The US lags behind other nations with similar economic development in key health outcomes like life expectancy and maternal mortality. Improving population health outcomes requires comprehensive real-world data (RWD) of health outcomes, but unfortunately, no such centralized data platform exists in […]
J&J Tamps Down M&A Ambitions
Johnson & Johnson’s new CEO Joaquin Duato has repeatedly told analysts and investors that the company was going to pursue an aggressive M&A campaign. In a call earlier today, July 19th, Duato signalled a shift and toned down those ambitions as the company’s expected 2022 sales growth dropped […]
ICER Report At a Glance: Beti-Cel for Beta Thalassemia
Beta Thalassemia is a blood disorder that results in dangerously low levels of functional hemoglobin and requires expensive lifelong medical care, including regular blood transfusions. Beti-cel is a gene therapy by Bluebird Bio that can potentially cure the disorder by genetically modifying a […]
Abbvie Applies for EMA Marketing Authorization for Migraine Drug Atogepant
The drugmaker Abbvie has applied to the European Medicines Agency (EMA) for marketing authorization for Atogepant, its prophylactic migrain treatment. Data supporting the application comes from two phase three studies, which showed the drug was well tolerated and was effective at reducing the […]
Joe Manchin Puts Democrats in a Corner with Drug Pricing Reform
Joe Manchin (W.V. - Dem) has rejected Democrat’s plans to pass climate and tax reform by July or August, saying that they must take a deal on healthcare and drug prices or wait until September. Other Democrats are livid, but may be forced to play ball with an upcoming midterm that is overshadowed by […]
Bavarian Nordic Makes Deal to Provide 1.5M Monkeypox Vaccine Doses to Unnamed European Country
The Danish drugmaker Bavarian Nordic has signed a deal with another unnamed European nation, this time promising 1.5 million doses of its monkeypox vaccine. This is the second deal with undisclosed European countries and comes hot off the heels of a deal with the US govt for 2.5 […]
Polpharma Files for EU Approval of Tysabri Biosimilar
Polpharma Biologics has filed for approval in the EU for its biosimilar of Tysabri, Biogen’s multiple sclerosis (MS) therapy. The application is the first of its kind in the EU, and covers the intravenous version of the drug. Biogen originally had 5 more years of exclusivity, but a key patent for […]
Improve Access to Mental Healthcare by Paying Trainees
Access to mental healthcare in the US has been a growing issue for decades, only made worse by the COVID-19 pandemic. Unfortunately, the slow trickle of trainees is far from sufficient to bridge this gap. Instead, at the current rate, there will be 14,000 less psychiatrists practicing in 2030. In a […]
Study Finds Healthcare IT Yields Incremental Improvements
Despite the widespread digitization of healthcare, a systematic review found improvements in healthcare productivity have been incremental rather than leaps and bounds. The study reviewed 975 research papers and was conducted as part of MIT’s Work of the Future project. IT applications have […]
Biosimilar Boom May be on the Horizon, Potentially Saving Patients Billions
Biosimilars, biologic generics, hold substantial promise in expanding access to lifesaving biologics, but growth has taken a while to ramp up. With 100 biosimilars currently in the pipeline, the industry may be set up for rapid growth in the next two years. With the potential influx of new […]
COVID-19 Pandemic Causes Largest Drop in Childhood Vaccinations in 30 Years
A report published by the World Health Organization (WHO) and UNICEF shows that 25 million children missed key childhood vaccines due to the COVID-19 pandemic. Coverage with the DTP3 vaccine, which protects against tetanus, pertussis and diphtheria, fell to 81% from 86% in 2019. According to […]
US Congress Makes Another Push for Drug Pricing Regulation
With tough odds in the upcoming midterm elections in mind, Democrats in the US Senate are making another push for drug pricing regulation. The latest attempt would limit the out-of-pocket drug costs to $2,000 and let Medicare negotiate drug prices. The proposal would also let the Department of […]
STATUS List 2022 Spotlights: Admiral Rachel L. Levine and Dr. Kirsten Bibbins-Domingo Talk Health Equity
STAT upcoming STATUS LIST 2022 will feature two leaders in health equity in their own spotlight sessions. Assistant Secretary for Health for the U.S. Department of Health and Human Services (HHS) Admiral Rachel L Levine will speak about her work towards trans health equity and goals for the agency […]
CBO: Senate Drug Price Cuts Would Curb Development of 10 Drugs Over 30 Years
Despite fears that drug pricing regulations would dampen innovation, an analysis by the US Congressional Budget Office found that the drug pricing proposal put forward by Senate Democrats would stifle development of 10 drugs in the next 30 years. This amounts to just shy of 1% of the estimated 1,300 […]
World Orphan Drug Congress Europe 2022 – 14-17 November 2022
Taking place in Spain this year, the World Orphan Drug Congress, the leading conference for orphan drugs and rare diseases worldwide, takes place in Sitges, Spain, from 17-14 November. The conference will bring together professionals from healthcare, research, regulatory agencies, payer […]
Novavax COVID-19 Vaccine Gets Emergency Use Authorization from FDA
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The announcement comes […]
780,000 Doses of Bavarian Nordic Monkeypox Vaccine to be Shipped to US by End of July
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The […]
Teva Asks US Supreme Court to Reverse Loss in “Skinny Label” Patent Suit, Says Decision is Competition-Killing for Generics
According to Teva Pharmaceuticals, the company’s legal battle with GSK over “skinny labels” portends a greater threat to the generic drug market. Skinny labeling is a practice where a manufacturer can get its generic approved by applying for some of the original drug’s indications, but not all. GSK […]
Two Labs Now Offers Medical Affairs and Communication Services
The pharma services company Two Labs is now offering medical affairs and communications services, according to a new press release. The company is aiming for startups and other smaller biotech and biopharma companies, helping clients plan medical communications and publication strategies. These […]
Royalty Pharma Buys Theravance to Get Royalties on GSK COPD Drug Trelegy Ellipta
Royalty Pharma has bought 85% of Theravance Biopharma to access royalty rights to its chronic obstructive pulmonary disease (COPD) drug Trelegy Elliptica, formerly owned by GSK. The deal also included $1.1 billion upfront with $400 million more set aside for sales milestone awards. Trelegy, the only […]
FDA Commissioner Rob Califf Says Agency Will Advance New Evidence Generation System
During a Zoom event on Tuesday, June 12th, Food and Drug Administration (FDA) Commissioner Robert Califf told members of the Alliance for a Stronger FDA that the agency would promote the development of new evidence generation systems. Califf remarked that the US had fallen behind in evidence […]
Syndicated Report: Global Gene Therapy Market Projections 2022-2031
Despite the global pandemic, cancer was still the leading cause of death in 2020. This pressing therapeutic need underlies the growth projected by Kenneth Research in their new report entitled, “Global Gene Therapy Market.” The report predicts that the gene therapy market will earn around $6 billion […]
New York AG: Teva Was Aware of its Contribution to NY’s Opioid Epidemic, Contrary to Previous Testimony
New York Attorney General Letitia James has leveled accusations at the Israeli drugmaker Teva that it misrepresented its role in the state’s opioid crisis. The company previously distanced itself from its US operations, but new information suggests that Teva was directly in charge of the unit. […]
On-Demand Webinar: Accelerating Patient Recruitment Post-COVID-19
The COVID-19 pandemic changed the playing field of clinical trial patient recruitment permanently. As the clinical research industry moves towards a potential post-COVID world, researchers and coordinators must adopt new strategies in order to accelerate their patient recruitment. Strategies to do […]
New Study Will Investigate Effect of Racial Inequity on Caregiver Resources and Health Outcomes
The COVID-19 pandemic has brought the public spotlight on racial disparities of health outcomes, but little research has been done to examine the effects of systemic racism on caregivers for people with serious illness. A new study by Professor Susan Desanto-Madeya at the University of Rhode Island […]
A Health Podyssey Podcast: Jane Zhu Gets Spooky About Phantom Providers
Mental healthcare is hard for many patients to access, especially those on Medicaid. In the newest episode of A Health Podyssey, Jane Zhu from Oregon Health and Science University talks about her recently published study on so-called “phantom providers” in Oregon’s managed care […]
How Decentralized Clinical Trials Can Center Patient Care
The COVID-19 pandemic drove decentralized care models to new prominence, allowing patients to safely access care from home through telehealth. The pandemic has also pushed decentralized clinical trials (DCTs) to the forefront in clinical research. DCTs help expand access to experimental therapeutics […]
China Announces Price Cuts, Hitting Astrazeneca, Pfizer, and Novartis’s Profits
China’s latest round of price cuts dinged profits of many major pharma companies, especially Astrazeneca, Pfizer, and Novartis. The companies were undercut by cheaper generics who, on average, shaved almost half of their cost to win contracts with public care providers. Over 200 companies […]
Using Technology and Supplemental Services to Improve Health Outcomes in Medicare Advantage Members
Medicare Advantage (MA) plans are increasingly focusing on tackling health inequities. Social determinants of health (SDOH) like income, food, shelter, and transportation all play into health disparities. One method that MA plans are using to address SDOH is by enhancing supplementary services and […]
HRA Pharma Files FDA Application for First Over-the-Counter Oral Contraceptive
HRA Pharma has submitted its application for the US’s first over-the-counter (OTC) birth control pill. The company, a subsidiary of Perrigo, filed for a prescription-to-OTC switch for Opill®, a move that would expand access to safe, effective birth control, an imperative as reproductive rights are […]
