Endpoints at #DIA23
The political issues circling the FDA this year could potentially ripple into biopharma on a scale that’s never been seen before. All eyes are on the FDA’s response to recent court rulings around the abortion pill mifepristone — and the potential effects on other approvals that might be questioned. What does the future look like, exactly? Join Endpoints’ Senior Editor Zachary Brennan in an expert panel to unpack what may come next. We’ll also touch on how the FDA is looking for new ways to spur more rare disease drug development with a fireside chat.
What Every Researcher Needs to Know About Using Medicare Data for Real World Evidence
Join three panelists who provide a practical overview of how and why to use data from Medicare for real world studies.
Medicare Part D: Price Negotiation Panel Discussion
Hear expert panelists bring their perspectives on critical issues around support for Medicare Part D products' fair market prices.
The Biotech landscape: Market trends, priorities, predictions, and pathways to FDA approval
As we adjust to the post-COVID environment, hear from industry leaders about the biotech global investment and drug pipeline environment. In addition, we'll look at why biotech companies are increasingly exploring clinical opportunities in APAC, to achieve FDA accepted data and what actionable strategies can be implemented to leverage APAC's streamlined regulatory processes and accelerated clinical development. Our Regulatory affairs leaders from North America and Australia will share insight into processes supporting a robust clinical program, and how Phase 1 FDA accepted data from Australia, specifically, can launch global drug development programs.
Switzerland is strong in many aspects, so also in its health care system, Dr. Peter Indra?
The Swiss healthcare system is rather complex but at the same time quite effective. High expenditures into health care corresponds with [...]
Podcast Q&A: Embracing FDA Guidance on Real World Data
Experts answer questions on embracing FDA’s guidance on the use of real world data (RWD) to understand how your organization can navigate data quality, curation, and management challenges for better research.
What can Europeans learn from Canada for the upcoming EU joint HTA, Gabriel Tremblay?
EU joint HTA will become reality in the next few years as communicated recently by the European Commission. However, applicability [...]
Marketplaces Drive Faster Science: HEOR, RWE & Market Access Sourcing
Join experts for an overview of the Scientist.com Marketplace for value, evidence, and access and a discussion on how it can increase efficiency in outsourced research projects to achieve "faster science".
Is Cost-Effectiveness Analysis Racist?
By: Michael Broder & Jesse Ortendahl Performing and using cost-effectiveness analyses is a core activity for many of us [...]
US Supreme Court to Consider Medicare Drug Pricing Challenge
The Supreme Court will consider a challenge brought forth by safety net hospitals. A Trump-era ruling leading to reduced drug [...]
National AHIP Conference Provides Information on Drug Pricing and Health Policy Outlook
The national AHIP (America’s Health Insurance Plans) conference took place earlier this week. It provided important information regarding prescription drug [...]
Trump Seeks to Send Seniors $8 Billion in Drug Discount Cards on Eve of Election
Yesterday The Washington Post provided an update on President Trump’s plan to mail $200 drug-discount cards to approximately 40 million Medicare [...]
NPC: CMS Proposed Rule Hinders Value-Based Arrangements
In a letter to the Centers for Medicare and Medicaid Services, the National Pharmaceutical Council (NPC) outlines some key issues [...]
Shulkin: COVID-19 Laying Foundation for ‘Tsunami of Challenges’ for Health System
David Shulkin, former secretary of the Department of Veterans Affairs, says the COVID-19 crisis is ultimately generating a "tsunami of [...]
Datta: CMS Proposal a ‘Grab-bag of Issues’
Sidley Austin LLP's Meena Datta told HealthLeaders that the Centers for Medicare and Medicaid Services' (CMS) latest proposal is a [...]
Zemcik, Fry Spotlight CMS Best Price Proposal
Commercial Solutions' Rick Fry and TrialCard's Jason Zemcik spotlight the Centers for Medicare and Medicaid Services' best price proposal in [...]
Bach Outlines ‘Gaping’ Loophole in Medicaid Proposal
A Centers for Medicare and Medicaid Services proposal includes a "gaping" loophole through which drugmakers could avoid selling drugs to [...]
Opinion: Discuss Price for COVID-19 Vaccine Now, Not Later
The U.S. should begin pricing discussions for a COVID-19 vaccine before we get "stuck paying dearly for shots that the [...]
Article: Researchers Point to Germany’s Model for Purchasing Cancer Drugs
Researchers say U.S. policymakers should look to Germany's drug purchasing model to try and better align cancer drug prices with [...]
Report: European Drug Regulatory Network Faces Uncertain, Complex Future
A new strategy produced by European regulators considers future challenges for the European drug regulatory network, The Pink Sheet reports. [...]
Study Finds Inconsistent Reimbursement Assessments Across EU Markets
While some modifications in the HTA process for orphan drugs have had some positive impacts, manufacturers still face key hurdles [...]
Report: FDA Mandates 50% Efficacy for COVID-19 Vaccines
Vaccine candidates must be at least 50 percent more effective than a placebo to be considered for Food and Drug [...]
Proposed Medicaid Changes Aim to Foster Innovative Contracts
The Centers for Medicare and Medicaid Services (CMS) is hoping to encourage greater use of innovative contracting models in a [...]
Legislation Aims to Prevent Pharma From Price-gouging During Pandemic
Two new bipartisan bills introduced by House Democrats aim to prevent the pharmaceutical industry from engaging in price-gouging on COVID-19 [...]
