Pharminent

FDA expands label for ImmunityBio’s Anktiva in bladder cancer

ImmunityBio’s bladder cancer drug Anktiva received an FDA label expansion in non-muscle invasive bladder cancer, with the agency deeming cases of carcinoma in situ and high-grade papillary-only NMIBC clinically similar.

FDA launches Rare Disease Framework Initiative for drug development

The FDA announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases, describing it as a holistic, fit-for-purpose framework.

NICE rejects NHS use of Roche’s breast cancer drug Itovebi

NICE turned down NHS use of Roche’s breast cancer drug Itovebi. Roche said the decision reveals a flaw in the appraisal of combination therapies.

MHRA publishes document on AI and medicines regulation

The MHRA published a document explaining how regulations will adapt to the era of AI and personalised medicine, which Pharmaphorum reported has been well received by the pharma industry.

Verastem’s G12D pancreatic cancer drug shows early data

Verastem reported early results from a small study of its G12D-targeted cancer drug, licensed from GenFleet, in pancreatic cancer. Wall Street analysts said the data make the drug competitive in the field.

Sanofi, Regeneron expand immunology pact worth up to $8B

On October 1, 2026, Sanofi and Regeneron announced an expansion of their existing immunology collaboration to develop and commercialize four long-acting antibodies. Sanofi will pay Regeneron $1 billion upfront plus up to $7 billion in development, regulatory and commercial milestone payments.

INmune Bio and QCi to study XPro using quantum computing

INmune Bio and QCi agreed to collaborate using quantum computing, AI and data analytics to explore new indications for XPro, an investigational treatment for Alzheimer’s disease and other conditions.

Ultragenyx raises $413M from two priority review voucher sales

Ultragenyx Pharmaceutical sold two rare pediatric disease priority review vouchers for a combined $413 million, each earned from an FDA approval of a gene therapy. Both therapies came to the company through business deals.

Iambic raises $150M in AI drug discovery IPO

AI drug discovery company Iambic raised $150 million in an initial public offering. In regulatory filings, the company said its approach has the potential to “disrupt legacy drug discovery paradigms.”

OMass Therapeutics raises $310M in third financing round

UK-based OMass Therapeutics raised $310 million in a third round of financing, supporting its ambition to join the ranks of ‘big biotech’ companies.

Celltrion launches omalizumab biosimilar Omlyclo in the US

Celltrion USA announced on October 5, 2026 that OMLYCLO (omalizumab-igec) is commercially available in the United States. It is the first and only FDA-approved interchangeable biosimilar to Genentech and Novartis’ XOLAIR, approved in March 2025 for all four XOLAIR indications.

Merck opens 120,000-square-foot research facility near Philadelphia

Merck officially opened a new 120,000-square-foot research facility in the Greater Philadelphia area. The company’s CEO told CNBC he expects its cancer vaccine will become faster to manufacture.