This Week’s Biopharma News: Long-Running CRISPR Patent Case Reopened

CRISPR back in court
 

A ruling by the US Court of Appeals for the Federal Circuit has reopened the contentious battle over the foundational patents for CRISPR-Cas9 gene editing technology. On May 12, 2025, the court vacated a 2022 decision by the US Patent Trial and Appeal Board (PTAB) that had awarded key CRISPR patents to Feng Zhang of the Broad Institute, affiliated with Harvard and MIT.

The appellate court found that the PTAB had applied incorrect legal standards and failed to adequately consider evidence suggesting that researchers at the University of California, Berkeley, led by Nobel laureates Jennifer Doudna and Emmanuelle Charpentier, were the first to conceive the use of CRISPR in eukaryotic cells.

The case now returns to PTAB for reconsideration under the correct legal framework. If UC Berkeley's claim is upheld, it could significantly alter the landscape of CRISPR-related intellectual property, potentially affecting existing and future licensing agreements, underscoring the ongoing complexities in determining the rightful ownership of CRISPR-Cas9 and other biotechnological developments.

Trump executive order demands lower drug prices
 

Donald Trump has signed an executive order to reduce US prescription drug costs by implementing “most favored nation” (MFN) pricing. The policy mandates that Americans pay no more for medications than the lowest price charged in other developed countries, and directs the Department of Health and Human Services to negotiate these prices with pharma manufacturers within 30 days. If negotiations fail, the administration plans to enforce MFN pricing through regulatory measures, including facilitating direct-to-consumer sales at reduced rates and expanding drug importation from countries with lower prices.

The order also tasks the US Trade Representative and Secretary of Commerce to address foreign practices that contribute to higher US drug prices, aiming to end what the administration describes as "global freeloading" on American-funded pharmaceutical innovation. “Should drug manufacturers fail to offer American consumers the most-favored-nation lowest price, my Administration will take additional aggressive action,” a White House statement says.

This initiative revives a similar effort from Trump's first term, previously halted by legal challenges, and seeks to extend its impact beyond Medicare to include Medicaid and private insurance markets.

EMA confirms finasteride side effects
 

The EMA has confirmed that suicidal thoughts can be a side effect of finasteride tablets for treating male pattern hair loss. The conclusion followed a comprehensive EU-wide safety review, which found that most cases of suicidal ideation are associated with the 1 mg tablets. While finasteride already carried warnings about mood changes, the EMA has now mandated additional measures, including updated product information highlighting the risk of suicidal thoughts and sexual dysfunction, as well as inclusion of a patient card advising users to seek medical advice if they experience mood changes or sexual issues.

The EMA has also been investigating dutasteride for similar reasons. Although no direct link was established between dutasteride and suicidal ideation, precautionary updates regarding mood changes will be added to its product information, given its similar mechanism of action to finasteride.

However, the EMA also added that the benefits of finasteride and dutasteride continue to outweigh potential harms for their approved uses.

Sino-Brazilian insulin agreement
 

Gan & Lee Pharmaceuticals has signed an agreement with Brazil’s Ministry of Health and local partner Biomm under Brazil’s Productive Development Partnership (PDP) program. The collaboration marks Gan & Lee as the first Chinese pharmaceutical company to participate in the PDP initiative, which aims to localize insulin production and strengthen Brazil’s public health infrastructure.

The agreement was formalized during Brazilian President Luiz Inácio Lula da Silva’s state visit to China, following the February 2025 approval of Gan & Lee’s insulin PDP project and subsequent discussions in April. Gan & Lee’s partnership with Biomm began in 2014, successfully registering and commercializing insulin glargine in Brazil. This latest development is intended to further enhance Brazil’s pharmaceutical self-sufficiency. Gan & Lee’s CEO, Du Kai, said, “Not only does this strengthen the resilience of Brazil's pharmaceutical supply chain, but it also delivers a distinctive Chinese approach to establishing reliable insulin access across South America.”

Research and clinical trials

Novo Nordisk and Septerna rethink R&D for metabolic disorders
 

Novo Nordisk and Septerna plan to collaborate on the development of oral small molecule therapies targeting obesity, type 2 diabetes and other cardiometabolic diseases. The partnership will combine Novo Nordisk’s expertise in metabolic disorders with Septerna’s capabilities in G protein-coupled receptor (GPCR) drug discovery. Initial efforts will focus on four programs targeting GPCRs such as GLP-1, GIP, and glucagon receptors.

Under the agreement, Septerna is eligible to receive up to $2.2 billion, including over $200 million in upfront and near-term milestone payments, along with tiered royalties on global net sales. Novo Nordisk has agreed to fund all R&D activities, assuming full responsibility from IND-enabling stages onward. Septerna will retain the option for a profit-sharing arrangement on one program. The agreement is subject to customary closing conditions and is expected to finalize in the second quarter of 2025.

GLP-1s take on cancer
 

Research led by Tel Aviv University and Clalit Health Services, Israel, has found that GLP-1 RAs are as effective as bariatric surgery in reducing the risk of obesity-related cancers. Researchers followed over 6,300 matched patients for up to 12.9 years, observing nearly identical cancer rates between the groups. Notably, GLP-1 RAs appeared to reduce cancer risk beyond their weight-loss effects, potentially through anti-inflammatory pathways.

GSK scratching an itch for PBC patients
 

GSK's phase III GLISTEN trial has demonstrated that linerixibat, an investigational oral ileal bile acid transporter inhibitor, significantly reduces cholestatic pruritus (itch) in patients with primary biliary cholangitis (PBC). Cholestatic pruritus is a debilitating symptom affecting up to 90 percent of PBC patients, often leading to sleep disturbances and diminished quality of life. Current treatments offer limited relief, highlighting the potential of linerixibat as a novel therapy. Both the FDA and EMA have granted orphan drug designation.

The global study enrolled 238 participants with moderate to severe itch, assessing outcomes using a 0-10 numerical rating scale for worst itch and itch-related sleep interference. Linerixibat met its primary endpoint, showing a statistically significant improvement in itch severity compared to placebo over 24 weeks. The drug works by inhibiting bile acid reuptake in the small intestine, thereby reducing circulating pruritogens.