There were already signs of change. While around 25% of employers provided coverage for GLP-1 drugs like Wegovy and Ozempic …
How Novo Nordisk’s Wegovy cardiovascular benefits could drive further growth
Semaglutide was already one of the best-selling drugs of recent memory. And Novo Nordisk the fastest-growing Big Pharma firm. Now, the FDA’s decision to expand the label of its weight-loss version of the drug to include cardiovascular benefits could help unlock more growth momentum for Novo Nordisk. This positions Wegovy as the first weight-loss medication also cleared for reducing the risk of heart attack, stroke, or heart-related death in at-risk individuals. The approval, based on a 17,600-patient SELECT study demonstrating a 20% lower risk of cardiac events with Wegovy versus placebo, could have a material impact on sales. The study also found that patients lost an average of 15% of their weight.
The expanded FDA label sanctions the use of Wegovy for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are obese or overweight. This marks a significa…
Could LSD change the game in anxiety treatment?
A once-controversial psychedelic substance could hold the key to treating Generalized Anxiety Disorder (GAD). This is the view of Dr. Rakesh Jain, a prominent psychiatrist who serves as a clinical professor at the Department of Psychiatry at Texas Tech University School of Medicine. While ack…
Eicos Sciences’ FDA-approved Aurlumyn promises to drastically reduce frostbite amputations
Eicos Sciences’s Aurlumyn, containing the active ingredient iloprost, offers a novel approach to treating severe frostbite. Iloprost, a synthetic version of a naturally occurring substance known as prostacyclin, targets two key problems. First, it addresses cold-induced blood vessel construction by widening them to restore essential blood flow to the affected tissues. Second, it prevents blood clots from forming, which can further block circulation…
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 …
Caribou Biosciences’ CEO discusses CRISPR progress, future goals, and gender equality in biotech
Founded in 2011, Caribou Biosciences is a pioneer in the development of CRISPR genome editing technologies, a field honored with the Nobel Prize in Chemistry in 2020. Co-founded by Jennifer Doudna, Ph.D., one of the Nobel laureates, and CEO Rachel Haurwitz, and two other CRISPR pioneers, the company has raised over $800 million in funding, including significant investments from industry giants like Pfizer. In 2021, the company entered the clinic with their lead program and completed a successful $350 million IPO.
“Today, we’re laser focused on using Caribou’s next generation CRISPR technology, which we call chRDNA technology to advance a pipeline of wholly owned off the shelf CAR-T and CAR-NK cell therapies,” said Haurwitz in a recent interview at the JP Morgan Health Care conference.
CRISPR: From lab to clinic in about a decadeRachel Haurwitz,…
Using AI to unlock new uses for existing cancer medicines
In keeping the law of unintended consequences, recent provisions introduced by the 2022 Inflation Reduction Act (IRA) blunted the potential benefits of drug repurposing. As a result of limiting the window of time during which pharmaceutical companies can recoup investments before…
MDMA’s potential shift from party drug to PTSD therapy could hinge on strict safety measures
MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks.
On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress disorder, based on positive phase 3 results demonstrating significant PTSD reductions for most trial participants. In the studies, a significant number of those receiving MDMA-assisted therapy no longer qualified for a PTSD diagnosis after three treatment sessions, with a large majority seeing clinically meaningful improvements.
Currently, the Drug Enforcement Administration (DEA) categorizes MDMA as a Schedule I controlled substance having no approved medical uses, although it is likely to reclassify the stimulant if it receives FDA approval.
MAPS founder Ric…
Cybin sees near future for psychedelic therapy after promising interim phase 2 data
As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But before long, data from multiple phase 3 trials will be available on psilocybin derivatives for various mood disorders.
Interim phase 2 CYB003 data as a ray of hope for treating mood disordersToronto, Canada–based Cybin recently unveiled upbeat interim phase 2 data related to CYB003, a proprietary deuterated psilocybin analog, in patients with moderate to severe major depressive disorder (MDD). In the randomized double-blind placebo-controlled study, CYB003 demonstrated a rapid and robust reduction in depression symptoms just three weeks …
Lilly’s Zepbound to enter the weight management market with competitive pricing
Lilly’s tirzepatide notched an FDA approval for chronic weight management, potentially clearly the way for billions in additional sales. Analysts have projected that the drug could fetch $26 billion in annual sales by 2030, with roughly two-thirds of that sum related to obesity treatment. Bank of America analyst Geoff Meacham is even more optimistic, predicting that sales could hit $48 billion annually.
The company is calling the obesity-branded version of the drug Zepbound, in contrast to Mounjaro, which won FDA approval for type 2 diabetes on May 13, 2022.
Lily’s stock was up 3.20% to $619.13. Year-to-date, its share price is up almost 70%, in part as a result of strong sales prospects for tirzepatide.
The table below outlines the starting cash prices for a range of GLP-1 receptor agonists. Lilly’s Zepbound, the obesity-branded version of tirzepatide, has a competitive starting price in the segment. With insurance, Zepbound could cost as lo…
Is the new $15,900 postpartum depression pill worth it?
Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV, which mostly includes benzodiazepines. That status could influence prescriber and patient perceptions concerning the drug’s safety profile and potential for abuse. The formulary review process for Zurzuvae, critical for insurance coverage, will occur throughout 2024.
Sage had initially aimed to price Zurzuvae under $10,000, but its failure to win approval earlier this year for zuranolone for major depressive disorder altered its pricing strategy.
Zurzuvae postpartum depression cost in contextThe wholesale acquisiti…
Eli Lilly’s obesity focus helps propel promising 2023
2023 is shaping up to be a blockbuster year for Eli Lilly. With the company’s stock soaring by almost 54% since the beginning of the year, analysts are largely upbeat about Lilly’s expanded focus on obesity and diabetes treatments. While the company has developed insulin for a century, the company is now broadening its horizons with Mounjaro (tirzapetide), a diabetes treatment used off-label for obesity. An FDA approval for tirzapatide, a dual GLP-1/GIP receptor agonist, in obesity could occur later this year.
While Lilly has seen its stock surge in 2023 thus far, its performance over the past month hasn’t been as robust — declining by close to 6% over the past month.
Momentum“We continue to be pleased with the strong momentum of Mounjaro as more type 2 diabetes patients benefit from the medicine,” said Dave Ricks, chairman and CEO of Eli Lilly, in the company’s second quarter earnings call. In fact, despite ramping up produ…