Pharma and Biotech Daily: Genmab Acquires Merus, GSK CEO Steps Down, FDA Transparency Concerns, and More!

Date: September 30, 2025
Host: Pharma and Biotech News

Episode Overview

This episode delivers a concise yet comprehensive roundup of the latest and most significant news in the pharma and biotech sectors. Key topics include Genmab’s acquisition of Merus, a leadership change at GSK, developments in FDA transparency, major company restructurings, recent FDA decisions, and notable drug advancements. The episode is tightly focused on developments that could have far-reaching consequences for industry stakeholders and patients alike.

Key Discussion Points & Insights

Genmab Acquires Merus for $8 Billion

[00:09]

• Genmab announced the acquisition of Merus, described as “a rising star in the field of Oncology.”
• The $8 billion deal includes Merus’s promising bispecific antibody that targets both EGFR and LGR5, particularly significant for head and neck cancer.
  • “Genmab has acquired Maris, a rising star in the field of Oncology, for $8 billion.” — Host [00:09]
  • The bispecific antibody’s success marks it as a high-value asset in Genmab’s pipeline.

Leadership Change at GSK

[00:23]

• GSK CEO Emma Walmsley is stepping down after a nine-year tenure.
• Chief Commercial Officer Luke Meals will take over in the next year.
  • “GSK CEO Emma Walmsley is stepping down after nine years, with Chief Commercial Officer Luke Meals set to replace her next year.” — Host [00:23]
• The transition is closely watched, marking a pivotal leadership change at one of pharma’s giants.

FDA Transparency & Real-Time Disclosures

[00:33]

• Discussion around the FDA’s new policy to release complete response letters (CRLs) in real time.
• This move raises questions about how much transparency is optimal regarding the agency’s regulatory actions.
  • “The FDA's decision to disclose complete response letters in real time has raised questions about transparency in the agency's role.” — Host [00:33]
• The main benefit is to investors, offering insight into the regulatory process and influencing company valuations and strategic moves.

Corporate Restructuring & Sector Shifts

[00:43]

• Biogen: Staff reshuffling follows the end of work on its AAV (adeno-associated viral vector) program.
• Heidelberg: Makes drastic cuts, letting go of 75% of its staff due to missed royalty payments.
  • “Biogen has shuffled staff after ending work on AAV, while Heidelberg has cut 75% of its staff after missed royalty payments.” — Host [00:43]
• These changes reflect ongoing volatility and challenges within the industry.

Summary of Major FDA Decisions in September

[00:54]

• Keytruda: Received regulatory boosts reflecting ongoing expansion and approvals.
• Spinal Muscular Atrophy Therapies: Two therapies rejected due to manufacturing issues.
  • “In September, the FDA's actions included boosting Keytruda while rejecting two spinal muscular atrophy therapies due to manufacturing issues.” — Host [00:54]
• These moves underscore how manufacturing quality and regulatory rigor continue to shape the market.

FDA Authority Over Laboratory Developed Tests

[01:05]

• Mentioned a judge’s ruling, influenced by a recent Supreme Court decision, that impacts FDA’s authority over laboratory-developed tests (LDTs).
  • “A judge's ruling on the FDA's authority over laboratory developed tests reflects the impact of a recent Supreme Court decision.” — Host [01:05]
• Anticipated to have significant ripple effects for diagnostics.

Key FDA Decisions to Watch in Q4

[01:14]

• Six upcoming FDA decisions spotlighted for their potential industry and patient impact.
  • “Six FDA decisions to watch for in Q4 could have significant implications for the biopharma industry and patients.” — Host [01:14]
• These are set to drive business strategies and clinical development focus for the coming months.

Additional Drug & Therapy Highlights

[01:24]

• Immuneering acid for pancreatic cancer shows positive results.
• Eli Lilly's oral SERD approved for treating breast cancer.
• Unicure’s Huntington’s therapy yields positive clinical outcomes.
• FDA streamlining of cell, gene, and regenerative therapies is underway, expediting the development pipeline.
  • “Recent developments include positive results for an immuneering acid in pancreatic cancer, FDA approval for Lilly's oral SERD for breast cancer, and positive outcomes for Unicure's Huntington's therapy.” — Host [01:24]

Other Industry News

[01:38]

• A dormant drug is seeing a revival as a possible autism treatment.
• Ongoing setbacks in obesity studies and some surprising rejections for key therapies.
• Announcements regarding upcoming webinars and job opportunities.

Notable Quotes & Memorable Moments

• “The FDA's Real Time Disclosure of complete response letters benefits investors by providing greater visibility into regulatory decisions.” — Host [00:36]
• “Listeners are encouraged to provide feedback on topics they would like to see covered in future episode.” — Host [01:49]

Timestamps for Important Segments

| Timestamp | Topic | |-----------|----------------------------------------------------------| | 00:09 | Genmab acquires Merus | | 00:23 | GSK CEO steps down; leadership transition | | 00:33 | FDA’s new transparency initiative | | 00:43 | Biogen and Heidelberg staff changes | | 00:54 | September FDA decisions: Keytruda, SMA therapy rejections| | 01:05 | FDA’s authority over laboratory-developed tests | | 01:14 | Six major upcoming FDA decisions to watch | | 01:24 | New drug successes and FDA approvals | | 01:38 | Autism drug revival, obesity trial setbacks, other news | | 01:49 | Listener feedback invitation |

Takeaway

This episode delivers essential updates for stakeholders tracking regulatory, clinical, and business turns in pharma and biotech. The discussions are direct and news-driven, offering valuable context and insight into the decisions and trends shaping the industry right now. If you want to stay ahead of key changes and innovations, this is a must-listen recap.