A new proposal by the FDA lays out new requirements to expand the use of a non-prescription drug to additional conditions while maintaining non-prescription status. If the agency finds that a product’s labeling is too unclear, drugmakers can set conditions for non-prescription use instead of making […]
Novartis to Lay Off 8,000 Employees
The pharma giant Novartis will lay off up around 8,000 employees in the near future amid internal restructuring efforts. The Swiss-American multinational will axe 1,400 positions in Switzerland, over 10% the company’s employees in the nation. The restructuring, according to the company, will save $1 […]
New Amsterdam Nets Over $1B for Second Shot at LDL Drug
Amgen’s CETP cholesterol drug Obicetrapib was shelved in 2017 after disappointing results in clinical trials. However, New Amsterdam Pharma has picked up just over a whopping $1 billion in investments for the drug’s revival, largely from the Italian pharma company, the Menarini Group. The […]
Webinar – June 29th: Unraveling the Complexities in Nasal Vaccine Development, Manufacturing and Device Selection
Intranasal vaccines represent a novel delivery system that gives drugmakers, providers, and patients additional options to choose from when making care decisions. Drugmakers need to consider formulations and manufacturing logistics from the beginning of the drug development pipeline in order to […]
2021’s Top 15 Highest Paid CEOs in Biotech and Pharma
Although many of the top 15 highest paid biopharma CEOs received raises in 2021, the year was peppered with high profile resignations. For example, the 13th place went to former Biogen CEO Michel Vounatsos, whose resignation was announced in May. Clay Siegall, former CEO of Seagen, earned nearly $19 […]
Webinar June 30th – Mission Critical: Cybersecurity
Biopharma companies have increasing become the target of cyberattacks in recent years. Tackling the issue of cybersecurity in pharma and biotech requires top-down solutions and an awareness of the true scope of the problem. This Thursday, June 30th, EGNYTE and Endpoints News are hosting a webinar […]
Study: Fragmentation of US Healthcare and Policy Negatively Impacts Diabetes Outcomes
Despite wide-ranging efforts in the US to reduce the incidence and morbidity associated with type 2 diabetes, progress has stalled, if not reversed. A newly published study in Health Affairs examines the effect that the fragmented nature of the US healthcare system has on diabetes outcomes. The […]
New Data Shows Bristol Meyers Squib’s Zeposia Improves Cognitive Outcomes in Multiple Sclerosis Patients
Results from Bristol Meyers Squib’s (BMS) Phase 3 DAYBREAK and SUNBEAM trials show that Zeposia helps improve and preserve cognitive abilities in the majority of relapsing remittent multiple sclerosis (MS) patients. The effects were most pronounced in patients with high thalamic volume. Cognitive […]
Promising Results Announced for Omicron-Adapted Pfizer and BioNTech COVID-19 Vaccines
Pfizer and BioNTech have announced positive results in the Phase 2/3 trial for two Omicron-adapted versions of their mRNA vaccine. One candidate vaccine is monovalent targets the spike protein of the Omicron BA. 1 variant, while the other is a bivalent combination of the first candidate and Pfizer […]
France’s New Pricing Rules Increase Access to Orphan Drugs
A March 2021 agreement between the Frrench Ministry of Health and the French Pharmaceutical Companies Association has reduced barriers to access to orphan drugs for patients in France, according to an analysis by GlobalData. The agreement set a flat rate payment for orphan therapies that cost over […]
Interview with Tobias Polak: Gleaning Real-World Data from Expanded Access Programs
Tobias Polak, a PhD student at Erasmus University and Director of Real-World Data (RWD) myTomorrows, recently published a paper in the British Journal of Clinical Pharmacology entitled, “Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.” Polak spoke with The […]
Real-World Data Study Shows that Biologics are Widely Used and Effective for Severe Asthma
A new real-world data (RWD) study published in the Annals of Allergy, Asthma & Immunology shows that biologics are both commonly used and very effective in the treatment of severe asthma. The results, taken from the ongoing CHRONICLE study, found that two-thirds of the nearly 2800 participants […]
US Attorney General Merrick Garland: States Can’t Ban Abortion Pill
Shortly after the US Supreme Court’s decision on Friday, June 24th, to reverse Roe V. Wade and allow states to end access to safe abortions, Attorney General Merrick Garland made an announcement that states cannot ban drugs used to induce abortions. Some speculate that pharma companies that produce […]
Biogen Ends Aduhelm Study Due to Medicare Restrictions
Biogen has ended its observational ICARE AD real-world data (RWD) trial for Aduhelm, another in a long series of setbacks for the drug. The move was caused in part by the Centers for Medicaid and Medicare Services’ (CMS) decision to only cover the drug for patients in clinical trials. The ICARE AD […]
Google Cloud Health Exec: Real-World Data May Supplant Use of Placebos in Clinical Trials
According to Shweta Maniar, Google Cloud’s director for healthcare and life sciences, real-world data (RWD) may speed up clinical trial and market access timelines for all forms of therapeutics. This advance is powered, Maniar argues, by the potential of RWD to empower decentralized clinical trials […]
How an NHS Trust Used Integrated Data Sets to Advance Better Population Health Outcomes
Lewisham and Greenwich NHS Trust, responsible for two hospitals and several community health centers, realized the need to address disparities in health outcomes and unmet community health needs in 2017. The Trust moved on this need by investing in a population health and care management program […]
US Supreme Court Won’t Hear UnitedHealth’s Medicare Advantage Lawsuit
UnitedHealth was handed a major setback Tuesday, June 21st, when the US Supreme Court declined to hear its lawsuit over the Medicare Advantage overpayment rule. The Centers for Medicare and Medicaid Services (CMS) established the overpayments rule in 2014, which mandates that MA plans must return […]
Politico Pulse: Addressing Monkeypox Antiviral Shortages
As monkeypox cases continue to spring up across the world, nations are seeking to stock up on the antiviral tecovirimat. The drug’s manufacturer Siga is currently in talks with the Biden administration regarding expanding their facilities to ramp up output. Tecovirimat is not currently approved for […]
BioNTech Starts Construction of Africa’s First mRNA Vaccine Manufacturing Plant
With the construction starting for BioNTech’s new plant in Kigali, Rwanda, Africa is finally getting its first mRNA vaccine manufacturing facility. Lower- and middle-income nations have not received enough COVID-19 vaccines since they’ve become available, especially nations in Africa. This new […]
Preventing Overdoses by Treating Opioid Use Disorder in Prisons
Compared to the general population, incarcerated people have a 40 times higher risk of death by opioid overdose shortly after their release. While treatment with medications for opioid use disorder (MOUD) has been shown to dramatically reduce these deaths, many prisons and jails withhold MOUDs as a […]
Health Affairs Policy Highlight: One-On-One with Admiral Rachel Levine
This Friday, June 24th, Health Affairs Editor-in-Chief Alan Weil will sit down with Admiral Rachel Levine, the US Department of Health and Human Services’ (HHS) Assistant Secretary for Health. Adm. Levine has overseen much of the department’s public health efforts since being appointed to the role […]
Enanta Sues Pfizer over Alleged Paxlovid Patent Infringement
Enanta Pharmaceuticals has filed a lawsuit against the pharma giant Pfizer over claims of patent infringement involving its COVID-19 treatment Paxlovid. The company claims Pfizer’s use of nirmatrelvir, a protease inhibor that makes up one half of Paxlovid, is in violation of several patents. Instead […]
FDA Will Present Draft Guidance on Real-World Evidence in Grand Rounds on June 22nd
The US Food and Drug Administration will unveil its highly anticipated draft guidance on real-world evidence this Friday, June 24th. The grand rounds session begins at 1:00 PM EST and will be presented by Dr. John Concato. According to Rethinking Clinical Trials, “Dr. Concato is the associate […]
RSS Course: Economic Evaluation of Cancer Drugs
Regulatory Scientific and Health Solutions is now offering a 1-day face-to-face course about health economics models for assessing cancer drugs. Attendees will learn how the models are made and applied, along with how their results are interpreted and acted upon by payer and health technology […]
Health Affairs Today: Using EHR to Boost Vaccination Rates in Unhoused or Incarcerated People in Minnesota
Compared to the rest of the population, vaccination rates are much lower amongst Minnesotans who are unhoused or in the penitentiary system. To help close the gap, a team of researchers developed a set of tools to guide and compare interventions enacted to reduce health disparities. The work, […]
14 Million May Lose Health Insurance When Public Health Emergency Ends
The Families First Coronavirus Response Act of 2020 helped provide coverage to millions who lost their employer-provided health insurance during the pandemic. However, with the end of the public health emergency looming over the horizon, those citizens are set to lose the coverage provided by the […]
American Medical Association Launches Initiative to Advance Health Equity
People from marginalized groups often face systemic bias that worsens their health outcomes. To combat this problem, the American Medical Association has announced a new initiative to bring equitable, quality patient-centered care to people of all backgrounds. The initiative comes will provide a […]
Labcorp Teams Up with HealthVerity in Real World Data Collaboration
The life sciences giant Labcorp has announced a new partnership with HealthVerity, a leader in real-world data (RWD). Labcorp will leverage HealthVerity’s Identity, Privacy, Governance, and Exchange (IPGE) platform to enhance their drug development and clinical trial offerings. This platform is the […]
Carbon Bioscience Partners with the Cystic Fibrosis Foundation to Develop New Viral Vector-Based Therapy
Although adeno-associated virus (AAV) gene therapies have represented a large swath of the gene therapeutic landscape for years, they have been weighed down by various limitations and adverse effects. The biotech Carbon Biosciences, led by seeks to disrupt the field of cystic fibrosis gene therapies […]
Bringing Data-Enabled Healthcare to Asian-Pacific Nations
Asia-Pacific (APAC) is the most population-dense region of the world with an increasingly growing aged populace. However, substantial disparities to healthcare access exist, setting the stage for an upcoming healthcare crisis. In an article published by the World Economic Forum, Ahmed Elhusseiny […]
