Excerpt of tHEORetically Speaking blog post sponsored by Veradigm Nonalcoholic fatty liver disease (NAFLD), including the more aggressive NASH (nonalcoholic steatohepatitis), has become a major public health concern, affecting about one in four Americans (Younossi 2018). Its increasing prevalence […]
ISPOR Seeks New Members for Health Science Policy Council
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is searching for three mid-career members for its Health Science Policy Council (HSPC). HSPC advises the ISPOR Board of Directors on research issues in health economics and outcomes research. The terms will last […]
On-Demand Webinar Offers Guidance for Getting Started in MedComms
A recent webinar hosted by NetworkPharma.tv offers guidance for individuals interested in entering a career in the medical communications landscape. The on-demand webinar is available to watch on YouTube. Featured speakers include: Linda Harrison, author of "Evidence generation and […]
Rubenstein Talks Modern RWD, RWE in Regulatory Decision-Making
FDA Center for Devices and Radiological Health Director of Personalized Medicine Wendy Rubenstein says modern sources of real-world evidence and data "are of a progressively higher quality," BioWorld reports. According to the report, Rubenstein made the comments during a recent webinar hosted by […]
FDA Rejects Intercept’s OCA for NASH
The Food and Drug Administration (FDA) last month rejected Intercept Pharmaceuticals' nonalcoholic steatohepatitis (NASH) drug, creating a major delay in the drugmaker's approval roadmap, BioPharma Dive reports. According to the report, Intercept says the FDA decided the benefits of obeticholic […]
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 rest of the world will get much cheaper," the author of a recent opinion piece published in The New York Times writes. Elisabeth Rosenthal, author and editor and chief of Kaiser […]
Report Explores Patient Centricity in Clinical Trials
A new report by the Economist Intelligence Unit explores the importance of expanding patient engagement in the clinical trial landscape. The report, which was sponsored by Medidata, features insights experts including: Jennifer Byrne, Javara CEO; Luther Clark, Merck deputy chief patient […]
ICER Hosting Series on Drug Pricing During a Pandemic
The Institute for Clinical and Economic Review (ICER) is scheduled to host a three-part series focused on drug pricing during a pandemic. The first session, which will discuss cost-recovery pricing, is set for noon EST July 24. Confirmed speakers include: Afton Cissell, JD, Senior Counsel […]
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 their clinical benefits, according to a STAT Pharmalot article. According to the article, Germany's model ultimately led to a 25 percent drop in prices one year […]
ICER Reschedules CF Meeting
The Institute for Clinical and Economic Review (ICER) has rescheduled its public meeting on cystic fibrosis treatments to Aug. 27. According to a press release, the meeting, which had originally been postponed due to the COVID-19 pandemic, will take place online. To read the full press […]
NPC Webinar on COVID-19 Prices Nears
The National Pharmaceutical Council's webinar on COVID-19 drug prices is less than a week away. Registration for the event remains open. "It's Time to Talk about COVID-19 Prices" is set for 3:30 p.m. EST July 24. Panelists include: Peter Bach, MD, MAPP, Director, Center for Health Policy […]
NICE Clinical Fellow Ali Highlights Sustainability Efforts
Fizzah Ali, a medical clinical fellow at the U.K.'s National Institute for Health and Care Excellence, discusses how the Sustainability Steering Group (SSG) is working toward a greener future. "Promoting sustainable implementation of guidance recommendations and obtaining information on […]
ISPOR to Host Webinar on Drug, Device Utilization Amid Pandemic
The International Society for Pharmacoeconomics and Outcomes Research is set to host a July 28 webinar highlighting the COVID-19 pandemic's impact on drug and medical device utilization. "Assessing the Impacts of a Pandemic on Pharmaceutical and Medical Device Utilization" is set to being 11 a.m. […]
Medidata, CTI Partner on Remote Trial Reviews
CTI Clinical Trial Solutions and Consulting Services is partnering with Medidata to facilitate remote monitoring and reviews for clinical trials across the globe. According to a press release, CTI will utilize Medidata's Remote Source Review solution. "Medidata is committed to developing and […]
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. The plan, per the report, looks to position the regulatory network to endure an uncertain future. To read the report, click here. […]
ICER Outlines Planned Review of High Cholesterol Treatments
The Institute for Clinical and Economic Review (ICER) in a recently-released document outlines its planned review of high cholesterol treatments. ICER's assessment will include Novartis' inclisiran, Esperion Therepeutics' Nexletol and Nexlizet, according to a press release. Comments on the […]
NPC, Duke-Margolis Center for Health Policy Name New Health Policy Fellow
The National Pharmaceutical Council (NPC) and Duke-Margolis Center for Health Policy recently named Salama Freed as the 2020-22 post-doctoral health policy fellow. According to a press release, the fellowship is "designed to bridge a persistent gap between health research and policy […]
IFAPP Academy, MAPS Offer Medical Affairs Course
IFAPP Academy and the Medical Affairs Professional Society (MAPS) are offering an online course for medical affairs professionals looking to expand their knowledge on drug development. Applications for the course, "Introduction to Medical Affairs in Medicines Development," will be accepted until […]
Measuring Care Value
Stacey Richter, Relentless Health Value host and Aventria Health Group co-founder, discusses metrics for measuring care value in the latest Relentless Health Value installment. The metrics used to measure care value are "critical," Richter says. " ... American health care is the biggest most […]
Capital Rx CEO Talks Price Transparency
Capital Rx CEO A.J. Loiacono in a new Patients Rising Podcast discusses the importance of price transparency at the pharmacy counter. Last year, Capital Rx, a pharmacy benefit manager, launched the "Clearinghouse Model," a new pricing model that aimed to eliminate spread pricing. To listen to […]
Cytel COVID-19 Clinical Development Quiz
Cytel is offering a quiz for users to gauge their knowledge on the state of COVID-19 clinical development across the globe. "There are currently 1570 registered clinical trials for COVID-19 therapies and vaccines," a description states. "Approximately 20% are registered in the United States and […]
OptumRx’s Calabrese: Top 3 Drugs in Pipeline
OptumRx Senior Vice President and Chief Pharmacy Officer David Calabrese in a recent interview with Managed Healthcare Executive discusses the top three drugs in the pipeline. To listen to the full discussion on Managed Healthcare Executive, click here. […]
ACS Researchers Receive RWD Award
Three American Cancer Society researchers have been awarded the Real-World Data Impact Award, ACS and Flatiron Health announced this week. The recipients of the awards are: Minal Kale, Icahn School of Medicine at Mount Sinai; Siran Koroukian-Hajinazarian, Case Western Reserve University […]
McClellan Stresses Need for RWE Infrastructure
Duke-Margolis' Mark McClellan tells The Pink Sheet a robust real-world evidence infrastructure is needed, and that RWE studies should be used to fill in evidence gaps post-approval. To read the report, click here. (Paid subscription required) […]
Gupta: Five Trends That Have Accelerated in 2020
Heron Therapeutics' Anita Gupta in a recent piece published on Forbes highlights five key trends that have accelerated during the COVID-19 pandemic. In addition to greater efforts to bolster efficiency using data analytics, Gupta writes the following trends have generated much momentum: […]
Panel Discusses Provider Prospective on Value-Based Care for mBC
A recent panel discussion on AJMC's Peer Exchange discusses how providers identify value-based care opportunities for metastatic breast cancer. The panel features Drs. William Gradishar and Joyce O'Shaughnessy, Bruce Feinberg, Kelli Davis and Steven Peskin. To listen to the discussion on […]
ICER Posts White Paper on Alternative Pricing Policies During Pandemic
The Institute for Clinical and Economic Review (ICER) announced the release of a new white paper on alternative policies for pricing drugs and vaccines during a pandemic. ICER is also set to host a three-part online series in which experts will discuss the advantages and disadvantages of […]
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 due to inconsistent reimbursement assessments in the EU markets, the authors of a recent study suggest. The authors, Chales River Associates' Steven Kelly, Ioanna […]
ICER Cancels Meeting for Non-Alcoholic Steatohepatitis Assessment
The Institute for Clinical and Economic Review (ICER) has canceled the August meeting of the Midwest CEPAC. The meeting was set to discuss the effectiveness and value of obeticholic acid for the treatment of non-alcoholic steatohepatitis. "This decision is the result of the Food and Drug […]
Evidation Looks to Bolster Platform to Include Virtual Treatment
After generating $45 million in investments, Evidation is looking to expand its virtual research platform to include digital interventions and treatments, FierceBiotech reports. According to the report, the platform already has some 4 million participants in the U.S. "Participation in research […]
