Novartis and Amgen axe BACE drug for Alzheimers

Pharmaphorum | July 12, 2019

Another Alzheimers disease drug has been axed after Novartis, Amgen and the Banner Alzheimers Institute decided to end two pivotal studies involving a medicine targeting BACE. The organisations have ended development of the BACE1 (beta secretase 1) inhibitor CNP520 – or umibecestat – which was in two phase 2/3 studies in the Alzheimer’s Prevention Initiative Generation Program. They made the decision after assessment of unblinded data during a regular pre-planned review identified worsening in some measures of cognitive function. CNP520 was being tested for safety and efficacy in the prevention or delay of the onset of Alzheimer’s in people at high risk of developing symptoms based on their age and genetic status. Study sponsors are informing investigators of the decision to discontinue the clinical program of CNP520 in Alzheimer’s prevention, and advising that participants should stop taking the investigational treatment. The clinical investigators will contact participants to discuss what happens next, including follow-up appointments as appropriate. It’s the latest in a long list of Alzheimer’s drug failures, with no new medicines making it to market since 2003 when Forest’s Namenda was approved by the FDA. Pharma has been trying to find ways to stop or slow the disease from spreading by targeting the amyloid plaques that are commonly seen in the brains of people with Alzheimer’s. However this latest failure adds to the growing body of evidence that targeting amyloid may not be the solution – BACE inhibitors work by preventing creation of a precursor protein to amyloid. Big pharma is also turning its back on BACE along with the first generation drugs directly targeting the rogue protein itself – AstraZeneca and Eli Lilly axed development of their BACE drug lanabecestat. Results from CNP520 are in line with other BACE drugs, which have been associated with slight worsening of symptoms. Pharma’s strategy is now to refine its approach to targeting amyloid, such as AZ and Lilly’s MEDI1814 targeting the most toxic form of the protein, or focusing on another approach together such as the “tau” tangles also associated with the disease.

Spotlight

Researchers led by Carnegie Mellon University’s Marcel Just and the University of Pittsburgh’s David Brent have developed an innovative and promising approach to identify suicidal individuals by analyzing the alterations in how their brains represent certain concepts, such as death, cruelty and trouble.

Spotlight

Researchers led by Carnegie Mellon University’s Marcel Just and the University of Pittsburgh’s David Brent have developed an innovative and promising approach to identify suicidal individuals by analyzing the alterations in how their brains represent certain concepts, such as death, cruelty and trouble.

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PHARMACY MARKET

Sensyne Health and Phesi Form a Joint Commercial Development Partnership with a Leading Pharmaceutical Company

Sensyne Health, Phesi | May 24, 2021

Sensyne Health plc, the Clinical AI company, today announced that it has entered a joint commercial clinical development partnership in an undisclosed disease area with a major pharmaceutical company that is an existing client of Phesi with its U.S.-based strategic partner Phesi Inc. Sensyne and Phesi have entered into a joint commercial collaboration with a pharmaceutical customer for the first time since forming a strategic alliance in January 2021. The development work will consist of comparing anonymized and de-identified real-world patient data available to Sensyne with Phesi's clinical trial data to optimize the design of a clinical trial program for the client. This collaboration's financial terms have not been disclosed. About Sensyne – Phesi Strategic Alliance Sensyne and Phesi decided to partner on an exclusive basis to offer synthetic clinical trial arms and clinical decision support tools that combine clinical trial data with real-world patient data under the terms of the strategic partnership arrangement. Many of the world's leading pharmaceutical and biotechnology companies are among Phesi's clients. About Sensyne Health Sensyne Health plc is a clinical artificial intelligence company with a unique business model – a for-profit plc with a positive social impact that shares its financial returns with health systems. Clinical AI is used by the company in the healthcare and life science industries. Sensyne provides remote patient monitoring and real-time decision-making services of healthcare for medical institutions and their patients. Sensyne analyses large complex anonymized data sets in life sciences to assist life sciences companies in accelerating the development of new medicines. About Phesi Inc. Phesi is a profitable, privately held company headquartered in Connecticut, United States. The goal of the organization is to enable data-driven drug development and commercialization through predictive analytics powered by patient-centric data science. Phesi's integrated offerings include the entire clinical development process, from development planning and indication evaluation to protocol evaluation and design (including a synthetic control arm), site selection, and trial implementation management. The company works with life science companies to deliver novel therapies quicker and at a lower cost, including all stages of clinical development and a wide range of indications, including rare diseases.

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PHARMACY MARKET

Ascentage Pharma Announces its 9th Orphan Drug Designation from the US FDA in 2020

Ascentage Pharma | January 05, 2021

Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignancies, persistent hepatitis B (CHB), and age-related sicknesses, today reported that the US Food and Drug Administration (FDA) has allowed an Orphan Drug Designation (ODD) to the organization's novel Bcl-2 inhibitor, APG-2575, for the therapy of patients with intense myeloid leukemia (AML). This is the fourth ODD allowed to APG-2575 by the US FDA, following the past ODDs for the therapy of Waldenström macroglobulinemia (WM), ongoing lymphocytic leukemia (CLL), and numerous myeloma (MM). Until this point, four of Ascentage Pharma's investigational drug up-and-comers have been allowed an aggregate of nine ODDs by the US FDA, a record number for any Chinese biopharmaceutical organization. AML is an exceptionally heterogenous hematologic threat that is more normal in the old populace with a middle age at analysis of 68 years1. The latest information from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) assessed 19,940 new instances of AML and 11,180 passings from this infection in the United States in 2020. Notwithstanding the critical advances in therapeutics as of late, the 5-year endurance pace of AML stays at 25%–30%, which actually speaks to a huge neglected clinical requirement for treatments with more solid viability and a superior wellbeing profile. The expression "vagrant medications" alludes to drug items produced for the counteraction, finding, and treatment of uncommon illnesses or conditions. In the United States, a vagrant sign is characterized as a sickness or condition with a pervasiveness of under 200,000 patients in the nation. Since the Orphan Drug Act was passed in 1983, the US government has given motivators and strategy backing to support advancement of vagrant medications. Treatments conceded ODDs by the FDA are equipped for different advancement motivators, including a tax break on consumptions brought about in clinical examinations, a waiver of the New Drug Application (NDA) charge, conceivable exploration award granted by the FDA, and above all, 7 years of US market restrictiveness upon endorsement.

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PHARMA TECH

InnovaCare Signs Agreement with MedAvail to Open Three SpotRx Locations in Florida

InnovaCare | November 09, 2021

MedAvail Holdings, Inc. a technology-enabled retail pharmacy company, will be opening an initial three SpotRx locations with InnovaCare Health in Florida in the fourth quarter of 2021. In-clinic SpotRx kiosks and courier home delivery, supported by onsite SpotRx clinic account managers, will be available to patients at three Trinity Medical Center clinics in the Lakeland area. Trinity Medical Center is part of the InnovaCare Health clinical network. SpotRx Pharmacy is the retail pharmacy brand owned and operated by MedAvail in the United States, which deploys and operates the MedAvail MedCenters. “Our physician-led models and innovative technology have placed InnovaCare on the forefront of healthcare transformation for 20 years. We are excited to be continuing this tradition through our partnership with MedAvail and embedding the SpotRx pharmacy in our clinicsWe believe that this collaboration with our skilled clinical teams will result in improved health outcomes for our patients – it is a game-changing technology and the future for pharmacy services.” Connie Garcia, Pharm D., Pharmacy Manager of InnovaCare Health and Trinity Medical Center InnovaCare Health operates more than 30 clinics and is recognized as a leader in transforming care delivery. With the SpotRx embedded pharmacy model, InnovaCare Health patients will receive: Immediate access to prescriptions at the three Trinity Medical Center clinics Free contactless next-day home delivery for all prescriptions and over-the-counter medications Follow up care calls from a local SpotRx pharmacist after receiving the prescription Refill reminder calls on all chronic medications to schedule free delivery or in-clinic pick-up Instant access to SpotRx pharmacists via kiosk or phone “We are honored to support InnovaCare in its efforts to deliver compassionate, high-quality care tailored to each distinct patient population it serves,” said Ed Kilroy, Chief Executive Officer of MedAvail. “Our partnership is another key part of our continued expansion in Florida with our embedded pharmacy solution. We are committed to collaborating with InnovaCare over time to meet its patients’ medication access and adherence needs.” About InnovaCare InnovaCare Health improves the lives of members and physicians through innovative solutions for value-based healthcare. Through an integrated portfolio of health plans, medical service organizations, clinical networks and more, the company manages more than 500,000 lives, including more than 150,000 dual-eligible beneficiaries. InnovaCare’s Medicare Advantage plans have received NCQA accreditation and 4.5-star quality ratings from the Centers for Medicare and Medicaid Services (CMS). About SpotRx SpotRx places control of the pharmacy experience back in the hands of consumers. SpotRx is a telehealth platform that delivers remote pharmacist consultations through an on-site dispensing kiosk, supplemented with home delivery capability. About MedAvail MedAvail Holdings, Inc. (NASDAQ: MDVL) is a technology-enabled pharmacy organization, providing turnkey in-clinic pharmacy services through its proprietary robotic dispensing platform, the MedAvail MedCenter, and home delivery operations, to Medicare clinics. MedAvail helps patients to optimize drug adherence, resulting in better health outcomes.

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