Pfizer's Xeljanz matches immunosuppressant combo in rheumatoid arthritis study

fiercepharma | June 13, 2019

Pfizer’s troubled JAK inhibitor Xeljanz has had its share of hiccups after pulmonary embolism fears derailed the drug’s higher dose in rheumatoid arthritis. Now, Pfizer is hoping for better results using Xeljanz to treat RA patients who wean off immunosuppressants. Patients treated with a solo Xeljanz dose after 24 weeks of combo therapy with Xeljanz and anti-rheumatic methotrexate showed roughly the same disease activity at 48 weeks as patients who stayed on the immunosuppressant, Pfizer said. Those findings are part of a late-breaking data set from a double-blind phase 3/4 trial set to be presented Saturday at the European Congress of Rheumatology (EULAR) meeting in Madrid. The drugmaker touted the data as the first of its kind to show noninferiority for a solo JAK inhibitor in RA after withdrawal from methotrexate, a powerful oral immunosuppressant often used in cancer treatment. “From a clinical perspective, these results give physicians data to help inform the decision to take appropriate patients off methotrexate,” Stanley Cohen, of Dallas’ Metroplex Clinical Research Center, said.

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Harbisson is one of many patients reaping the benefits of increased connectivity in the healthcare industry. Connected medical device—such as pacemakers and insulin pumps that communicate with other networks and devices over the Internet—provide patients and physicians with technology to better manage chronic conditions, improve outcomes, and reduce the overall cost of care2.


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DisperSol Technologies Announces Collaboration with Ajax Therapeutics to Develop Enhanced KinetiSol Drug Formulations

DisperSol Technologies | December 18, 2021

DisperSol Technologies LLC announced that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies. “Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates. This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need.” Dr. Edward Rudnic, CEO of DisperSol Technologies About DisperSol Technologies DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder and DST-2970 in Phase 2 for refractory metastatic prostate cancer. Additional earlier-stage programs include DST-5407 for non-squamous non-small cell lung cancer. About Ajax Therapeutics Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms from our founding partner, Schrödinger, Inc., we aim to discover and develop more precisely designed therapies to address significant unmet needs for patients with hematologic malignancies.

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BUSINESS INSIGHTS

Angelini Pharma, a New Partner in Epilepsy

Angelini Pharma | March 26, 2022

On the occasion of Purple Day an annual international event aimed at raising awareness of epilepsy, Angelini Pharma, international Italian pharmaceutical company, is committed to provide patients and healthcare professionals with innovative solutions improving the care of patients with epilepsy. Epilepsy is a common neurological disorder that typically results in seizures of various types, with focal seizures being the most common one.1 The essential treatment goal of epilepsy therapy is seizure freedom.2 The global disease burden of epilepsy is high. 3,4 A diagnosis of epilepsy confers significant disability on the individual, including physical, psychological, and social issues that negatively impact self-esteem, family environment, relationships, leisure and working life. 3,5 Long-term outcomes for patients who have not responded to at least 2 antiepileptic drugs remain without significant improvement for more than 2 decades despite the availability of many new antiepileptic drugs. 6,7 Indeed, even today 40% of all patients with epilepsy do not achieve seizure freedom despite treatment with 2 different drugs.6,8 The probability of achieving the therapeutic goal of seizure freedom decreases significantly with each failed treatment. 6 Aware of the existence of an unmet medical need, Angelini Pharma is committed to make available a new anti-epileptic drug. The product received the Market Authorization from the European Medicines Agency in March 2021 and many Early Access Program authorization across European countries, including in France. The product is already marketed in Germany, Austria, United Kingdom, Sweden, and Denmark. About Angelini Pharma Angelini Pharma is an international pharmaceutical company, part of the Italian privately group owned Angelini Industries. Angelini Pharma is committed to helping patients in the therapeutic areas of Mental Health Rare Diseases and Consumer Healthcare. In particular, Angelini Pharma is committed to brain health working every day to reduce and mitigate neurological disorders, while restoring and protecting mental health and cognitive function.

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BUSINESS INSIGHTS

SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance

SurGenTec® | March 03, 2022

SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for ION™ Screw, its proprietary stand-alone spine fixation implant. This unique device can be used to treat a variety of pathologies throughout the spine from C2-S1. The patented ION implant is the smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – and can be placed through a tiny incision with minimal tissue disruption. ION screws are enhanced with Nanotex™ surface technology designed with bony interdigitation in mind. ION provides patients with a treatment option between conservative care and major interbody fusion in the algorithm of care. “The ION screw technology truly changes the game for spine surgery. Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option. Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants,” added Greenhalgh. Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec ION can be used in a variety of open or true minimally invasive surgery (MIS) applications including facet fusions, adjunct to decompressive procedures, the treatment of adjacent level disease or to provide added stability with interbody fusions. The ION facet screw system instruments were designed to minimize tissue trauma and incision size while delivering the ION implants to the surgical location. "The ION system is a great fit for the ambulatory surgery center environment by providing a cost-effective solution for physicians looking to minimize trauma while still providing a high level of spinal care to patients. Patients are demanding access to a more efficient operating environment with less risk of illness and disease transmission," said Andrew Shoup, Chief Operating Officer of SurGenTec. “ION represents a tremendous paradigm shift in the ability to treat my patients suffering from chronic degenerative lumbar conditions more definitively and less invasively,” said Dawood Sayed M.D., Division Chief and Professor of Anesthesiology and Pain Medicine at The University of Kansas Medical Center in reference to the recent FDA cleared ION facet screw system. “Traditionally, our patients with chronic back pain from lumbar degenerative disc disease, spondylosis, and spondylolisthesis are offered temporary relief with injections and ablations or invasive open surgical procedures. ION bridges an important gap for patients and physicians seeking less invasive options for these debilitating conditions. I am very honored to be amongst the first in the world to offer this remarkable treatment at our medical center,” continued Sayed. Unlike other spinal fixation options, the ION has zero profile above the bone which may prevent soft tissue contact and the potential for irritation. The implants may be packed with bone graft prior to and after insertion to help facilitate fusion while providing an opportunity for bone to bridge over the implant and prevent implant migration. “Using the ION system was intuitive and safe. It allowed me to provide a less invasive solution than I would have typically provided. The standard of care is changing, and ION offers a simple solution to advanced spinal conditions,” said Dr. Raphael Roybal M.D., orthopedic spine surgeon Coral Gables, FL. SurGenTec is a privately owned medical device company based in Boca Raton, Florida that is focused on unique technologies for the orthopedic and spine fields. SurGenTec develops and manufactures innovative products with patient and surgeon safety in mind. SurGenTec looks to launch ION immediately, with plans in the future of obtaining CE mark to market overseas. The vast pipeline of unique implants, instruments, biologics and ancillary solutions will continue to develop through a high level of internal research and development. SurGenTec currently has multiple products lines to market which are sold within the US and internationally. In 2018 and 2020, SurGenTec received the Spine Technology Awards for their ALARA™ target needle system and 3D Graftrasp presented at NASS.

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BUSINESS INSIGHTS

New Interactive App From rXperius Set to Provide Pharma Industry with Vital Patient Experience Insights

rXperius | February 16, 2022

Patients can now provide pharmaceutical manufacturers with real-time feedback on prescription medicines they are taking following the launch of a new app by rXperius, a Raleigh, NC-based company that specializes in the design of innovative technology platforms. The MedXer app, which can be downloaded from the Apple and Google app stores, is the first prescription survey app that allows patients to give feedback on their medications in real time, and over time. MedXer pays patients for their experiences. The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences. MedXer is designed to complement other data analytics on consumer insights that drugmakers are already collecting. “We know how hard it can be for pharma to reach their true end users – patients. Pharmaceutical companies only receive direct feedback from a limited number of patients. Often, they have to rely on second- or third-hand information to gain any kind of understanding of patients’ medicines experiences. MedXer will bring the patients’ story to the manufacturer in a dynamic and actionable way,” Steve Castillo, Founder of rXperius Pharmaceutical companies will have access to an interactive dashboard that is updated daily to reflect the latest information collected through the app. All patient data is anonymized and aggregated before it is shared with third parties. The stakes for the pharmaceutical industry are high; manufacturers only have around five to seven years to recover the money they invest in bringing a medicine to market. A company will typically spend around $3.5 billion developing and launching a drug, but 40 percent of recent drug launches have failed to achieve a return on investment. Since the launch of MedXer on January 1, approximately eight percent of people who have viewed the app have downloaded it, above market trends of 1-2%. MedXer, which is currently available for migraine and depression medications, will be expanded to include medicines from other disease areas following completion of the initial launch phase. About rXperius rXperius is a data analytics startup that was established in 2019 by veterans of the pharmaceutical industry with a combined pharma experience of more than 100 years. rXperius was incorporated in Delaware in 2020 with HQ in Raleigh, NC.

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Spotlight

Harbisson is one of many patients reaping the benefits of increased connectivity in the healthcare industry. Connected medical device—such as pacemakers and insulin pumps that communicate with other networks and devices over the Internet—provide patients and physicians with technology to better manage chronic conditions, improve outcomes, and reduce the overall cost of care2.

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