AstraZeneca's Calquence treads on Imbruvica's turf with second phase 3 CLL win

fiercepharma | June 06, 2019

AstraZeneca’s Calquence has been battling it out in mantle cell lymphoma since it won its first approval back in late 2017, but all along, the company has had its eye on another disease: chronic lymphocytic leukemia. And that’s where it’s scored its latest win. In a phase 3 trial, Calquence—combined with Roche’s Gazyva—beat out a regimen of chlorambucil chemotherapy and Gazyva at staving off disease progression in previously untreated CLL patients, AstraZeneca said Thursday. And the trial nailed a key secondary endpoint, too, showing solo Calquence could top the Gazyva-chemo combination at the same feat. The British drugmaker is keeping the details under wraps for now; they’ll debut at a future medical meeting. But in the meantime, later this month, the company plans to unveil full results from another Calquence CLL win that it top-lined in early May.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

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PHARMACY MARKET, PHARMA TECH

Shields Health Solutions and Elliot Health System Establish New Specialty Pharmacy Services

Businesswire | April 12, 2023

Shields Health Solutions the premier specialty pharmacy accelerator in the country, announces that it is partnering with Elliot Health System, the largest provider of comprehensive healthcare services in Southern New Hampshire, to launch a new pharmacy program to meet the unique needs of patients with complex, chronic conditions. The program will increase access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health. The program with Elliot Health System and Shields will initially serve a variety of disease states and clinics including rheumatology, gastroenterology, neurology, pulmonology, oncology, endocrinology and family medicine. Specialty pharmacy liaisons will guide patients and caregivers who fill prescriptions with Elliot Health System and will work with patients on-site. These liaisons can assist patients and families with navigating barriers to care, such as health insurance prior authorizations or securing financial assistance, regardless of the location where they fill their prescription. “Through our partnership with Shields, we can provide Elliot patients, and patients from other health care systems in our community, with expanded access to critical medications to achieve even greater positive health outcomes, particularly for the patients who require the highest degree of expertise to meet their needs,” said Molly Mortimer, Elliot Health System Director of Pharmacy Services. “We are pleased to join the Shields network to ensure we are doing all that we can to best care for our community.” Expanded patient support services, combined with access to recently approved and newly available specialty medications, give patients greater availability for onsite treatment options. Shields currently partners with more than 75 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery — often within two days — and improved medication adherence greater than 90 percent on average. “Through a commitment to outstanding complex patient care and its position as a health care leader in the region, Elliot Health System, and SolutionHealth as a regional system, align well with Shields’ core mission and will make it a highly valued addition to our membership,” said John Lucey, Chief Executive Officer at Shields. “By securing access to 90 percent of the limited distribution drugs that complex patients need and opening the door to restricted payer networks, our partnership will elevate access to affordable care, while improving therapy management and care coordination for Elliot Health System’s patients.” About Shields Health Solutions Shields Health Solutions is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.

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BUSINESS INSIGHTS, PHARMACY MARKET

OM1 Unveils Patented, AI-powered Platform to Accelerate Personalized Medicine

businesswire | April 17, 2023

OM1, a leading real-world data, outcomes and technology company with a focus on chronic conditions, today launched PhenOM™, its artificial intelligence-powered platform for personalized medicine. Calibrated using OM1’s longitudinal health history datasets, PhenOM uses AI to identify unique digital phenotypes associated with conditions and outcomes and compare patients’ records to them to highlight risks and opportunities. PhenOM powers personalized healthcare insights at scale across the entire healthcare ecosystem, from life science research to point-of-care clinical decision making. PhenOM is an AI that gathers detailed information from large patient datasets – including unstructured clinical notes and disease activity metrics – to isolate unique patterns associated with patients with distinct characteristics. PhenOM synthesizes these patterns into unique digital phenotypes or ‘fingerprints.’ These phenotypes can be studied to inform research and deployed in real-world datasets – inside and outside OM1 – as well as in health systems and through standalone patient-facing web portals. Calibrated using OM1’s differentiated, high-quality data cloud – which is based on billions of data points from more than 300 million patients – PheonOM was built with expert clinician oversight. With an overarching mission to improve individual care and population health, the platform powers five solutions that address pain points across the healthcare system Diagnostic Insights: Finding patients with rare, undiagnosed, or misdiagnosed conditions, including subgroups of interest Treatment Insights: Personalizing treatment recommendations to improve access to care and individualizing treatment selection Risk Insights: Predicting risk of specific negative outcomes, including disease progression, complications, and catastrophic events Utilization Insights: Enabling focus on patients at risk for higher utilization, and utilization growth, over time Clinical Trial Insights: Accelerating trial startup and recruitment by identifying patients most likely to meet qualifications for enrollment, including those potentially overlooked Patient expectations over the last several years have shifted – from the adoption of virtual care and accessibility to the use of advanced technology to improve outcomes – but a persistent gap remains between population-level insights and individual patient experience: personalization. Recognizing this gap, OM1 developed PhenOM to translate patterns in large-scale data into meaningful outputs at the individual level and to better understand patient populations, diagnoses, progression, and treatment response. “Most people have now heard of the promise of AI through GPT-4, but we still have not seen many really mature, real-world clinical applications using advanced language models,” said Dr. Joseph Zabinski, Managing Director of AI & Personalized Medicine at OM1. “PhenOM is groundbreaking technology because it uses AI to translate actionable insights from our highly enriched datasets and phenotyping technology into opportunities for more personalized healthcare. This capability creates a huge potential for impact for all stakeholders, from identifying patients with under-diagnosed conditions to enabling personalized assessments of benefit for particular therapies and accelerating clinical trial enrollment.” About OM1 With specialization in chronic conditions, OM1 is re-imagining real-world data and evidence by developing large electronically connected networks of clinicians and health data in rheumatology, dermatology, gastroenterology, cardiometabolic, respiratory, mental health, central nervous system, and other specialty areas. Leveraging its extensive clinical networks and an unparalleled technology and artificial intelligence (AI) platform, OM1 offers industry leading enriched healthcare datasets, research analytics, data modeling, decision support, and retrospective and prospective clinical studies. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.

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BUSINESS INSIGHTS, PHARMACY MARKET

Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

prnewswire | April 20, 2023

Ajinomoto Bio-Pharma Services a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States Food and Drug Administration (FDA) has approved the company's high potency vial line to manufacture a commercial product. "Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of preparation, diligence and support from the Aji Bio-Pharma team across our whole organization. As a leading global CDMO, we are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide." said Bert Barbosa, President & COO, Ajinomoto Bio Pharma Services, US. Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line that offers a range of configurations, including prefilled syringes, cartridges and vials. The high-speed process is rated to move up to 22,000 syringes per hour through the line, with a batch capacity of over 200 thousand syringes. This multi-purpose fill line has been designed to meet FDA and EMEA commercial compliance. About Ajinomoto Bio-Pharma Services Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP API manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including high potency APIs (HPAPI), continuous flow manufacturing, oligonucleotide synthesis, biocatalysis, Corynex® protein expression technology, antibody drug conjugations (ADC) and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs.

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