Prophylaxis News and Research

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Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Hemispherx Biopharma, Inc., announced that it has received a report, prepared by Hideki Hasegawa, M.D. Ph.D., Director, Laboratory of Infectious Disease Pathology, National Institute of Infectious Disease, that summarizes the results of a three year Japanese government funded program to develop and test a nasally delivered H5N1 (Avian Flu) vaccine which, when coupled with Ampligen®, an experimental therapeutic, provided a robust and long lasting immune response to the vaccine.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia.

9 Jul 2010

Semuloparin reduces incidence of VTE in orthopedic surgery patients, study finds

An ultra-low-molecular-weight heparin called semuloparin has been found to reduce the incidence of venous thromboembolism in orthopedic surgery patients in a large clinical program being lead by a steering committee chaired by McMaster University professor Dr. Alexander Turpie.

9 Jul 2010

Phase II trial results of TB-402 presented at International Congress on Thrombosis

BioInvent International AB and ThromboGenics NV announce that the positive results from a Phase II trial of TB-402 (Anti-Factor VIII antibody) were presented at the 21st International Congress on Thrombosis in Milan, Italy yesterday. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism following orthopaedic surgery.

9 Jul 2010

Allergan receives UK MHRA authorisation of BOTOX for prophylaxis of headache in chronic migraine

Allergan is pleased to announce that BOTOX® (botulinum toxin type A) has been licensed by the MHRA in the UK for the prophylaxis of headaches in adults who have chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). This is the first licence worldwide of BOTOX® for this indication, and is also the first prophylactic (preventative) treatment to receive a specific licence for patients with chronic migraine.

9 Jul 2010

PharmAthene reports progress in lyophilized rPA anthrax vaccine development program

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it continues to make solid progress in its lyophilized recombinant Protective Antigen (rPA) anthrax vaccine development program. The Company has recently demonstrated that its lyophilized rPA vaccine candidate is structurally stable and potent at various temperatures up to and including 70 degrees centigrade.

9 Jul 2010

Idera announces issuance of patents for synthetic immune modulatory oligonucleotides targeted to TLRs

Idera Pharmaceuticals, Inc. today announced the issuance of patents covering compositions and methods of using its synthetic immune modulatory oligonucleotides targeted to Toll-like receptors (TLRs). The Company's intellectual property portfolio currently contains over 500 patents and patent applications worldwide and includes claims for TLR-targeted compounds, second-generation antisense chemistry, and oral delivery of certain oligonucleotides.

8 Jul 2010

Extended treatment with blood thinner benefits patients immobilized by acute medical illness: Study

A treatment plan used to prevent potentially dangerous blood clots in recovering surgical patients can also benefit some patients immobilized by acute medical illness, doctors have found in a multi-institutional study.

7 Jul 2010

Watson Laboratories receives FDA approval for Tacrolimus ANDA

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Tacrolimus 5 mg capsules, the generic equivalent to Astellas' Prograf® capsules.

2 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced results from a second study of QPI-1007, a neuroprotective siRNA drug, in rat ocular hypertension model of glaucoma, conducted by Prof. Adriana Di Polo of the Department of Pathology and Cell Biology, Universite de Montreal.

29 Jun 2010

New affiliation formed to accelerate nation's progress in fighting HIV/AIDS

Two leading institutions in public health and health policy are joining forces to accelerate the nation's progress in fighting HIV/AIDS, hepatitis C and tuberculosis in Washington – the Forum for Collaborative HIV Research and the University of California, Berkeley, School of Public Health.

28 Jun 2010

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that two of its siRNA drug candidates were featured in the following two presentations at the Glaucoma & Retinopathies 2010 conference, which was held June 21-22, 2010 in London, UK.

25 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

BD, PEPFAR commence multi-year initiative to improve blood collection practices in African clinics, hospitals

BD (Becton, Dickinson and Company), a leading global medical technology company, and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention (CDC) today set in motion a joint, multi-year initiative to improve blood collection practices in African clinics and hospitals.

From BD (Becton, Dickinson and Company) 22 Jun 2010

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.

21 Jun 2010

Preclinical study shows treatment with DAS181 inhibits infection with multiple HPIV strains

NexBio, Inc. announced today the publication of a "Major Article" in the Journal of Infectious Diseases of a preclinical study showing that treatment with DAS181 (Fludase) inhibits infection with multiple human parainfluenza virus strains. DAS181 is a broad spectrum host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness.

19 Jun 2010

Maternal, infant ART drives down mother-to-child HIV transmission through breast-feeding, studies show

According to two new studies, "giving pregnant and nursing women triple antiretroviral drug therapy, or treating breast-fed infants with an antiretroviral medication, can dramatically cut transmission rates, enabling moms to both breast-feed and to protect nearly all children from infection," HealthDay News/Bloomberg Businessweek reports (Goodwin, 6/16).

18 Jun 2010

Prophylaxis News and Research

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Semuloparin reduces incidence of VTE in orthopedic surgery patients, study finds

Phase II trial results of TB-402 presented at International Congress on Thrombosis

Allergan receives UK MHRA authorisation of BOTOX for prophylaxis of headache in chronic migraine

PharmAthene reports progress in lyophilized rPA anthrax vaccine development program

Idera announces issuance of patents for synthetic immune modulatory oligonucleotides targeted to TLRs

Extended treatment with blood thinner benefits patients immobilized by acute medical illness: Study

Watson Laboratories receives FDA approval for Tacrolimus ANDA

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

New affiliation formed to accelerate nation's progress in fighting HIV/AIDS

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

BD, PEPFAR commence multi-year initiative to improve blood collection practices in African clinics, hospitals

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

Preclinical study shows treatment with DAS181 inhibits infection with multiple HPIV strains

Maternal, infant ART drives down mother-to-child HIV transmission through breast-feeding, studies show

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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