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Rescooped by Dawn VanDam from Melanoma BRAF Inhibitors Review
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Bind Therapeutics R&D Accurins™ targeted therapies and nanomedicine

Bind Therapeutics R&D  Accurins™ targeted therapies and nanomedicine | Drug Safety | Scoop.it

Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload.

Prolonged circulation. We design Accurins with a stealth and protective layer that enables them to circulate within the bloodstream for a prolonged period of time, and accumulate at the diseased site before being cleared from the circulatory system.

Targeting. We design Accurins with specific pharmaceutical properties intended to target tumors at three levels: tissue, cellular and molecular. Tissue targeting is achieved by engineering the physical and chemical properties—size, shape and surface properties—of the Accurin to allow it to escape through gaps in the blood vessels surrounding tumors and other disease sites. Cellular targeting is achieved using proprietary targeting ligands on the surface of the Accurin that binds to specific cell surfaces or tissue markers. The specific characteristics of the therapeutic payload may enable molecular targeting within the diseased cells. The following diagram depicts the mechanisms of tissue targeting and cellular targeting.

Controlled and timely release. We design Accurins with specific polymers that provide for the controlled and timely release of the therapeutic payload. Upon administration, the therapeutic payload begins to diffuse through the polymeric matrix. Subsequently, the polymer breaks down to lactic acid, a compound naturally found in the body. If the therapeutic payload releases before the Accurins accumulate at the disease site, the Accurins will be unable to effectively increase drug concentration in the diseased tissue and the anticipated therapeutic impact will be minimized or lost. Similarly, if the therapeutic payload is not released, or releases too slowly, the anticipated therapeutic impact will be lost or minimized and new toxicities may be created. By combining prolonged circulation, triple targeting and controlled and timely release of the therapeutic payload, Accurins have the potential to significantly increase the net clinical benefit associated with the therapeutic payload and result in efficacy and safety currently not achievable through other therapeutic modalities.


Via Krishan Maggon
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Krishan Maggon 's curator insight, March 11, 2015 5:32 AM
 Develop Accurins in several therapeutic areas, with an initial focus on the treatment of various types of cancer. In addition, we have entered into collaboration agreements with several major biopharmaceutical companies Pfizer, Astra Zeneca, Merck to develop and commercialize Accurins that are based on our collaborators' proprietary therapeutic payloads. The following table depicts our proprietary and collaboration products in development: 
Proprietary Programs BIND-014
(PSMA-targeted docetaxel) Non-small cell lung cancer
Prostate cancer

 BIND-510
(PSMA-targeted vincristine)
Solid tumor Accurin
Hematologic cancer Accurin

 PLK1-, KSP-inhibitor Accurins
Multiple PLK1 oncology targets
Multiple KSP oncology targets

Krishan Maggon 's curator insight, March 11, 2015 5:37 AM

Develop Accurins in several therapeutic areas, with an initial focus on the treatment of various types of cancer. In addition, we have entered into collaboration agreements with several major biopharmaceutical companies Pfizer, Astra Zeneca, Merck to develop and commercialize Accurins that are based on our collaborators' proprietary therapeutic payloads. The following table depicts our proprietary and collaboration products in development: 
Proprietary Programs BIND-014
(PSMA-targeted docetaxel) Non-small cell lung cancer
Prostate cancer

 BIND-510
(PSMA-targeted vincristine)
Solid tumor Accurin
Hematologic cancer Accurin

 PLK1-, KSP-inhibitor Accurins
Multiple PLK1 oncology targets
Multiple KSP oncology targets

Rescooped by Dawn VanDam from Drugs, Society, Human Rights & Justice
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Drug Testing Policies and Problems | Drug Policy Alliance

Drug Testing Policies and Problems | Drug Policy Alliance | Drug Safety | Scoop.it
Drug testing policies are invasive and overused. They do nothing to increase safety and everything to deny drug users equal freedoms and opportunities.

Via Julian Buchanan
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Rescooped by Dawn VanDam from Top Selling Monoclonal Antibodies 2014
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Immune Pharmaceuticals R&D NanomAbs

Immune Pharmaceuticals R&D NanomAbs | Drug Safety | Scoop.it
Our focus is on personalized medicine and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer Technology Focus NanomAbs, nanoparticle monoclonal chemotherapy, are targeted nanoparticles that could improve cancer therapy outcomes by optimizing the efficacy-to-safety ratio of chemotherapeutics through targeted drug delivery of high payloads of cytotoxic …

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Krishan Maggon 's curator insight, March 12, 2015 4:08 AM

Immune’s proprietary NanoMabs platform is a conjugate of a monoclonal antibody to stealth polymeric nanoparticles incorporating mainstream chemotherapeutic drugs. The safety, improved efficacy and PK profile have been established in murine metastatic cancer models. The antibodies specifically target the nanoparticles to tumor cells and initiate binding to the cell surface. After binding, the tumor cells take up the nanoparticles and the chemotherapy is released / activated inside the cell through a controlled release.

 

The significant long-term potential for NanomAbs lies in the fact that this technology can work with many existing drugs to improve outcomes, including Paclitaxel, as well as novel chemotherapeutics. Since chemotherapy is extremely toxic to the body, any improvement in targeting could help dramatically improve patient outcomes by leaving the immune system in tact to continue fighting the disease.

 

NanomAbs hold a number of distinct advantages over current antibody drug conjugates (ADCs) such as the ability to deliver a larger payload of molecules, a wider array of compounds (e.g., chemotherapies, peptides, RNAi therapies) and controlled release of therapeutic agents.

Thus, NanomAbs mechanism of action enhances the efficacy of the chemotherapeutic agent and could lead to a reduction in off-target effects.

Rescooped by Dawn VanDam from Social Media, Mobile, Wearable News & Views
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Searching social networks to detect adverse reactions

Searching social networks to detect adverse reactions | Drug Safety | Scoop.it

Up to 90% of side effects to drugs are not reported, according to some estimates. “Adverse drug reactions (ADRs) are grossly under reported by everyone, including healthcare professionals, but particularly so by patients,” says David Lewis, head of global safety at Novartis, who is co-ordinating the involvement of pharmaceutical companies in a €2.3m three-year public-private project called Web-RADR (Recognising Adverse Drug Reactions).


Via Marie Ennis-O'Connor, Pharma Guy
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Marie Ennis-O'Connor's curator insight, March 16, 2015 8:37 AM

Ethical implications of data mining by pharma?

Pharma Guy's curator insight, March 17, 2015 8:27 AM


The use of smartphone technology and social media for gathering information on suspected adverse drug reactions (ADRs) is to be evaluated by a new European consortium.


WEB-RADR's founding members include pharma, academics and European medicines regulators like the UK's MHRA and it is funded through the Innovative Medicines Initiative - a partnership between the EC and EFPIA.


The three-year project's goals include developing a mobile app for healthcare professionals and the public to report suspected ADRs to national EU regulators and investigating the potential for publicly available social media data to be used for identifying potential drug safety issues.


WEB-RADR will also make a series of recommendations on how smartphone and social media should be used ethically and scientifically for international drug safety monitoring.

Rescooped by Dawn VanDam from Life Sciences Supply Chain
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U.S. Clears First Copycat Biotech Drug, Jolting Sector

U.S. Clears First Copycat Biotech Drug, Jolting Sector | Drug Safety | Scoop.it
The FDA approved its first “biosimilar” drug, a decision expected to launch a new industry of lower-cost versions of expensive drugs that could help the U.S. curb its $376 billion in yearly drug spending.

Via Cathy Roberson
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Rescooped by Dawn VanDam from Drug discovery and drug safety
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Improving computer modelling of cardiac properties by ditching the one-size-fits-all approach | NC3Rs

Improving computer modelling of cardiac properties by ditching the one-size-fits-all approach | NC3Rs | Drug Safety | Scoop.it
For the first time since the prize was launched in 2005, the highest accolade has gone to a PhD student, Mr Oliver Britton, working with Professor Blanca Rodriguez, at the University of Oxford.

Via Marc Pourrier
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E-cigarettes affect cells - Nature.com

E-cigarettes affect cells - Nature.com | Drug Safety | Scoop.it
Nature.com
E-cigarettes affect cells
Nature.com
The work is at a very early stage and therefore cannot establish that e-cigarettes can cause cancer in vitro, let alone in vivo.
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Fourteen from MSU honored by Society of Toxicology - MSUToday

Fourteen from MSU honored by Society of Toxicology - MSUToday | Drug Safety | Scoop.it
MSUToday Fourteen from MSU honored by Society of Toxicology MSUToday Several faculty members, alumni and students from the Michigan State University Department of Pharmacology and Toxicology were honored recently during the Society of Toxicology's...
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Health Canada starts posting drug-safety reviews - The Province

Health Canada starts posting drug-safety reviews - The Province | Drug Safety | Scoop.it
The Province Health Canada starts posting drug-safety reviews The Province TORONTO — Health Canada has begun posting summaries of drug safety reviews on its website with the goal of better informing the public about potential harm associated with...
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Better-informed consumers -- better drugs?

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Human testes respond differently to endocrine disrupting chemicals - News-Medical.net

Human testes respond differently to endocrine disrupting chemicals - News-Medical.net | Drug Safety | Scoop.it
Human testes respond differently to endocrine disrupting chemicals
News-Medical.net
They simulated normal testicular development in each of these species using a novel in vitro culture system called FeTA.
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Procellera technology enhances cell migration in in-vitro laboratory testing - News-Medical.net

Procellera technology enhances cell migration in in-vitro laboratory testing - News-Medical.net | Drug Safety | Scoop.it
Procellera technology enhances cell migration in in-vitro laboratory testing News-Medical.net Procellera® – the world's first wireless microcurrent generating dressing that produces electrical fields through its matrix of microcell batteries – was...
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Want info on how a CRO can help with preclinical imaging?

Want info on how a CRO can help with preclinical imaging? | Drug Safety | Scoop.it
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This picture shows scientists at work, analyzing images generated by a PET study.  Listen to these podcasts http://bit.ly/1bZ7zep and understand their extensive disease modeling and imaging experience and how it can bring robust, clinically translatable data to your next study, as well as enabling better decisions, trial design and lead selection. Find out more at www.molecularimaging.com

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What are the benefits of biodistribution imaging?

What are the benefits of biodistribution imaging? | Drug Safety | Scoop.it
Dawn VanDam's insight:

Listen to Dr. Patrick McConville of Molecular Imaging, Inc. and Dr. Maria Vosjan of BV Cyclotron VU http://bit.ly/17cNFZk to learn more about how PET, SPECT, and FMT studies can help you make the informed decisions to move your drug discovery study forward.  

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FDA Finally Requires Labeling Change for "Low-T" Drugs: Must Mention Risk of Stroke & Heart Attack

FDA Finally Requires Labeling Change for "Low-T" Drugs: Must Mention Risk of Stroke & Heart Attack | Drug Safety | Scoop.it

AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient


ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.


Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.


BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.


RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.


Via Pharma Guy
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Pharma Guy's curator insight, March 3, 2015 12:33 PM


This comes after the FDA issued a Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014. Read FDA Says Men Who Receive Drugs for "Low-T" Have 30% Increased Risk of Major Adverse Cardiovascular Events (http://bit.ly/1KdPpLw).


More worrisome is the fact that only about one-half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy.


It's good that the FDA "cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone."


But how is this information going to reach all the men out there who have been inappropriately prescribed these products?

Rescooped by Dawn VanDam from Melanoma BRAF Inhibitors Review
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Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma

Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma | Drug Safety | Scoop.it
Purpose Up to 50% of patients with uveal melanoma (UM) develop metastatic disease with limited treatment options. The immunomodulating agent ipilimumab has shown an overall survival (OS) benefit in patients with cutaneous metastatic melanoma in two phase III trials. As patients with UM were excluded in these studies, the Dermatologic Cooperative Oncology Group (DeCOG) conducted a phase II to assess the efficacy and safety of ipilimumab in patients with metastatic UM. Patients and Methods We undertook a multicenter phase II study in patients with different subtypes of metastatic melanoma. Here we present data on patients with metastatic UM (pretreated and treatment-naïve) who received up to four cycles of ipilimumab administered at a dose of 3 mg/kg in 3 week intervals. Tumor assessments were conducted at baseline, weeks 12, 24, 36 and 48 according to RECIST 1.1 criteria. Adverse events (AEs), including immune-related AEs were graded according to National Cancer Institute Common Toxicity Criteria (CTC) v.4.0. Primary endpoint was the OS rate at 12 months. Results Forty five pretreated (85%) and eight treatment-naïve (15%) patients received at least one dose of ipilimumab. 1-year and 2-year OS rates were 22% and 7%, respectively. Median OS was 6.8 months (95% CI 3.7–8.1), median progression-free survival 2.8 months (95% CI 2.5–2.9). The disease control rate at weeks 12 and 24 was 47% and 21%, respectively. Sixteen patients had stable disease (47%), none experienced partial or complete response. Treatment-related AEs were observed in 35 patients (66%), including 19 grade 3–4 events (36%). One drug-related death due to pancytopenia was observed. Conclusions Ipilimumab has very limited clinical activity in patients with metastatic UM. Toxicity was manageable when treated as per protocol-specific guidelines. Trial Registration ClinicalTrials.gov NCT01355120

Via Krishan Maggon
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Krishan Maggon 's curator insight, March 15, 2015 8:29 AM

Citation: Zimmer L, Vaubel J, Mohr P, Hauschild A, Utikal J, et al. (2015) Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma. PLoS ONE 10(3): e0118564. doi:10.1371/journal.pone.0118564

Rescooped by Dawn VanDam from Pharmaguy's Insights Into Drug Industry News
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FDA Updates Chantix Label to Include Potential Alcohol Interaction

FDA Updates Chantix Label to Include Potential Alcohol Interaction | Drug Safety | Scoop.it

AUDIENCE: Family Practice, Patient, Pulmonology


ISSUE: FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks. Refer to the Drug Safety Communication for a detailed data summary.


BACKGROUND: Chantix is a prescription medicine that is FDA-approved to help adults quit smoking.


RECOMMENDATION:  Healthcare professionals should weigh the potential risk of seizures against the potential benefits before prescribing Chantix in patients with a history of seizures or other factors that can lower the seizure threshold. Advise patients to immediately stop taking Chantix if they develop agitation, hostility, aggressive behavior, depressed mood, or changes in behavior or thinking that are not typical for them, or if they develop suicidal ideation or behavior.

Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.


Also refer to the Drug Safety Communication for more information for patients and healthcare professionals.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


Via Pharma Guy
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Pharma Guy's curator insight, March 10, 2015 6:41 AM


Meanwhile, it's long been reported that Chantix is "eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch." Read more about that here.

Rescooped by Dawn VanDam from Neurological Disorders
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For Dementia Patients, Behavioral Therapy May Outweigh Antipsychotic Drugs - NPR

For Dementia Patients, Behavioral Therapy May Outweigh Antipsychotic Drugs - NPR | Drug Safety | Scoop.it
Non-drug approaches for treating aggression and other symptoms of dementia work better than antipsychotic drugs, a study finds, and are less risky. That includes teaching caregivers how to respond.

Via George Huba
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How To Get People With Dementia To Take Pills - Medications - Alzheimer's

How To Get People With Dementia To Take Pills - Medications - Alzheimer's | Drug Safety | Scoop.it
How To Get People With Dementia To Take Pills

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Bladder Drug Re-Grows Myelin, Could Help Ease Multiple Sclerosis Symptoms

Bladder Drug Re-Grows Myelin, Could Help Ease Multiple Sclerosis Symptoms | Drug Safety | Scoop.it
An unlikely drug, already marketed to treat overactive bladder, has triggered the regrowth of myelin in mice.

Via Krishan Maggon , Marc Pourrier
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Krishan Maggon 's curator insight, March 10, 2015 6:25 AM

Vesicare (solifenacin) is marketed by Astellas, Teva, GSK for overactive bladder.


It is only a rodent study but since the same receptor blocks myelin regrowth, it may work in the clinic as well.

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ConsumerMedSafety.org - Prevent Medication Errors - Consumer Med Safety

ConsumerMedSafety.org - Prevent Medication Errors - Consumer Med Safety | Drug Safety | Scoop.it
If you or a loved one have experienced a mistake with a medication or have a safety concern to share with others, we would like to hear from you. Learn how reporting events can help others.
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Research and Markets: Global In-Vitro Toxicology/Toxicity Testing (Cell ... - Business Wire (press release)

Research and Markets: Global In-Vitro Toxicology/Toxicity Testing (Cell ... - Business Wire (press release) | Drug Safety | Scoop.it
Research and Markets: Global In-Vitro Toxicology/Toxicity Testing (Cell ...
Business Wire (press release)
The global market of in-vitro toxicology testing is subdivided into industry, technology, method, application and geography.
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Positive results from in vitro test for skin sensitisation - Chemical Watch (subscription)

Positive results from in vitro test for skin sensitisation - Chemical Watch (subscription) | Drug Safety | Scoop.it
Positive results from in vitro test for skin sensitisation Chemical Watch (subscription) Initial validation studies of an in vitro skin sensitisation assay suggest that it can correctly identify sensitisers, according to an international science...
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Global Market for in vitro and in silico Safety Testing Projected to Reach $9 ... - PR Newswire (press release)

Global Market for in vitro and in silico Safety Testing Projected to Reach $9 ...
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Want to know what Single Photon Emission Computed Tomography (SPECT) imaging is?

Want to know what Single Photon Emission Computed Tomography (SPECT) imaging is? | Drug Safety | Scoop.it
Dawn VanDam's insight:

It is a non-invasive, 3D imaging modality that can help provide illuminating images to help researchers make informed decisions regarding their drug discovery trials. Visit www.molecularimaging.com and watch this webinar at http://www.chacorporate.com/cha/Events/WEBINAR--Advancing-Discovery-and-Development-Through-Non-Invasive-Biodistribution-Imaging/sponsored by Molecular Imaging, Inc. and Cambridge Healthtech Associates™ (www.chacorporate.com) to learn more about what SPECT can do for you.  This photo is a visualization of 99m Tc-MDP uptake in regions of bone turnover. 

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Take a look this image of FMT-based tumor tracking.

Take a look this image of FMT-based tumor tracking. | Drug Safety | Scoop.it
Dawn VanDam's insight:

With Fluorescence Molecular Tomography (FMT), you can get informative images to support decision-making in preclinical drug studies.  Learn more about the relevance of biodistribution preclinical imaging by listening to a couple of podcasts: http://bit.ly/1bZ7zep and at www.molecularimaging.com.

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