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Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.

Cartesian Therapeutics’ mRNA CAR-T therapy met its primary endpoint in a mid-stage trial for the chronic autoimmune disorder and expects to raise $130 million via private placement equity financing.

The Department of Justice and Securities and Exchange Commission are investigating two senior employees of Cassava Sciences in connection with allegations of data manipulation for its Alzheimer’s disease candidate simufilam.

The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after the company allegedly ignored directives to withdraw or amend contentious patent listings on the FDA’s Orange Book.

In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.

Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains.

Pyzchiva, developed by Samsung Bioepis, will be commercialized in the U.S. by Sandoz with the license period beginning on Feb. 22, 2025, according to a settlement and licensing agreement with Johnson & Johnson’s Janssen Biotech.

In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.

The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.

Due to Bristol Myers Squibb’s ongoing portfolio reprioritization, Eisai is taking over the development and commercialization of farletuzumab ecteribulin, an investigational antibody-drug conjugate targeting solid tumors.

Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains.

In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.

Expanded sweetener molecule development program aims to broaden access to plant-based sweetening solutions tailored to diverse customer food and beverage categories.

• $5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027 • $4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026 • Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing Authorisations (CMAs) for OST-HER2 in prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (“Metastatic Osteosarcoma”) • 2.5-year overall survival data expected to be released during ASCO 2026 • EMA and ATGA have aligned on key design aspects of confirmatory Phase 3 Metastatic Osteosarcoma protocol required to have commenced prior to grant of CMAs or FDA BLA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint • Upcoming U.S. FDA Type C meeting and U.K. MHRA SAM meeting to align with EMA & ATGA prior to Australia Clinical Trial Notification submission for Phase 3, including alignment on 3-year overall survival as a primary clinical efficacy endpoint. U.S. FDA (“FDA”) Pre-BLA meeting to confirm alignment on surrogate and primary clinical efficacy endpoints with EMA/ATGA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint, and seek decisions on rolling review acceptance and RMAT designation following the EMA and U.K. MHRA granting ATMP designation (EMA/MHRA RMAT equivalent) for OST-HER2 in Metastatic Osteosarcoma • OS Animal Health S-1 filing for proposed ‘Go-Public’ transaction and receipt of SEC comments