// 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.
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.
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.
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.
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.
// 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.
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.
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.
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?
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.
// 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.
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.
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.
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.
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.
// 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.
Regulatory tracker: AbbVie’s Rinvoq, Bristol Myers Squibb’s Sotyktu get nods in the UK
May 18, 2023 / U.S. FDA / NICE
Fierce 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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
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.