Geron secures drug approval; Califf discusses China, GLP-1s at BIO

This week, several noteworthy updates have emerged from the biopharmaceutical sector, highlighted by events at the BIO Annual Meeting in San Diego, as well as pivotal news from Geron, AbbVie, and Deerfield Management.

FDA Commissioner’s Views on Pharmaceutical Supply Chains and Obesity Treatments

During a panel discussion on Wednesday, FDA Commissioner Robert Califf expressed concerns about the pharmaceutical industry's heavy reliance on China. Speaking with BIO President John Crowley, Califf emphasized the importance of a diversified and resilient supply chain. “There could be a catastrophic event like an earthquake or a geopolitical conflict, so you want a distributed supply chain that can withstand such disruptions,” he stated.

Califf also voiced his strong support for GLP-1 drugs approved by the FDA for obesity treatment but stressed the need for preventive measures. “I fear that my descendants will read about an America where the average person gains a pound per year due to poor eating habits, and instead of addressing this, the country developed drugs costing $20,000 annually to counteract basic eating habits,” he commented.

Geron’s Milestone FDA Approval

In a significant development, Geron, a 34-year-old biotech firm, received its first drug approval on Thursday when the FDA approved Rytelo for treating myelodysplastic syndromes (MDS). This approval, which follows previous clinical challenges, positions Rytelo to compete with Bristol Myers Squibb’s Reblozyl in treating lower-risk MDS and anemia. Analysts had expected a warning for hematological side effects on Rytelo’s label, but the FDA’s decision to exclude such a warning has increased investor interest. As a result, Geron’s shares surged over 20% on Friday.

Shionogi’s Obesity Drug Development Strategy

Shionogi experienced a significant drop in its stock price on the Tokyo stock exchange on Friday, likely influenced by the company’s announcement of a new development strategy for its obesity drug. Preliminary data from Phase 2 trials showed that the treatment led to less than 5% weight loss among participants. Consequently, Shionogi is considering developing the drug in combination with other therapies to enhance its effectiveness.

AbbVie’s Acquisition and Success with Elahere

AbbVie, which spent $10 billion last year to acquire ImmunoGen, is seeing positive results from this investment. ImmunoGen's portfolio includes several promising antibody-drug conjugates, notably Elahere, an ovarian cancer treatment. On Thursday, AbbVie announced that Elahere achieved significant results in a new study, shrinking tumors in half of the participants with platinum-sensitive ovarian cancer. Detailed results will be shared at an upcoming medical conference.

Frank Nestle’s New Role at Deerfield Management

Frank Nestle, the former chief scientific officer and head of research at Sanofi, is embarking on a new chapter with Deerfield Management, a biotech company creator. Nestle, who joined Sanofi in 2016 and played a key role in advancing the company's immunology pipeline, will serve as CEO of Deerfield Discovery and Development. Additionally, he will join Deerfield's therapeutics team as a partner, leveraging his extensive experience to drive innovation.

In summary, this week has brought significant developments within the biopharmaceutical industry, showcasing advancements and strategic shifts that could impact future drug development and healthcare solutions. From regulatory perspectives to breakthrough approvals and leadership changes, these updates highlight the dynamic nature of the sector.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!