Laboratorios Wachoski
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Laboratorios Wachoski
Industria farmaceutica, biotecnologica, inmunologia y divulgacion sanitaria en general
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Could Humira (adalimumab, ABBVie) the World's Top-Selling Drug Be Toppled ? - Nasdaq

Could Humira (adalimumab, ABBVie) the World's Top-Selling Drug Be Toppled ? - Nasdaq | Laboratorios Wachoski | Scoop.it
“ You might not have heard it, but a warning shot was just fired over the bow of the world's biggest-selling drug. AbbVie 's Humira generated sales of.”
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FDA allows marketing of non-invasive device to help evaluate heart blood flow. HeartFlow FFRCT

FDA allows marketing of non-invasive device to help evaluate heart blood flow. HeartFlow FFRCT | Laboratorios Wachoski | Scoop.it
Welcome to HeartFlow, recipient of the 2011 EuroPCR Innovation award. Read to learn about non-invasive FFRCT (computed FFR), DISCOVER-FLOW and DeFACTO studies. The U.S. Food and Drug Administration today allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease. Coronary artery disease, also called coronary heart disease, is the leading cause of death for both men and women in the United States. It occurs when one or more of the major arteries on the surface of the heart become narrow or blocked, reducing blood flow that supplies the heart muscle with oxygen-rich blood. Coronary artery disease can lead to chest pain (angina), heart attack, heart failure and death. One piece of clinical information health care professionals use to determine the extent of a blockage in the heart or a coronary artery is a value called fractional flow reserve (FFR). Obtaining this value requires an invasive procedure called cardiac catheterization. The HeartFlow FFR-CT software can non-invasively provide an estimate of FFR using data from a computed tomography (CT) scan of the patient’s heart. The health care professional uses the estimate, along with other clinical patient data, to determine the likelihood that the actual FFR is below accepted limits and whether or not a more accurate FFR assessment using cardiac catheterization is necessary.
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Krishan Maggon 's curator insight, November 28, 2014 1:50 AM

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424945.htm

 

The HeartFlow FFR-CT software is housed at HeartFlow, Inc.’s headquarters in Redwood City, California. A health care professional electronically sends the patient’s CT scan data to HeartFlow, Inc. where a case analyst creates 3D computer models of different sections of the patient’s heart and runs a blood flow simulator program on the models. After analyzing the data and the models, the case analyst electronically sends a report with the estimated FFR values (called FFR-CT values) displayed as color images of the patient’s heart.  

The FDA reviewed the data for HeartFlow FFR-CT through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

Data submitted to support the safety and effectiveness of HeartFlow FFR-CT included clinical studies that compared FFR-CT measurements to FFR values directly measured by cardiac catheterization on subjects with suspected coronary artery disease who were therefore referred for catheterization and FFR. The results showed that Heart Flow FFR-CT was able to correctly identify 84 percent of the significant blockages identified by FFR as requiring intervention, and 86 percent of blockages identified by FFR as not requiring intervention. The company also submitted data and information showing how they have mitigated risks associated with the device, such as controlling for erroneous calculations that can lead to delayed or improper treatment.

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ThyssenKrupp, Germany, unveils the revolutionary multi-directional elevator concept

ThyssenKrupp, Germany, unveils the revolutionary multi-directional elevator concept | Laboratorios Wachoski | Scoop.it
Elevator design hasn't progressed very much during the past 160 years, and still comprises cabins which move vertically in a shaft supported by cables. This is inefficient and limiting, taking up a relatively large footprint and requiring people to wait a long time for the next lift. However, German conglomerate ThyssenKrupp has unveiled a revolutionary Willy Wonka-style elevator concept that allows several cabins to move both horizontally and vertically in the same elevator shaft, at the same time.Dubbed the "Multi", ThyssenKrupp's elevator concept is cited by the firm as the world's first cable-free elevator. We're not sure about this, as electromagnetic specialist MagneMotion may have got there first. Still, ThyssenKrupp's system looks far more involved than simply doing away with cables, and it poses potential implications for the future design of tall buildings. The Multi is propelled by a magnet-based drive that uses the same technology behind Shanghai's super-fast Maglev train, which was built by Transrapid International, a joint venture of Siemens and ThyssenKrupp. Each elevator will feature one motor for horizontal and vertical movement, and rather than a single shaft, a skyscraper featuring the Multi would sport a complex system of shafts that could offer passengers access to an elevator every 15 to 30 seconds.ThyssenKrupp says that because the Multi requires smaller shafts than typical elevators, it could increase a building's usable area by up to 25 percent. It's lighter too, and the use of lightweight materials for cabins and doors slims the Multi down to around 50 percent of a typical elevator's weight. The firm says that a 300 m (984 ft)-tall building would be the ideal starting height for the technology.
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Enrico De Angelis's curator insight, November 30, 2014 5:18 AM

Innovation starts, often, from dreams. Cinema often comes before technology: http://en.wikipedia.org/wiki/Charlie_and_the_Chocolate_Factory_%28film%29

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EMA/EC approve Signifor®(pasireotide, Novartis) for acromegaly

EMA/EC approve Signifor®(pasireotide,  Novartis) for acromegaly | Laboratorios Wachoski | Scoop.it
Novartis announced today that the European Commission has approved Signifor® (pasireotide) as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA). Next-generation SSA Signifor offers the first alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs. The approval is based on data from two multicenter Phase III studies, C2402 and C2305, which respectively evaluated patients with inadequately controlled acromegaly on first-generation SSAs, and medically naïve patients who were post-surgery, or newly diagnosed patients for whom surgery is contraindicated. Both studies showed Signifor to have superior efficacy in providing biochemical control, as measured by both GH and IGF-1 levels, compared to a first-generation SSA[5]. About study C2402 The Phase III multicenter, randomized, three-arm, parallel-group study C2402 evaluated the efficacy and safety of double-blind Signifor intramuscular injection 40 mg and 60 mg versus maximal doses of Sandostatin LAR or Somatuline Autogel* in patients with inadequately controlled acromegaly treated for at least 6 months with first-generation SSAs. The primary efficacy objective was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 Mu g/L and normalization of sex- and age-adjusted IGF-1) with Signifor 40 and 60 mg separately, versus active control represented by Sandostatin LAR and Somatuline Autogel. The primary endpoint was met in both Signifor dose groups with 15.4% (P=.0006) and 20.0% (P<.0001) of patients receiving Signifor 40 mg and 60 mg achieving biochemical control, respectively, compared with zero in the active control arm. In patients treated with Signifor in whom reductions in GH and IGF-1 were observed, these changes occurred during the first 3 months of treatment and were maintained at week 24[5]. Additionally, 24.6% (P<.0001) and 26.2% (P<.0001) of patients receiving Signifor 40 mg and 60 mg achieved normalization of IGF-1, respectively, compared with zero in the active control arm; 35.4% and 43.1% of patients receiving Signifor 40 mg and 60 mg achieved GH levels <2.5 Mu g/l, respectively, compared with 13.2% in the active control arm. A higher proportion of patients on Signifor (18.5% and 10.8% for 40 and 60 mg, respectively) achieved a reduction in tumor volume of at least 25% versus 1.5% on active control[5]. The most common adverse reactions observed (frequency >=20%) in either of the Signifor arms were hyperglycemia and diabetes mellitus. Common Toxicity Criteria (CTC) Grade 3 and 4 adverse reactions were mostly related to hyperglycemia[5]. About study C2305 In the Phase III multicenter, randomized and blinded study, medically naïve patients with active acromegaly received either Signifor intramuscular injection (starting dose of 40 mg with possibility to up titrate to 60 mg) or Sandostatin LAR (starting dose of 20 mg with possibility to up titrate to 30 mg) for 12 months. Medically naïve patients enrolled in the trial included those who were post-surgery, or newly diagnosed patients for whom surgery was contraindicated. The primary endpoint was met, showing superiority of Signifor over Sandostatin LAR in providing biochemical control, as defined by the proportion of patients with a reduction of mean GH level to <2.5 Mu g/l and the normalization of IGF-1 to within normal limits. Specifically, 31.3% and 19.2% of patients achieved biochemical control on Signifor and Sandostatin LAR, respectively, demonstrating a statistically significant superior result that favored Signifor (P=.007). In addition, 80.8% of patients achieved a tumor volume reduction greater than 20% with Signifor compared with 77.4% with Sandostatin LAR[5]. The most common adverse reactions observed (frequency >=20%) with Signifor were diarrhea, cholelithiasis, hyperglycemia and diabetes mellitus. Common Toxicity Criteria (CTC) Grade 3 and 4 adverse reactions were mostly related to hyperglycemia[5]. About acromegaly Worldwide, the prevalence of acromegaly is estimated to be 60 cases per million, with an annual incidence of 3 to 4 new cases per million[3]. However, recent studies suggest that pituitary adenomas may be more prevalent than previously thought, and that the prevalence of acromegaly may be between 115 and 295 cases per million globally[10]. Acromegaly most commonly presents in middle-aged men and women[3]. This debilitating disease can be difficult to detect because it can develop gradually and/or individual symptoms may be mistaken for another medical condition, with the average delay from disease onset to diagnosis between 6 to 10 years[3],[10],[11]. Acromegaly is also associated with two- to three-fold increased mortality rates and serious health complications, including heart disease, hypertension, diabetes, arthritis and colon cancer[1],[3],[4]. In fact, heart disease is responsible for approximately 60% of deaths among people with acromegaly[12].
Via Krishan Maggon
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Krishan Maggon 's curator insight, November 24, 2014 2:59 AM

Image  Acromegaly therapy  from NLM/NIH

 

 

Acromegaly is a rare pituitary disorder, which requires normalization of hormonal levels to help prevent the serious consequences of the disease[1],[2],[3],[4]Approval based on two large phase III trials showing superior efficacy of new formulation of Signifor over current SSAs in patients with acromegaly[5]Additional regulatory filings of this new long acting release formulation of Signifor currently under review by health authorities worldwide The EU approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in September 2014 for Signifor for the treatment of acromegaly and applies to all 27 EU member states, plus Iceland and Norway[7]. Additional regulatory applications for the new long acting release formulation of Signifor have been filed worldwide for the treatment of acromegaly, including an application currently filed in the United States. In the EU, Signifor has orphan drug designation for acromegaly[8]. Orphan drugs are those that treat a condition which affects no more than five in 10,000 people in the EU[9].

About Signifor
Signifor® (pasireotide) intramuscular injection is now approved in the EU to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA).

Signifor is available for patients with acromegaly through carefully controlled and monitored clinical trials which are designed to better understand the potential benefits and risks of the compound. For various reasons, including the uncertainty of clinical trials, there is no guarantee that Signifor will become commercially available for acromegaly or any other indication anywhere else in the world.

 

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AstraZeneca developing anticlotting reversal mab for heart drug Brilinta

AstraZeneca developing anticlotting reversal mab for heart drug Brilinta | Laboratorios Wachoski | Scoop.it
“ * Antibody to reverse blood-thinning effect in emergencies* Currently no products to reverse anti-platelet drugs* Move may give Brilinta an edge in competitive market (Adds more detail on Brilinta”
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Krishan Maggon 's curator insight, November 15, 2014 1:28 AM

Currently there are  no antidotes to reverse anticlotting agents during emergency or surgery in patients. Development of such a mab will help struggling Brilinta to gain market share vs generic Plavix and currently approved anticlotting agents.

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Brodalumab (Amgen, Astra Zeneca) tops Stelara (ustekinumab, J&J) in Phase III psoriasis trial

Brodalumab (Amgen, Astra Zeneca) tops Stelara (ustekinumab, J&J) in Phase III psoriasis trial | Laboratorios Wachoski | Scoop.it
THOUSAND OAKS, Calif. and LONDON, Nov. 11, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) andAstraZeneca (NYSE: AZN) today announced that AMAGINE-3TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab was shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1). All key secondary endpoints comparing brodalumab with Stelara and placebo were also met. Results showed that 36.7 percent of patients in the brodalumab 210 mg group, 27.0 percent of patients in the brodalumab 140 mg group, 18.5 percent of patients in the Stelara group and 0.3 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100). In addition, 85.1 percent of patients in the brodalumab 210 mg group, 69.2 percent of patients in the brodalumab 140 mg group, 69.3 percent of patients in the Stelara group and 6.0 percent of patients in the placebo group achieved PASI 75.
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Krishan Maggon 's curator insight, November 12, 2014 7:23 AM
Brodalumab Meets All Primary and All Key Secondary EndpointsMeets Primary Endpoint of Superiority to Stelara® (ustekinumab) in Achieving Total Skin Clearance (PASI 100)Meets Co-Primary Endpoints Against Placebo
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Novartis landmark Phase III data for secukinumab in psoriatic arthritis and ankylosing spondylitis at ACR 2014

Novartis  landmark Phase III data for secukinumab in psoriatic arthritis and ankylosing spondylitis at ACR 2014 | Laboratorios Wachoski | Scoop.it

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Krishan Maggon 's curator insight, November 13, 2014 7:21 AM
Detailed results of four pivotal Phase III studies of secukinumab in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) to be presented for the first time at ACR 2014Secukinumab is the first selective interleukin-17A (IL-17A) inhibitor with Phase III data to demonstrate efficacy and improve symptoms in patients with PsA and ASData will include study results from FUTURE 1 and FUTURE 2 in PsA and MEASURE 1 and MEASURE 2 in AS; data to be presented include joint structural damage progression in PsA and symptoms, quality of life/physical function in PsA and ASPsA and AS are part of a family of long-term diseases impacting joints, known as spondyloarthritis (SpA); high unmet treatment need exists for patients living with SpA[1]
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Neutrino history, what's NEXT? -- ¿Neutrinos?

Neutrino history, what's NEXT? -- ¿Neutrinos? | Laboratorios Wachoski | Scoop.it
“Esta es algo que he tenido muchas ganas de escribir desde hace un tiempo pero que nunca he hecho. Pero, cosas de la vida, ha salido el siguiente artículo: The NEXT experiment Este artículo present...”
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pH-dependent antigen-binding antibodies as a novel therapeutic modality

pH-dependent antigen-binding antibodies as a novel therapeutic modality | Laboratorios Wachoski | Scoop.it
Highlights •pH-dependent antigen-binding antibody is a novel antibody engineering. •It dissociates the antigen in endosome and binds to the antigen multiple times. •It can be generated by histidine engineering, immunization and phage display. •Its efficiency can be further improved by increasing binding to the Fc receptors. •It can overcome the limitation of conventional therapeutic antibodies. AbstractMonoclonal antibodies have become a general modality in therapeutic development. However, even with infinite binding affinity to an antigen, a conventional antibody is limited in that it can bind to the antigen only once, and this results in antigen-mediated antibody clearance when the a membrane-bound antigen is targeted, or in antibody-mediated antigen accumulation when a soluble antigen is targeted. Recently, a pH-dependent antigen-binding antibody that binds to an antigen in plasma at neutral pH and dissociates from the antigen in endosome at acidic pH has been reported to overcome this limitation and to reduce antigen-mediated antibody clearance and antibody-mediated antigen accumulation. A pH-dependent binding antibody against a soluble antigen can be further improved by Fc engineering to enhance the Fc receptor binding. Various approaches, including histidine-based engineering, direct cloning from immunized animals, and synthetic and combinatorial libraries, have been successfully applied to generate pH-dependent binding antibodies against various antigens. This review discusses the features, approaches, advantages, and challenges of developing a pH-dependent binding antibody as a novel therapeutic modality. This article is part of a Special Issue entitled: Recent advances in molecular engineering of antibody.
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Krishan Maggon 's curator insight, November 11, 2014 7:23 AM
Biochimica et Biophysica Acta (BBA) - Proteins and Proteomics

Volume 1844, Issue 11, November 2014, Pages 1943–1950

Recent advances in molecular engineering of antibody

Review pH-dependent antigen-binding antibodies as a novel therapeutic modality ☆T. Igawa, , F. Mimoto, K. Hattori  DOI: 10.1016/j.bbapap.2014.08.003
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Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Asthma - MarketWatch

Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Asthma.
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Skin disease drug finally wins approval

“ A synthetic hormone developed years ago at the UA can now be marketed in Europe, and U.S. approval will be sought next.”
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Is there still value in the biotech boom? - Investors Chronicle

Is there still value in the biotech boom? - Investors Chronicle | Laboratorios Wachoski | Scoop.it
“ The biotech boom of the early 2000s left investors with their fingers burnt and a lack of positive sentiment has plagued the sector ever since.”
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Bleeding risk from new blood thinner Pradaxa higher than first reported

Bleeding risk from new blood thinner Pradaxa higher than first reported | Laboratorios Wachoski | Scoop.it
“ The FDA’s approval in 2010 of the blood-thinner dabigatran (Pradaxa) got many doctors excited. This drug got the green light after a head-to-head trial with warfarin (generic, Coumadin) in people with an irregular heart beat from atrial fibrillation.” ABSTRACT Importance It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice. Objective To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data. Design, Setting, and Participants In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011. Exposures Dabigatran users (n = 1302) and warfarin users (n = 8102). Main Outcomes and Measures We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities. Results Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease. Conclusions and Relevance Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.
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Krishan Maggon 's curator insight, November 6, 2014 3:11 AM
Original Investigation | November 03, 2014Risk of Bleeding With Dabigatran in Atrial FibrillationONLINE FIRSTInmaculada Hernandez, PharmD1; Seo Hyon Baik, PhD1; Antonio Piñera, MD2; Yuting Zhang, PhD1[+] Author AffiliationsJAMA Intern Med. Published online November 03, 2014. doi:10.1001/jamainternmed.2014.5398Text Siz
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20 years after initiating preventive tamoxifen, less breast cancer but no survival benefit

20 years after initiating preventive tamoxifen, less breast cancer but no survival benefit | Laboratorios Wachoski | Scoop.it
"Five years of tamoxifen provided 20 years of breast cancer prevention to some at-risk women who took it prophylactically.However, their 20-year all-cause mortality was no different from those taking placebo (182 vs. 166 deaths), nor was their mortality from breast cancer (31 vs. 26, respectively), Jack Cuzick, Ph.D., said at the San Antonio Breast Cancer Symposium.“While we saw clear, lasting benefits of tamoxifen in reducing breast cancer incidence, uncertainty with respect to mortality remains,” said Dr. Cuzick, the John Snow professor of epidemiology at Wolfson Institute of Preventive Medicine at Queen Mary University, London.He suggested that, in light of the small number of deaths, the study was not sufficiently powered to detect any significant survival difference. But women in the IBIS-1 trial will continue to be observed, and future analyses could clarify the issue, he added.“Although 20 years seems like a long follow-up time, it is actually too early to make any clear statement about mortality,” he said. “However, we are concerned about an excess emergence of ER-negative tumors, which we saw after 10 years.”The study was simultaneously published on Dec. 13 in Lancet Oncology"
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Brodalumab (Amgen, Astra Zeneca) Excels in AMAGINE-2 Phase III Psoriasis trial

Brodalumab (Amgen, Astra Zeneca) Excels in AMAGINE-2 Phase III Psoriasis trial | Laboratorios Wachoski | Scoop.it
THOUSAND OAKS, Calif. and LONDON, Nov. 25, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) andAstraZeneca (NYSE: AZN) today announced that AMAGINE-2TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab 210 mg given every two weeks and the brodalumab weight-based analysis group were each shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1). Results showed that 44.4 percent of patients in the brodalumab 210 mg group, 33.6 percent of patients in the brodalumab weight-based group, 25.7 percent of patients in the brodalumab 140 mg group, 21.7 percent of patients in the Stelara group and 0.6 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100). In addition, 86.3 percent of patients in the brodalumab 210 mg group, 77.0 percent of patients in the brodalumab weight-based group, 66.6 percent of patients in the brodalumab 140 mg group, 70.0 percent of patients in the Stelara group and 8.1 percent of patients in the placebo group achieved PASI 75. All key secondary endpoints comparing brodalumab with placebo were met. The first key secondary endpoint comparing PASI 100 for brodalumab (140 mg) with Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints against Stelara were also numerically greater (all nominal p-values were less than 0.05), but could not be deemed statistically significant due to the sequential testing method. The most common adverse events that occurred in the brodalumab groups (more than 5 percent of patients in either group) were common cold, upper respiratory tract infection, headache and joint pain. Serious adverse events occurred in 1.0 percent of patients in the 210 mg group, 1.2 percent of patients in the weight-based group, and 2.1 percent of patients in the 140 mg group compared with 1.3 percent for Stelara and 2.6 percent for placebo during the placebo-controlled period. There was one (0.2 percent) fatal event of stroke in the brodalumab 210 mg group during the 12-week placebo-controlled induction phase, deemed by the study investigator as unrelated to treatment. Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestations of plaque psoriasis.
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Krishan Maggon 's curator insight, November 27, 2014 12:16 PM


PASI 100    Brodalumab  44%Stelara      22%
Study Met All Primary Endpoints Against Stelara® (ustekinumab) and PlaceboThree Pivotal Studies Form the Basis for Global Regulatory Filings, Planned In 2015

About Brodalumab (AMG 827)
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.5 In addition to moderate-to-severe plaque psoriasis (Phase 3), brodalumab is currently being investigated for the treatment of psoriatic arthritis (Phase 3) and asthma (Phase 2).

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Medicinal Engineering® Platform. Bind Therapeutics

Medicinal Engineering® Platform. Bind Therapeutics | Laboratorios Wachoski | Scoop.it
We create Accurins using a proprietary Medicinal Nanoengineering platform that enables predictable, rapid design and optimization of targeted therapeutics with precisely controlled pharmacokinetic and biodistribution properties. We apply this platform to develop highly selective targeted therapeutics with unprecedented efficacy and tolerability. The Medicinal Nanoengineering platform has demonstrated proof of concept across a broad range of API classes and therapeutic areas. Preclinical studies validate the ability of our technology to improve the therapeutic index of cytotoxic agents, molecularly targeted anticancer drugs, and therapies for treating inflammation and pain. We manufacture candidate Accurins using a readily-scalable, self-assembly nanoemulsion process with well-defined, robust unit operations. This highly specialized and precisely controlled manufacturing process enables us to reproducibly manufacture Accurins across many scales, from gram-scale at the laboratory bench to hundreds of grams for IND-enabling toxicology studies to the multi-kilogram scale for clinical batches.Accurins: Engineered for Optimal TargetingOur technology incorporates a therapeutic payload into a nanoparticle and achieves targeting through the combined effects of tissue and cellular targeting.
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Krishan Maggon 's curator insight, November 30, 2014 8:08 AM

Tissue Targeting (Passive/Biophysical Targeting): We engineer biophysical properties of the nanoparticles to avoid immune surveillance and escape through gaps in blood vessels surrounding tumors and other disease sites.

Cellular Targeting (Active/Ligand-Directed, Receptor-Mediated Binding): We attach a targeting ligand on the surface of the nanoparticle to bind to specific cell-surface or tissue markers.

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FDA Grants 70 Breakthrough Therapy Drugs out of 200 requests in 2 years

FDA Grants 70 Breakthrough Therapy Drugs out of 200 requests in 2 years | Laboratorios Wachoski | Scoop.it
The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner, according to Janet Woodcock, director of the CDER The breakthrough drug program, which was established by the FDA Safety & Innovation Act of 2012 (FDASIA), should encourage legislative action. Not only is it a boon for industry and for patients, but it has brought about a change in culture at FDA, Woodcock commented. The importance attached to streamlining research and review of highly effective treatments, she noted, sends a signal to review staff that health promotion is equally important as ensuring safety. An internal analysis indicates that FDA grants the breakthrough designation to only one-third of requests. The magnitude of clinical effect for a new treatment is the main factor in gaining breakthrough status, and is seen clearly in new compounds that achieve a 50% reduced risk of disease progression in clinical trials. Targeted therapies with some genetic component are more likely to be designated; denials occur most often for drugs demonstrating limited efficacy, tested in very few patients, or containing flaws in trial design. The program’s success, though, means considerable work for FDA. CDER and the Center for Biologics Evaluation and Research (CBER) have vetted more than 200 requests for designation since January 2013 and have granted nearly 70, a process that involves dozens of meetings with sponsors and within the agency. Woodcock noted a high level of concurrence between CDER review divisions and the agency’s Medical Policy Council, which oversees the designation process. New breakthroughs get “focused attention” from FDA on development programs, which may lead to streamlined clinical trial designs or use of innovative statistical methods. Equally important is assistance in accelerating the manufacturing process and scheduling timely plant inspections for a drug likely to come to market much faster than expected. Drug quality reviewers in CDER work with manufacturers to clarify clinically relevant specifications and to determine what quality testing can occur post-approval. .
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Krishan Maggon 's curator insight, November 24, 2014 7:48 AM

The success of the BTD  has attracted lot of attention to give give FDA more resources to implement and extend the BTP.

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Ektomun® Mode of Action: Lindis Biotech

Ektomun® Mode of Action: Lindis Biotech | Laboratorios Wachoski | Scoop.it
Ektomun® is a member of the highly innovative, validated family of Triomab® antibodies. It combines the halves of two distinct full-size antibodies, a GD2-specific mouse antibody and a T -cell specific rat antibody, in one molecule. GD2 is a clinically validated tumor target opening many potential applications for ektomun®. It is broadly present in tumors of neuroectodermal origin, including small cell lung cancer (SCLC), melanoma, neuroblastoma and glioblastoma. In healthy tissues, however, GD2 expression is strictly limited to very few, distinct cell types. Due to its trifunctional design, ektomun® can simultaneously bind to GD2, expressed by tumor cells, to a T-cell and, via its Fc-region, to an accessory cell of the innate immune system, as e.g. macrophages, dendritic or NK cells. The resulting tri-cell-complex triggers multiple immune mechanisms at the same time. Not only are tumor cells specifically and potently destroyed, but a long-lasting anti-tumor immunity is also induced – an effect that can otherwise only be achieved through vaccination.
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New Cholesterol Drug Evolocumab Carries Great Promise

New Cholesterol Drug Evolocumab Carries Great Promise | Laboratorios Wachoski | Scoop.it
“ New cholesterol medication evolocumab looks promising in clinical trials.”
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A deep look at synaptic dynamics : Nature : Nature Publishing Group

A deep look at synaptic dynamics : Nature : Nature Publishing Group | Laboratorios Wachoski | Scoop.it
“ The processes behind neuronal communication have not yet been resolved in detail, but dyes, microscopy and protein analysis are beginning to fill in the gaps” What neuroscientists need, says Kavalali, is high-resolution images of living neurons stimulated to release neurotransmitters. He thinks highly of flash-and-freeze electron microscopy and has high hopes for super-resolution microscopy. These techniques will help researchers to map the synapse and track the events that occur before, during and after neurotransmitter release, and perhaps even to determine which hypothesis is the most accurate..
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Krishan Maggon 's curator insight, November 13, 2014 2:57 PM
A deep look at synaptic dynamicsVivien MarxNature 515, 293–297 (13 November 2014) doi:10.1038/515293aPublished online 12 November 2014The processes behind neuronal communication have not yet been resolved in detail, but dyes, microscopy and protein analysis are beginning to fill in the gaps.
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Closing The Gap For Generic Nanomedicines. CEN

Closing The Gap For Generic Nanomedicines. CEN | Laboratorios Wachoski | Scoop.it
FDA authorized the temporary importation of an Indian Doxil copycat called Lipodox in February 2012. In keeping with theexecutive order, the agency evaluated and approved the drug formulation within a year, roughly one-third of the time it takes for an average generic medicine to receive approval. Doxorubicin hydrochloride liposome injection—still widely, but unofficially, referred to as Lipodox—became what many consider to be the first generic nanodrug approved in the U.S. Copaxone is a jumble of amino acids and polymers thatTeva Pharmaceutical Industries developed as a nanomedicine for relapsing-remitting multiple sclerosis. Copaxone brought in more than $4 billion last year. Although all of its patents have expired, there is no generic version of it.
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Dupilumab (Sanofi, Regeneron) effective in Phase II asthma trial

Key results included: • In the high eosinophils patient group: Mean improvements from baseline in FEV1 (and mean percent change in FEV1) at 12 weeks, the primary (and a secondary) endpoint of the study were: 390ml (26 percent) dupilumab 300mg every other week (Q2W); 430 ml (26 percent) dupilumab 200 mg Q2W; 180 ml (10 percent) placebo. (p less than 0.01) • In the overall population: Mean improvements from baseline in FEV1 at 12 weeks (and mean percent change in FEV1) were: 280 ml (18 percent) dupilumab 300mg Q2W; 310 ml (18 percent) dupilumab 200 mg Q2W; 120 ml (6 percent) placebo. (p less than 0.001) • In both the high eosinophils patient group and overall patient group: Dupilumab showed a reduction in adjusted annualized rate of severe exacerbations compared to placebo (64 to 75 percent reduction, p less than 0.05 for high eosinophils group and p less than 0.01 for the overall population). • These results were based on a pre-specified interim analysis, which occurred when all patients had reached Week 12 of the 24-week treatment period; the average treatment duration at the time of the analysis was 21.5 weeks. The final analyses on exacerbations and safety will occur at 24 weeks.
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KaloBios (KB001-A) Humaneered® high-affinity, PEGylated Fab’ antibody Pseudomonas aeruginosa

KaloBios (KB001-A) Humaneered® high-affinity, PEGylated Fab’ antibody Pseudomonas aeruginosa | Laboratorios Wachoski | Scoop.it
KB001-A is a Humaneered® high-affinity, PEGylated Fab’ antibody for the prevention and treatment of Pa infections. Initial studies have focused on cystic fibrosis patients with Pa lung infections and mechanically ventilated patients colonized with Pa. A Phase 2 clinical trial in cystic fibrosis (CF) patients with chronic Pa lung infection is currently ongoing. KaloBios has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency for KB001-A for the treatment of Pa lung infection in CF patients. Cystic fibrosis is a disease with a vicious cycle. Patients with cystic fibrosis often cannot clear mucus from their lungs, leading to obstruction of the airways, infection, inflammation, and further mucus build-up. KB001-A could break this cycle given its dual anti-infective and anti-inflammatory effect. KB001-A is a Humaneered®, high-affinity, PEGylated Fab' antibody designed to block Pa from causing harm to host cells, thus preserving immune and lung epithelial cell function. KB001-A blocks an extracellular component of the type III secretion system (TTSS) which enables bacteria to kill immune cells by direct puncture (oncosis) or injection of protein toxins. Blocking the TTSS is intended to prevent immune cells from being killed and reduce inflammatory cytokine release. Unlike with antibiotics, the only current treatment for Pa, bacteria are not likely to develop resistance to KB001-A because loss of the KB001-A target leads to a loss in Pa pathogenicity. KB001-A also has potential in the reduction of Pa ventilator-associated pneumonia. A Phase 1/2 clinical trial with the precursor molecule, KB001 was completed and showed a greater trend toward lower Pa pneumonia adverse events and an increase in Pa-event free survival. KB001-A has U.S. FDA Fast Track Designation for the prevention of mechanical ventilator-associated pneumonia caused by Pa.
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Krishan Maggon 's curator insight, November 12, 2014 4:18 AM

KaloBios’ patented proprietary Humaneered® technology platform is designed to address problems of therapeutic antibodies (e.g., specificity, affinity, immunogenicity etc.), as well as equally important downstream processing issues (e.g., solubility, expression, aggregation, etc.). The process is fast and produces antibodies close to human germ-line in sequence while retaining the specificity and improving the affinity of the reference antibody. Humaneered® antibodies have now been tested clinically and to date no anti-drug antibodies have been detected even after dosing healthy human volunteers.

 

Engineered humanLow/No immunogenicityEqual or higher affinity than starting antibodyFastSolves antibody problems:AggregationStabilityExpression level (in both mammalian and microbial systems)Binding kinetics (select for Ka vs. Kd)

This novel system allows a true alternative to classic antibody engineering technologies, bringing a cost advantage to our pipeline as well as the opportunity to provide service to others.

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A vaccine directed against tumor blood vessels suppress tumor growth and metastasis

“ In a new study published in the scientific journal Oncotarget researchers from Uppsala University show that a therapeutic vaccine directed against tumor vessels can reduce tumor burden and suppress formation of spontaneous lung metastases in a...”
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Seattle Genetics to Present Clinical Data from Broad ADCETRIS® (Brentuximab ... - MarketWatch

Seattle Genetics to Present Clinical Data from Broad ADCETRIS® (Brentuximab ... - MarketWatch | Laboratorios Wachoski | Scoop.it
Seattle Genetics to Present Clinical Data from Broad ADCETRIS® (Brentuximab ... MarketWatch multiple abstracts will be presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Francisco, California, December 6-9, 2014, highlighting the following: An oral presentation of phase 3 AETHERA clinical trial results for ADCETRIS (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma (HL) patients at risk of relapse;Multiple presentations of ADCETRIS data in CD30-positive lymphomas, including frontline, salvage and relapsed HL, as well as diffuse large B-cell lymphoma (DLBCL) and cutaneous T-cell lymphoma (CTCL);First interim clinical data for SGN-CD33A in acute myeloid leukemia (AML) to be presented in an oral session;Updated phase 1 clinical data to be presented for SGN-CD19A in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL); andAdditional results from the phase 2 ROMULUS study assessing two ADC candidates that utilize Seattle Genetics’ proprietary technology being developed by Genentech, polatuzumab vedotin and pinatuzumab vedotin (ADCs targeting CD79b and CD22, respectively).
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