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Eli Lilly and other pharma firms have begun submitting their anti-amyloid drug hopefuls for approval. But questions linger over the controversial precedent set by Biogen's aducanumab. Eli Lilly and other pharma firms have begun submitting their anti-amyloid drug hopefuls for approval. But questions linger over the controversial precedent set by Biogen's aducanumab., Author(s): Asher Mullard Author Affiliations: More Alzheimer's drugs head for FDA review: what scientists are watching A clinical-trial participant receives an infusion of Biogen's aducanumab in May 2021. Credit: Kayana [...]

Many scientists say there is not enough evidence that Biogen's aducanumab is an effective therapy for the disease. Many scientists say there is not enough evidence that Biogen's aducanumab is an effective therapy for the disease., Author(s): Asher Mullard Author Affiliations: Landmark Alzheimer's drug approval confounds research community Plaques of amyloid-[beta] in the brain are one target of Alzheimer's disease treatments. Credit: Thomas Deerinck, NCMIR/SPL Amyloid [...]

Author(s): Nicole A. Doria-Rose [sup.1] , Chaim A. Schramm [sup.2] , Jason Gorman [sup.1] , Penny L. Moore [sup.3] [sup.4] [sup.5] , Jinal N. Bhiman [sup.3] [sup.4] , Brandon J. [...], Antibodies capable of neutralizing HIV-1 often target variable regions 1 and 2 (V1V2) of the HIV-1 envelope, but the mechanism of their elicitation has been unclear. Here we define the developmental pathway by which such antibodies are generated and acquire the requisite molecular characteristics for neutralization. Twelve somatically related neutralizing antibodies (CAP256-VRC26.01-12) were isolated from donor CAP256 (from the Centre for the AIDS Programme of Research in South Africa (CAPRISA)); each antibody contained the protruding tyrosine-sulphated, anionic antigen-binding loop (complementarity-determining region (CDR) H3) characteristic of this category of antibodies. Their unmutated ancestor emerged between weeks 30-38 post-infection with a 35-residue CDR H3, and neutralized the virus that superinfected this individual 15 weeks after initial infection. Improved neutralization breadth and potency occurred by week 59 with modest affinity maturation, and was preceded by extensive diversification of the virus population. HIV-1 V1V2-directed neutralizing antibodies can thus develop relatively rapidly through initial selection of B cells with a long CDR H3, and limited subsequent somatic hypermutation. These data provide important insights relevant to HIV-1 vaccine development. A longitudinal study of an individual patient developing neutralizing antibodies against HIV-1 (targeting the V1V2 region of gp120) reveals how such neutralizing antibodies develop and evolve over time, providing important insights relevant to vaccine development. HIV-neutralizing antibody formation examined A better understanding of how HIV-1-neutralizing antibodies are generated could be a useful contribution to the design of improved AIDS vaccines. John Mascola and colleagues have now elucidated the immunological pathway of an important category of HIV-1-neutralizing antibody -- those that target the variable V1V2 region of the viral envelope. These antibodies are more frequently elicited than CD4-binding site antibodies in the early stages of HIV infection and feature modest affinity maturation, a process that favours mutations in antibody variable domains that enhance antigen binding.

Author(s): Bruno E. Correia [sup.1] [sup.2] [sup.3] , John T. Bates [sup.4] , Rebecca J. Loomis [sup.5] , Gretchen Baneyx [sup.1] , Chris Carrico [sup.6] , Joseph G. Jardine [sup.1] [...], Vaccines prevent infectious disease largely by inducing protective neutralizing antibodies against vulnerable epitopes. Several major pathogens have resisted traditional vaccine development, although vulnerable epitopes targeted by neutralizing antibodies have been identified for several such cases. Hence, new vaccine design methods to induce epitope-specific neutralizing antibodies are needed. Here we show, with a neutralization epitope from respiratory syncytial virus, that computational protein design can generate small, thermally and conformationally stable protein scaffolds that accurately mimic the viral epitope structure and induce potent neutralizing antibodies. These scaffolds represent promising leads for the research and development of a human respiratory syncytial virus vaccine needed to protect infants, young children and the elderly. More generally, the results provide proof of principle for epitope-focused and scaffold-based vaccine design, and encourage the evaluation and further development of these strategies for a variety of other vaccine targets, including antigenically highly variable pathogens such as human immunodeficiency virus and influenza. Computational protein design methods are used to generate new candidates for a human respiratory syncytial virus (RSV) vaccine; artificial protein scaffolds that mimic the structure of a RSV epitope are shown to induce RSV-specific neutralizing antibodies in macaques. Vaccine design with a twist William Schief and colleagues explore computational protein design methods to generate novel candidates for a human respiratory syncytial virus (RSV) vaccine. Artificial protein scaffolds that mimic the structure of an RSV epitope or antigenic determinant are shown to induce RSV-neutralizing antibodies in macaques. The protein design method used here, that builds a protein around a functional motif in order to stabilize the conformation of that motif, could have broad application in vaccine development.

Lack of rigor in approving aducanumab for Alzheimer's disease may lead to serious harm., Author(s): Joel S. Perlmutter [sup.1] Author Affiliations: (1) Departments of Neurology, Radiology and Neuroscience and Programs in Physical Therapy and Occupational Therapy, Washington University in St. Louis, St. Louis, USA [...]

Author(s): Amanda B. Keener Green light Spinraza In an August announcement, Biogen and Ionis Pharmaceuticals shared encouraging results from an ongoing phase 3 trial for Spinraza (nusinersen) in patients with [...]

ARTICLE INFO Keywords: Sub-threshold anxiety Neurasthenia Post-traumatic stress disorder Lavender oil Oral administration Efficacy Clinical trial ABSTRACT Silexan, a novel lavender oil preparation for oral use, has been authorized in [...]

The latest science news, in brief. The latest science news, in brief., Author Affiliations: Swine flu snipers, Alzheimer's drug push and Google's latest gaming bot Pigs to be culled at a farm infected with African swine fever in Paju, a South Korean [...]

ACNE Nd: YAG Laser for Acne Keloidalis Nuchae Sponsored by Henry Ford Health System. Acne keloidalis nuchae (AKN) is a long standing hair follicle disease with bumps and scars on [...]

The week in science: 22-28 March 2019. The week in science: 22-28 March 2019., Author Affiliations: Baby monkey, antimatter puzzle and Alzheimer's disappointment EVENTS Scientists join huge Brexit protest Scientists took to the streets of London on 23 March as part of a major [...]

The Food and Drug Administration (FDA) approved Ranibizumab on June 30, 2006, which is manufactured by Genentech and marketed as Lucentis - for the treatment of neovascular age-related macular degeneration. Genentech's Ranibizumab belongs to the same group of drug named Bevacizumab, also produced by Genentech, which is another monoclonal antibody that was used by ophthalmologists to treat patients who had neovascular macular degeneration or other chorioretinal diseases mediated by vascular endothelial growth factor.

Active cultures can add function to yogurt and other cultured dairy foods. The category is becoming a major one among the nutraceuticals. Various organisms have positions in a continuum, from probiotics to prebiotics to nutribiotics. Boundaries between fortified foods, medical foods and healthy foods are not well defined. Topics include specific probiotics, calcium-fortified yogurt, flavor enhancement, and antibodies from colostrum. Companies whose products and new patents are discussed include Kraft, Nestec, Rhodia, Biogaia, Nestle, and Galagen, with the Land O' Lakes brand.

Probiotic yogurts, kefir and other cultured dairy foods and supplements designed to improve health are marketed more and more in Europe and the United States, with education or consumers important. Prevention of infant diarrhea is a major focus and new health benefits being researched. Lessons learned in Asia and Europe, where probiotics are widely accepted, are of interest relative to the US, where this is a new idea for most people. In Japan 24 mil people drink Yakult, a probiotic drink, daily. New forms of soy yogurt are in development, with Stonyfield to launch one soon. The role of genetically modified organisms (GMOs) may be of interest as new products are developed. Cultures are discussed. STandards have not been set up. Companies whose products and strategies are discussed include Stonyfield Farms, a very aggressive player with a number four share, and targeting products demographically, General Mills, Latteria Montelo, McNeil Consumer Healthcare, Natren, which markets cultures in capsules, Columbo, Kraft's Breyers, Lifeway, Dannon, Danone and Nestle, which puts out an infant formula with cultures to prevent diarrhea.

Mass market combinations have emerged from the European nations under the European Union, with its varied needs and demographic groups. Information is crossing borders via the Internet and more similarities than differences exist, but there are some definite variances. Convenience foods are very important in Northern Europe an many teens are vegetarian. Organically grown and free-range foods are important. Food safety concerns are intens, and genetically modified foods largely unwelcome. Functional and probiotic foods are wanted. Influences of the Americas, the Orient, Africa and the Middle East can be found. American supermarkets and fast-food outlets influence retailing. McDonalds, Starbucks and KFC units are in easy to find. Companies whose products or acquisitions are discussed include Asda, Walmart, Mars, whose Uncle Ben's Risotto Range hip advertising is discussed, Nestle, Danone with its Jahreszeit brand, McVities's Prepared Foods, Granarolo Felsinea, Schneekoppe and Unilever. Brands discussed include Calve, Linda McCartney, Zile Function+, Vivi vivo, Stefi+ and Biolabor Toffitis. Restaurant concepts are discussed. Import regulations on UK and US beef in France are discussed.

On 20 March, at the International Conference on Alzheimer's and Parkinsons Diseases and related neurological disorders in Nice, France, the Massachusetts-based company Biogen Idec announced the results of a phase [...]

The US Food and Drug Administration has approved a drug to treat people infected with anthrax (Bacillus anthracis) after inhaling spores, for instance in a bioterror attack. In 2011, the [...]

Two months before the 11 September terrorist attacks, the U.S. Department of Defense (DOD) sent Congress a report that attracted little attention at the time but has suddenly been catapulted [...]

Eighty years after the first tuberculosis vaccine, health leaders say they need a new one. Scientists have several promising candidates--but who will pay for them? Tuberculosis is an anachronism to [...]

A year after it invaded New York City, there's still much that scientists don't know about the West Nile virus. But they're sure it will keep spreading. When the West [...]

Using a host of new technologies, vaccine developers are trying to target the parasite at every stage of its complex life cycle 'Optimism' is not a word usually associated with [...]

Companies such as PDL Biopharma and Centocor, which make fontoluzimab, a humanized interferon-γ (IFN-γ)-specific antibody, and ustekinumab, the fully human antibody specific for interleukin-12 (IL-12) and IL-23 p40, respectively, expected [...]

Helix BioPharma Corp. has announced that it has achieved last-patient-out in its phase 2 trial of topical interferon alpha-2b for the treatment of ano-genital warts (AGW). All patients enrolled in [...]

An experimental antibody drug aimed at protecting nerves from the ravages of multiple sclerosis offers hope for a new way to combat the neurological disease--if researchers can definitively show that [...]

An experimental Alzheimer's drug slowed cognitive decline in a small trial, said the drug's manufacturer, Biogen Idec of Cambridge, Massachusetts, on 20 March. Aducanumab targets amyloid-[beta] plaques, high levels of [...]

On 19 December, the US Food and Drug Administration (FDA) in Silver Spring, Maryland, approved the first system aimed at making blood transfusions safer by clearing out pathogens. The Intercept [...]

The discovery in 2002 that West Nile virus can be transmitted via blood prompted two companies to begin developing a blood test for the virus that can be used by blood banks. Both companies say they will have a test ready by July 1, 2003. However, the death of two birds from West Nile virus in March, 2003 signals the beginning of the West Nile virus season.

The frustrating search for an AIDS vaccine entered a new phase this week, as hopes for one approach all but died while prospects for another got a welcome boost when [...]

Safeguarding children from pneumococcal infections: A new vaccine shows promise in helping to prevent the spread of pneumococcal infections in children. Each year, Streptococcus pneumoniae is implicated in the deaths [...]

Technology push and marketing pull, the 'Find a need and fill it' concept, and their interplay are discussed in relation to product development involving cranberries, eggs, yogurt and veal. In each of these products some new developments have been made based both on technological advances and on the needs consumers perceive, largely related to health issues.

Gilead Sciences of Foster City, California, won US approval on 6 December for the first treatment against hepatitis C that does not need to be coupled with injections of an [...]

Teva Pharmaceuticals, the Israeli drug company behind the blockbuster multiple sclerosis drug Copaxane (glatiramer acetate), has asked the FDA not to approve an experimental multiple sclerosis pill developed by Massachusetts's [...]

Cazandra MacDonald's 16-year-old son is more concerned with musical theater and video games than he is with sticking to an injection schedule. Her 6-year-old is afraid of needles. Yet both [...]

You cannot make an omelet without breaking eggs, and the same could be said about influenza vaccines. Most vaccine makers today grow the influenza virus in fertilized eggs, a manufacturing [...]

On 27 August, the FDA approved Gilead Sciences's four-in-one HIV pill Stribild (formerly known as the 'Quad'), a combination of an integrase inhibitor called elvitegravir, a boosting agent known as [...]

Trying to decide which influenza B strain to include in the seasonal flu vaccine is enough to give anyone a headache. Manufacturing constraints limit public health officials to including only [...]

Cytomedix Inc. executives now can turn to a six-member Scientific Advisory Board for guidance with clinical trial data gathering and publishing, Medicare reimbursement, and product development. Board members include doctors, [...]

Glucocorticoids (GCs) and their synthetic analogs are used widely to treat transplant recipients and patients with numerous other conditions, including rheumatoid arthritis, asthma, and some forms of cancer. The beneficial [...]

Over the past 15 years there has been a change in perceptions of what constitutes vaccine innovation to meet developing country needs. This change could reduce the global burden of [...]

Sponsored by RegeneRx Biopharmaceuticals, Inc. Collaborator: FDA Office of Orphan Products Development. The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic [...]

The path of drug development is fraught with hurdles. Gaining a clear understanding of how a drug works before it enters clinical trials is the intelligent route to drug discovery and could increase the likelihood for drug success., Drug development is a risky business. According to the US Food and Drug Administration (FDA), only eight percent of drugs that enter clinical trials are eventually approved. For a drug [...]

Aug 24 The multinational company Proctor & Gamble announced that Warner Chilcott, a drug company based in Ireland, would acquire its global pharmaceuticals business for an up-front cash payment of [...]

Pandemic flu: The US National Institute of Allergy and Infectious Diseases reported on 11 September that early data from its own trials of pandemic H1N1 flu vaccines, manufactured by French [...]

Bristol-Myers Squibb Company and Medarex, Inc. recently announced results from extensions of three phase 2 trials. The trials studied the effects of ipilimumab in patients with metastatic melanoma (stage 3 [...]

The US Food and Drug Administration (FDA) has issued its first approval of a drug produced by a genetically engineered animal. The drug, marketed as ATryn, is the human blood [...]

The FDA has granted 510(k) clearance to Osteotech for its Plexur M biocomposite for spinal applications. The product may be used with autograft as a bone void filler in the […]

Sponsored by: RegeneRx Biopharmaceuticals Inc. The purpose of this study is to evaluate the safety, tolerability and effectiveness of thymosin beta 4 administered topically in patients with pressure ulcers. Condition [...]

Sponsored by: Genentech. This is a multicenter, prospective, 5-year surveillance study of approximately 5000 Raptiva-treated patients and approximately 500 non-Raptiva treated patients (formerly 2500 comparison patients who were treated with [...]