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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Eli Lilly and ProQR Therapeutics expand their RNA-editing collaboration.
U.S. recession will inevitably make many biopharma companies change course. However, it could cause some biotechs to change for the better.
Merck entered into a license and collaboration agreement with Chinese company Kelun-Biotech to develop seven antibody-drug conjugates candidates against oncology targets.
I Peace, Inc. is a Palo Alto-based biotech company focusing on Nobel Prize-winning technology of induced pluripotent stem cells (iPSCs) and has successfully developed a novel system to mass manufacture clinical-grade iPSCs for cell therapy in a palm-sized closed cassette.
Mergers and acquisitions are expected to be a key theme in the pharmaceutical industry in 2023.
Lexicon Pharmaceuticals’ LX9211 fell short of its primary efficacy endpoint, according to topline data from the Phase II RELIEF-PHN-1 study in post-herpetic neuralgia.
The FDA’s top five approvals in 2022 represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
Jazz Pharmaceuticals exercised its option on Zymeworks’ promising anti-cancer agent.
The U.S. Department of Justice indicted former CytoDyn Inc. CEO Nader Z. Pourhassan and the CEO of Amarex Clinical Research on multiple counts of fraud.
2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications.
Verona Pharma’s COPD candidate hits the mark in late-stage testing.
The FDA placed a clinical hold on Entrada’s experimental DMD candidate.
PRESS RELEASES
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