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San Diego
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EU Orders Grail Sale; Illumina Continues Appeals But Plans for Multiple Outcomes
European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.
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Bristol Myers Squibb Bolsters Its Cancer Presence With $4.8B Mirati Acquisition
Acquiring Mirati Therapeutics brings Bristol Myers Squibb Krazati, one of two FDA-approved therapies addressing a KRAS cancer mutation. The deal comes as BMS looks to add revenue-generating products as patent expirations loom for several of its cancer products.
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Jorie Healthcare CEO Shares Why Automation is Critical to Revenue Cycle Management
The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.
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Once a Blockbuster Prospect, Is Travere’s Kidney Drug on Track to Become a Bust?
Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year.
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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.
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Sanofi Puts Up $125M to Partner on Oral Drug That Could Be Dupixent’s Successor
Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent.
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Here’s Why Novartis Is Paying $500M to Acquire a Preclinical RNA Startup
Novartis’s acquisition of DTx Pharma brings a lead program for a rare disease with no FDA-approved therapies. But the deal could also help the pharma giant bring new RNA therapies to new places in the body, a top Novartis executive explained.
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Travere Therapeutics Drug for Rare Kidney Disease Falls Short in Pivotal Test
Sparsentan failed to meet the main goal of a Phase 3 test in focal segmental glomerulosclerosis (FSGS). Nevertheless, Travere Therapeutics says the totality of data points to patient improvement in the rare kidney disorder and the biotech will talk with regulators about a potential path forward.
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Merck’s $11B Prometheus Acquisition Brings IBD Drug & Precision Medicine Platform
Merck is acquiring Prometheus Biosciences and a lead drug candidate in development for inflammatory bowel disorders. The deal comes as Merck looks for drug prospects that could make up for revenue declines facing blockbuster seller Keytruda, which faces patent expirations in coming years.
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Startup Function Oncology Aims to Make CRISPR Part of Next Revolution in Cancer
Function Oncology goes beyond next-generation sequencing with a CRISPR-based technology that identifies targets for a patient’s cancer regardless of whether or not they are mutated. Now out of stealth, the company will present data validating its approach during the American Association for Cancer Research annual meeting.
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Navigating Healthcare’s Data Revolution: Priorities, Opportunities, and Challenges for Health Systems
Arcadia recently partnered with HIMSS Market Insights to survey executives, IT, technology, and clinical leaders. Here’s what we found.
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Patient Deaths and Partial Hold Prompt Gossamer Bio to Stop Work on Cancer Drug
Two fatalities were reported in an early-stage study testing a Gossamer Bio drug intended to treat a rare cancer affecting the central nervous system. Due to the adverse events and a partial FDA clinical hold, Gossamer has decided to stop work on the program.
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Devices & Diagnostics, BioPharma, Legal
FTC Orders Illumina to Divest Grail, Says Deal Stifles Cancer Test Competition
The Federal Trade Commission has ordered Illumina to divest Grail, the liquid biopsy company it acquired for more than $7 billion. The agency said Illumina’s proposed remedies are insufficient and the tie-up is likely to reduce competition in the R&D and commercialization of new cancer tests.
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FDA Approval of Travere Kidney Disease Drug Sets Up Blockbuster Expectations
Travere Therapeutics drug Filspari won accelerated FDA approval to treat a rare disorder that can lead to kidney failure. The small molecule is also in late-stage testing for another rare kidney disease; analysts say each indication represents a blockbuster opportunity.
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MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies
Syena, the latest company formed by startup creator Replay, is developing cancer treatments based on a type of immune cell called a natural killer cell. This NK cell therapy technology, licensed from The University of Texas MD Anderson Cancer Center, could overcome many of the limitations facing first-generation cell therapy.
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Scripps Spinout Belharra Unveils $130M to Catch Next Big Wave of Drug Discovery
Versant Ventures-backed Belharra Therapeutics has launched with $130 million in funding and a partnership with Roche subsidiary Genentech. The startup’s technology analyzes proteins in the context of the entire cell, enabling it to discover molecules that bind to targets previously deemed undruggable.
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Neurocrine Commits $175M to Voyager in New Neuro Gene Therapy Alliance
Neurocrine Biosciences is paying $175 million up front for rights to a preclinical Voyager Therapeutics gene therapy that could put the biotech in competition with Eli Lilly among other companies. Voyager could earn up to $4.2 billion in milestone payments.