 inhibitors

Bayer's regorafenib granted FDA Fast Track designation for treatment of GIST

Treatment with estrogen-lowering drugs shrinks tumors and reduces mastectomy rates in breast cancer patients

Pfizer presents SA3Ag staphylococcal vaccine Phase 1 trial data at ECCMID/ICC

MGH, Duke University and Angion Biomedica partner to develop novel therapeutics for ischemic stroke

OncoGenex first quarter revenue decreases to $1.2 million

Kowa presents three K-115 study results against glaucoma at ARVO 2011

Nexvax2- coeliac disease vaccine shows promising results in Phase I clinical trial

Acceleron presents RAP-661 preclinical data in osteopenic mice at international meeting

Abbott, Sucampo present lubiprostone phase 3 trial data in Japanese CIC at DDW 2011

Uganda: First vaccination for GMZ2 malaria vaccine trial

New GARDASIL data against Human Papillomavirus presented at EUROGIN conference

GTx reports net loss of $2.6 million for first quarter 2011

EMA agrees to Swedish Orphan Biovitrum, Biogen Idec's pediatric rFIXFc trial in hemophilia

Inovio reports VGX-3100 Phase I study data in cervical dysplasia and cancer

Diamyd Medical announces European Phase III study results in type 1 diabetes

Cempra to present solithromycin Phase 1 study data at ECCMID/ICC meeting

Millennium presents VELCADE Phase III trial data in multiple myeloma at IMW meeting

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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