PM Live Smart Thinking Blog: The Holy Grail of Healthcare Pricing
Healthcare pricing reform has been a goal for patients and politicians for decades, but a provision in a 2003 Medicare overhaul prohibited the US federal government from negotiating prices with pharma companies. In the latest Smart Thinking Blog, Rohit Khanna of Catalytic Health describes how the Inflation Reduction Act’s drug pricing negotiation provision is, and isn’t, the holy grail of healthcare pricing reform.
Eiger’s Scraps Emergency Use Authorization Submission for COVID-19 Treatment
The US Food and Drug Administration has rejected Eiger BioPharmaceuticals’ request to meet with the agency regarding peginterferon lambda, its repurposed hepatitis D treatment for use in COVID-19. The company asked for the meeting to discuss an emergency use authorization in September based on data from the TOGETHER Phase III trial. However, it appears the data was insufficient for the agency.
Pharma Plays Balancing Act with US Democrats After Drug Pricing Reform Passes
While pharma mulls over how to fight back over the new US drug pricing reforms, they are carefully weighing how to navigate negotiations with Democrats. Lawsuits have already been filed, but the timeline for those is yet to be determined, so the industry can’t be too hardball with the party if it maintains power after the midterm elections next month.
Amylyx Takes Heat for $158,000 Annual Price of New ALS Drug
Amylyx Pharmaceuticals’ new amyotrophic lateral sclerosis (ALS) was approved by the US Food and Drug Administration last week and is already taking flak. The company has set the annual price of the drug to $158,000, a number decried by many as exorbitant. According to ICER, the drug should be priced no higher than $30,000 a year until more evidence comes in regarding the drugs efficacy.
Natalie Douglas and Patti Peeples Join Global Pricing Innovations Board of Directors
Global Pricing Innovations (GPI) has announced that Natalie Douglas and Patti Peeples, PhD, will join the company’s board of directors. Douglas, who will join as the new Chair, is the founder of RealiTi Health and serves as a strategic advisor for GPI. Peeples is the founder and former CEO of HealthEconomics.com, and is a leading voice of the health economics and outcomes research (HEOR) community.
FTC Chair Plans to Explore All Options in PBM Investigations
The chair of the US Federal Trade Commission (FTC), Lina Khan, has pledged to use all the tools at her disposal to investigate the practices of pharmacy benefit managers (PBMs), who have recently faced increasing scrutiny. This is due to allegations of anti-competition and price fixing. A formal investigation by the agency was announced this summer.
US State of Georgia Reaches $3.3 Million Settlement with Teva in Price Fixing Lawsuit
Teva Pharmaceuticals has settled yet another lawsuit with the government of a US State, this time with Georgia. The company reached a settlement worth $3.3 million with the state, the third and most expensive settlement of its kind. The lawsuits faced by the company surrounded claims of price fixing
Generics Companies Considering Cuts in Europe Over Drug Pricing Laws and Energy Crisis
World events and pricing legislation are putting pressure on generic manufacturers, according to an open letter written by the lobbying group Medicines for Europe. The industry group notes that raw material costs have skyrocketed by between 50%-160%, dwarfing the inflation rate of 9%. Energy costs have been another concern due to disruptions caused by the war in Ukraine. Finally, the group points out that drug pricing regulations and other laws have made it difficult for the industry.
Jennifer Fillman Takes Role at Genesis Research
The former senior vice president and CFO of Clinical Solutions at Syneos Health has taken on a new position as CFO for Genesis Research. Jennifer Fillman will take over the position at Genesis, a health economics and outcomes research (HEOR) company known for its real-world evidence (RWE)-based offerings. Fillman will help Genesis in its goal of providing evidence solutions to biotech, pharma, and medical device companies to accelerate development and market access.
Novartis Leans into US Market, Drug Pricing Reform Notwithstanding
Novartis investors were told that the pharma giant would laser focus on the US market in an event on Thursday, September 22nd. The announcement comes weeks after the US government passed drug pricing reform which critics argued would stifle innovation and investments in the nation. This push would help expand the company’s patient recruitment efforts and invest in its US personnel.
Walgreens to Buy Out the Rest of Shields Health in $1.37 Billion Deal
Walgreens is finishing its acquisition of Shields Health in a new deal worth $1.37 billion. The pharmacy giant, which already owns 71% of Shield Health, will buy the remaining shares of the company. Shields is a specialty pharmacy that provides therapeutics to 30 health systems. The move will come with a bit of an executive shakeup.
BioGene Scores NICE Approval for Rare Lymphoma Drug Brukinsa
The UK’s National Institute for Health and Care Excellence (NICE) has approved BioGene’s drug Brukinsa for patients with Waldenstrom macroglobulinemia (WM), a rare form of B-cell lymphoma. The drug, approved for the same purpose last year in the US, will meet a previously unmet need due to issues with the current standard of care.
Biden Declares Pandemic is Over – Vaccine Stocks Take a Hit
US President Joe Biden declared the pandemic ‘over’ in a “60 Minutes” interview this Sunday, September 18th. In response, many vaccine manufacturers saw a drop in share prices, including Moderna, Novavax, and BioNTech. This reflects a larger dip in the biotech market, particularly companies working with COVID-19 therapeutics.
Webinar – Personalize Patient Engagement by Integrating Your Innovation and Digital Strategies – September 22
Pivoting to patient-centered care is a major step towards improving health outcomes, but barriers exist that stop or slow implementation. To achieve a truly patient-centered approach, these barriers must be addressed. In an upcoming webinar on September 20th, speakers from industry and healthcare will share their insights into digital strategies that can help personalize patient engagement.
Webinar – The Clinical Trial Recruitment Crisis Hits Home – September 29th
Patient recruitment for clinical trials has historically been one of the most challenging parts of drug development; recent world events have only made this more difficult. In an upcoming webinar on September 29th, Kyle LaHucik of Endpoints News explores the current patient recruitment landscape and possible solutions moving forward.
South African Biotech Biovac Produces First Batch of COVID-19 Vaccine
Biovac, a vaccine producer located in South Africa, has produced its first batch of Pfizer and BioNTech’s mRNA vaccine. The company was added to Pfizer and BioNTech’s vaccine manufacturing network just over a year ago. The South African Health Regulatory Products Authority still needs to inspect the vaccines before they can be distributed.
WHO Conditionally Recommends Remdesivir for Severe COVID-19
The World Health Organization (WHO) has conditionally recommended Gilead’s COVID-19 antiviral Remsdesivir (Veklury), which was already conditionally recommended for non-severe COVID-19. The recommendation was made on positive results from the organization’s SOLIDARITY, which found that patients had a 13% decrease to relative risk of mortality in severe COVID-19 patients.
Bayer Begins Search for New CEO
Sources have indicated that Bayer is seeking out a new CEO, possibly before the end of Warner Baumann’s current term as CEO is due to end in 2024. The reports signal that Baumann may be leaving his position early, with plans to name a candidate for the role by next April’s shareholder meeting. This comes after facing a vote of no confidence due to the fallout of Bayer’s acquisition of Monsanto and the subsequent lawsuits about the controversial weedkiller Roundup.
Eli Lilly CFO Talks Splitting Tirzepatide into Two Brands for Obesity and Diabetes
In a talk at the Morgan Stanley healthcare conference this week, Eli Lilly’s CFO Anat Ashkenazi spoke about the company’s deliberations in deciding whether to split Tirzepatide into two brands, one for diabetes and one for obesity. Lilly has done this before with Prozac (fluoxetine), making a new brand for premenstrual dysphoric disorder. It did not do the same for the drug Cialis, an erectile dysfunction drug also indicated for benign prostatic hyperplasia.
Takeda Invests €300 M in Expansions at Belgium Plasma Manufacturing Facility
Takeda is seeking to boost its manufacturing operations in Europe with expansions at its site in Lessines, Belgium. The expansions will run Takeda approximately €300 and will go towards building a new storage warehouse and manufacturing facility. The company expects to be finished with the expansion, which will support the site’s plasma-based therapy production, by winter 2023.
Novartis Whistleblower Case Dismissed Again
A US District Judge has dismissed a whistleblower case against Novartis yet again. The case, brought by Steven Camburn, a former Novartis sales rep who alleged that the company was giving physicians kickbacks to encourage them to prescribe Gilenya, a drug for multiple sclerosis. Judge Kimba Wood ruled that Camburn has not provided enough evidence to support his claims
Webinar – A Journey without a Map: Building an Oncology Powerhouse Where Innovation Thrives – Sept. 21
The landscape of next-generation cancer treatment development is rapidly changing. Achieving success in advanced requires careful consideration of the shifting tides of the industry and quick adoption of new concepts and technologies. In an upcoming Endpoints webinar on September 21st, leaders from Astellas discuss how they built an oncology powerhouse.
Biden Relaunches Cancer Moonshot With Goal of Halving Cancer Deaths in 25 years
US President Joe Biden is revamping and relaunching his cancer moonshot, a project he began as Vice President in 2016. Biden set a goal of reducing cancer deaths by 50% in the next 25 years by policy changes that would spur new innovation in biopharma, increase healthcare data infrastructure, and reduce drug prices.
Whitepaper – Engaging the End Prescriber: A Practical Guide to Working With Physicians
Adapting pharmaceutical marketing to the changing healthcare landscape requires understanding the perspective of physicians. However, there is often a big divide between clinicians and marketers that must be bridged in order to achieve market success. In a new whitepaper by flipMD, learn why you should include physicians in your planning and how to do it.
Pretzel Therapeutics Nets $72.5 Million in Series A Funding For Mitochondrial-Targeted Therapeutics
The biotech Pretzel Research has been awarded a total of $72.5 million in Series A funding. Pretzel develops therapeutics that target the mitochondria, often referred to as “the powerhouse of the cell.” There are many diseases caused by mitochondrial dysfunction and even more that are affected by it. To start, Prezel will focus on “primary” mitochondrial disorder, which affect 1 out of every 5,000 people.
