// Biotech and Pharma Therapeutics
Bayer Receives U.S. FDA Fast Track Designation for asundexian Atrial Fibrillation Program
May 16, 2023 / Bayer / FDA / Fibrilation Program – Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news follows asundexian’s first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022. Read Full Article on Biospace >>
May 16, 2023 / Bayer / FDA / Fibrilation Program – Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news follows asundexian’s first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022. Read Full Article on Biospace >>
New biotech Siren calls for gene therapy and cancer to ‘get into the weeds together’
May 18, 2023 / Preclinical Research / Emerging Biopharma / Cell & Gene Therapy / Siren Biotechnology – Just before noon on May 17 at the American Society for Gene and Cell Therapy’s annual meeting, a young, buzzing crowd filled a small conference room at the Los Angeles Convention Center for a special lunch session. Snapshots of the host company’s staff embarking on outdoor adventures rolled across the projector screen to the tune of upbeat pop music blaring from loudspeakers. Read Full Article on Fierce Biotech >>
May 18, 2023 / Preclinical Research / Emerging Biopharma / Cell & Gene Therapy / Siren Biotechnology – Just before noon on May 17 at the American Society for Gene and Cell Therapy’s annual meeting, a young, buzzing crowd filled a small conference room at the Los Angeles Convention Center for a special lunch session. Snapshots of the host company’s staff embarking on outdoor adventures rolled across the projector screen to the tune of upbeat pop music blaring from loudspeakers. Read Full Article on Fierce Biotech >>
New Eli Lilly-backed neurological disease biotech Nido unveils with $109M
May 15, 2023 / Neurological Disorders / 5AM / Eli Lilly / Emerging Biopharma – Nido Biosciences is exiting stealth with $109 million in hand to develop new precision medicines for neurological diseases and a lead asset that takes aim at Kennedy’s disease, a rare degenerative disorder.
Read Full Article on Fierce Biotech >>
May 15, 2023 / Neurological Disorders / 5AM / Eli Lilly / Emerging Biopharma – Nido Biosciences is exiting stealth with $109 million in hand to develop new precision medicines for neurological diseases and a lead asset that takes aim at Kennedy’s disease, a rare degenerative disorder.
Read Full Article on Fierce Biotech >>
After string of setbacks, FibroGen and AstraZeneca’s anemia drug Evrenzo finally chalks up a win
May 18, 2023 / AstraZeneca / FibroGen / Evrenzo / China – After an FDA rejection, commercial disappointments in Europe and Japan and a clinical trial flop, FibroGen and AstraZeneca’s oral anemia drug Evrenzo has finally found a win back in China. Read Full Article on Fierce Pharma >>
May 18, 2023 / AstraZeneca / FibroGen / Evrenzo / China – After an FDA rejection, commercial disappointments in Europe and Japan and a clinical trial flop, FibroGen and AstraZeneca’s oral anemia drug Evrenzo has finally found a win back in China. Read Full Article on Fierce Pharma >>
AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA
May 16, 2023 /PhRMA / AstraZeneca / Lobbying – With its recent decision to leave the influential U.S. lobbying group, AZ is the third company to leave the Pharmaceutical Research and Manufacturers of America in the last six months. Read Full Article on Fierce Pharma >>
May 16, 2023 /PhRMA / AstraZeneca / Lobbying – With its recent decision to leave the influential U.S. lobbying group, AZ is the third company to leave the Pharmaceutical Research and Manufacturers of America in the last six months. Read Full Article on Fierce Pharma >>
// 4th Industrial Revolution
AI Partnership to Reduce Hospital Nurses’ Documentation Burden
May 17, 2023 / AI / Nurses’ / BayCare – BayCare Health System and healthPrecision announced a strategic partnership to co-develop the company’s artificial intelligence (AI)-based Medical Brain platform, a clinical decision support solution aimed at reducing nurse documentation burden, improving patient care, and optimizing workflow efficiency. Read Full Article on Health IT Analytics >>
May 17, 2023 / AI / Nurses’ / BayCare – BayCare Health System and healthPrecision announced a strategic partnership to co-develop the company’s artificial intelligence (AI)-based Medical Brain platform, a clinical decision support solution aimed at reducing nurse documentation burden, improving patient care, and optimizing workflow efficiency. Read Full Article on Health IT Analytics >>
Smith+Nephew helps personalize robotically-enabled surgery with AI-powered planning software and data visualization platform
May 16, 2023 / AI / Smith+Nephew – The global medical technology company, today introduces two key products that close the feedback loop for its robotics and digital surgery portfolio – Personalized Planning powered by AI and RI.INSIGHTS Data Visualization Platform. Read Full Article on Biospace >>
May 16, 2023 / AI / Smith+Nephew – The global medical technology company, today introduces two key products that close the feedback loop for its robotics and digital surgery portfolio – Personalized Planning powered by AI and RI.INSIGHTS Data Visualization Platform. Read Full Article on Biospace >>
How ChatGPT can boost patient engagement and communication
May 17, 2023 / ChatGBT / AI – Patient engagement is top of mind for executives and clinicians at hospitals and health systems today. While there may be a need for more constant touchpoints with patients, that would bring with it an unintended physician burden. Read Full Article on Healthcare IT News >>
May 17, 2023 / ChatGBT / AI – Patient engagement is top of mind for executives and clinicians at hospitals and health systems today. While there may be a need for more constant touchpoints with patients, that would bring with it an unintended physician burden. Read Full Article on Healthcare IT News >>
Telehealth is here to stay, survey shows. How should the industry adapt?
May 15, 2023 / TeleHealth / Industry – Telehealth use skyrocketed early in the COVID-19 pandemic, accounting for a significant share of all doctors’ appointments at its peak. And while virtual visits have since dipped in volume, telehealth still supports millions of appointments each year. But will the trend continue? Read Full Article on Fierce Pharma >>
May 15, 2023 / TeleHealth / Industry – Telehealth use skyrocketed early in the COVID-19 pandemic, accounting for a significant share of all doctors’ appointments at its peak. And while virtual visits have since dipped in volume, telehealth still supports millions of appointments each year. But will the trend continue? Read Full Article on Fierce Pharma >>
Amazon Omics announces direct upload to storage and new automated capabilities
May 16, 2023 / Amazon Omics / New Functionalities – At the annual AWS Life Sciences Executive Symposium, Amazon announced new Amazon Omics capabilities to help customers build, run and scale 35 Ready2Run workflows by Element Biosciences, NVIDIA and Sentieon Inc.
Read Full Article on Healthcare IT News >>
May 16, 2023 / Amazon Omics / New Functionalities – At the annual AWS Life Sciences Executive Symposium, Amazon announced new Amazon Omics capabilities to help customers build, run and scale 35 Ready2Run workflows by Element Biosciences, NVIDIA and Sentieon Inc.
Read Full Article on Healthcare IT News >>
// Business & Markets
CVS Health Winding Down Clinical Trial Business
May 17, 2023 / CVS Health / Clinical Trials – CVS Health is shuttering its clinical trial business two years after announcing the initiative, a spokesperson told BioSpace. Read Full Article on Biospace >>
May 17, 2023 / CVS Health / Clinical Trials – CVS Health is shuttering its clinical trial business two years after announcing the initiative, a spokesperson told BioSpace. Read Full Article on Biospace >>
Amgen ‘Remains Committed’ to $27.8B Horizon Acquisition After FTC Challenge
May 16, 2023 / Amgen / Horizon Acquisition / FTC Challenge – Amgen and Horizon Therapeutics are gearing up for a fight after the Federal Trade Commission sued Tuesday to block the California-based biopharma giant from closing a $27.8 billion deal to acquire Ireland-based Horizon. Read Full Article on Biospace >>
May 16, 2023 / Amgen / Horizon Acquisition / FTC Challenge – Amgen and Horizon Therapeutics are gearing up for a fight after the Federal Trade Commission sued Tuesday to block the California-based biopharma giant from closing a $27.8 billion deal to acquire Ireland-based Horizon. Read Full Article on Biospace >>
Kaiser Permanente announces $3M in new AI and ML grants
May 18, 2023 / Kaiser Permanente / AI / Healthcare / ML Grant – The Permanente Medical Group this week announced the new Kaiser Permanente Northern California Division of Research Augmented Intelligence in Medicine and Healthcare Initiative Coordinating Center, or AIM-HI. Read Full Article on Healthcare IT News >>
May 18, 2023 / Kaiser Permanente / AI / Healthcare / ML Grant – The Permanente Medical Group this week announced the new Kaiser Permanente Northern California Division of Research Augmented Intelligence in Medicine and Healthcare Initiative Coordinating Center, or AIM-HI. Read Full Article on Healthcare IT News >>
AstraZeneca Deepens Gene Editing Capabilities with Revvity Partnership
May 18, 2023 / AstraZeneca / Gene Editing / Revvity – AstraZeneca inked a non-exclusive licensing agreement with Revvity for access to the Massachusetts biotech’s proprietary gene editing technology to develop cell therapies for cancer and immune-mediated conditions, Revvity announced Thursday. Read Full Article on Biospace >>
May 18, 2023 / AstraZeneca / Gene Editing / Revvity – AstraZeneca inked a non-exclusive licensing agreement with Revvity for access to the Massachusetts biotech’s proprietary gene editing technology to develop cell therapies for cancer and immune-mediated conditions, Revvity announced Thursday. Read Full Article on Biospace >>
AstraZeneca Expands ADC Portfolio with $600M Deal with LaNova
May 15, 2023 / AstraZeneca / LaNova / ADC Portfolio – As antibody-drug conjugates make a steady comeback, AstraZeneca strikes its second deal this year with a Chinese company. The Cambridge-based biopharma announced Friday it’s putting potentially $600 million on the line for LaNova Medicines’ preclinical stage ADC. Read Full Article on Biospace >>
May 15, 2023 / AstraZeneca / LaNova / ADC Portfolio – As antibody-drug conjugates make a steady comeback, AstraZeneca strikes its second deal this year with a Chinese company. The Cambridge-based biopharma announced Friday it’s putting potentially $600 million on the line for LaNova Medicines’ preclinical stage ADC. Read Full Article on Biospace >>
// Legal & Regulatory
AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease
May 18, 2023 / AbbVie / FDA Approval / Oral Drug / Crohn’s Disease – FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors. Read Full Article on Med City News >>
May 18, 2023 / AbbVie / FDA Approval / Oral Drug / Crohn’s Disease – FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors. Read Full Article on Med City News >>
Regulatory tracker: AbbVie’s Rinvoq, Bristol Myers Squibb’s Sotyktu get nods in the UK
May 18, 2023 / U.S. FDA / NICE – TFierce Pharma is reintroducing the Pharma Regulatory Tracker. Here, we’re recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Read Full Article on Fierce Pharma >>
May 18, 2023 / U.S. FDA / NICE – TFierce Pharma is reintroducing the Pharma Regulatory Tracker. Here, we’re recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Read Full Article on Fierce Pharma >>
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen
May 18, 2023 / Sanofi / Regeneron Pharmaceuticals / Praluent / Amgen – After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court. Read on Fierce Pharma >>
May 18, 2023 / Sanofi / Regeneron Pharmaceuticals / Praluent / Amgen – After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court. Read on Fierce Pharma >>
AbbVie’s Rinvoq scores its 7th FDA nod, this one for Crohn’s disease
May 18, 2023 / AbbVie / Rinvoq / FDA / Humira – In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it. Read on Fierce Pharma >>
May 18, 2023 / AbbVie / Rinvoq / FDA / Humira – In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it. Read on Fierce Pharma >>
Supreme Court Denies Teva’s Challenge to $235M GSK Award in Patent Dispute
May 16, 2023 / Supreme Court / Teva / GSK Award –The U.S. Supreme Court has denied Teva Pharmaceuticals a hearing for its appeal of a 2020 appellate court ruling over a patent dispute with GlaxoSmithKline, according to a High Court order form released Monday. Read on Biospace >>
May 16, 2023 / Supreme Court / Teva / GSK Award –The U.S. Supreme Court has denied Teva Pharmaceuticals a hearing for its appeal of a 2020 appellate court ruling over a patent dispute with GlaxoSmithKline, according to a High Court order form released Monday. Read on Biospace >>
// Research & Development
Roche’s MS Drug Hits Phase II Mark, Rivals Remain Under Clinical Holds
May 17, 2023 / Roche / MS Drug / Clinical Holds – Roche confirmed its slot in the race to bring a Bruton’s tyrosine kinase inhibitor to multiple sclerosis on Wednesday as its subsidiary Genentech announced its candidate met the mark in a Phase II trial. Read Full Article on BioSpace >>
May 17, 2023 / Roche / MS Drug / Clinical Holds – Roche confirmed its slot in the race to bring a Bruton’s tyrosine kinase inhibitor to multiple sclerosis on Wednesday as its subsidiary Genentech announced its candidate met the mark in a Phase II trial. Read Full Article on BioSpace >>
Lilly’s Prevail, Doudna’s Scribe Partner on Genetic Treatments for Neuro Diseases
May 17, 2023 / Eli Lilly / Genetic Treatments – Tuesday, Jennifer Doudna-founded Scribe Therapeutics and Eli Lilly subsidiary Prevail entered into a strategic collaboration to develop CRISPR-based genetic medicines for neurological and neuromuscular indications. Read Full Article on Biospace >>
May 17, 2023 / Eli Lilly / Genetic Treatments – Tuesday, Jennifer Doudna-founded Scribe Therapeutics and Eli Lilly subsidiary Prevail entered into a strategic collaboration to develop CRISPR-based genetic medicines for neurological and neuromuscular indications. Read Full Article on Biospace >>
PTC, chasing BioMarin, posts phase 3 rare disease win but fails to silence skeptics
May 18, 2023 / PTC Therapeutics / BioMarin Pharmaceutical / Clinical Trial Data / Rare Diseases – PTC Therapeutics’ phase 3 clinical trial in the rare inherited disorder phenylketonuria (PKU) has met its primary endpoint. And yet, the design of the study means analysts remain unsure about the strength of PTC’s hand and whether it can rival BioMarin’s Kuvan and live up to its $400 million peak sales forecast. Read Full Article on Fierce Biotech >>
May 18, 2023 / PTC Therapeutics / BioMarin Pharmaceutical / Clinical Trial Data / Rare Diseases – PTC Therapeutics’ phase 3 clinical trial in the rare inherited disorder phenylketonuria (PKU) has met its primary endpoint. And yet, the design of the study means analysts remain unsure about the strength of PTC’s hand and whether it can rival BioMarin’s Kuvan and live up to its $400 million peak sales forecast. Read Full Article on Fierce Biotech >>
Biotech Breakthroughs: How Puerto Rico’s Unique Advantages Drive Innovation
May 18, 2023 / Drug Discovery / Industry News / Resources – Join this GEN webinar, sponsored by Invest Puerto Rico, where we will explore the latest innovations in biotech and how they are accelerating drug development in Puerto Rico. Our expert panelists, including Rafael Perez, Senior Business Development Director for Invest Puerto Rico, and Jose Rodriguez-Orengo, PhD, CEO of MBQ Pharma, will discuss the advantages of doing biotech in Puerto Rico. Read Full Article on Genetic Engineering & Biotechnology News >>
May 18, 2023 / Drug Discovery / Industry News / Resources – Join this GEN webinar, sponsored by Invest Puerto Rico, where we will explore the latest innovations in biotech and how they are accelerating drug development in Puerto Rico. Our expert panelists, including Rafael Perez, Senior Business Development Director for Invest Puerto Rico, and Jose Rodriguez-Orengo, PhD, CEO of MBQ Pharma, will discuss the advantages of doing biotech in Puerto Rico. Read Full Article on Genetic Engineering & Biotechnology News >>
Novavax’s New CEO Leads Vaccine Trial Success, and Big Layoffs Too
May 13, 2023 / Novavax’s / Vaccine / Trial Success – Novavax investors have been on edge ever since the company fell behind in the coronavirus vaccine race. To make matters worse, earlier this year, Novavax even questioned its ability to continue operations. Read Full Article on The Motley Fool >>
May 13, 2023 / Novavax’s / Vaccine / Trial Success – Novavax investors have been on edge ever since the company fell behind in the coronavirus vaccine race. To make matters worse, earlier this year, Novavax even questioned its ability to continue operations. Read Full Article on The Motley Fool >>
// Politics
SCOTUS Rules Against Amgen in PCSK9 Patent Dispute with Sanofi, Regeneron
May 18, 2023 / SCOTUS / Sanofi / Amgen – The U.S. Supreme Court unanimously sided with pharmaceutical companies Sanofi and Regeneron, ruling in their favor in a decade-long patent dispute with Amgen over the PCSK9 cholesterol drug, Repatha, in an opinion released Thursday. Read Full Article on Biospace >>
May 18, 2023 / SCOTUS / Sanofi / Amgen – The U.S. Supreme Court unanimously sided with pharmaceutical companies Sanofi and Regeneron, ruling in their favor in a decade-long patent dispute with Amgen over the PCSK9 cholesterol drug, Repatha, in an opinion released Thursday. Read Full Article on Biospace >>
US Appeals Court Panel Questions FDA Due Diligence on Abortion Pill
May 18, 2023 / US Appeals / Abortion Pill / FDA – A three-judge panel in Louisiana’s 5th Circuit Court of Appeals proffered probing questions during oral arguments Wednesday about whether the FDA had done due diligence before it made changes in recent years that made the abortion pill, mifepristone, more accessible. Read Full Article on Biospace >>
May 18, 2023 / US Appeals / Abortion Pill / FDA – A three-judge panel in Louisiana’s 5th Circuit Court of Appeals proffered probing questions during oral arguments Wednesday about whether the FDA had done due diligence before it made changes in recent years that made the abortion pill, mifepristone, more accessible. Read Full Article on Biospace >>
How Vivek Ramaswamy made a fortune before pivoting to politics
May 14, 2023 / Vivek / Ramaswamy / Entrepreneurs – The flush of cash highlighted Axovant’s then-29-year-old CEO, Vivek Ramaswamy, whose jump from hedge fund analyst to biotech executive attracted headlines and put his net worth in the hundreds of millions. Since that 2015 offering, Ramaswamy spun out other pharmaceutical companies, founded an “anti-woke” financial firm, wrote two books and became a semi-regular cable news commentator. Read Full Article on Politico >>
May 14, 2023 / Vivek / Ramaswamy / Entrepreneurs – The flush of cash highlighted Axovant’s then-29-year-old CEO, Vivek Ramaswamy, whose jump from hedge fund analyst to biotech executive attracted headlines and put his net worth in the hundreds of millions. Since that 2015 offering, Ramaswamy spun out other pharmaceutical companies, founded an “anti-woke” financial firm, wrote two books and became a semi-regular cable news commentator. Read Full Article on Politico >>
Security needed in second phase of Biden’s presidency
May 14, 2023 / Biden / Security – If you had asked me that question in 2021, I would have said the Biden administration’s chief purpose is to narrow the economic chasm. America is bitterly divided between highly educated people who live in places that are thriving and less educated people who live in places that are left behind. Read Full Article on Las Vegas Sun >>
May 14, 2023 / Biden / Security – If you had asked me that question in 2021, I would have said the Biden administration’s chief purpose is to narrow the economic chasm. America is bitterly divided between highly educated people who live in places that are thriving and less educated people who live in places that are left behind. Read Full Article on Las Vegas Sun >>
House Republican deficit plan seen as shift in thinking on China
May 16, 2023 / House Republican / China – Federal spending on scientific research and development could face steep reductions under the House Republican plan to cut government funding to fiscal 2022 levels in exchange for lifting the debt ceiling — a move that advocates say could jeopardize competitiveness vis-a-vis China. Read Full Article on Microsoft Start >>
May 16, 2023 / House Republican / China – Federal spending on scientific research and development could face steep reductions under the House Republican plan to cut government funding to fiscal 2022 levels in exchange for lifting the debt ceiling — a move that advocates say could jeopardize competitiveness vis-a-vis China. Read Full Article on Microsoft Start >>
