Immunodeficiency News and Research

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Immunodeficiency (or immune deficiency) is a state in which the immune system's ability to fight infectious disease is compromised or entirely absent.

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

Progenics Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for use in their respective territories. These pre-filled syringes provide a simplified dosing option for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness.

30 Sep 2010

New website offers real-life case studies and immunology breakthroughs on HIV

Amid a devastating HIV epidemic, some South African pediatricians treat as many as 100 children per day. With such overwhelming case loads, the physicians have little time to review the information they were offered in medical school on the topic of immunology. Recognizing the potential value of an understanding of up-to-date immunology in the treatment of HIV, immunologist Clive Gray developed Immunopaedia, a Web site that quickly and efficiently gives doctors a working knowledge of immunology through real-life case studies and news of immunology breakthroughs.

24 Sep 2010

FDA grants clearance for HPβCD treatment for Niemann Pick Type C disease

Children's Hospital & Research Center Oakland announced today that the US Food and Drug Administration (FDA) has granted clearance of an Investigational New Drug (IND) application to introduce Trappsol Cyclo (Hydroxypropyl Beta Cyclodextrin or HPβCD) into the brains of six year old identical twin girls dying of a rare brain-destroying cholesterol disease called Niemann Pick Type C (NPC).

24 Sep 2010

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

Aethlon Medical reestablishes efforts to advance Aethlon Hemopurifier

Aethlon Medical, Inc., the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed today that it has reestablished efforts to advance the Aethlon Hemopurifier within U.S. Government programs that support the development and purchase of treatment countermeasures against bioterror threats.

21 Sep 2010

FDA grants orphan drug designation for MultiStem stem cell therapy

Athersys, Inc. announced today that MultiStem, Athersys' multipotent adult progenitor stem cell therapy, has been granted orphan drug designation by the U. S. Food and Drug Administration for the prevention of graft vs. host disease (GvHD).

21 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

Simian immunodeficiency virus is at least 32,000 to 75,000 years old

An ancestor of HIV that infects monkeys is thousands of years older than previously thought, suggesting that HIV, which causes AIDS, is not likely to stop killing humans anytime soon, finds a study by University of Arizona and Tulane University researchers.

17 Sep 2010

FDA updates dosing recommendation for Valcyte medication

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant.

16 Sep 2010

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Progenics Pharmaceuticals, Inc. today presented preclinical findings for its humanized monoclonal antibodies against the disease-causing toxins produced by the bacterium Clostridium difficile.

14 Sep 2010

Research Roundup: Shifting ER visits to urgent care centers; Evaluating doctors; Medicare Advantage quality ratings

Health Affairs: Many Emergency Department Visits Could Be Managed At Urgent Care Centers And Retail Clinics - Researchers analyzed samples of patient records and found "13.7 percent of all emergency department visits could take place at a retail clinic" - 7.9 percent when hours are restricted - and "an additional 13.4 percent of emergency department visits could take place at a urgent care center—8.9 percent when hours are restricted.

10 Sep 2010

Koronis Pharmaceuticals to present KP-1461 clinical trial data at ICAAC Conference

Koronis Pharmaceuticals, Inc., a biotechnology company focused on the development of antiviral therapeutics, today announced that clinical trial data demonstrating that the Company's lead HIV drug, KP-1461, resulted in increased HIV mutations consistent with the Viral Decay Acceleration mechanism will be featured in a late-breaker oral presentation by James Mullins, Ph.D., Professor of Microbiology and Medicine at the University of Washington, at the upcoming 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) taking place in Boston, MA.

10 Sep 2010

Aethlon Hemopurifier captures immunosuppressive exosomes from individuals with metastatic melanoma.

Aethlon Medical, Inc., the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that its researchers have demonstrated the ability of the Aethlon Hemopurifier® to capture immunosuppressive exosomes derived from individuals with metastatic melanoma.

9 Sep 2010

Progenics commences Phase 3 trial of oral methylnaltrexone for opioid-induced constipation

Progenics Pharmaceuticals, Inc. today announced the initiation of an international 700-patient, phase 3 trial of oral methylnaltrexone in patients with chronic, non-cancer pain who are experiencing constipation as a result of their opioid-pain management regimens. The goal of the study is to evaluate the safety and efficacy of oral methylnaltrexone to treat opioid-induced constipation (OIC) in this patient setting.

8 Sep 2010

PPTA supports CMS' proposal for hospital outpatient reimbursement for plasma protein therapies

The Plasma Protein Therapeutics Association (PPTA) recommends that the Centers for Medicare and Medicaid Services (CMS) finalize its Proposed Rule regarding reimbursement to better ensure patient access to vital medicines in the hospital outpatient setting.

8 Sep 2010

NIH announces award to improve human microbiome research

The National Institutes of Health today announced it has awarded approximately $42 million to expand the scope of eight demonstration projects designed to link changes in the human microbiome to health and disease.

8 Sep 2010

Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Octapharma AG today announced the imminent start of the biggest ever study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

8 Sep 2010

Teleflex partners with Access Scientific to distribute The PICC WAND vascular access device

Teleflex has partnered with Access Scientific Incorporated, San Diego, California to become the U.S. distributor of The PICC WAND™ Safety Introducer with ARROW® peelable sheath. This new, all- in-one vascular access device provides clinicians a faster, safer, simpler way to insert a peel away sheath for PICC or Midline catheter placements.

7 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

Human endogenous retroviruses may provide insight evidence to HIV diagnosis

Why is it so hard to isolate and purify human immunodeficiency virus (HIV).Why has no one been able to see, by electron microscopy, a single HIV particle in the blood of AIDS patients, even those who have a "high viral load" Why does HIV seem to mutate with startling rapidity. AIDS researchers have not been able to come up with answers to these questions.

4 Sep 2010

Immunodeficiency News and Research

Further Reading

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

New website offers real-life case studies and immunology breakthroughs on HIV

FDA grants clearance for HPβCD treatment for Niemann Pick Type C disease

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Aethlon Medical reestablishes efforts to advance Aethlon Hemopurifier

FDA grants orphan drug designation for MultiStem stem cell therapy

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Simian immunodeficiency virus is at least 32,000 to 75,000 years old

FDA updates dosing recommendation for Valcyte medication

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Research Roundup: Shifting ER visits to urgent care centers; Evaluating doctors; Medicare Advantage quality ratings

Koronis Pharmaceuticals to present KP-1461 clinical trial data at ICAAC Conference

Aethlon Hemopurifier captures immunosuppressive exosomes from individuals with metastatic melanoma.

Progenics commences Phase 3 trial of oral methylnaltrexone for opioid-induced constipation

PPTA supports CMS' proposal for hospital outpatient reimbursement for plasma protein therapies

NIH announces award to improve human microbiome research

Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Teleflex partners with Access Scientific to distribute The PICC WAND vascular access device

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Human endogenous retroviruses may provide insight evidence to HIV diagnosis

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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