Industry News

As the biopharmaceutical industry moves increasingly toward applied AI in GMP manufacturing, emphasizing real-world use, PDA Week 2026 is expected to evolve as it further dives into risk management and data-driven quality decisions.

Survodutide delivers significant Phase III weight loss results, FDA grants RMAT status to Orca-Q, and Ligand expands its portfolio with a $739 million acquisition of XOMA.

Biopharma news highlights: Henlius and Organon gain EU approval for a pertuzumab biosimilar, while Pfizer reports Phase 3 success for Elrexfio in multiple myeloma. Genexine advances GX-BP1 targeting SOX2, signaling new progress in overcoming cancer resistance and expanding oncology innovation.

Boehringer Ingelheim announced promising Phase III data showing that survodutide achieved up to 16.6% weight loss and significant metabolic improvements in adults with obesity or overweight. The dual glucagon/GLP-1 agonist may offer a new approach targeting both weight reduction and liver-related metabolic health.

The BioPharm Brief covers three recent FDA developments shaping the autoimmune and inflammatory disease landscape. The agency cleared a subcutaneous autoinjector for anifrolumab in systemic lupus erythematosus, enabling at-home administration. It also granted Priority Review to nipocalimab for warm autoimmune hemolytic anemia, highlighting its potential as a targeted treatment for a rare condition. In addition, a supplemental application has been submitted for subcutaneous risankizumab as an induction therapy in Crohn disease, which could reduce the need for infusion-based initiation. Together, these updates reflect a growing focus on patient convenience, expanded access, and more precise treatment approaches in immune-mediated diseases.

BioNTech’s decision to close its Singapore manufacturing facility reflects mounting financial pressure, ongoing restructuring efforts, and uncertainty around the pace at which next-generation mRNA therapies will scale.

FDA expands approval of Novo Nordisk’s once-weekly Sogroya to include three new pediatric growth disorder indications, offering children as young as 2.5 an alternative to daily growth hormone injections backed by Phase III non-inferiority data.

The facility builds on Eli Lilly's $50 Billion investment strategy to strengthen the company's domestic manufacturing capabilities.

The company composed a letter addressed to global governments to harness competitiveness and innovation to navigate the current global trade economy.

The study by Integra Therapeutics and partners reveals how AI-engineered proteins could expand gene-editing tools and streamline development of advanced therapies.

Aaron Cowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs.

Bristol Myers Squibb is seeking approval of Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory marginal zone lymphoma, making this the fifth cancer type for which the cell therapy would be approved.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

BioPharm International® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.