Biotech – Tekrati https://www.tekrati.com Experts' Views on Modern Business Wed, 31 May 2023 06:00:01 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://www.tekrati.com/wp-content/uploads/2022/04/cropped-Tekrati-Guest-Posts-32x32.jpeg Biotech – Tekrati https://www.tekrati.com 32 32 Veracyte drops $600M to acquire cancer testing Decipher Biosciences https://www.tekrati.com/veracyte-drops-600m-to-acquire-cancer-tester-decipher-biosciences/ Thu, 04 Feb 2021 16:32:56 +0000 https://www.tekrati.com/?p=16243 Veracyte drops $600M to acquire cancer testing Decipher Biosciences

Veracyte drops $600M to acquire cancer testing Decipher Biosciences

Genomic cancer testing company Veracyte is moving to acquire Decipher Biosciences in a $600 million deal, with the goal of broadening its diagnostic reach to seven of the 10 most common tumor types affecting over 1 million new patients per year. Decipher, once known as GenomeDx, maintains its own portfolio of tests focused on urologic [...]

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Veracyte drops $600M to acquire cancer testing Decipher Biosciences

Veracyte drops $600M to acquire cancer testing Decipher Biosciences

Genomic cancer testing company Veracyte is moving to acquire Decipher Biosciences in a $600 million deal, with the goal of broadening its diagnostic reach to seven of the 10 most common tumor types affecting over 1 million new patients per year.

Decipher, once known as GenomeDx, maintains its own portfolio of tests focused on urologic cancers, including whole-transcriptome analysis and machine-learning-based algorithms.

Its prostate test is currently included in national cancer treatment guidelines, while its kidney and bladder cancer tests are currently under development, with the latter expected to launch commercially this year.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

They’ll join Veracyte’s established genomic classifiers for lung, thyroid and breast cancers as well as tests for idiopathic pulmonary fibrosis, plus an upcoming diagnostic for lymphoma.

In addition, Veracyte hopes to wield Decipher’s Grid, a genomics research database profiling more than 85,000 urologic cancer samples, in its R&D partnerships with biopharma companies.

RELATED: With positive early data, Veracyte eyes 2021 launch for nasal-swab lung cancer test

Decipher, with its San Diego-based team and lab facilities, will operate as a wholly owned subsidiary; its president and CEO, Tina Nova, Ph.D.—who has also served on Veracyte’s board of directors since 2015—has since resigned her seat and is slated to become the new general manager of Veracyte’s planned urologic cancer business.

The deal includes $250 million in upfront cash plus up to $350 million in stock considerations and is expected to close by this May.

The two companies hope to see their combined suite of genomic cancer tests access a near-term addressable market estimated at $12 billion. Decipher placed its testing volume for the year of 2020 at about 16,000, for a total preliminary revenue of nearly $40 million, the companies said.

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AmerisourceBergen Hosts First-Ever ThinkLive Commercialization Global Conference https://www.tekrati.com/amerisourcebergen-hosts-first-ever-thinklive-commercialization-global-conference/ Wed, 03 Feb 2021 00:44:25 +0000 https://www.tekrati.com/amerisourcebergen-hosts-first-ever-thinklive-commercialization-global-conference/ AmerisourceBergen Hosts First-Ever ThinkLive Commercialization Global Conference

AmerisourceBergen Hosts First-Ever ThinkLive Commercialization Global Conference

Valley Forge, PA (February 2, 2021) – Today, AmerisourceBergen kicked off its first-ever ThinkLive Commercialization global event, a new extension to its annual manufacturer summit centred on strategies and opportunities for manufacturers that are bringing new products to market. The COVID-19 pandemic has disrupted research and development efforts and created new challenges throughout the commercialization [...]

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AmerisourceBergen Hosts First-Ever ThinkLive Commercialization Global Conference

AmerisourceBergen Hosts First-Ever ThinkLive Commercialization Global Conference

Valley Forge, PA (February 2, 2021) – Today, AmerisourceBergen kicked off its first-ever ThinkLive Commercialization global event, a new extension to its annual manufacturer summit centred on strategies and opportunities for manufacturers that are bringing new products to market. The COVID-19 pandemic has disrupted research and development efforts and created new challenges throughout the commercialization journey. Over the three-day virtual summit, AmerisourceBergen leaders will share market access and commercialization strategies, innovative solutions to increase patient access, and how the company will collaborate with manufacturers at each step of the commercialization process to drive product success.

“This is a critically important time to connect with our manufacturer partners to discuss and address their ever-evolving needs—from clinical trial to market availability,” said Doug Cook, President of Commercialization Services & Animal Health at AmerisourceBergen. “While the COVID-19 pandemic has created new and unprecedented challenges for our industry, it has also fostered a heightened level of agility, innovation, and collaboration to ensure we can continue bringing life-changing products to the patients who need them. ThinkLive Commercialization is an opportunity for AmerisourceBergen to share our diverse perspectives that will help unlock product potential and move health forward.”

Conference programming will include remarks from AmerisourceBergen Chairman, President & CEO Steve Collis, as well as a conversation with former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, about global health, product innovation and the nation’s response to the COVID-19 pandemic. The global summit will also feature dynamic panel discussions, presentations, and roundtables on topics ranging from commercializing cell and gene therapies to the role of automation in the patient and provider journey. Content and meetings will be facilitated through AmerisourceBergen’s event platform, AmerisourceBergen Live.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

AmerisourceBergen Partnership:

On the first day of the summit, attendees will hear from AmerisourceBergen executives about the role of partnerships in maximizing product potential and patient outcomes, the distribution of COVID-19 vaccines and therapies in countries across the world, and the value of data throughout the product journey. Day two of ThinkLive Commercialization will focus on launch strategies for cell and gene therapies and orphan and rare disease products. The final day of the conference will feature outside perspectives from Wall Street financial analysts, as well as a conversation on breaking down disparities in patient health outcomes—and the role of technology and patient support programs in closing these gaps.

For more in-depth perspectives from ThinkLive Commercialization and AmerisourceBergen on commercialization strategies, innovative therapies, medication access, and more, please visit: https://www.fiercebiotech.com/topic/commercialization

About AmerisourceBergen
AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies and providers, we create unparalleled access, efficiency and reliability for human and animal health. Our 22,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #10 on the Fortune 500 with more than $185 billion in annual revenue. Learn more at www.amerisourcebergen.com.

Contact:
Mike Iorfino, AmerisourceBergen
610-545-9189 – Mobile
[email protected]

Lisa Rediker, Tierney
215-790-4312 – Office
lisa.rediker@tierneyagency.com

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Canon Medical expands reach of its MRI artificial intelligence programs https://www.tekrati.com/canon-medical-expands-reach-of-its-mri-artificial-intelligence-programs/ Mon, 01 Feb 2021 17:00:22 +0000 https://www.tekrati.com/canon-medical-expands-reach-of-its-mri-artificial-intelligence-programs/ Canon Medical expands reach of its MRI artificial intelligence programs

Canon Medical expands reach of its MRI artificial intelligence programs

Canon Medical is expanding the clinical reach of its artificial intelligence programs designed to improve MRI image quality, saying it can now be used in 96% of all scanning procedures. The company’s Advanced intelligent Clear-IQ Engine, or AiCE, aims to sharpen scans taken by lower-dose, 1.5 Tesla MRIs, to bring their image quality up to [...]

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Canon Medical expands reach of its MRI artificial intelligence programs

Canon Medical expands reach of its MRI artificial intelligence programs

Canon Medical is expanding the clinical reach of its artificial intelligence programs designed to improve MRI image quality, saying it can now be used in 96% of all scanning procedures.

The company’s Advanced intelligent Clear-IQ Engine, or AiCE, aims to sharpen scans taken by lower-dose, 1.5 Tesla MRIs, to bring their image quality up to par with 3.0 Tesla machines.

The system was previously cleared by the FDA for certain brain- and knee-focused indications, using Canon Medical’s Vantage Orian 1.5 Tesla system. Now its applications span all joints, as well as cardiac, abdomen, spine and pelvic scans.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

“In today’s environment, making images easy to read and acquire is more important than ever, and this is the latest demonstration of our commitment to offering accessible AI that clinicians can use to make the greatest impact on patient care,” said Jonathan Furuyama, managing director of Canon Medical’s MR business unit.

RELATED: Canon gets FDA nod for high-resolution CT system

The expansion follows two recent FDA clearances for Canon Medical in December and January, including an AI-equipped, large-bore CT scanner and software designed to boost 3D MRI imaging times.

The company’s Speeder software, also for its Vantage Orian 1.5 Tesla system, was cleared to help accelerate surgical planning and orthopedic applications by reconstructing full resolution images from under-sampled data. This allows technicians to perform a scan at least twice as fast, the company said. The software also includes an application to help clinicians quantify fatty liver disease.

The company’s Aquilion Exceed large-bore CT system, meanwhile, uses AiCE technology to provide more distinct images with an opening nearly one meter wide, with an extended field-of-view of 90 centimeters.

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Innomar Strategies and FedEx Express Canada Begin Distribution of Moderna COVID-19 Vaccine Across Canada https://www.tekrati.com/innomar-strategies-and-fedex-express-canada-begin-distribution-of-moderna-covid-19-vaccine-across-canada/ Sat, 30 Jan 2021 11:34:49 +0000 https://www.tekrati.com/innomar-strategies-and-fedex-express-canada-begin-distribution-of-moderna-covid-19-vaccine-across-canada/ Innomar Strategies and FedEx Express Canada Begin Distribution of Moderna COVID-19 Vaccine Across Canada

Innomar Strategies and FedEx Express Canada Begin Distribution of Moderna COVID-19 Vaccine Across Canada

MISSISSAUGA, ON. December 24, 2020 – FedEx Express Canada, a subsidiary of FedEx Corp., and Innomar Strategies, announced today that the country’s first operations to distribute the Moderna COVID-19 vaccine in Canada on behalf of the Government of Canada are underway. The first shipment arrives at the FedEx Express Canada hub in Toronto this afternoon. Part of [...]

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Innomar Strategies and FedEx Express Canada Begin Distribution of Moderna COVID-19 Vaccine Across Canada

Innomar Strategies and FedEx Express Canada Begin Distribution of Moderna COVID-19 Vaccine Across Canada

COVID-19 vaccine

MISSISSAUGA, ON. December 24, 2020 – FedEx Express Canada, a subsidiary of FedEx Corp., and Innomar Strategies, announced today that the country’s first operations to distribute the Moderna COVID-19 vaccine in Canada on behalf of the Government of Canada are underway. The first shipment arrives at the FedEx Express Canada hub in Toronto this afternoon. Part of this initial shipment will continue onwards to the territories to facilitate vaccine distribution in Canada’s northern regions. The vaccine roll-out will be facilitated by the vast FedEx Express Canada network, utilizing the specialized, cold-chain storage and packaging capabilities of Innomar Strategies, a part of AmerisourceBergen and a leading patient support provider in the Canadian specialty pharmaceutical market.

The arrival of the vaccine from Brussels, Belgium, occurred within 48-hours of Health Canada’s approval, a key logistical requirement from the federal government. Meeting the deadline was made possible by extensive collaboration with the government of Canada to move more vaccines from Europe into Canada. Additionally, the delivery of COVID-19 vaccines requires coordination of numerous teams including customs brokers, airports, ground transportation crews and internal security teams working with provincial, and federal law enforcement agencies, all during a time when lockdowns and border closures are commonplace.

The delivery of the first Moderna COVID-19 vaccine is notable as it will be the first vaccine to arrive in the Northwest Territories. The Canadian roll-out comes shortly after the FedEx network started delivering both the Pfizer-BioNTech and later the Moderna vaccines across the U.S., beginning mid-December. FedEx is well-positioned to handle COVID-19 vaccine shipments around the world with temperature-control solutions, near real-time monitoring capabilities, and a dedicated healthcare team to support the express transportation of vaccines and bioscience shipments.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

Innomar will safely and securely store the vaccines in its GMP-compliant Canadian storage facilities across Canada. The storage facilities—which are equipped to store complex pharmaceutical products, including those with cold chain requirements—are temperature-controlled and have a validated monitoring system to protect the vaccine shipments. Before the vaccines are shipped, teams will put them in packages that support the temperature requirements specified by the manufacturer.

These temperature-sensitive vaccines will move quickly through the FedEx Express Canada network with consistent reporting on the condition of the vaccine, thanks to FedEx SenseAware technology packed along with the shipment. Through the SenseAware device, dedicated agents are able to monitor critical data including temperature, location and light exposure to help ensure the integrity and security of the vaccines,  and allow teams to be fully prepared when the shipment arrives.

“The mandate given to us by the government of Canada to support the distribution of vaccines across Canada is without a doubt, one of the most important efforts in our company’s history. We are proud and humbled to be able to lend our network and expertise to help bring an end to the pandemic which has affected both the lives and livelihoods of our fellow Canadians,” said Lisa Lisson, president, FedEx Express Canada. “Delivering critical COVID-19 vaccines is more than an important assignment for the thousands of FedEx team members making this a reality – it’s who we are and what we do.”

“As health care providers nationwide prepare to administer the initial wave of COVID-19 vaccines, we are focused on providing the logistics support needed to help ensure residents in all corners of Canada have safe and timely access to a vaccine—both now and in the months to come,” said Guy Payette, president of Innomar Strategies. “This initial shipment marks a significant milestone in the country’s efforts to combat the COVID-19 pandemic. Our team at Innomar is prepared and ready to support the successful rollout of this first shipment—and all subsequent COVID-19 vaccine shipments that we receive over the next several months.”

# # #

About FedEx Corp.

FedEx Corp. (NYSE: FDX) provides customers and businesses worldwide with a broad portfolio of transportation, e-commerce and business services. With annual revenue of $75 billion, the company offers integrated business solutions through operating companies competing collectively, operating collaboratively and innovating digitally under the respected FedEx brand. Consistently ranked among the world’s most admired and trusted employers, FedEx inspires its nearly 600,000 team members to remain focused on safety, the highest ethical and professional standards and the needs of their customers and communities. To learn more about how FedEx connects people and possibilities around the world, please visit about.fedex.com.

About Innomar Strategies

Innomar Strategies, a part of AmerisourceBergen, is the leading patient support provider in the Canadian specialty biopharmaceutical market. We deliver end-to-end commercialization solutions to improve product access, increase supply chain efficiency and enhance patient care. Strategic consulting, patient support programs, nursing, and clinical services, and specialty pharmacy and logistics are just a few of our key areas of specialization. We partner closely with manufacturers, healthcare providers, pharmacies and payers to ensure patients have consistent and reliable access to specialty medication. With our integrated approach and commitment to best-in-class care, Innomar Strategies helps navigate the patient journey to optimize health outcomes. Visit us at www.innomar-strategies.com.

About AmerisourceBergen 

AmerisourceBergen provides pharmaceutical products, value-driving services and business solutions that improve access to care. Tens of thousands of healthcare providers, veterinary practices and livestock producers trust us as their partner in the pharmaceutical supply chain. Global manufacturers depend on us for services that drive commercial success for their products. Through our daily work—and powered by our 22,000 associates—we are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #10 on the Fortune 500, with more than $175 billion in annual revenue. The company is headquartered in Valley Forge, Pa. and has a presence in 50+ countries. Learn more at amerisourcebergen.com.

FedEx SenseAware Technology

At FedEx, the information about the package is as important as the package itself as it moves through the network. FedEx SenseAware Mobile, a multi-sensor device, will be included in these vaccine shipments, helping to ensure these temperature-sensitive deliveries move swiftly and safely through the FedEx Express Canada network. Dedicated FedEx Priority Alert® customer support agents will use SenseAware monitoring technology to track the location, temperature, humidity and light exposure of vaccine shipments in near real-time.

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Harnessing the power of a digital assistant to accelerate patient access https://www.tekrati.com/harnessing-the-power-of-a-digital-assistant-to-accelerate-patient-access/ Sat, 30 Jan 2021 10:48:19 +0000 https://www.tekrati.com/harnessing-the-power-of-a-digital-assistant-to-accelerate-patient-access/ Harnessing the power of a digital assistant to accelerate patient access

Harnessing the power of a digital assistant to accelerate patient access

Technology in the healthcare landscape is evolving, and leading hub services providers are implementing solutions that help accelerate speed to therapy for patients. One crucial portion of accessing medication is being able to receive benefit verification information in a timely manner. The rise of electronic benefits verification (eBV) has helped healthcare providers minimize time going [...]

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Harnessing the power of a digital assistant to accelerate patient access

Harnessing the power of a digital assistant to accelerate patient access

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Technology in the healthcare landscape is evolving, and leading hub services providers are implementing solutions that help accelerate speed to therapy for patients. One crucial portion of accessing medication is being able to receive benefit verification information in a timely manner.

The rise of electronic benefits verification (eBV) has helped healthcare providers minimize time going back and forth with payers via phone or fax, making it possible for them to spend more time on patient care. When done right, eBV gives providers and patient support specialists accurate and up-to-date payer information when they need it—not days after the fact.

Yet, even with all the technological advancements in the field in recent years, end-to-end automation for the more complex benefit verification cases has remained out of reach—until now.

In late 2019, Lash Group collaborated with Infinitus Systems to pilot their digital assistant technology as part of Lash Group’s eBV service. This groundbreaking advancement incorporates a unique digital assistant into the eBV solution to place automated calls to payers. By combining artificial intelligence, natural language recognition, and speech synthesis technology, digital assistants can engage in a human-like interaction with the payer on the other end of the line. The digital assistant can verbally interact with systems and users just as a human would. That means it can open up new doors for patient support programs, promising to free up more time for patient counselors to manage complex cases and guide patients through results or engage with other hub services. These digital helpers allow programs to more quickly scale their capacity as patient demand fluctuates.

“The digital assistant is just one of many new features we’re launching as part of our expanded electronic benefits verification service, but it is perhaps the most exciting,” says Myra Reinhardt, Vice President of Product Innovation and Analytics at Lash Group. “This is really the next generation of eBV technology and we’re thrilled to be leading the way.”

Reinhardt acknowledged that even this powerful technology doesn’t work in a vacuum. “We are always innovating to improve our eBV services, recognizing that different clients have different needs,” she says.

The most effective provider portals make it possible for healthcare professionals to conduct on-demand patient eligibility checks and full benefit verifications, as well as submit requests for prior authorization. Meanwhile, manufacturers can take advantage of customized dashboards that provide real-time data and insights, allowing them to work with providers to resolve any barriers to access patients might be experiencing. Offered in tandem, real-time electronic pharmacy benefit verification service provides on-demand access to information just as robust as electronic medical benefit verifications.

Leading-edge benefit verification systems also require the agility to respond to ongoing changes to each patient’s benefits, as well as to changes in the broader healthcare landscape that might affect patient access.

Innovation in eBV means delivering what’s essential to truly meet patient needs: expertise working with patients and providers to understand payer rules and industry dynamics coupled with an ongoing investment in new technology.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

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Mayo Clinic, nference to big data partnership spanning COVID-19 and more https://www.tekrati.com/mayo-clinic-nference-to-expand-data-partnership-spanning-covid-19-and-more/ Sat, 30 Jan 2021 09:45:08 +0000 https://www.tekrati.com/?p=16100 Mayo Clinic, nference to big data partnership spanning COVID-19 and more

Mayo Clinic, nference to big data partnership spanning COVID-19 and more

After launching a data analytics collaboration one year and one pandemic ago, the Mayo Clinic and nference say they plan to expand their big data partnership to include research projects in digital pathology and heart rhythm diagnostics. In January 2020, shortly after backing its $60 million Series B round, the Mayo Clinic tapped nference to [...]

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Mayo Clinic, nference to big data partnership spanning COVID-19 and more

Mayo Clinic, nference to big data partnership spanning COVID-19 and more

Mayo%20Clinic%20logo

After launching a data analytics collaboration one year and one pandemic ago, the Mayo Clinic and nference say they plan to expand their big data partnership to include research projects in digital pathology and heart rhythm diagnostics.

In January 2020, shortly after backing its $60 million Series B round, the Mayo Clinic tapped nference to build an artificial intelligence-powered engine that would take years of clinical records—including millions of tissue slides and physician-written notes—and transform them all into an annotated database capable of being used for research.

“We have built a software platform that brings vast, curated quantities of scientific and biological knowledge―previously siloed and inaccessible―to researchers’ and clinicians’ fingertips so they can, for the first time, draw on the collective wisdom and experience of millions of scientists, physicians, and patients,” said nference co-founder and CEO Murali Aravamudan.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

RELATED: Mayo Clinic, nference launch ambitious data platform initiative

But in the past 12 months, the spread of COVID-19 has instead provided an opportunity to use the system to answer questions about the disease’s long-term complications, as well as its relationships with pre-existing conditions.

This includes collating and digesting 100 million biomedical documents—including open biomedical research, structured and unstructured clinical data, and human cell and protein atlases—to profile the body’s cellular receptors that can fuel coronavirus infections.

RELATED: Nference matches B round with a new $60M financing, eyes coronavirus work

In collaboration with researchers at Mayo and Janssen, nference’s platform found the virus’ favored ACE2 receptor spanned multiple tissues. From the tongue, nose and airway, to the kidneys and gastrointestinal tract, they realized the disease had the potential to affect much more than a typical respiratory infection.

And last month, nference collected another $60 million, this time for its series C round, which will help support COVID-focused projects on virus transmission, symptoms and progression, as well as diagnostic predictions of conditions such as pulmonary hypertension.

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WCLC: Amgen’s KRAS drug pads its case for approval with global filings https://www.tekrati.com/wclc-amgens-kras-drug-pads-its-case-for-approval-with-global-filings-underway/ Fri, 29 Jan 2021 11:14:52 +0000 https://www.tekrati.com/?p=16082 WCLC: Amgen’s KRAS drug pads its case for approval with global filings

WCLC: Amgen’s KRAS drug pads its case for approval with global filings

As regulators across the world make their way through the submission for what could be the first approved KRAS inhibitor, Amgen is unveiling its biggest data set yet in patients with non-small cell lung cancer (NSCLC). The drug, sotorasib, curbed tumor growth in 81% of patients and shrank tumors in 37% of them. The phase [...]

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WCLC: Amgen’s KRAS drug pads its case for approval with global filings

WCLC: Amgen’s KRAS drug pads its case for approval with global filings

AmgenHQ

As regulators across the world make their way through the submission for what could be the first approved KRAS inhibitor, Amgen is unveiling its biggest data set yet in patients with non-small cell lung cancer (NSCLC). The drug, sotorasib, curbed tumor growth in 81% of patients and shrank tumors in 37% of them.

The phase 2 data, to be presented virtually on Friday at the World Conference on Lung Cancer, come from 126 patients with NSCLC whose tumors harbor KRAS G12C mutations and whose cancer has gotten worse despite trying as many as three prior lines of therapy. All 126 patients received 960 mg once each day until their cancer progressed.

Besides shrinking tumors in more than one-third of patients, sotorasib eliminated all signs of cancer in three patients (2%). It staved off tumor growth for a median of 6.8 months and patients responded to the treatment for a median of 10 months. The numbers are similar to those seen from a smaller group of patients from a phase 1 study of sotorasib, where 32% of patients saw their tumors shrink and 88% had their tumors stop growing.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

RELATED: ESMO: Amgen’s KRAS drug tackles 32% of lung cancers—and this is just the beginning

“At ESMO, we peeled out all the lung cancer patients from a larger phase 1 study and there was some heterogeneity in those patients—it was 59 patients treated at different dose levels,” Greg Friberg, Amgen’s vice president of global oncology development, said. “We were really pleased to see responses across the different cohorts… Of course, the goal of oncology is to take that and run a dedicated cohort asking the question, is it consistent? The data we’re reporting now is one step closer to where we want to be.”

Jefferies analyst Michael Yee agreed. “This was expected to be positive already so this is just confirmation the data is good and is already under review by the FDA, and as the prior top-line disclosure by the co stated the efficacy is ‘consistent’ with phase 1 results,” he wrote in a note to clients on Thursday.

Right now, the patient group lacks a targeted therapy, even as patients with other mutations benefit from tailored treatments. And that’s the void Amgen is hoping to fill.

“6.8 months compares quite favorable to what we typically think of as two to four months for a drug like docetaxel, and that’s before we get into side effect profiles,” Friberg said. “Essentially, what we’re answering is this drug looks like it has consistent, deep, durable responses and very promising survival numbers at this point. We are hopeful this is the beginning of our opportunity to deploy the drug into different settings.”

Part of that plan includes testing sotorasib in earlier lines of therapy and in combination with one or more cancer drugs. And success in those arenas requires a good safety profile.

RELATED: Amgen guns for speedy KRAS cancer approval as it leads race

About two-thirds of patients reported side effects, most of which were mild to moderate. The most common side effects were diarrhea, affecting 31% of patients; nausea, striking 19%; and elevated liver enzymes, afflicting 15%. There were no treatment-related deaths, but 7% of the patients quit the study because of side effects and one-fifth of them needed dose modifications.

“With the unfortunate baggage of prior therapies those patients are living with, as well as (the effects of) their tumor, from that standpoint, what we saw in the study was a side effect profile that looked consistent with phase 1,” Friberg said, adding that the drug’s safety profile was promising compared with docetaxel and other treatments.

Over time, Amgen and the investigators have learned how to manage side effects so that patients can remain on treatment, Friberg said.

Amgen is seeking approval for sotorasib as a second-line treatment for this patient group in the U.S., U.K., European Union, Canada, Australia and Brazil. Yee expects a speedy OK.

“We are positive on ‘fast FDA approval’ by spring/summer and strong uptake—but big focus and stock move is contingent on KRAS ‘combo’ data in lung, etc., which is maybe at ASCO 2021 to move consensus estimates across the Street,” he wrote.

Amgen is also testing the drug against docetaxel in a randomized phase 3 study in previously treated patients, but it’s also conducting a single-arm phase 2 study in the first-line setting to figure out which of those patients will benefit the most from sotorasib as a single agent. And the company is also testing 10 different combinations featuring sotorasib in an adaptive study that will allow it to quickly move into phase 2.

Those combinations include antibodies and kinase inhibitors that target EGFR, as well as SHP2 inhibitors, MEK inhibitors and PD-1 blockers, David Hong, M.D., said in a previous interview. Hong, a professor of investigational cancer therapeutics at MD Anderson Cancer Center, presented the phase 1 data for sotorasib virtually at the European Society for Medical Oncology meeting in September.

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AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs https://www.tekrati.com/astrazeneca-benevolentai-home-in-on-computer-generated-target-for-chronic-kidney-disease-drugs/ Wed, 27 Jan 2021 21:13:27 +0000 https://www.tekrati.com/astrazeneca-benevolentai-home-in-on-computer-generated-target-for-chronic-kidney-disease-drugs/ AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs

AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs

After launching a collaboration nearly two years ago to bring artificial intelligence to kidney drug design, AstraZeneca and BenevolentAI believe they’ve discovered a winner. Using its biomedical datasets, BenevolentAI’s machine learning platform predicted the existence of a novel target in the underlying cellular mechanisms that cause chronic kidney disease—which was later confirmed through experiments by [...]

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AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs

AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs

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After launching a collaboration nearly two years ago to bring artificial intelligence to kidney drug design, AstraZeneca and BenevolentAI believe they’ve discovered a winner.

Using its biomedical datasets, BenevolentAI’s machine learning platform predicted the existence of a novel target in the underlying cellular mechanisms that cause chronic kidney disease—which was later confirmed through experiments by AstraZeneca researchers.

The AI-generated target has been selected by the drugmaker as a new goal for its portfolio, making it the first product to come out of the companies’ partnership, which also focuses on idiopathic pulmonary fibrosis.

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

“The collaboration with BenevolentAI has seen our scientists work side-by-side to develop a knowledge graph that will enable us to explore and find new targets for chronic kidney disease,” said Pernille Laerkegaard Hansen, AstraZeneca’s head of renal biosciences. 

“Together we are transforming how new medicines are discovered and the identification of this first target is only the beginning of what our partnership hopes to achieve,” Hansen said.

RELATED: Eli Lilly, spurred by AI analysis, starts pivotal study of arthritis med Olumiant in COVID-19

Last year, BenevolentAI also turned its programs toward finding established therapies that could be repurposed to help treat COVID-19, landing on Eli Lilly’s arthritis drug Olumiant (baricitinib). Earlier this month, results from a clinical trial published in the New England Journal of Medicine showed that combining the treatment with Gilead’s remdesivir antiviral could improve recovery times. The FDA granted the Olumiant an emergency authorization last November.

RELATED: AI’s hunt for the molecule to stop COVID-19

BenevolentAI’s models work to predict the potential opportunities for drugs that may be overlooked, by identifying the differences in proteins expressed by healthy and diseased cells.

“Complex diseases like [chronic kidney disease] have defied conventional research efforts,” BenevolentAI Chief Scientific Officer Anne Phelan said. “Working with our partners at AstraZeneca, we leveraged our AI models and platform tools to reason across vast quantities of curated biomedical information.”

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Butterfly Network nets new CEO ahead of going public https://www.tekrati.com/butterfly-network-nets-new-ceo-ahead-of-going-public/ Wed, 27 Jan 2021 13:28:44 +0000 https://www.tekrati.com/?p=16039 Butterfly Network nets new CEO ahead of going public

Butterfly Network nets new CEO ahead of going public

Ahead of its upcoming merger and plans to go public, hand-held ultrasound developer Butterfly Network has named a new president and CEO. Todd Fruchterman, former president and general manager of 3M’s $4.8 billion medical solutions division, will helm the company starting Feb. 1. The announcement was made jointly with Butterfly’s corporate suitor, Longview Acquisition Corp., [...]

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Butterfly Network nets new CEO ahead of going public

Butterfly Network nets new CEO ahead of going public

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Ahead of its upcoming merger and plans to go public, hand-held ultrasound developer Butterfly Network has named a new president and CEO. Todd Fruchterman, former president and general manager of 3M’s $4.8 billion medical solutions division, will helm the company starting Feb. 1.

The announcement was made jointly with Butterfly’s corporate suitor, Longview Acquisition Corp., a special-purpose company backed by hedge fund Glenview Capital Management. Former CEO Laurent Faracci stepped down earlier this week.

The $1.5 billion acquisition deal was announced last November, following Longview’s $300 million IPO in early 2020.

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

Before spending nearly 10 years at 3M, where he also served as chief medical officer and chief technology officer, Fruchterman held roles at Acelity, Johnson & Johnson, Schering-Plough and Response Genetics. Since last fall, he has been group president of reliability solutions at contract manufacturer Flex.

“We are very excited Todd has joined Butterfly Network as President and CEO to lead the Company at this critical stage,” Butterfly Network founder and Chairman Jonathan Rothberg said. “Todd brings together his unique qualifications and experience as an M.D., Ph.D. and proven business executive in public medical device companies, where he has successfully scaled disruptive technologies throughout his entire career.”

RELATED: Special Report—The top 10 M&A targets in medtech | Butterfly Network 

In addition, Butterfly and Longview have also put forward new names for the board of directors of the emerging public company. Joining Rothberg, Fruchterman and Glenview founder Larry Robbins, they include: Dawn Carfora, global business vice president at Facebook; John Hammergren, former McKesson chairman and CEO; Gianluca Pettiti, Thermo Fisher Scientific’s president of specialty diagnostics; and S. Louise Phanstiel, chair of the board at Myriad Genetics.

“I am grateful to these independent directors for supporting our movement to use Ultrasound-on-Chip technology to make safe diagnostic imaging more accessible, more affordable and more effective,” Rothberg said. “We expect that their deep skills and directly relevant experiences will bring to the company wisdom and insight across operational, strategic, cultural and fiduciary spheres.”

RELATED: Butterfly Network nets $250M to start shipping ultrasound-on-chip

Longview has scheduled a meeting Feb. 12 to approve its acquisition of Butterfly and elect the seven nominated directors, with the deal expected to close later that day. Public trading on the New York Stock Exchange is slated to begin Feb. 16 under the ticker “BFLY.”

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Backed by BD and Siemens, Babson begins clinical testing of its retail pharmacy blood draw device https://www.tekrati.com/backed-by-bd-and-siemens-babson-begins-clinical-testing-of-its-retail-pharmacy-blood-draw-device/ Tue, 26 Jan 2021 14:18:37 +0000 https://www.tekrati.com/?p=16019 Backed by BD and Siemens, Babson begins clinical testing of its retail pharmacy blood draw device

Backed by BD and Siemens, Babson begins clinical testing of its retail pharmacy blood draw device

Babson Diagnostics hopes to make real the industry’s long-held dream of bringing quick and thorough clinical testing to retail markets and pharmacies—without the use of needles, tubes or trained phlebotomists—and it’s starting to build the clinical evidence to support it. Typical venipuncture requires a trained professional and takes about 4 to 10 milliliters of blood out [...]

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Backed by BD and Siemens, Babson begins clinical testing of its retail pharmacy blood draw device

Backed by BD and Siemens, Babson begins clinical testing of its retail pharmacy blood draw device

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Babson Diagnostics hopes to make real the industry’s long-held dream of bringing quick and thorough clinical testing to retail markets and pharmacies—without the use of needles, tubes or trained phlebotomists—and it’s starting to build the clinical evidence to support it.

Typical venipuncture requires a trained professional and takes about 4 to 10 milliliters of blood out of the arm—but produces a high-quality sample, capable of consistent results. Squeezing drops of blood from a pricked finger, on the other hand, can contaminate or alter the sample and at times be less accurate.

To help mitigate these problems, Babson aims to deploy a new, capillary-based collection device being developed in partnership with BD, which requires about one-tenth of the amount of blood and can be used by any healthcare technician.

Virtual Clinical Testing Summit

Virtual Clinical Testing Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

It is designed to draw a pea-sized amount of blood from the finger without the same pressure and squeezing that could harm the sample. The droplet is then placed in a specialized handling container that automatically works to preserve the blood and prepare it for analysis at a central laboratory while reducing the amount wasted in the testing process.

RELATED: BD, Babson pair up to bring capillary blood draws to retail pharmacies

“The combination of BD’s capillary collection device and Babson’s sample handling and analysis technology has incredible potential to improve the retail diagnostic blood testing process, with the ultimate goal of enabling simple, convenient, and accessible blood testing for all,” said Dave Hickey, president of life sciences for BD.

Babson—which was spun out of Siemens Healthineers in 2017—said it has now completed a clinical study putting its collection system up against conventional venipuncture in the retail setting.

Among 81 people tested with each method in a pharmacy over six weeks last fall, the company said it found a strong correlation between the two across routine testing panels and described the study as a step toward establishing full clinical equivalence in the future.

“COVID-19 has put the world’s focus on our healthcare systems, directing us to reexamine how we access care. We believe that reimagining the current diagnostic clinical testing process is an important place to start, as diagnostic blood testing is crucial for preventive care, but can be made more accessible and convenient,” said Babson CEO David Stein, a former Siemens executive who joined the company last September alongside a $13.7 million venture capital round.

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