The accelerated approval pathway: Helping patients with serious or life-threatening diseases
Today, the House Energy& Commerce Committee ’s Subcommittee on Healthwill meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing comes at the same time members of Congress are considering the reauthorization of the user fee programs, thePrescription Drug User Fee Act (PDUFA VII) and theBiosimilar User Fee Act (BsUFA III). The U.S. Department of Health and Human Services ’ transmittal of the proposed PDUFA VII and BsUFA III packages to Congress in January marked the beginning of the legislative phase and an important milestone in the reauthoriz...
Source: The Catalyst - March 17, 2022 Category: Pharmaceuticals Tags: Research and Development FDA PDUFA Biologics and Biosimilars Source Type: news

Sharing rebates can save Americans with diabetes $500 each year and improve adherence, especially for Black and Hispanic Americans
A new study byGlobalData looked at brand oral antidiabetic drugs (OADs) and found that sharing negotiated rebates with patients in commercial health plans at the pharmacy counter can help lower costs, improve adherence and reduce health disparities. This common-sense solution can help us build a more affordable and equitable health care system and help avoid nearly 700 premature deaths each year. (Source: The Catalyst)
Source: The Catalyst - March 16, 2022 Category: Pharmaceuticals Authors: Katie Koziara Tags: Adherence Drug Cost Out-of-Pocket Costs Health Equity Source Type: news

Biopharmaceutical industry drives economic growth in all 50 states
The innovative biopharmaceutical industry has long been a significant driver of the nation ’s economic growth and a key contributor to state and regional economies. Anew report from TEConomy Partners highlights industry ’s impact and reach across the country. (Source: The Catalyst)
Source: The Catalyst - March 14, 2022 Category: Pharmaceuticals Authors: Tim McClung Tags: Research and Development Economic Impact PhRMA Member Company Source Type: news

Guest Post: If we truly want to cure complex diseases, politicians should reject price setting
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today ’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. (Source: The Catalyst)
Source: The Catalyst - March 14, 2022 Category: Pharmaceuticals Authors: Guest Contributor Tags: Drug Cost Voters for Cures Government Price Setting Source Type: news

Veterans Affairs 101: Three charts show how the VA system differs from Medicare
The U.S. Department of Veterans Affairs (VA) primarily provides medical coverage for veterans who have experienced service-related disabilities. Its unique system was developed to meet the targeted health care needs of veterans, unlike other federal government programs that provide health coverage to a large and diverse population of patients. While it provides access to care for our nation ’s 9 million veterans, the VA tends to cover fewer medicines on its national formulary than what is available in other large government programs, like Medicare Parts B and D. (Source: The Catalyst)
Source: The Catalyst - March 11, 2022 Category: Pharmaceuticals Authors: Gabby Migliara Tags: Drug Cost Health Insurance Policy Solutions Proactive Agenda Government Price Setting Source Type: news

If drug prices are growing below the rate of inflation, why are patients still feeling the sting at the pharmacy?
Concerns about inflation continue to be top of mind for many Americans, as prices for basic services and necessities climb at a rapid pace. But there is one bright spot in this otherwise bleak picture: Between January 2021 and January 2022, prices for prescription drugs only increased marginally and well below the rate of general inflation.  (Source: The Catalyst)
Source: The Catalyst - March 8, 2022 Category: Pharmaceuticals Authors: Brian Newell Tags: Drug Cost Health Insurance Out-of-Pocket Costs Source Type: news

Biopharmaceutical research and development has ushered in a decade of innovation in rare disease
This year onRare Disease Day, we join families and communities around the world building awareness around rare diseases and encouraging patients to share their stories. (Source: The Catalyst)
Source: The Catalyst - February 28, 2022 Category: Pharmaceuticals Authors: Samantha Hinkle Tags: Research and Development Rare Diseases Source Type: news

The patient experience: Insurance barriers continue to impede access to health care, especially among the country ’s underserved
The second installment of thePatient Experience Survey finds insurer-imposed practices pose significant barriers for Americans as they attempt to access the care they need – and that they are paying for each month in premiums. (Source: The Catalyst)
Source: The Catalyst - February 28, 2022 Category: Pharmaceuticals Authors: Cynthia Hicks Tags: Health Insurance Out-of-Pocket Costs Polling Source Type: news

New Data: COVID-19 vaccine global production capacity projected to exceed 20 billion doses this year
Biopharmaceutical companies areworking across the industry and around the world to meet the global demand for COVID-19 vaccines. Companies have continued to ramp up their efforts to source needed supplies, identify manufacturing efficiencies and increase manufacturing capacity through partnerships in the United States and around the globe to get as many COVID-19 vaccine shots in arms as possible. (Source: The Catalyst)
Source: The Catalyst - February 24, 2022 Category: Pharmaceuticals Authors: Megan Van Etten Tags: Vaccines Manufacturing Coronavirus Source Type: news

4 things to know about biopharmaceutical efforts to fight cancer
A recent study published inNature is a profound reminder of how far we ’ve come in the fight against cancer. Authors of the study, which examined the long-term effects of CAR-T cell therapy, characterized one of the first patients treated as part of clinical trials in 2010 as “cured,” a term rarely used in oncology. CAR-T is a form of gene modified cell therapy i nvolving permanently altering a patient’s T-cells to recognize, target and kill cancer cells, with the goal of eliciting an enduring immune response over the long-term. (Source: The Catalyst)
Source: The Catalyst - February 24, 2022 Category: Pharmaceuticals Tags: Research and Development Cancer Immunotherapy Source Type: news

Government price setting leaves behind families counting on new medicines
Rather than pursuing policies that would actually address our broken insurance system and lower costs for patients – while protecting medical innovation – policymakers keep going back to the same, tired and flawed government price setting proposals. Changing the name or structuring the policy differently doesn’t change the truth: government price setting leads to the development of fewer new treatments and cures, which means patients lose out on potentially lifesaving medicines. (Source: The Catalyst)
Source: The Catalyst - February 23, 2022 Category: Pharmaceuticals Tags: Drug Cost Medicare Policy Solutions Government Price Setting Source Type: news

What you need to know about newly authorized COVID-19 antiviral treatments
In December 2021, the U.S. Food and Drug Administration (FDA)granted emergency use authorization (EUA) for the first two oral antivirals for the treatment of certain COVID-19 patients. These treatments mark a step forward in the fight against the pandemic, due to their ability to be taken at home, which can reduce the burden on both patients and the health care system. Additional treatments are also under investigation by several other biopharmaceutical companies. (Source: The Catalyst)
Source: The Catalyst - February 22, 2022 Category: Pharmaceuticals Authors: Richard Moscicki, M.D. Tags: Research and Development Vaccines Coronavirus Source Type: news

Part B 101: Three charts show the program helps control costs for health care system and enrollees
Medicare Part B covers a wide range of health care services, including physician office visits, hospital outpatient care and medical equipment. It also covers medicines that are usually administered by a physician, like many medicines administered by injections and infusions. Many of the medicines covered by Part B are for serious and complex conditions, such as cancer, rheumatoid arthritis and mental illness, among others. (Source: The Catalyst)
Source: The Catalyst - February 18, 2022 Category: Pharmaceuticals Tags: Medicare Part B Source Type: news

Guest post: Joining forces to combat the COVID-19 mental health crisis
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today ’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. (Source: The Catalyst)
Source: The Catalyst - February 17, 2022 Category: Pharmaceuticals Authors: Guest Contributor Tags: Research and Development PhRMA Member Company Mental Health Coronavirus Source Type: news

Guest Blog: COVID-19 vaccines are the key to keeping kids healthy
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today ’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. (Source: The Catalyst)
Source: The Catalyst - February 16, 2022 Category: Pharmaceuticals Authors: Guest Contributor Tags: Vaccines Mental Health Coronavirus Source Type: news