// Biotech and Pharma Therapeutics
AstraZeneca withdraws COVID-19 vaccine, citing declining demand
May 8, 2024 / AstraZeneca / Covid-19 / Vaccine
Like other companies that successfully developed a coronavirus shot during the pandemic, AstraZeneca is grappling with a seismic shift in the market.
Amgen shares soar as executives outline obesity drug push
May 3, 2024 / Obesity / Novo Nordisk / Eli Lilly / Amgen
A possible rival to Novo Nordisk’s and Eli Lilly’s medicines looks promising enough to move into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.
San Diego biotech news: Local maker of mRNA used in COVID-19 vaccine opens new facility
May 8, 2024 / San Diego / TriLink BioTechnologies / Vaccines / mRNA
San Diego-based TriLink BioTechnologies went from working with a few local biotechs in 2019 to months later helping pharmaceutical giants Pfizer-Biontech deliver the life-saving, COVID-19 vaccine globally.
Program to prepare next generation of biotech experts receives renewed funding
April 30, 2024 / Eli Lilly / Obesity / Diabetes / New Drug / Drug Development / GLP-1
The Rhode Island IDeA Network of Biomedical Research Excellence (RI-INBRE) program will continue preparing students to be the next leaders in the state’s biotechnology industries after receiving renewed funding from the Rhode Island Department of Labor and Training.
Snoop Dogg-backed cannabis biotech startup to quit ‘turbulent’ London stock market
May 8, 2024 / London / Snoop Dogg / Startup
A British biotech start-up backed by Snoop Dogg has unveiled plans to ditch the “turbulent” London stock market, dealing a fresh blow to the beleaguered exchange.
// 4th Industrial Revolution
Large language models, other GenAI options stimulating tech purchasing in healthcare
April 30, 2024 / GenAI / Healthcare / New Tech
Budgeting for generative AI in healthcare has skyrocketed, albeit in pockets, by as much as 300% year over year, according to a survey of technology decision-makers spanning providers, vendors and other employers in the healthcare sector.
Cedars-Sinai research shows deep learning model could improve AFib detection
May 8, 2024 / Cedars-Sinai / AFib / Deep Learning
Trained using more than 100,000 echocardiograms from atrial fibrillation cases, the algorithm has shown its ability to predict which patients could develop irregular heart rhythms within 90 days.
Oncology Care Partners’ digital transformation: AI, CDS and virtual care
May 8, 2024 / Oncology / AI / Virtual Care / SVP / Digital Health
The group practice’s SVP of digital health reveals how she and her team have created new care models, integrated artificial intelligence-enabled clinical decision support and used other emerging technologies to power better care journeys.
Getting Ready for Generative AI in Academic Medical Centers
May 1, 2024 / MedTech / FDA Approval / AI / Healthcare / Patient Monitoring / Digital Healthcare
This video provides a wide-ranging discussion of data acquisition, analytics, and AI in health care involving Dr. Keith Morse, MD, Professor, Pediatrics, and Medical Director of Clinical Informatics at Stanford Children’s Health, and Dr. Armando Bedoya, MD, Chief Analytics and Medical Informatics Officer at Duke Health.
Machine learning reveals link between metabolites and Alzheimer’s
May 3, 2024 / Alzheimer’s / Cleveland Clinic / Machine Learning
A team of researchers from Cleveland Clinic found that machine learning can help characterize how gut microbial metabolites and cell receptors interact to influence Alzheimer’s disease, according to a recent study in Cell Reports.
// Business & Markets
Chiesi and Gossamer collaborate to develop drug to treat respiratory diseases
May 8, 2024 / Chiesi / Gossamer / Drug Development / Respiratory Disease
Chiesi Group and Gossamer Bio have announced a global collaboration and license agreement to develop and commercialise seralutinib to treat respiratory diseases.
High costs, investor exit prompt closure of cell therapy biotech Walking Fish
May 7, 2024 / Cell Therapy / Layoffs / Biotech Graveyard
CEO Rusty Williams, M.D., Ph.D., said in an interview with Fierce Biotech that the company was on the precipice of securing fresh capital to enter the clinic when an unnamed top investor backed out, citing concerns about the cost of a multiyear lease.
Top 10% Biotech Stock Catalyst Pharma Doubles Wall Street’s Profit Views
May 8, 2024 / Catalyst Pharma / Firdapse
During the March quarter, Catalyst earned an adjusted 40 cents per share on $98.4 million in sales. Earnings handily beat projections for 20 cents a share, while sales were narrowly below forecasts for $98.8 million, according to FactSet. Sales grew 15.4%, while earnings fell 9.1%.
Krystal Biotech adds to revenue despite challenges in Q1
May 6, 2024 / Krystal Biotech / Pittsburgh
The Pittsburgh-based biotech firm, whose Vyjuvek treats a rare skin disease, dealt with two issues beyond its control in the first quarter.
How Moderna’s cost-cutting moves hit a Bay Area biotech
May 2, 2024 / Moderna / Bay Area / Vaccines
As the vaccine-maker works toward expanding its approved products, it is prioritizing certain R&D efforts and eliminating others.
// Legal & Regulatory
Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg
May 8, 2024 / Pfizer / Zantac / Litgation / Sanofi
Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg, citing anonymous sources.
The FDA approves Apple Watch’s heart monitoring tool for use in clinical trials
May 6, 2024 / FDA / Clinical Trials / Apple
The FDA announced the Apple Watch atrial fibrillation (AFib) tool is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, enabling researchers to use it to detect arrhythmias or abnormal heart beat.
UPC issues preliminary injunction in DNA kits patent spat
May 2, 2024 / UPC / DNA / Curio Bioscience
The Unified Patent Court (UPC) has ordered biotech company Curio Bioscience to stop selling certain nucleic acid detecting kits in Germany, Sweden and France as they have been found to infringe the patent of its rival 10x Genomics.
FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay
May 6, 2024 / FTC / Novo Holdings / Catalent
Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.
Teva Pharmaceuticals Loses Bid to Toss Inhaler Antitrust Claims
May 8, 2024 / Teva Pharmaceuticals / Antitrust Claims
Teva Pharmaceutical Industries Ltd. will face antitrust claims that it hampered generic competition in the asthma inhaler market after a federal judge denied the company’s bid to toss those allegations.
// Research & Development
Cell therapy fails to slow early type 1 diabetes, but safety is established
May 8, 2024 / Cell Therapy / Type 1 Diabetes / Autoimmune Disease
Tolerance is the holy grail in calming autoimmune disease, a truce in the immune system’s faulty battle against the body’s own fabric. In type 1 diabetes, immune fighters attack beta cells in the pancreas that produce insulin, the hormone that controls glucose levels in the blood.
International phase 3 clinical trial for new melanoma treatment recruits first patients
May 3, 2024 / Clinical Trials / Melanoma Treatments / Moderna / Merck & Co.
A phase 3 international trial evaluating a new personalised immunotherapy treatment for melanoma has recruited its first patients at University College London Hospitals (UCLH) NHS Foundation Trust.
Pfizer Halts Dosing in Late-Stage DMD Study Following Death of Young Patient
May 8, 2024 / Pfizer / DMD Study / Gene Therapy
Pfizer on Tuesday announced that a patient died in the Phase II DAYLIGHT study, evaluating its investigational gene therapy fordadistrogene movaparvovec in Duchenne muscular dystrophy.
Johns Hopkins scientists depict molecular pathway to track replication in cancer cells
May 8, 2024 / Cancer Cells / Johns Hopkins / Molecular Pathways
Johns Hopkins Medicine scientists have revealed a molecular pathway that lures cells down a path of genome duplication, a hallmark of cancer cells, which could potentially lead to new therapies and could stop the growth of cancers.
Regeneron gene therapy improves hearing in two children
May 8, 2024 / Regeneron / Gene Therapy Deafness / Eli Lilly
Regeneron’s announcement follows news that Eli Lilly’s competing experimental gene therapy gave an 11-year-old boy who was born deaf the ability to hear. The treatment, which Lilly acquired in a buyout of biotechnology company Akouos, also targets otoferlin.
// Politics
Senators float Medicare program that would offer incentive payments to combat drug shortages
May 8, 2024 / Drug Shortage / Medicare / Drug Purchasing / Senate Committee on Finance
In a recent draft proposal, lawmakers from the Senate Finance Committee introduced a new voluntary Medicare program that could bolster purchasing patterns by offering incentive payments to various players in the healthcare ecosystem.
House lawmaker brings FDA into biosecurity crackdown on China
May 8, 2024 / FDA / China / Robert Califf
Amid a U.S. biosecurity crackdown on certain Chinese life sciences service providers, the House Committee on Oversight and Accountability is dialing up the pressure by unleashing a salvo of letters to different government agencies—including the U.S. Food and Drug Administration.
The Supreme Court is nearing the end of its term. Here are the major cases it still has to decide.
May 7, 2024 / The Supreme Court / Purdue Pharma / Bankruptcy
The Supreme Court has wrapped up arguments for its current term and until around the end of June, it will be handing down opinions for the remaining cases, among them, over a dozen involving hot-button issues including abortion, guns, homelessness, Purdue Pharma’s bankruptcy plan and the prosecution of former President Donald Trump.
Belgian innovative pharma sector urges government to prioritise competitiveness
April 29, 2024 / Belgian / EU pharma
The Belgian innovative pharmaceutical industry continues to grow, but competitiveness dynamics and EU pharma package revisions are causing uncertainty. Euractiv spoke in depth with Caroline Ven, CEO of pharma.be, about the sector’s concerns.
Opioid epidemic reaches beyond health impacts to influence politics
May 2, 2024 / Opioid Epidemic / Politics / CDC / University of Notre Dame
And it undeniably is. According to the Centers for Disease Control and Prevention (CDC), drug overdose deaths in the United States topped 100,000 in 2022 — with nearly 83,000 of those deaths involving opioids. And over the past two decades, mortality from opioid overdoses in the U.S. has increased at an alarming rate, claiming the lives of more than 645,000 individuals. In that same 20-year period, nearly 280,000 people died from overdoses involving prescription opioids.