ASTELLAS PHARMA

In Q4 2018, Cortellis Deals Intelligence recorded 140 M&A deals worth $33.1 billion in the life sciences sector, with 30 high-value deals over $100 million, including the $5.7 billion acquisition of athenahealth by Veritas and Elliott Management. Key therapeutic M&As included GSK's $5.1 billion acquisition of TESARO, Novartis' $2.1 billion acquisition of Endocyte, and LEO Pharma's $0.8 billion acquisition of PellePharm. Japan led APAC M&A activity with deals totaling $4.1 billion, including J&J's $2.1 billion acquisition of Ci:z Holdings and BMS' $1.6 billion acquisition of Taisho Pharmaceutical.

Astellas Pharma withdraws its marketing authorisation application for avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from the European Medicines Agency (EMA) following discussions with the CHMP. ACP, an investigational synthetic aptamer, inhibits the complement C5 protein, which contributes to GA-related vision loss. Astellas remains confident in ACP's clinical profile and its potential to benefit GA patients, despite the withdrawal, and is committed to exploring all options to make ACP accessible globally.

Astellas Pharma withdrew its marketing application for avacincaptad pegol from the EMA due to interactions, despite positive U.S. results. The company remains optimistic about the drug's clinical benefits.

Matica Biotechnology Inc. signed an LOI with KaliVir Immunotherapeutics to explore a new manufacturing process for KaliVir’s oncolytic virus product using Matica Bio’s proprietary MatiMax™ cell line.

Roche and Dyno Therapeutics expand their collaboration to develop next-gen AAV vectors for neurological diseases using Dyno’s AI-driven LEAP technology, with potential payments exceeding $1 billion.

Japan's bioanalytical testing services market valued at US$ 75.6 million in 2023, projected to reach US$ 203.0 million by 2032, driven by precision medicine, biologics, and biosimilars. The market's growth is supported by chronic diseases, aging population, and government investments in biopharmaceutical research. Key segments include small molecule bioanalysis (53.7% market share) and oncology applications (32.2% revenue). Technological advancements and regulatory streamlining are expected to further boost market expansion.

Astellas Pharma receives FDA approval for Vyloy (zolbetuximab-clzb) as a first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, targeting CLDN18.2. The approval is supported by positive phase 3 clinical trials Glow and Spotlight. A companion diagnostic test by Roche identifies eligible patients with 75% or more tumor cells testing positive for CLDN18.2.