Patient Advocacy Organizations (PAOs) Thrilled With Biogen’s Aduhelm Approval As Northeastern and Yale Experts Call for Revised Scope of PAOs
Patient advocacy groups (PAOs) look to drugs receiving accelerated approval from the Food and Drug Administration, such as the contentious [...]
Biogen Controversy Highlights FDA’s Rules Surrounding Expert Panels
The Food and Drug Administration (FDA)’s approval of Biogen’s Aduhelm was based on shaky data. The resulting controversy continues to [...]
Why Are Drug Manufacturers Disregarding Clinical Trial Transparency Regulations?
A recent study found that most pharmaceutical companies do not meet rules demanding transparency in clinical trials. This lack of [...]
Unique Relationship Between FDA and Biogen Brings Scrutiny and Pharma Envy
As the controversy surrounding the relationship between Biogen and the FDA continues, pharmaceutical companies are trying to determine how Biogen [...]
Aetion eBook Notes Half of 2019 Submissions to FDA Included RWE
Aetion has released an eBook detailing trends in regulatory submissions that include real world evidence (RWE). Aetion notes that approximately [...]
Aetion Discusses RWE in FDA’s Review of Multiple Myeloma Drug
The Food and Drug Administration (FDA) approved ABECMA for use in patients with relapsed or refractory multiple myeloma. The FDA [...]
ICER Proposes Legislative Mechanisms to Keep Prices Low for Drugs Receiving FDA’s Accelerated Approval Designation
The Institute for Clinical and Economic Review (ICER) suggests enacting federal legislation that would keep prices low for drugs receiving [...]
Updated FDA Guidance Recommends Inclusion of Patients with Incurable Cancers in Clinical Trials
The Food and Drug Administration (FDA) has issued draft guidance instructing clinical trial sponsors to include patients with incurable cancers [...]
Acting FDA Commissioner Janet Woodcock to Speak at STAT Breakthrough Science Summit
STAT News will hold its 2021 Breakthrough Science Summit on July 13th and 14th, 2021. Acting Commissioner of the U.S. [...]
Patient Engagement Strategies Include Core Compensation Principles
The International Society for Pharmacoeconomics and Outcomes Research recently published its May/July issue of its Value & Outcomes Spotlight journal [...]
Expanded Cures 2.0 Legislation Considers Patient Access and Broadened Use of RWD in Clinical Trials
A recent article, published by the Regulatory Affairs Professionals Society (RAPS), notes that a discussion draft meant to further the [...]
Biogen Partners with Cigna and CVS Health to Promote Access to Contentious Alzheimer’s Drug
Biogen has announced that it will partner with Cigna and CVS Health to improve patient access to aducanumab, which received [...]
Former FDA Commissioner Joins Moderna’s Sponsor Flagship Pioneering
Former FDA Commissioner Stephen Hahn has taken a position at venture group Flagship Engineering as CMO of its Preemptive Medicine and [...]
FDA Turns Down Verily’s Application to Monitor Parkinson’s Disease Using Smartwatch
The Food and Drug Administration (FDA) has rejected Verily’s application to use a smartwatch to assess the severity of Parkinson’s [...]
FDA’s Amy Abernethy Transitions to Google’s Verily
Amy Abernethy recently stepped down from her position as principal deputy commissioner for the Food and Drug Administration, where she [...]
Innovent Biologics and Eli Lilly Submit Joint Low-Cost Lung Cancer Drug to FDA
Eli Lilly and Innovent Biologics have partnered to submit an application to the Food and Drug Administration (FDA) for a [...]
RWE Replicates Randomizes Controlled Trial Findings as FDA Leaders Discuss Decision-Making Trends
Researchers were able to utilize real world evidence (RWE) to reproduce findings from a type 2 diabetes randomized controlled trial. [...]
FDA’s Accelerated Drug Approval Process Brings Questions and Uncertainty
The FDA’s Accelerated Approval program offers an avenue to improve research and access in instances where therapeutic options are limited. [...]
Fate of Biogen’s Alzheimer’s Disease Drug Remains Uncertain
Biogen is awaiting the Food and Drug Administration’s decision regarding its Alzheimer’s disease drug, aducanumab. However, mixed data regarding the [...]
New Article Discusses 35 Oncology Drugs Receiving Accelerated Approval
An article published in the New England Journal of Medicine (NEJM) discusses 35 oncology drugs that received accelerated approval from [...]
ICER Publishes Draft Evidence Report on Alzheimer’s Disease Drug
The Institute for Clinical and Economic Review (ICER) published a Draft Evidence Report regarding Biogen’s aducanumab. The drug is designed to treat [...]
ICER’s New Whitepaper Features Insight on FDA’s Accelerated Approval Pathway and Proposes Drug Pricing Reform
The Institute for Clinical and Economic Review (ICER) published a whitepaper discussing the Food and Drug Administration’s Accelerated Approval Pathway (AAP). The [...]
ICER Whitepaper on Successfully Navigating the FDA’s Accelerated Approval Pathway
Today, ICER (the Institute for Clinical and Economic Review) announced a new whitepaper on understanding and navigating the FDA’s accelerated [...]
FDA to Discuss Fates of Half a Dozen Cancer Drugs Next Week
The Food and Drug Administration has set a three-day meeting from April 27th to the 29th where a host of [...]
New FDA Drug Director Appointment Announced, FDA Commissioner Role Remains Open
Patricia Cavazzoni will serve as director of the US Food & Drug Administration’s CDER (Center for Drug Evaluation and Research). [...]