// Biotech and Pharma Therapeutics

Takeda, Denali drop Alzheimer’s asset after phase 1 peak reveals ‘narrow therapeutic window’
August 9, 2023 / Takeda / Denali Therapeutics / Alzheimer’s Disease – ProQR The Japanese Big Pharma took up the offer at the tail end of 2021 to co-develop the asset, an antibody transport vehicle (ATV) called DNL919 or TAK-920, but the program was soon hit by a clinical hold from the FDA due to a preclinical toxicology assessment. While the drug eventually entered the clinic in July 2022, it seems that the early data have raised some alarm bells. Read Full Article on Fierce Biotech >>
Regeneron adds Decibel to gene therapy playlist, turning up volume on long-running hearing loss collaboration
August 9, 2023 / Decibel Therapeutics / Regeneron Pharmaceuticals / Cell & Gene Therapy / Mergers & Acquisitions – Regeneron and Decibel were already working together through a 2017 collaboration for three gene therapies for different forms of congenital, monogenic hearing loss. Decibel’s lead hearing loss candidate is DB-OTO, which is currently moving through a phase 1/2 trial called CHORD for individuals with hearing loss caused by mutations of the otoferlin gene. Read Full Article on Fierce Biotech>>
Report: Fewer Adults Are Interested in Weight Loss Drugs If Not Covered by Insurance
August 7, 2023 / Obesity / Insurance – However, just 16% of adults are still interested in taking weight-loss drugs if they’re not covered by insurance. In addition, KFF found that only 14% of adults are still interested in taking the drugs if they heard they could gain weight back after going off the drug, 16% would be interested if it wasn’t approved by the FDA for weight loss but was approved for another use, 23% would be interested if it was self-administered as a weekly injection and 44% would be interested if it could be taken as a pill. Read Full Article on Med City News >>
Is DEA putting a telehealth controlled substance registry on the table?
August 7, 2023 / DEA / Telehealth / Healthcare – The American Telemedicine Association released a statement on Friday saying that it applauds the Drug Enforcement Agency for posting a meeting notice on Friday that indicates that it is “openly considering” a special registration that would allow providers to prescribe medically necessary substances by telehealth. Read Full Article on Biopharma Dive >>
Novo’s Wegovy Protects Heart Health in Overweight, Obese Adults
August 8, 2023 / Novo Nordisk / Obesity / Cardiovascular – Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday. Read Full Article on Biospace >>

// 4th Industrial Revolution

Google, ChatGPT: Inadequate Dementia Resources Despite Strengths
August 9, 2023 / Google / ChatGPT / Dementia / Alzhemier’s – A new study from the University of California, Riverside (UCR) indicated that Google and ChatGPT contained positive features such as up-to-date and nonbiased information. When used effectively, these tools can provide resources for Alzheimer’s and dementia. Read Full Article on Health IT Analytics >>
Deep Learning Model Detects Diabetes Using Routine Chest Radiographs
August 8, 2023 / Emory University / Deep Learning / Diabetes – Researchers at Emory University have validated a deep learning (DL) model capable of detecting early warning signs of diabetes using routinely collected chest radiographs and electronic health record data (EHR) in patients who do not meet the guidelines for elevated risk. Read Full Article on Health IT Analytics >>
Healthcare software and firmware risks up 59%, says H-ISAC
August 8, 2023 / Healthcare / New Tech / Medical Devices / Health IT – The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the critical and high-rated vulnerabilities that put the underpinning software and firmware of connected medical devices and healthcare applications at greater risk than they have ever been before. Read Full Article on Healthcare IT News >>
What ChatGPT Means for Virtual-First Care
August 8, 2023 / Chat GPT / Healthcare / Virtual Care – ChatGPT has been dominating headlines since its release in November. While the AI Chatbot has already led to some truly whimsical poetry, comedic greetings, and helpful travel suggestions, it has also started to raise questions about its application in healthcare. Read Full Article on Healthcare IT Today >>
Ransomware attack shuts down hospital emergency rooms in several states
August 8, 2023 / Ransomeware / Healthcare / California – A large ransomware attack has wreaked havoc on Prospect Medical Holdings, a California-based health system operating 17 hospitals and 165 outpatient facilities in four states, my colleague Annalisa Merelli tells us. Read Full Article on STAT News >>

// Business & Markets

J&J’s Stelara settlement streak rolls on with Fresenius Kabi, Formycon deal
August 7, 2023 / Johnson & Johnson / Fresenius Kabi / Amgen / Biosimilars – By inking a third Stelara patent settlement, Johnson & Johnson is getting more clarity around the forthcoming loss of exclusivity for its top product by sales. Read Full Article on Fierce Pharma >>
Lilly Beats Q2 Estimates, Increases Revenue Forecast on Strong Mounjaro Demand
August 8, 2023 / Eli Lilly / Q2 / Diabetes – Eli Lilly bumped up its full-year forecast after the company exceeded revenue expectations in the second quarter. Profit jumped 85% from the same period a year ago, with shares up 9% in premarket trading Tuesday morning on the news. Read Full Article on BioSpace >>
BioNTech sheds €400M from full-year R&D spending guidance to ‘increase cost consciousness’
August 7, 2023 / BioNTech / Costs / Pfizer / Covid-19 – BioNTech has cut full-year R&D expense guidance by 400 million euros ($440 million) as part of a “company-wide cost optimization” effort, though management relayed few details on the extent of the plans. Read Full Article on Fierce Biotech >>
Lilly market value soars on higher sales, obesity drug potential
August 8, 2023 / Eli Lilly / Alzheimer’s / Drugmaker’s – Eli Lilly became the most valuable healthcare company in the U.S. after a stock price surge Tuesday morning propelled the Indianapolis drugmaker’s market value above $500 billion for the first time in its 147-year history. Read Full Article on Biopharma Dive >>
VistaGen Stock Soars 1,000% After Phase III Social Anxiety Win
August 8, 2023 / VistaGen / Anxiety – VistaGen Therapeutics on Monday posted positive topline data from the Phase III PALISADE-2 trial, showing that its investigational nasal spray fasedienol met its primary endpoint, strongly easing distress among patients with social anxiety disorder. Read Full Article on BioSpace >>

// Legal & Regulatory

Takeda shells out $42M to settle Medicaid fraud claims in Texas
August 9, 2023 / Takeda / Shire / Baxter International / Baxalta – After a whistleblower lawsuit accused Takeda and its subsidiaries of Medicaid fraud through illegal reimbursement arrangements and paid referrals in Texas, the company has agreed to pay more than $42 million to settle the claims. Read on Fierce Pharma >>
Drugmakers Promised Cheaper Insulin but Diabetics Can’t Find It
August 9, 2023 / Drugmakers / Diabetics / Eli Lilly – So when drugmaker Eli Lilly & Co. cut the list price this spring of its generic insulin, Lispro, to $25 a vial, the 32-year-old nonprofit executive from Shelton, Conn. set out to find it at area pharmacies. Read Full Article on Bloomberg Law >>
Guardant and Illumina bury the legal hatchet, ink cancer partnership
August 9, 2023 / Illumina / Guardant Health / Lawsuits / DNA Sequencing – What’s a little litigation between friends? After accusing Guardant Health and its founders of absconding with company secrets more than 10 years ago, Illumina has opted to drop its lawsuit in favor of a new commercial partnership deal. Read Full Article on Fierce Biotech >>
Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis
August 7, 2023 / FDA / New Drug / Mapi Pharma / Viatris – Viatris President Rajiv Malik said, “The NDA filing acceptance for GA Depot is yet another example of our continuous commitment to look for opportunities to enhance existing therapies and innovation to support unmet medical needs. Our application is backed by Phase III efficacy and safety data, and we believe, when approved, GA Depot could improve patient experience through fewer injections, greater tolerability and increased compliance. This milestone gives us further confidence in the strength of our GA Depot clinical program, and we look forward to continuing to work closely with FDA to bring access to this important complex medicine to patients.” Read on Cision PR Newswire >>
Two lots of Tydemy birth control pills are under recall. The FDA warns of ‘reduced effectiveness’
August 3, 2023 / Tydemy / Birth Control Pills / FDA –Federal regulators are warning consumers that now-recalled lots of the Tydemy birth control pill “may have reduced effectiveness” due to decreased levels of a key ingredient of the product. Read on abc News >>

// Research & Development

Novo obesity drug protects heart health in large trial
August 8, 2023 / Novo / Obesity / Cardiovascular – Wegovy, one of several drugs now surging in popularity due to their potent weight-loss effects, can also protect the heart, according to results from a large international study called SELECT. Read Full Article on Biopharma Dive >>
Novartis says drug helps control chronic hives in studies
August 9, 2023 / Novartis / Chronic Hives / BTK Inhibitors – Remibrutinib is part of a new generation of drugs called BTK inhibitors, which are best known as treatments for blood cancers. Recent research suggests the medicines have promise in a range of conditions, and Novartis is also studying remibrutinib in patients with multiple sclerosis, food allergies, hidradenitis suppurativa and Sjögren’s syndrome. Read Full Article on Biopharma Dive >>
Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges
August 9, 2023 / Novartis / Phase II / Sanofi – With Xolair’s patents set to expire over the next year, Novartis has been looking to strengthen its grip on the chronic spontaneous urticaria market. Thursday, the Swiss pharma shared positive Phase III results for chronic hives with its BTK inhibitor and announced plans to submit for regulatory approval next year. Read Full Article on BioSpace >>
Takeda, Denali Scrap Phase I Alzheimer’s Drug Showing ‘Narrow Therapeutic Window’
August 9, 2023 / Takeda / Alzhemier’s / Denali Therapeutics – The two companies first partnered back in 2018 to investigate three different targets for neurodegenerative disorders. Later, in late 2021, they agreed to go forward with a drug collaboration using an antibody transport vehicle (ATV) called DNL919, to activate the TREM2 receptor. Read Full Article on BioSpace >>
Bavarian Nordic Touts Second Round of Positive Phase III Chikungunya Vaccine Data
August 7, 2023 / Vaccine / Bavarian Nordic – The competitive race to develop an effective chikungunya vaccine is heating up, after Danish biotech Bavarian Nordic posted positive Phase III results for its vaccine candidate—the second late-stage trial data in as many months. Read Full Article on BioSpace >>

// Politics

California Battles Fentanyl With a New Tactic: Treating Addiction in Prison
August 9, 2023 / California / Opioids / Overdose – The federal government estimates that a majority of incarcerated Americans have substance use disorder, many of them with opioid addiction that can be complicated to manage in the age of potent synthetic opioids like fentanyl. Deaths in state prisons from drug or alcohol intoxication rose by more than 600 percent from 2001 to 2019, according to the Justice Department. Read Full Article on New York Times>>
Biden Administration Proposes Significant Changes to Regulations Implementing the National Environmental Policy Act
August 8, 2023 / Biden Administration / Environmental Policy Act – The energy transition and increased public focus on environmental issues have strained the existing regulatory regime including the National Environmental Policy Act (NEPA). NEPA directs agencies to conduct environmental assessments before taking “major federal actions.” Read Full Article on The National Law Review >>
Senator wants Google to answer for accuracy, ethics of generative AI tool
August 9, 2023 / Senator / Google / AI – Sen. Mark Warner, D-Virginia, wrote a letter to Sundar Pichai, CEO of Google parent company Alphabet, on Aug. 8, seeking clarity into the technology developer’s Med-PaLM 2, an artificial intelligence chatbot, and how it’s being deployed and trained in healthcare settings. Read Full Article on Healthcare IT News >>
Legislators Will Seek to Cap Prescription Drug Prices in Virginia
August 5, 2023 / Legislators / Drug Prices / Virginia – Armed with an AARP poll showing strong public support for the idea, a bipartisan duo of state legislators will urge the Virginia General Assembly next year to create an agency to review prescription drug prices and limit how much pharmaceutical companies can charge for certain medications. Read Full Article on AARP >>
Cannabis industry scales back its lobbying in Washington
August 1, 2023 / Cannabis Industry / Pullback – Curaleaf, one the largest cannabis companies in the world, spent nearly 40% less on lobbying in the first half of 2023 than it did at its peak in 2019. Others like Columbia Care and Pax Labs got rid of their entire lobbying teams. Of the four major cannabis industry coalitions that have been pushing for federal legalization of marijuana the longest, one has seen its revenue cut in half; two others appear to have folded completely. Together, their spending on advocacy has dipped by more than 50% since 2019, back when federal weed lobbying was at its height. Read Full Article on STAT News >>