In this week’s edition of InnovationRx, we explore potential pain treatments from cannabis, the implications of new vaccine restrictions, virtual clinical trials at the Mayo Clinic, GSK’s $30 billion U.S. manufacturing commitment, and more. To receive it in your inbox, subscribe here.
Despite the addictive nature of opioids, they remain a primary treatment for pain due to the lack of effective alternatives. The FDA recently released new guidelines for non-opioid painkillers. However, the development of these drugs has faced challenges. Vertex Pharmaceuticals, for instance, abandoned a next-generation non-opioid drug after a failed clinical trial. Acadia also abandoned a promising candidate after a trial failure.
One potential source for non-opioid pain relief is cannabis. Researchers at Washington University and Stanford conducted a study earlier this year demonstrating the pain-relieving properties of a cannabis-derived compound with minimal side effects in mice.
Vertanical, a pharmaceutical company based in Munich, is leading the charge in developing a cannabinoid-based extract for chronic pain treatment. Their drug, Ver-01, contains low levels of cannabinoids, including THC, to alleviate pain without causing a high. Founder Clemens Fischer aims for Ver-01 to be the first cannabis-based painkiller prescribed by physicians and covered by insurance.
Vertanical has invested over $250 million in its drug development, with successful phase III clinical trials in Germany. The company anticipates approval from German and Austrian authorities this year and plans to launch phase III trials in the U.S. in 2026. Fischer is optimistic about the potential of Ver-01, stating, “We believe that we will be the first non-opiate chronic pain treatment worldwide.”
Vaccines Are A Hard Business. RFK Jr.’s CDC Is Making It Even Harder
HHS Secretary Robert F. Kennedy, Jr.
Getty Images
The CDC’s immunization advisory committee, which saw its membership overhauled by Health and Human Services Secretary Robert F. Kennedy Jr., is scheduled to convene this week. The agenda includes discussions on childhood vaccinations, particularly those protecting against hepatitis B, measles, chickenpox, and COVID-19.
These committee meetings typically play a crucial role in shaping immunization recommendations and schedules that influence public health policies at state and national levels. However, Kennedy’s anti-vaccine stance has raised concerns about the future of U.S. immunization policy. Speculations suggest that the committee may restrict COVID-19 vaccine recommendations to specific age groups and individuals with certain health conditions.
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, expressed apprehension about the current state of the committee, stating, “We should be very worried because ACIP isn’t ACIP anymore. It’s essentially an arm of our Secretary of HHS who is an anti-vaccine denialist and has been for the last 20 years.”
For more information, read the full article here.
BIOTECH AND PHARMA
GSK announced a $30 billion investment in R&D and manufacturing facilities in the U.S. over the next five years. This includes advancements in manufacturing and AI for next-generation biopharma facilities, with a focus on respiratory diseases and cancer therapies. Lilly also revealed plans for a $5 billion manufacturing facility near Richmond, Va.
Additionally, Krystal Biotech’s Vyjuvek, a topical gene therapy for dystrophic epidermolysis bullosa, received FDA approval for expanded use, allowing infants to be treated at home without a healthcare professional. This development led to an 8% increase in Krystal’s stock.
DIGITAL HEALTH AND AI
Researchers at the Mayo Clinic have introduced “virtual clinical trials” to predict the efficacy of heart failure treatments. Utilizing data from thousands of heart failure patients, computer models are used to identify potential repurposed drugs for heart disease. The Mayo team’s findings were published in npj Digital Medicine.
Furthermore, Lila Sciences raised $235 million to integrate AI into scientific research, with a valuation of $1.2 billion.
PUBLIC HEALTH AND HOSPITALS
According to a Harris poll, over half of healthcare professionals intend to seek new job opportunities next year. Dissatisfaction with current roles and feelings of being undervalued by employers were key factors driving this trend.
Moreover, investments in disease prevention and early detection could result in significant cost savings for the U.S. healthcare system by 2040, as per a report by Deloitte.
WHAT WE’RE READING
Former CDC director Susan Monarez testified about Robert F. Kennedy Jr.’s plans to alter childhood vaccine schedules and her dismissal for opposing the changes.
The FDA cracked down on pharmaceutical ads, issuing 40 letters to companies like Pfizer, Novartis, BMS, and Lilly.
San Francisco’s tech circles are embracing DIY dosing with Chinese peptide dealers for health and performance enhancement.
Former surgeon general Jerome Adams criticized RFK Jr.’s anti-vaccine stance and advocated for change.
Novo Nordisk’s weight-loss drug, Wegovy, has shown potential to suppress thoughts about food in a recent study.
A judge dismissed two murder charges related to acts of terrorism against Luigi Mangione, the alleged killer of UnitedHealthcare’s CEO.
Surgeon general nominee Casey Means disclosed significant earnings from promoting supplements and pledged to divest from her family’s tobacco holdings.
Merck and AstraZeneca scrapped planned projects in the U.K., raising concerns about future investments in the region.
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