FDA's Regulatory Delay is The Reason For Novavax, Lucira Health's Failure: WSJ

 Failures of Covid vaccine maker Novavax Inc 

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 and diagnostic start-up Lucira Health Inc 

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 show that companies often succeed or fail, owing to the whims of the government. 

Last week, while reporting Q4 earnings, Novavax raised doubts about its ability to remain in business and announced plans to cut spending. 

The Covid-19 vaccine was Novavax's first and only commercial product in its 36-year history, Wall Street Journal writes. However, the product flopped after successful trials thanks to regulatory delays and manufacturing hiccups.

Operation Warp Speed awarded Novavax $1.6 billion to cover testing and manufacturing costs of its experimental vaccine in exchange for 100 million doses if the FDA authorized it. 

Novavax's struggled to scale manufacturing, which delayed the start of its late-stage U.S. trial to December 2020. 

By then, the FDA had authorized COVID-19 vaccines from Moderna Inc 

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 and Pfizer Inc 

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. Yet there was still expected to be enormous demand for its vaccine in low-income countries and among Americans hesitant to get mRNA shots. 

Novavax announced in June 2021 that its vaccine was 90.4% effective against symptomatic infection and offered 100% protection against moderate and severe illness—similar to the mRNA vaccines. But Novavax struggled to procure raw ingredients for its vaccine, including plastic bags to grow cells. 

Rather than help Novavax increase manufacturing, Wall Street reported that Biden officials bullied Moderna to donate more doses to low-income countries to compensate for the Novavax shortfall.

The Moderna and Pfizer vaccines have been enormous commercial successes because of their flexible mRNA technology and support from regulators who have accelerated their reviews. 

The FDA hinders rather than promotes innovation. Consider Lucira Health. In an investor report, Lucira blamed the FDA's "protracted" authorization process for its combination Covid and flu at-home test. 

Lucira applied to the FDA for authorization of its novel test last May and expected to receive a thumbs-up by the end of summer before the flu season started. Canada authorized Lucira's test last August.

The FDA finally authorized Lucira's test two days after it filed for bankruptcy and past the flu season peak.

https://www.benzinga.com/general/biotech/23/03/31242301/fdas-regulatory-delay-is-the-reason-for-novavax-lucira-healths-failure-wsj-report

FDA Accepts BioMarin Application to Expand Use of VOXZOGO for Achondroplasia Under Age 5

 he Supplemental New Drug Application is Based on Positive Results from Global Randomized Phase 2 Study in Infants and Young Children

FDA set PDUFA Target Action Date of October 21, 2023

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand treatment in the United States to include children with achondroplasia under the age of 5. Achondroplasia is the most common form of disproportionate short stature.

https://finance.yahoo.com/news/fda-accepts-biomarins-supplemental-drug-210500506.html

Best Buy Pushes Deeper Into Healthcare With ‘Hospital At Home’ Partnership

 Best Buy is partnering with a large U.S. healthcare system to develop “new hospital at home offerings,” pushing deeper into developing new healthcare services and products.

Best Buy Health disclosed Tuesday a partnership with Atrium Health, which is part of one of the nation’s largest hospital operators, to improve the delivery of “hospital-level care in the home.” Atrium in December closed on its merger with Advocate Aurora Health to form Advocate Health, the nation’s fifth-largest healthcare system, which operates 67 hospitals and more than 1,000 sites of care across six states.

“The goal of the partnership is to enable providers to deliver high-quality care to patients in the comfort of their own homes, while helping reduce emotional and financial burdens on patients and caregivers,” the companies said.

Best Buy said the partnership will leverage Atrium Health’s expertise as a provider of telehealth services that includes a “well-established hospital at home program.” Based in Charlotte, N.C., Atrium first launched its hospital at home program in the early part of the COVID-19 pandemic as “a means to address patient surges.” Since then, Atrium said it has “evolved the program to be able to care for such conditions as cardiac, COPD, pneumonia, asthma, various infections and other medical and post-operative conditions.”

Meanwhile, the retailer said its Best Buy Health unit will work to improve patient education and “enabling technology in the home with the help of specially trained Geek Squad Agents to assist with logistics and technical support.”

It's the latest push into healthcare services and products for Best Buy. Last year, Best Buy introduced sales of hearing aids as part of what it called a “new experience for hearing devices” that included an expanded collection of such devices as well as “an in-store experience in more than 300 stores, and a new online hearing assessment tool.” And in 2021, Best Buy acquired Current Health, a technology platform that includes remote patient monitoring.

“Best Buy Health enables care at home for everyone by leveraging its strengths from the Best Buy enterprise and focusing on three key areas: wellness at home, aging at home and care at home,” said Deborah Di Sanzo, president of Best Buy Health.

With the partnership with Atrium Health, Best Buy finds itself entering a hospital care at home area with much more established partners with broader reach, offering their hospital care at home programs across the U.S.

Boston-based technology company Medically Home, for example, last year landed an investment of more than $100 million from medical product giant Baxter International, Cardinal Health and Global Medical Response to advance a new healthcare delivery model that delivers “advanced care” typically available inside a hospital into patient homes. Medically Home’s platform is used in 20 states, working with healthcare systems including the Mayo Clinic and Kaiser Permanente.

Neither Best Buy nor Atrium Health would disclose financial terms of their partnership but those involved said there will be more investments with the idea to scale it beyond the system.

“We combine our omnichannel, geek squad, caring centers, and Current Health services to enable care,” Di Sanzo said. “At scale, no other company has the holistic combination of resources that when combined, will change the lives of consumers and enable them to heal right in their own home surrounding by the people and things they love the most. Those strengths, combined with Atrium Health’s extensive clinical expertise and deep experience leading in virtual care, will help us improve and enable care in the home for everyone.”

https://www.forbes.com/sites/brucejapsen/2023/03/07/best-buy-pushes-deeper-into-healthcare-with-home-care-partnership/

Caris, Incyte In Broad Precision Medicine Partnership to Advance Incyte's Oncology Pipeline

  Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte's oncology pipeline.

Caris' unique platform combines data from whole exome sequencing, whole transcriptome sequencing, protein analysis, and proprietary AI models and signatures to improve patient outcomes through advancement of personalized medicine. The partnership will apply Caris' data and analytics tools, comprehensive molecular tissue and liquid profiling services, and clinical trial enrollment program capabilities across two therapeutic programs initially, with the option for Incyte to expand to four total programs.

"This partnership with Incyte will leverage Caris' leading molecular science and technology solutions to support Incyte's oncology research and development efforts," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. "The aggregate strength of our platform, which provides patient level DNA and RNA data both in tissue and  blood, may help to better identify and predict patient response to therapy, which in turn may accelerate clinical trial enrollment, optimize clinical positioning and potentially enhance technical and regulatory success."

Under the terms of the agreement, Incyte will leverage Caris' data insights and analytics capabilities to discover novel biomarkers and optimize clinical positioning strategies for its oncology programs. For drug candidates developed under the collaboration, patients enrolled in Incyte-led clinical trials will undergo longitudinal testing with Caris' comprehensive tissue and liquid molecular profiling assays. Incyte will also leverage Caris' biomarker-driven patient selection for clinical trials including options to partner on developing companion diagnostics for programs in the partnership.

https://finance.yahoo.com/news/caris-life-sciences-incyte-enter-113000114.html

PacBio To Begin Commercial Shipment of 'Low-Cost' Human Genome System

 Broad Commercialization and Scale-Up of Revio Enables Researchers with 15 Times More HiFi Data and High-Quality Human Genomes for Under $1,000

 PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced the first customer shipments of Revio long-read sequencing systems will commence on March 8, 2023. As previously announced, the Revio system features significant advances in SMRT Cell design, compute, and system architecture. Together, this enables a dramatic increase in throughput and lower sequencing costs with the trusted power of HiFi chemistry, which offers exceptional accuracy and direct methylation detection.

With the Revio system, researchers will be able to scale their interrogation of the full genome: from telomere-to-telomere with phasing information, small variants, structural variants, and epigenetic profiles all in the same run. This will allow further exploration of biology and offers the potential to better understand the role of genetics in health and disease.

Among the first customers receiving Revio systems are many who have deep roots in the Human Genome Project: Baylor College of Medicine, the Broad Institute of MIT and Harvard (Broad), Wellcome Sanger Institute, and Washington University in St. Louis. Broad is one of many customers to purchase multiple systems, ordering ten Revio systems to scale long-read sequencing for population sequencing initiatives. The ten Revio systems at Broad will have the same sequencing capacity as 150 Sequel IIe systems.

https://finance.yahoo.com/news/pacbio-begin-commercial-shipment-revio-120500009.html