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Posted by Bill Gadless on July 28, 2023

Welcome to biopulse, your weekly briefing on key marketing trends and insights in the biopharma sector. Every week, I (Bill Gadless) probe top stories, studying product launches, branding, and communication. I’ll feature pivotal campaigns, innovative marketing tech, thought leadership and regulatory shifts reshaping healthcare engagement.

Week of July 10, 2023

❝ A quote (from me):

“In the midst of recovery and innovation, the Medical Device industry shows remarkable resilience and growth. With increased investments, active M&A, and a positive market sentiment, we’re seeing not just a resurgence, but MedTech shaping the future of healthcare.”

Myself

❝ Another quote (from someone else):

“I think history would say that medical research has, throughout many changes of parties, remained as one of the shining lights of bipartisan agreement, that people are concerned about health for themselves, for their families, for their constituents.”

Francis Collins, Former NIH Director

🤔 Question for you:

Considering the increasingly prominent role of patient empowerment and digital health tools in the healthcare journey, how does your marketing strategy adapt to convey the value of these innovations in a way that resonates with the tech-savvy, informed patients of today, while maintaining regulatory compliance and ethical considerations?

📰 The Week’s Top Stories

LeBron James Grateful for Support Following Son’s Cardiac Arrest Incident

LeBron James expressed gratitude to well-wishers and shared a positive update on his son’s condition following a cardiac arrest. Bronny James, an 18-year-old incoming freshman at the University of Southern California and a highly touted basketball player, collapsed in Los Angeles earlier this week. The elder James stated, “Everyone doing great. We have our family together, safe and healthy,” thanking those sending love and prayers to his family. He also promised to share more information when the family is ready, highlighting the importance of public support during this challenging time.

Bipartisan Senate Bill Seeks to Boost Domestic Generic Drug Manufacturing Amid Shortages

A bipartisan team of senators introduced the RAPID Reserve Act on Thursday, aiming to stimulate domestic generic drug production and mitigate the ongoing drug shortages, including critical medicines like antibiotics and chemotherapies. The legislation proposes a $500 million fund for generic drug manufacturing grants to U.S.-based or OECD member companies. The bill, presented by Senators Gary Peters (D-MI), Marsha Blackburn (R-TN), and Sherrod Brown (D-OH), aims to strengthen the pharmaceutical supply chain and healthcare capacity by increasing emergency production. The bill was applauded by stakeholders for potentially reducing drug shortages and dependency on foreign manufacturers.

Senate Committee Advances Proposal to Study Alternatives for Lowering Drug Prices

The Senate Committee on Health, Education, Labor, and Pensions has voted 17-3 in favor of investigating new models for drug development, aiming to lower pharmaceutical prices. An amendment to the Pandemic and All-Hazards Preparedness Act proposes a $3 million allocation to the National Academies of Sciences, Engineering, and Medicine (NASEM) to research alternative funding strategies, including direct government funding and innovation prizes. If successful, this could lead to cheaper, publicly available generic drugs, disrupting the traditional patent model and potentially saving Americans billions annually. However, the proposal faces hurdles in the Senate, House, and from the pharmaceutical industry.

Depression in Adulthood Could Double Dementia Risk

A study in JAMA Neurology indicates that adults diagnosed with depression may have over double the risk of developing dementia later in life. The research, which followed 1.4 million Danish citizens from 1977-2018, showed a link between dementia risk and depression diagnoses in both early and mid-life. Although the exact reasons for this association remain unclear, potential factors could include shared risk factors between depression and dementia, alterations in key neurotransmitters, or changes in health behaviors due to depression. The study further showed a stronger association in men, requiring additional research.

Pfizer and FDA Tackle Supply Concerns after Tornado Hits NC Plant

Following a tornado that devastated Pfizer’s major injectables plant in North Carolina, Pfizer and the FDA are working together to manage potential drug supply shortages. The plant, which accounts for nearly 25% of Pfizer’s sterile injectable production, suffered damage mainly in its warehouse facility. Pfizer has begun moving products to other sites for storage, relocating finished medicines, and potentially shifting production of certain drugs to alternate facilities while recovery efforts proceed. Despite the circumstances, the FDA does not anticipate any immediate significant impacts on supply as most affected products are already in the distribution system.

Merck and Moderna Begin Phase III Trial for Novel mRNA Cancer Vaccine

Merck and Moderna have initiated a significant Phase III trial for their mRNA-based personalized cancer vaccine, in combination with Merck’s Keytruda, for high-risk melanoma. The trial follows a successful Phase IIb and will include stage IIb-IV patients, enrolling roughly 1,089 participants across over 25 countries. The cancer vaccine, which has demonstrated reduced risk of recurrence or death, utilizes mRNA technology to stimulate tumor-specific T-cell responses. The FDA has granted Breakthrough Therapy Designation to the vaccine, offering potential for accelerated approval and priority review. Plans to extend development to other tumor types are underway.

Lilly’s Experimental Obesity Drug Promises Significant Weight Loss in Latest Trials

Eli Lilly reported that its under-development obesity drug, Mounjaro (tirzepatide), led to an average weight reduction of 26.6% across two late-stage trials. The drug was tested on obese or overweight patients without type 2 diabetes. If approved, Mounjaro is expected to become a blockbuster treatment and a significant growth driver for Lilly. The data bolsters Lilly’s standing in the increasingly competitive obesity treatment market, challenging rivals like Novo Nordisk, Pfizer, and Amgen. Both trials met secondary objectives, and the drug’s safety profile was in line with previous studies.

Biden Unveils Advanced Cancer Research Initiative as Part of ‘Moonshot’ Effort

President Biden’s administration has launched the first cancer-focused initiative under the Advanced Research Projects Agency for Health (ARPA-H). The initiative, named the Precision Surgical Interventions program, aims to improve surgical outcomes by enhancing the distinction between cancerous cells and healthy tissue during surgeries. ARPA-H, modeled after the military-focused DARPA, hopes to develop tools that enable surgeons to avoid healthy nerves and blood vessels while removing all cancerous cells. This initiative is a significant component of Biden’s “unity agenda” introduced in his 2022 State of the Union address, aimed at battling cancer, improving veterans’ health, and enhancing mental health accessibility.

Biogen to Slash Workforce by 11.5% Amid Strategic Transition, Saving $1 Billion by 2025

In a major restructuring move, Biogen will lay off 1,000 employees by 2025, a workforce reduction of 11.5%, expected to save the firm $1 billion in operating expenses. The cuts come after the unsuccessful launch of Alzheimer’s drug Aduhelm and as the company shifts focus to more profitable ventures like new Alzheimer’s drug Leqembi. Although the firm’s revenue declined 5% to $2.46 billion in Q2 2023, it still surpassed analysts’ predictions. CEO Chris Viehbacher stated the company is transitioning, necessitating a shift of resources towards areas of highest value creation.

Amazon Unveils AI-Powered HealthScribe to Revolutionize Clinical Documentation

Amazon Web Services (AWS) is launching HealthScribe, a generative AI tool designed to aid clinical documentation. Revealed at the AWS Summit in New York, HealthScribe enables healthcare software providers to build applications using speech recognition and AI to transcribe and summarize doctor-patient interactions. HealthScribe extracts vital medical information for input into electronic health records, focusing initially on general medicine and orthopedics. Clinicians can verify the accuracy of AI-generated summaries before they’re entered into EHRs. Although still in preview, AWS aims to address healthcare documentation pain points, potentially enhancing accuracy by reducing reliance on clinicians’ memories and handwritten notes.

Teladoc Health Forecasts Increased Revenue and Earnings Amidst Q2 Growth

Teladoc Health has reported a 10% rise in revenue to $652.4 million in Q2 as integrated care membership grew 7%. Despite a net loss of $65.2 million, the virtual care company raised its low-end revenue and adjusted EBITDA guidance for the year, indicating continued growth momentum. CEO Jason Gorevic pointed to consistent growth across business lines, with BetterHelp membership increasing 17% to 476,000. The company also highlighted plans to incorporate AI in its products and focus on growth in unserved clinical areas, expressing optimism about increased employer spending on virtual care over the next three years.

🧬 Other Stuff

The Medical Device Sector is Back!

My latest industry update focuses on the MedTech sector: from the significant upsurge in VC investments to a reinvigorated M&A landscape, the MedTech sector is on an upward trajectory. 📈 As CNBC’s Jim Cramer puts it, we are witnessing a bullish market for medical devices.

In my latest video, I dive into these trends and data points, examining the key factors behind this phenomenal growth:

✅ The $1.8 billion pumped into MedTech by venture capital firms in just Q1 of 2023

✅ The robust M&A activity, with a whopping $155.3 billion deal value in March alone

✅ The resurgence in non-urgent surgeries post-pandemic, fueling sales of medical devices

✅ The big strides of major MedTech companies like InMode, J&J, Intuitive Surgical, and GE HealthCare


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