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Global Briefs: Moderna, Biogen, Merck KGaA & More 

A roundup of news from Moderna, Biogen, Merck KGaA, Celltrion, Hengrui/Glenmark Pharmaceuticals, Incyte, Sanofi, bluebird bio and Scholar Rock. Highlights below.  

Mfg News 
* Celltrion To Acquire Lilly’s NJ Drug-Substance Plant for $330 M 
* Moderna Opens New UK Vaccine R&D & Mfg Facility
* FDA Issues CRL for CMC Issues for Biogen’s High-Dose Version of SMA Drug 
* FDA Issues CRL for Scholar Rock’s SMA Drug for Mfg Issues 
Partnering News 
* Hengrui, Glenmark Pharmaceuticals in $1.1-Bn ADC Pact
Appointments 
* Merck KGaA Appoints new CEO 
* Incyte Names EVP, Chief Strategy Officer
General 
* Sanofi Commits Additional $625 M in Sanofi Ventures
* Gene-therapy Company bluebird bio rebrands as Genetix Biotherapeutics 

Mfg News 

Celltrion To Acquire Lilly’s NJ Drug-Substance Plant for $330 M 
Celltrion, an Incheon, South Korea-based bio/pharmaceutical company, has agreed to acquire Eli Lilly and Company’s Branchburg, New Jersey, drug-substance manufacturing facility, for $330 million. The site covers approximately 37 acres, including four buildings (with 10 acres of vacant land available for future use). 

Preparations are underway to transfer operations and complete closing procedures by year-end (2025). During this period, Celltrion will proceed with required regulatory approvals, including US merger control filings, and expects to finalize the transaction by the end of this year (2025). 

Source: Celltrion 

Moderna Opens New UK Vaccine R&D & Mfg Facility 
Moderna has announced that the Moderna Innovation and Technology Centre (MITC) at the Harwell Science and Innovation Campus in Oxfordshire, UK, has officially opened.  

The MITC will now produce British-made mRNA respiratory vaccines for the UK public to support the National Health Service’s seasonal vaccination programs. Beyond respiratory diseases, the MITC will also support research into the potential of mRNA science in areas such as cancer, rare diseases,  and immune disorders. 

The site can produce up to 100 million mRNA vaccine doses per year, with the capacity to increase to 250 million in the event of a pandemic. The clinical R&D facility at the MITC also includes laboratories that will analyze samples from Moderna’s clinical trials globally. 

Source: Moderna 

FDA Issues CRL for CMC Issues for Biogen’s High-Dose Version of SMA Drug 
Biogen has announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company’s supplemental new drug application (sNDA) for the high-dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA), a rare neuromuscular disorder.  

FDA requested an update to the technical information be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA. The company reported that the CRL did not cite any deficiencies in the clinical data of the high-dose regimen. The FDA provided options for resolution, and Biogen stated it is planning to resubmit the application promptly (as reported on September 23, 2025) based upon readily available information. 

Source: Biogen 

FDA Issues CRL for Scholar Rock’s SMA Drug for Mfg Issues 
Scholar Rock, a bio/pharmaceutical company focused on spinal muscular atrophy (SMA) and additional rare neuromuscular diseases, has announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its biologics license application (BLA) for apitegromab for treating SMA.  

The CRL is related to observations identified during a routine general site inspection of Catalent Indiana, a third-party fill–finish facility that was acquired by Novo Nordisk in December 2024. The observations are not specific to apitegromab. The CRL did not cite any other approvability concerns, including apitegromab’s efficacy and safety data or the third-party drug-substance manufacturer. 

The Catalent Indiana observations were discussed during Scholar Rock’s second-quarter 2025 earnings announcement. Catalent Indiana submitted a comprehensive response in early August 2025 to address the observations noted by FDA. Following that submission, Catalent Indiana has continued to work to take corrective action and has kept the FDA apprised of that progress. 

Upon Catalent Indiana’s successful remediation of the FDA observations, Scholar Rock will resubmit the apitegromab BLA. Scholar Rock says it believes that the FDA will be able to act expeditiously on the application once the manufacturing issues have been resolved. 

Source: Scholar Rock 

Partnering News 

Hengrui, Glenmark Pharmaceuticals in $1.1-Bn ADC Pact 
Jiangsu Hengrui Pharmaceuticals, a Lianyungang, China-based bio/pharmaceutical company, has entered an agreement with Glenmark Specialty, the Swiss unit of Glenmark, an India-based bio/pharmaceutical company, for a paid license of Jiangsu Hengrui’s antibodiy drug conjugate (ADC), trastuzumab rezetecan, in a deal worth up to $1.1 billion ($18 million upfront and $1.09 billion in milestone payments). 

Trastuzumab rezetecan is Hengrui’s self-developed HER2-targeted ADC. In May 2025, trastuzumab rezetecan was approved in China for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer, who have HER2 activating mutations and have received at least one prior systemic therapy. 

Under the agreement, Glenmark Specialty will pay Hengrui an upfront payment of $18 million. Hengrui is also eligible to receive regulatory and commercial milestone payments of up to US $1.093 billion. Based on the net sales of trastuzumab rezetecan within the licensed territory, Glenmark Specialty will pay corresponding royalties to Hengrui. 

Source: Hengrui 

Appointments 

Merck KGaA Appoints new CEO 
Merck KGaA, Darmstadt, Germany, has appointed Kai Beckmann, current CEO of the company’s Electronics Business, as future Chair of the Executive Board and CEO. He will take over this position on May 1, 2026, from Belén Garijo, current CEO and Chair of Merck KGaA, who will continue to lead the company until the end of her tenure.  

Beckmann will become Deputy CEO, effective immediately (as reported on September 25, 2025) and will continue in his role as CEO of Electronics until a successor is announced. Garijo will leave Merck KGaA after 15 years in the company of which she led six years as CEO of Healthcare and since 2021 as Chair of the Executive Board and CEO of Merck KGaA. 

Beckmann has served as a Member of the Executive Board of Merck KGaA since 2011 and assumed responsibility for the Performance Materials business sector in 2017. Under his leadership, the sector underwent a comprehensive transformation to become a pure-play electronics business. Prior to his current role, Beckmann served as Chief Administration Officer on the Executive Board. His responsibilities encompassed a broad portfolio of functions, including, among others, HR, IT, and the headquarters of Merck KGaA. Since joining the company in 1989, Beckmann has held global roles of increasing responsibility, such as Managing Director in Singapore & Malaysia as well as Chief Information Officer. 

Source: Merck KGaA 

Incyte Names EVP, Chief Strategy Officer 
Incyte has announced that Dave Gardner, current Partner on the Therapeutics Team at Rock Springs Capital Management, has been appointed Executive Vice President and Chief Strategy Officer, effective September 22, 2025. In his new role, Gardner will serve as a key member of the Executive Leadership Team and be responsible for the company’s strategy and business development. 

With more than 20 years of experience in pharmaceutical and biotechnology investing and advising, Gardner most recently served as Partner on the Therapeutics Team at Rock Springs Capital Management, where he led strategy across oncology, neurology, immunology and rare diseases. Prior to that, Gardner spent a decade at BlackRock as Vice President and Equity Research Analyst, where he was responsible for the Health Care sector. He holds an Executive MBA from Columbia Business School and a bachelor’s degree from the University of Virginia’s McIntire School of Commerce.  

After nine years as a key member of the Incyte leadership team, Vijay Iyengar, M.D., Executive Vice President and Head of Global Medical Affairs and Product and Partnership Strategy, will be retiring from Incyte. He will continue to provide transitional support to Gardner through the end of the year. 

Source: Incyte 

General 

Sanofi Commits Additional $625 M in Sanofi Ventures 
Sanofi Ventures has announced an additional $625 million multi-year capital commitment from Sanofi, increasing its total assets under management to over $1.4 billion.  

Sanofi Ventures is the corporate venture capital arm of Sanofi, investing in biotech and artificial intelligence/digital health companies. Since its inception in 2012, the fund has deployed over $800 million across more than 70 companies in biotech and digital health. The team leads investments across all stages of the private company lifecycle, from seed to crossover, serves on boards, and participates in IPOs.  

Source: Sanofi 

Gene-therapy Company bluebird bio rebrands as Genetix Biotherapeutics 
bluebird bio, a Somerville, Massachusetts-based bio/pharma company specializing in gene therapies, has announced it has rebranded as Genetix Biotherapeutics. 

Genetix Biotherapeutics’ early strategic priorities include: 

  • Strengthening Qualified Treatment Center (QTC) partnerships – expanding its footprint to make it easier for patients to obtain care and supporting the essential work of QTCs through targeted initiatives. 
  • Expanding manufacturing capacity – planning to substantially increase its manufacturing capacity within the next year to meet growing demand. 
  • Enhancing manufacturing capabilities – making investments to enhance its manufacturing capabilities, including the ability to cryopreserve patient stem cells, which will significantly improve the treatment experience. 
  • Lovo-cel clinical development – continue executing the ongoing, fully enrolled lovo-cel (lovotibeglogene autotemcel) HGB-210 Phase III study, an open-label, multi-site, single-dose trial in adults and pediatric patients with sickle cell disease. 

Source: Genetix Biotherapeutics