Here are the latest stories being discussed in biopharma today:
Title: AbbVie Retains 96% Hold on Humira Market despite Biosimilar Competition
Despite competition from nine biosimilars, AbbVie continues to dominate the adalimumab market with a 96% hold on its best-selling drug Humira, according to a report from Samsung Bioepis. The increase in biosimilars market share is just 1% since six months ago, suggesting that serious competition for AbbVie’s biologic may take years. A significant hurdle seems to be that shifting to adalimumab biosimilars, although it could save the US health system up to $6 billion, would reduce profits for PBMs by up to 84%, discouraging many large payers from switching.
Title: SEC Victorious in Biopharma ‘Shadow’ Insider Trading Case
The SEC has won a lawsuit against a former executive of Medivation, Matthew Panuwat, for insider trading. Despite not trading in his own company’s stock, Panuwat purchased shares in a rival pharma company using inside knowledge that Pfizer was planning to buy Medivation. The legal case, which set a new precedent in ‘shadow trading,’ resulted in a jury finding Panuwat liable for violating the Federal Securities Act. As a result of his unlawful trading, Panuwat made more than $100,000 after Pfizer’s $14 billion acquisition of Medivation.
Title: Stealth Bio Wins FDA Review for Previously Rejected Rare Disease Drug
Seven years after Stealth BioTherapeutics received a fast-track designation from the FDA, the company’s application for a treatment for rare, genetic disease Barth syndrome will undergo review. While the application won’t receive a priority or accelerated review, the FDA will convene an advisory committee to discuss the drug, dubbed elamipretide. The agency has not officially scheduled the meeting but expects it to occur within several months.
Title: Study Shows Lack of Clinical Benefit in Half of Fast-Tracked Cancer Drugs
Nearly half of cancer drugs that were quick-tracked did not show improved quality of life or survival after five years, according to a study by Harvard University. The research, published in JAMA, reveals the uncertainty surrounding the commonly used regulatory pathway for cancer treatments.
Title: Takeda Continues Rare Disease Awareness Campaign with Patient-Inspired Imagery
Takeda is extending its ‘Discover HAE’ campaign, highlighting the unpredictable burdens of hereditary angioedema (HAE), a rare disease causing recurrent severe swelling in the body. The campaign includes personal stories and imagery inspired by patients’ insights, aiming to broaden awareness and understanding of the disease.
Title: Thermo Fisher to Downsize Plasmid Manufacturing Lab, Lay Off 74 Workers
Thermo Fisher is set to ‘adjust staffing levels’ at a plasmid manufacturing laboratory in California, resulting in 74 layoffs from the end of May. The adjustments are being made to align with current volume demands. Impacted employees will receive job transition support to help find new opportunities.
