// Biotech and Pharma Therapeutics
Obesity drug shortage expands to Saxenda as Novo Nordisk warns of limited supply for 2023 and beyond
July 19, 2023 / Novo Nordisk / Saxenda / Weight Loss / Obesity Drugs – After Novo Nordisk’s popular obesity medicine Wegovy went into short supply, people turned to the company first-generation weight-loss drug, Saxenda, for treatment. Now, the company is struggling to handle demand for that product. Read Full Article on Fierce Pharma >>
July 19, 2023 / Novo Nordisk / Saxenda / Weight Loss / Obesity Drugs – After Novo Nordisk’s popular obesity medicine Wegovy went into short supply, people turned to the company first-generation weight-loss drug, Saxenda, for treatment. Now, the company is struggling to handle demand for that product. Read Full Article on Fierce Pharma >>
Sanofi expands research deal with gene editing startup Scribe
July 17, 2023 / Sanofi / Startup / Scribe / Cancer / Gene Editing – Scribe and Sanofi initially inked a partnership in September for the pharmaceutical company to gain access to the startup’s ex vivo gene editing technology. Its plan was to use the platform to develop cancer cell therapies. Read Full Article on Biopharma Dive >>
July 17, 2023 / Sanofi / Startup / Scribe / Cancer / Gene Editing – Scribe and Sanofi initially inked a partnership in September for the pharmaceutical company to gain access to the startup’s ex vivo gene editing technology. Its plan was to use the platform to develop cancer cell therapies. Read Full Article on Biopharma Dive >>
AstraZeneca bails on failed Pieris asthma asset, forcing the biotech to restructure, lay off 70% of staff
July 18, 2023 / Pieris / AstraZeneca / Layoffs / Asthma – AstraZeneca has sailed away from a licensing deal for Pieris Pharmaceuticals’ asthma med, forcing the biotech to begin charting a new corporate course and lay off 70% of its staff in the process. Read Full Article on Fierce Biotech >>
July 18, 2023 / Pieris / AstraZeneca / Layoffs / Asthma – AstraZeneca has sailed away from a licensing deal for Pieris Pharmaceuticals’ asthma med, forcing the biotech to begin charting a new corporate course and lay off 70% of its staff in the process. Read Full Article on Fierce Biotech >>
A stroke of good luck for Sangamo: Biotech snags $1B-plus biobucks deal with Lilly’s Prevail after layoffs, 2 other deals dissolve
July 17, 2023 / Prevail Therapeutics / Eli Lilly / Sangamo Therapeutics / Cell & Gene Therapy – After losing two Big Pharma partners in quick succession this spring, Sangamo Therapeutics has snagged a deal with Eli Lilly’s Prevail Therapeutics centering around its preclinical neurology adeno-associated virus (AAV) capsids. Read Full Article on Fierce Biotech >>
July 17, 2023 / Prevail Therapeutics / Eli Lilly / Sangamo Therapeutics / Cell & Gene Therapy – After losing two Big Pharma partners in quick succession this spring, Sangamo Therapeutics has snagged a deal with Eli Lilly’s Prevail Therapeutics centering around its preclinical neurology adeno-associated virus (AAV) capsids. Read Full Article on Fierce Biotech >>
Doctors Without Borders Calls on J&J to Stop Enforcing Sirturo Extended Patents
July 19, 2023 / Doctors Without Borders / Johnson & Johnson / Sirturo / Tuberculosis – The international non-profit, also known as Médecins Sans Frontières (MSF), is urging J&J to withdraw any pending secondary patent applications and to refrain from launching legal action against manufacturers that might export generic versions of Sirturo to countries where secondary patent protections are still in place. Read Full Article on BioSpace >>
July 19, 2023 / Doctors Without Borders / Johnson & Johnson / Sirturo / Tuberculosis – The international non-profit, also known as Médecins Sans Frontières (MSF), is urging J&J to withdraw any pending secondary patent applications and to refrain from launching legal action against manufacturers that might export generic versions of Sirturo to countries where secondary patent protections are still in place. Read Full Article on BioSpace >>
// 4th Industrial Revolution
Teladoc Health will integrate Microsoft AI for automated clinical documentation
July 18, 2023 / Teladoc Health / Microsoft AI / GPT4 / OpenAI – The virtual care company will integrate Microsoft Azure OpenAI Service, Azure Cognitive Services, and conversational and ambient clinical documentation solution Nuance Dragon Ambient eXperience (DAX) into Teladoc Health Solo. Solo is an enterprise platform that can be integrated with existing IT systems to offer virtual care. Read Full Article on Mobi Health News >>
July 18, 2023 / Teladoc Health / Microsoft AI / GPT4 / OpenAI – The virtual care company will integrate Microsoft Azure OpenAI Service, Azure Cognitive Services, and conversational and ambient clinical documentation solution Nuance Dragon Ambient eXperience (DAX) into Teladoc Health Solo. Solo is an enterprise platform that can be integrated with existing IT systems to offer virtual care. Read Full Article on Mobi Health News >>
Latest wearable sensor in Japan helps predict muscle fatigue
July 18, 2023 / Wearable Tech / New Tech / Japan / Muscle Fatigue – The study, whose findings were published in the journal ACS Sensors, verified the bubble-trapping mechanism of the novel sensor. It also found that the lactate measurement was not affected by sweat flow rate while sensor response remained stable for two hours. The sensor had also been tested on a volunteer who exercised on a stationary bike for about an hour. Read Full Article on Mobi Health News >>
July 18, 2023 / Wearable Tech / New Tech / Japan / Muscle Fatigue – The study, whose findings were published in the journal ACS Sensors, verified the bubble-trapping mechanism of the novel sensor. It also found that the lactate measurement was not affected by sweat flow rate while sensor response remained stable for two hours. The sensor had also been tested on a volunteer who exercised on a stationary bike for about an hour. Read Full Article on Mobi Health News >>
Deep Learning Model Accurately Detects Cardiac Function, Disease
July 17, 2023 / Deep Learning Model / Cardia Function / Valvular Disease – The study indicates that while chest radiographs provide a common and widely available option for cardiovascular examination and certain cardiac structures are visible using this method, the ability of chest radiographs to help classify valvular disease and cardiac function is not well understood. Read Full Article on Health IT Analytics >>
July 17, 2023 / Deep Learning Model / Cardia Function / Valvular Disease – The study indicates that while chest radiographs provide a common and widely available option for cardiovascular examination and certain cardiac structures are visible using this method, the ability of chest radiographs to help classify valvular disease and cardiac function is not well understood. Read Full Article on Health IT Analytics >>
Ensuring Healthcare AI/ML Models Aren’t “Failed Science Fair Projects”
July 18, 2023 / Healthcare / Artificial Intelligence / Machine Learning – According to a survey by the Society of Actuaries, 93% of healthcare organizations (HCOs) believe leveraging predictive analytics is key to the future of their business, but a staggering 87% of all data science projects never actually make it into production. HCOs implementing AI must also address healthcare-specific challenges, accounting for everything from defining episodes of care with dynamic healthcare terminologies to ensuring clinical adoption of predictions. Read Full Article on HIT Consultant >>
July 18, 2023 / Healthcare / Artificial Intelligence / Machine Learning – According to a survey by the Society of Actuaries, 93% of healthcare organizations (HCOs) believe leveraging predictive analytics is key to the future of their business, but a staggering 87% of all data science projects never actually make it into production. HCOs implementing AI must also address healthcare-specific challenges, accounting for everything from defining episodes of care with dynamic healthcare terminologies to ensuring clinical adoption of predictions. Read Full Article on HIT Consultant >>
Advice Given by ChatGPT Vs. Human Providers Is Nearly Indistinguishable, NYU Study Says
July 17, 2023 / Chat GPT / NYU / Healthcare – The study, which was conducted by NYU researchers in January, was meant to assess the feasibility of using ChatGPT or similar large language models to answer the long list of questions that providers face in the electronic health record. It concluded that the use of LLMs like ChatGPT could be an effective way to streamline healthcare providers’ communication with patients. Read Full Article on Med City News >>
July 17, 2023 / Chat GPT / NYU / Healthcare – The study, which was conducted by NYU researchers in January, was meant to assess the feasibility of using ChatGPT or similar large language models to answer the long list of questions that providers face in the electronic health record. It concluded that the use of LLMs like ChatGPT could be an effective way to streamline healthcare providers’ communication with patients. Read Full Article on Med City News >>
// Business & Markets
A cancer biotech’s collapse gives Neurogene a path to Wall Street
July 18, 2023 / Cancer / Gene Therapy / Startup / Neurogene – The new company will operate under the name Neurogene, be led by its management team and trade on the Nasdaq stock exchange with the ticker symbol “NGNE.” The startup’s shareholders will own 84% of the company, with Neoleukin stockholders getting the remainder. Read Full Article on Biopharma Dive >>
July 18, 2023 / Cancer / Gene Therapy / Startup / Neurogene – The new company will operate under the name Neurogene, be led by its management team and trade on the Nasdaq stock exchange with the ticker symbol “NGNE.” The startup’s shareholders will own 84% of the company, with Neoleukin stockholders getting the remainder. Read Full Article on Biopharma Dive >>
Novartis buys a preclinical biotech and its RNA drug technology
July 17, 2023 / Novartis / RNA / New Tech / DTx Pharma / Neurological Disease – Small, interfering RNA, or siRNA, drugs work by disrupting the way cells translate DNA into proteins. SiRNA drugs can obstruct this process, preventing or limiting the production of specific proteins involved in disease. Read Full Article on Biopharma Dive >>
July 17, 2023 / Novartis / RNA / New Tech / DTx Pharma / Neurological Disease – Small, interfering RNA, or siRNA, drugs work by disrupting the way cells translate DNA into proteins. SiRNA drugs can obstruct this process, preventing or limiting the production of specific proteins involved in disease. Read Full Article on Biopharma Dive >>
Neurogene inks Neoleukin reverse merger, raises $95M to fund gene therapies to clinical data drops
July 18, 2023 / Neurogene / Reverse Merger / Cell & Gene Therapy – Former Wall Street analyst Rachel McMinn, Ph.D., founded Neurogene and led it to a $68.5 million series A round and a $115 million series B financing. Since disclosing the series B round late in 2020, the gene therapy specialist has advanced treatments for Rett syndrome and CLN5 Batten disease toward readouts. Preliminary data from phase 1/2 clinicals trials are due in the second half of next year. Read Full Article on Fierce Biotech >>
July 18, 2023 / Neurogene / Reverse Merger / Cell & Gene Therapy – Former Wall Street analyst Rachel McMinn, Ph.D., founded Neurogene and led it to a $68.5 million series A round and a $115 million series B financing. Since disclosing the series B round late in 2020, the gene therapy specialist has advanced treatments for Rett syndrome and CLN5 Batten disease toward readouts. Preliminary data from phase 1/2 clinicals trials are due in the second half of next year. Read Full Article on Fierce Biotech >>
Startup Tenpoint Lands $70M to Bring Vision-Restoring Cell Therapy to the Eye
July 16, 2023 / Startup / Cell Therapy / Vision-Restoring – For some degenerative vision disorders, the therapies available don’t restore sight, they mainly slow its decline. To realize this benefit, a patient must receive an eye injection as frequently as once a month. The scientists at Tenpoint Therapeutics are trying to improve on the efficacy and the patient experience with cell therapies that restore vision with a single treatment. Read Full Article on Med City News >>
July 16, 2023 / Startup / Cell Therapy / Vision-Restoring – For some degenerative vision disorders, the therapies available don’t restore sight, they mainly slow its decline. To realize this benefit, a patient must receive an eye injection as frequently as once a month. The scientists at Tenpoint Therapeutics are trying to improve on the efficacy and the patient experience with cell therapies that restore vision with a single treatment. Read Full Article on Med City News >>
UK Startup OrganOx Secures $32.6M for Liver Transplantation Device
July 17, 2023 / Startup / Liver Transplantation / OrganOx – In addition, investment will be made in new infrastructure in both the UK and the US over the coming months to facilitate and accelerate programs within the R&D pipeline, some of which will address large and underserved markets adjacent to liver transplantation. Read Full Article on HIT Consultant >>
July 17, 2023 / Startup / Liver Transplantation / OrganOx – In addition, investment will be made in new infrastructure in both the UK and the US over the coming months to facilitate and accelerate programs within the R&D pipeline, some of which will address large and underserved markets adjacent to liver transplantation. Read Full Article on HIT Consultant >>
// Legal & Regulatory
The Kraft Heinz Lawsuit Against Aetna Is the ‘Tip of the Iceberg’
July 17, 2023 / Lawsuit / Kraft Heinz / Aetna – Self-funded employers have always had a fiduciary responsibility to make sure they’re providing the best medical benefits for the best price to their employees. But the Consolidated Appropriations Act of 2021 has given employers better access to claims data to ensure that they are fulfilling this responsibility. And Aetna’s alleged noncompliance with the law is at the heart of this. Read Full Article on Med City News >>
July 17, 2023 / Lawsuit / Kraft Heinz / Aetna – Self-funded employers have always had a fiduciary responsibility to make sure they’re providing the best medical benefits for the best price to their employees. But the Consolidated Appropriations Act of 2021 has given employers better access to claims data to ensure that they are fulfilling this responsibility. And Aetna’s alleged noncompliance with the law is at the heart of this. Read Full Article on Med City News >>
J&J ordered to pay mesothelioma patient $18.8M in talc case, pledges to appeal
July 19, 2023 / Talc Litigation / Johnson & Johnson / Mesothelioma / Bankruptcy – Amid a nationwide freeze on Johnson & Johnson’s talc litigation, one case that had been allowed to proceed has ended in a trial verdict in favor of the plaintiff. Read Full Article on Fierce Pharma >>
July 19, 2023 / Talc Litigation / Johnson & Johnson / Mesothelioma / Bankruptcy – Amid a nationwide freeze on Johnson & Johnson’s talc litigation, one case that had been allowed to proceed has ended in a trial verdict in favor of the plaintiff. Read Full Article on Fierce Pharma >>
Johnson & Johnson becomes 4th drugmaker to file suit against IRA’s drug price negotiations
July 18, 2023 / Johnson & Johnson / Astellas / Inflation Reduction Act / Lawsuit – In U.S. District Court in New Jersey, J&J claimed that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Read on Fierce Pharma >>
July 18, 2023 / Johnson & Johnson / Astellas / Inflation Reduction Act / Lawsuit – In U.S. District Court in New Jersey, J&J claimed that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Read on Fierce Pharma >>
Humira Biosimilars and Others Face Uncertain Future Under IRA
July 19, 2023 / Humira Biosimilars / IRA / Inflation Reduction Act – The recent flood of Humira biosimilars to enter the market highlights the uncertainty that surrounds generic competition for biologics following the introduction of the Inflation Reduction Act. Read on BioSpace >>
July 19, 2023 / Humira Biosimilars / IRA / Inflation Reduction Act – The recent flood of Humira biosimilars to enter the market highlights the uncertainty that surrounds generic competition for biologics following the introduction of the Inflation Reduction Act. Read on BioSpace >>
CDC vaccine committee sets August date to weigh use of Sanofi, AZ’s RSV antibody Beyfortus
July 18, 2023 / Beyfortus / CDC / Advisory Council on Immunization Practices / RSV –After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee’s calendar to determine its place in U.S. immunization guidelines. Read on Fierce Pharma >>
July 18, 2023 / Beyfortus / CDC / Advisory Council on Immunization Practices / RSV –After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee’s calendar to determine its place in U.S. immunization guidelines. Read on Fierce Pharma >>
// Research & Development
Eli Lilly Strengthens the Case for Going Early in Alzheimer’s Treatment
July 17, 2023 / Eli Lilly / Alzheimer’s / FDA – Eli Lilly has submitted its Alzheimer’s disease drug candidate for FDA review, and the pharmaceutical giant is now revealing a more complete look at the clinical data supporting an application that could make the therapy the second anti-amyloid antibody to win full regulatory approval. Read Full Article on Med City News >>
July 17, 2023 / Eli Lilly / Alzheimer’s / FDA – Eli Lilly has submitted its Alzheimer’s disease drug candidate for FDA review, and the pharmaceutical giant is now revealing a more complete look at the clinical data supporting an application that could make the therapy the second anti-amyloid antibody to win full regulatory approval. Read Full Article on Med City News >>
FDA approves new RSV drug to protect infants, toddlers
July 17, 2023 / FDA / RSV / Children / AstraZeneca / Sanofi – The drug, called Beyfortus and developed by partners AstraZeneca and Sanofi, is intended to prevent lower respiratory tract disease in newborns and infants who are entering their first RSV season. It’s also cleared for use in children up to two years old who remain vulnerable to severe disease. Read Full Article on Biopharma Dive >>
July 17, 2023 / FDA / RSV / Children / AstraZeneca / Sanofi – The drug, called Beyfortus and developed by partners AstraZeneca and Sanofi, is intended to prevent lower respiratory tract disease in newborns and infants who are entering their first RSV season. It’s also cleared for use in children up to two years old who remain vulnerable to severe disease. Read Full Article on Biopharma Dive >>
Lilly shares full pivotal data on Alzheimer’s drug, revealing how it shapes up against Leqembi
July 17, 2023 / Eli Lilly / Donanemab / Alzheimer’s Drugs / Clinical Trial Data – Eli Lilly has held the grand reveal of the Alzheimer’s disease trial data it hopes will secure FDA approval for donanemab by the end of the year. The update shows improvements over placebo continued to grow over the course of the study, even after patients stopped taking the drug, but confirmed concerns about safety and the value of treating patients early. Read Full Article on Fierce Biotech >>
July 17, 2023 / Eli Lilly / Donanemab / Alzheimer’s Drugs / Clinical Trial Data – Eli Lilly has held the grand reveal of the Alzheimer’s disease trial data it hopes will secure FDA approval for donanemab by the end of the year. The update shows improvements over placebo continued to grow over the course of the study, even after patients stopped taking the drug, but confirmed concerns about safety and the value of treating patients early. Read Full Article on Fierce Biotech >>
Sanofi, AstraZeneca advance immunization master plan with US nod for infant RSV drug Beyfortus
July 17, 2023 / Sanofi / AstraZeneca / Beyfortus / Respiratory Syncytial Virus – Monday, the U.S. FDA gave a thumbs-up to Sanofi and AstraZeneca’s antibody Beyfortus, also known as nirsevimab, as a preventive for RSV lower respiratory tract disease in babies. The approval covers newborns and infants born during or entering their first RSV season, as well as young kids up to 24 months old who remain at risk of RSV through their second disease season. Read Full Article on Fierce Pharma >>
July 17, 2023 / Sanofi / AstraZeneca / Beyfortus / Respiratory Syncytial Virus – Monday, the U.S. FDA gave a thumbs-up to Sanofi and AstraZeneca’s antibody Beyfortus, also known as nirsevimab, as a preventive for RSV lower respiratory tract disease in babies. The approval covers newborns and infants born during or entering their first RSV season, as well as young kids up to 24 months old who remain at risk of RSV through their second disease season. Read Full Article on Fierce Pharma >>
Promontory Therapeutics Expands Phase 2 Trial of PT-112 in Metastatic Castrate-Resistant Prostate Cancer to France
July 20, 2023 / Promontory Therapeutics / Prostate Cancer / Clinical Trials – The Phase 2, open-label, multi-center proof of concept study has the objective of characterizing the benefit-risk ratio and selecting the optimal dose regimen for pivotal development of PT-112, in line with the FDA’s Project Optimus. In addition to proof of concept via safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, for example on immune activation by PT-112 monotherapy, and by examining circulating tumor cell reductions. Read Full Article on BioSpace >>
July 20, 2023 / Promontory Therapeutics / Prostate Cancer / Clinical Trials – The Phase 2, open-label, multi-center proof of concept study has the objective of characterizing the benefit-risk ratio and selecting the optimal dose regimen for pivotal development of PT-112, in line with the FDA’s Project Optimus. In addition to proof of concept via safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, for example on immune activation by PT-112 monotherapy, and by examining circulating tumor cell reductions. Read Full Article on BioSpace >>
// Politics
House Judiciary Committee Probes Big Pharma’s Potential Role in COVID-19 Censorship
July 19, 2023 / House Judiciary Committee / Covid-19 / Censorship Regime – In a news release posted Tuesday, Jordan pointed to documents obtained by his committee, which claimed that the three drugmakers met with representatives from Stanford University, tech companies and agencies of the U.S. government’s executive branch in December 2020 to form a united front against misinformation related to COVID-19 vaccines. Read Full Article on BioSpace >>
July 19, 2023 / House Judiciary Committee / Covid-19 / Censorship Regime – In a news release posted Tuesday, Jordan pointed to documents obtained by his committee, which claimed that the three drugmakers met with representatives from Stanford University, tech companies and agencies of the U.S. government’s executive branch in December 2020 to form a united front against misinformation related to COVID-19 vaccines. Read Full Article on BioSpace >>
Officials tout $44m federal investment in N.H. biotech industry
July 15, 2023 / Federal Investment / Healthcare – That’s one piece of the grand vision behind emerging work in biofabrication – which is the manufacture of living cells, tissues, and organs – and it’s part of a potential economic engine that officials hope will transform Manchester in the years to come, with a $44 million boost from the federal government. Read Full Article on Boston Globe >>
July 15, 2023 / Federal Investment / Healthcare – That’s one piece of the grand vision behind emerging work in biofabrication – which is the manufacture of living cells, tissues, and organs – and it’s part of a potential economic engine that officials hope will transform Manchester in the years to come, with a $44 million boost from the federal government. Read Full Article on Boston Globe >>
House panel advances bill to expand telehealth accesss
July 20, 2023 / House Panel / Telehealth Access – A key Covid-19 telehealth flexibility would be extended through legislation a House committe advanced Wednesday. Read Full Article on Modern Healthcare >>
July 20, 2023 / House Panel / Telehealth Access – A key Covid-19 telehealth flexibility would be extended through legislation a House committe advanced Wednesday. Read Full Article on Modern Healthcare >>
CMS announces actions against states over Medicaid redeterminations
July 19, 2023 / CMS / Medicaid – The Centers for Medicare and Medicaid Services is taking action to stem the tide of Medicaid and Children’s Health Insurance Program enrollees losing benefits for procedural reasons as states carry out eligibility redeterminations, federal officials said Wednesday. Read Full Article on Modern Healthcare >>
July 19, 2023 / CMS / Medicaid – The Centers for Medicare and Medicaid Services is taking action to stem the tide of Medicaid and Children’s Health Insurance Program enrollees losing benefits for procedural reasons as states carry out eligibility redeterminations, federal officials said Wednesday. Read Full Article on Modern Healthcare >>
Elon Musk and Twitter Blue subscribers are boosting RFK Jr. anti-vax conspiracies to millions
July 20, 2023 / Robert F. Kennedy Jr. / Anti-Vax / Elon Musk – Before he announced his candidacy for president in April, it seemed that anti-vaxxer Robert F. Kennedy Jr. and his slew of conspiracy theories would remain consigned to the fringes of political debate. Read Full Article on Business Insider >>
July 20, 2023 / Robert F. Kennedy Jr. / Anti-Vax / Elon Musk – Before he announced his candidacy for president in April, it seemed that anti-vaxxer Robert F. Kennedy Jr. and his slew of conspiracy theories would remain consigned to the fringes of political debate. Read Full Article on Business Insider >>
