pharmaceutical industry Archives - Medical Design Sourcing

Are Big Pharma giants getting the right ROI on their R&D investments? A visual exploration

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While annual reports show broadly similar R&D strategies among Merck & Co., Pfizer, Johnson & Johnson and AbbVie, their 2020–2023 financial metrics reveal a concerning trend. Merck & Co. may be the new top dog of Big Pharma, but the firm’s 1.4% revenue growth in 2023 represents a significant slowdown. Pfizer’s 41.7% revenue decline from its COVID-inflated $100.3 billion peak in 2022 is even more stark. Similarly, J&J’s modest 4.2% growth and AbbVie’s 6.4% revenue dip also signal a departure from previous patterns.

In raw numbers, R&D spending in the pharmaceutical industry has surged over the past few decades, jumping from about $30 billion across the industry to more than $200 billion annually by the 2020s. Despite record-breaking R&D spending hitting $161 billion in 2023, marking a nearly 50% increase since 2018, as IQVIA has noted, …

A timeline of Aduhelm’s rise and fall

The story of Aduhelm has been rocky now for years. Biogen turned heads when its controversial Alzheimer’s therapy won accelerated approval from the FDA against the advice of its own advisory panel in mid-2021. The company had high hopes for the antibody at that point, pricing it at an average of $56,000 per year. Aduhelm would encounter a series of blows after that – rejected coverage, dismal sales, discontinued trials. Biogen would ultimately pull the plug on the drug this year.

Now, Biogen aims to prioritize other Alzheimer’s programs like the lecanemab, which was jointly developed with Eisai and FDA-approved in July 2023. Biogen noted in a statement that insights gained from Aduhelm hold value for the company. Ultimately, Biogen recorded a $60 million charge tied to wrapping up Aduhelm’s development.

A timeline showing the ups and downs in Aduhelm’s journey in reverse-chronological order follows. Stock data are from Yfinance and annotation chart …

Kristofer Mussar on VectorBuilder’s ethical imperative in gene delivery

VectorBuilder

As genetic technologies unlock new possibilities, companies like VectorBuilder aim to navigate progress responsibly, guided by a strong moral compass. “Ethics to me is the one thing that really is so, so important,” said Kristofer Mussar, managing director of VectorBuilder GmbH. “I have such a high ethical threshold I make decisions that are sometimes not the best business decisions, but they are the right ethical decisions.”

VectorBuilder offers an array of products and services, including vector design, vector cloning, plasmid DNA preparation, AAV capsid evolution, mRNA gene delivery systems, and CDMO services. Its international customer base includes thousands of labs and biotech/pharma companies.

In business practices, especially in a field such as gene delivery, ethics are tantamount. “If you have very strong ethics, that means you have trust,” he explained. “If everybo…

Biotech boomtowns: Comparing salaries and cost of living in 9 global hotspots

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Boston is arguably the top biotech hub in the U.S., but the salaries in San Francisco and New York City tend to be higher. According to recent data, the San Francisco area offers the top average salaries for biotech jobs, followed closely by New York City. But the cost of living in all three cities remains stubbornly high, with New York City taking the cake for the highest overall cost of living in the U.S. San Francisco came in third while Boston was eighth.

Still, while the pandemic hit New York City and San Francisco especially hard, both cities remain competitive biotech hubs. According to Crunchbase data, both areas have especially high concentrations of biotech companies.

While other major cities with strong biotech sectors such as Boston, London, and Paris offer competitive salaries, none are in the vicinity of the average wages found in San Francisco and New York.

Sa…

Navigating the new regulatory terrain pharma companies face with IRA and 340B

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The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals to allow Medicare to negotiate drug prices for the first time and imposing rebates on drug price increases that outpace inflation. Additionally, the 340B Drug Pricing Program, which was created in 1992, is a U.S. federal government program that aims to allow healthcare organizations to offer affordable prescription drugs to underserved and low-income populations. In 2021, 340B backed entities purchased $43.9 billion worth of covered outpatient drugs under the program.

To get a clearer sense of how the indu…

Transparency-Rx promises reform in the PBM landscape

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Pharmacy benefit managers (PBMs) have recently emerged as a punching bag with the pharma trade group PhRMA accusing such orgs of driving up drug prices. Now, an alliance of PBMs known as Transparency-Rx has emerged, promising a reform initiative in a digital campaign attempting to put pressure on rival PBMs. This coalition’s efforts could reshape drug pricing dynamics, with potentially significant consequences for pharma companies, which may potentially need to adapt to a market with more straightforward and possibly more stringent pricing structures.

Transparency-Rx pushes for PBM reform

Transparency-Rx, comprising PBMs such as AffirmedRx, Liviniti and SmithRx, claim they can generate major per-prescription savings. In doing so, they aim to differentiate themselves from the “big three” PBMs, which include CVS Caremark, Express Scr…

Eli Lilly’s Mounjaro sees explosive sales growth, yet demand outpaces supply

Eli Lilly’s diabetes medication Mounjaro (tirzepatide) is seeing explosive sales growth, jumping from $187.3 million in the third quarter of 2022 to $1.4 billion in the same period this year. Conversely, sales of Lilly’s Trulicity, another diabetes drug, have declined, dipping from $1.85 billion in Q3 2022 to $1.67 billion in Q3 2023.

Mounjaro is selling so briskly that Lilly is having trouble making enough of it. The company is aiming to boost supply by recruiting a diverse portfolio of contract manufacturers. It plowed $450 million in its Research Triangle Park facility in North Carolina to support additional drug filling, device assembly, and packaging capacity. It also invested an additional $1.6 billion in new manufacturing sites in its home state of Indiana. Despite the efforts, the company notes that supply problems have led to “intermittent delays” in filling orders and tight supply of the medication throughout most of the third quarter…

How the latest AI executive order might impact drug development in the U.S.

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The White House has released an executive order that contains what it hails as “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.” Relevant to drug development, a fact sheet on the order describes its aim to help further “the responsible use of AI in healthcare and the development of affordable and life-saving drugs.” The order also is designed to protect against the risks of using AI to synthesize new chemicals and biological materials, and will require government agencies funding life science projects to follow these standards as a prerequisite.

Other provisions of the order that could affect drug developers include its potential to affect AI-assisted clinical trials. The order could require drug developers to ensure that their algorithms do not exacerbate discrimination in clinical trials or patient interactions. Drug …

GLP-1 drug tirzepatide shines in SURMOUNT-3 trial with weight loss of 26.6%

In the phase 3 SURMOUNT-3 trial, tirzepatide recipients saw some of the most impressive weight loss results among trials of GLP-1 drugs, including most notably semaglutide. In the study, participants’ total mean weight loss was 26.6% over 84 weeks following a 12-week intensive lifestyle intervention and subsequent tirzepatide treatment. In all, participants who received tirzepatide lost an additional 18.4% of their body weight compared to a weight gain of 2.5% in the placebo group.

In SURMOUNT-3, some 87.5% of participants who received tirzepatide achieved an additional weight reduction of 5% or more, compared to 16.5% of those in the placebo group.

While it is difficult to compare data from separate studies, the highest weight loss percentage for tizepatide, 26.6%, was 53% higher than the highest percentage, 17.4%, for semaglutide (OASIS 1).

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10 major pharma and biotech companies that downsized in 2023

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At Day 21, low-dose ketamine KET01 shows no statistical edge over placebo.

Ketabon GmbH revealed positive top-line results from its phase 2 KET01-02 study investigating KET01, an oral slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). Results were promising initially. Investigators noted improvements in depression severity as early as day 4, but data were not statistically significant over placebo at day 21.

A look at Ketabon GmbH’s KET01-02 study in treatment-resistant depression

The trial studied KET01 doses of 120 mg and 240 mg per day. It involved 122 individuals who were outpatients with current major depressive episodes not responding to at least two standard antidepressants. Participants received KET01 once daily in addition to a traditional antidepressant treatment over the three-week period. In particular, the 240 mg/day dose showed clinically relevant improvements with statistical significance versus placebo on days 4 and 7. The drug, however, did not maintain significance at day 21.

K…

Prices of top 25 Medicare Part D drugs more than doubled since market entry; AARP offers new insights in drug pricing report

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Medicare Part D drug prices have seen a significant surge in recent years. The price of the arthritis drug Enbrel has soared 701% since its launch in 1998, and the diabetes drug Januvia has jumped 275% since its debut 2006. All in all, the average price increase for the 25 brand-name drugs with the highest Medicare Part D spending in 2021 was 226%, noted AARP in a recent drug pricing report.

Such attention-grabbing stats aren’t isolated cases, but part of a bigger picture. Almost 60% of the current list price for the top 25 drugs is a result of price increases post launch. “On average, the prices of the 25 top Medicare Part D drugs have more than tripled since they first entered the market,” said Leigh Purvis, director, health care costs and access at AARP, in a media briefing. “Some of the prices are more than eight times higher than they were when they launched.”

The economic…