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FDA approves ISTA's Bepreve for treating ocular itch

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

9 Sep 2009

KRYSTEXXA development and treatment failure gout to be presented

Savient Pharmaceuticals, Inc. announced that five abstracts relating to KRYSTEXXA (pegloticase) development and treatment failure gout will be presented at the 2009 ACR/ARHP Annual Scientific Meeting taking place in Philadelphia from October 16-21, 2009.

8 Sep 2009

Valeant develops an acne drug with a low concentration of BPO combined with clindamycin

One of the most widely prescribed drugs for acne vulgaris is benzoyl peroxide (BPO). However, at concentrations of 5-10%, BPO has the potential for skin irritation and dryness leading to poor patient compliance. Increasingly, BPO is combined with clindamycin in a fixed combination where the efficacy effects of the two ingredients are synergistic.

8 Sep 2009

Opexa Therapeutics releases Phase IIb TERMS clinical study results

Opexa Therapeutics, Inc., a company developing Tovaxin, a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced results from further analysis of the double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS).

8 Sep 2009

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology company, announced today that the National Institutes of Health (NIH) has awarded DOR a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.

8 Sep 2009

Pharma manufacturer's failure to disclose endangers Swine Flu vaccination program

As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, the integrity of all vaccine developers has been called into question by the financial relationship of a leading vaccine advocate and a pharmaceutical manufacturer. Dr. Paul Offit of Children's Hospital of Philadelphia (CHOP), who was interviewed for a Dateline NBC television special, failed to tell millions of viewers that while he was promoting MMR as safe he had also made tens of millions of dollars from selling another vaccine patent to Merck, which is the manufacturer of MMR.

8 Sep 2009

COPD patients to have better protection against pneumonia with new vaccine

A new vaccine against pneumonia may offer better protection from chronic obstructive pulmonary disease (COPD) patients than the currently accepted vaccine, according to recent research that will be published in the September 15 issue of the American Journal of the Respiratory and Critical Care Journal, a publication of the American Thoracic Society.

8 Sep 2009

Insects can be used to test the efficiency of new drugs

Insects, such as some moths and fruit flies, react to microbial infection in the same way as mammals and so can be used to test the efficiency of new drugs, thereby reducing the need for animal testing. Dr Kevin Kavanagh from the National University of Ireland - Maynooth, presented his research findings at the Society for General Microbiology's meeting at Heriot Watt University, Edinburgh, today (8 September).

7 Sep 2009

ASNM inaugral conference to discuss the latest in nanomedicine

Nanomedicine - the science and technology of diagnosing, treating and preventing disease to improve human health using nanotechnology - has the potential to revolutionize healthcare. Current and future products range from miniaturized "smart pills" that precision-target certain cancers to nanosensors that are capable of navigating through the body for early detection of disorders.

5 Sep 2009

Opinion: Local drug production in developing countries; Obama's PEPFAR changes

The international community focuses on lowering drug prices as a means of improving access and "today its idea is local pharmaceutical production .

5 Sep 2009

SoftScan clinical results from a breast cancer treatment monitoring study to be presented at IEEE International Conference

ART Advanced Research Technologies Inc. (ART) (TSX:ARA), a Canadian medical device company and a leader in optical molecular imaging products for the healthcare and pharmaceutical industries, is pleased to announce that Dr. Gregory Czarnota, MD, PhD, Radiation Oncologist at Odette Cancer Centre, Sunnybrook Health Sciences Centre, will be presenting SoftScan® clinical results from a breast cancer treatment monitoring study, at the IEEE Engineering in Medicine and Biology Society 31st Annual International Conference in Minneapolis, Minn.

5 Sep 2009

FDA notifies PDUFA action date for Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding CTI's NDA for pixantrone as potential treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

5 Sep 2009

Nurses urge CDC to follow the recommendations for swine flu protection from the Institute of Medicine

The California Nurses Association/National Nurses Organizing Committee (CNA/NNOC) today applauds the Institute of Medicine for recommending strong patient safety protections for patients and caregivers to avoid airborne transmission during the ongoing H1N1/swine flu pandemic--and calls on the Centers for Disease Control to meet the same, stringent standards.

5 Sep 2009

Spectrum's ZEVALIN expanded label receives FDA approval for treating non-Hodgkin’s Lymphoma

Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration (FDA) for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy.

5 Sep 2009

Clinical trial of Cerebroprotein Hydrolysate for Injection completes

Hard to Treat Diseases (the "Company") announced today, that its China based subsidiary Mellow Hope, has just finished (August 2009) the clinical trial of Cerebroprotein Hydrolysate for Injection (Brand name: NUTRIPROTEIN) in India.

5 Sep 2009

Novel SLE Responder Index as the primary endpoint in two Phase 3 clinical trials

Human Genome Sciences, Inc. today announced publication by the journal Arthritis Care & Research of an article describing the development and use of a novel evidence-based systemic lupus erythematosus (SLE) Responder Index selected as the primary endpoint of two pivotal Phase 3 clinical trials of BENLYSTA (belimumab) in serologically active patients with SLE.

4 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

OSI Pharmaceuticals initiates two clinical trials with OSI-906 oral insulin-like growth factor-1 receptor inhibitor

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today the initiation of two clinical trials with OSI-906, the Company’s potential first-in-class, oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor. The first study is a Phase III, multi-center study that will evaluate the use of OSI-906 for patients with locally advanced or metastatic adrenocortical carcinoma (ACC).

4 Sep 2009

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that data from the Company's third generation recombinant protective antigen (rPA) anthrax vaccine program and its Valortim((R)) anthrax anti-toxin program were presented at the Bacillus - ACT 2009 meeting, August 30 - September 3, 2009, organized by the American Society for Microbiology.

4 Sep 2009

HTDS announces closure of Regulation D 504 offering

Hard to Treat Diseases (the "Company") (HTDS.PK) announced today that it has closed its Regulation D, Rule 504 offering and is no longer selling shares of its common stock to accredited investors.

4 Sep 2009

Efficacy News and Research

FDA approves ISTA's Bepreve for treating ocular itch

KRYSTEXXA development and treatment failure gout to be presented

Valeant develops an acne drug with a low concentration of BPO combined with clindamycin

Opexa Therapeutics releases Phase IIb TERMS clinical study results

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

Pharma manufacturer's failure to disclose endangers Swine Flu vaccination program

COPD patients to have better protection against pneumonia with new vaccine

Insects can be used to test the efficiency of new drugs

ASNM inaugral conference to discuss the latest in nanomedicine

Opinion: Local drug production in developing countries; Obama's PEPFAR changes

SoftScan clinical results from a breast cancer treatment monitoring study to be presented at IEEE International Conference

FDA notifies PDUFA action date for Cell Therapeutics' NDA for pixantrone

Nurses urge CDC to follow the recommendations for swine flu protection from the Institute of Medicine

Spectrum's ZEVALIN expanded label receives FDA approval for treating non-Hodgkin’s Lymphoma

Clinical trial of Cerebroprotein Hydrolysate for Injection completes

Novel SLE Responder Index as the primary endpoint in two Phase 3 clinical trials

Shire receives FDA approval for INTUNIV extended release tablets

OSI Pharmaceuticals initiates two clinical trials with OSI-906 oral insulin-like growth factor-1 receptor inhibitor

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

HTDS announces closure of Regulation D 504 offering

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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