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Biologics

Genezen to Manufacture Lentiviral Vector for Optieum’s CAR-T Therapy Targeting Glioblastoma

Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies, Inc. (Optieum), a preclinical stag...

May 06, 2025 | News

Fangzhou Launches Otsuka’s Iclusig® Online for Leukemia Care in China

Fangzhou Inc. , a leader in Internet healthcare solutions, announced the availability of Otsuka Pharmaceutical's third-generation tyrosine kinase inhi...

May 06, 2025 | News

Nutshell Therapeutics Receives FDA IND Clearance for First-in-Human Trial of NTS071 Targeting p53 Y220C Mutation

Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate Phase 1 clinical ...

May 05, 2025 | News

Genmab to Submit sBLA for Epcoritamab-R2 Combination in Relapsed/Refractory Follicular Lymphoma Following Positive Phase 3 Data

--Genmab A/S (Nasdaq: GMAB) announced its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to t...

May 05, 2025 | Regulatory

AstraZeneca’s BREZTRI AEROSPHERE Demonstrates Significant Lung Function Gains in Phase III Asthma Trials

Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose tripl...

May 05, 2025 | News

S&E bio Receives MFDS Approval for Korea’s First Clinical Trial of Exosome-Based Stroke Therapy

S&E bio Co., Ltd., a biotechnology company specializing in exosomal microRNA-based therapies, has received approval from Korea's Ministry of Food...

May 01, 2025 | News

Asimov and Cytiva Unite to Fast-Track Complex Biologics Production

Biomanufacturers producing protein biologics including complex modalities, will have access to a full suite of custom cell line development and c...

April 30, 2025 | News

Innovent Biologics Doses First Patient in Global Phase 1 Trial of IBI3020, a First-in-Class Dual-Payload CEACAM5 ADC

Innovent Biologics, a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment ...

April 30, 2025 | News

RoosterBio and Thermo Fisher Partner to Accelerate Cell and Exosome Therapy Development

RoosterBio, Inc., a leading supplier of adult human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services,&n...

April 30, 2025 | News

Thermo Fisher Scientific Accelerates IND Timelines With Enhanced Platform and High-Yield CHO K-1 Cell Line

Enhanced platform technology and the addition of a robust, high-quality CHO K-1 cell line decreases lead time to Investigational New Drug (IND) Thermo Fis...

April 29, 2025 | News

Merck to Acquire SpringWorks Therapeutics for $3.9 Billion, Strengthening Rare Tumor Leadership

Purchase price of $47 per share in cash represents an enterprise value of €3.0 billion ($3.4 billion), or an equity value of approximately $3.9 bill...

April 28, 2025 | News

Keymed Biosciences Advances CDH17-Targeted ADC CM518D1 Into Phase I/II Trials for Solid Tumors in China

Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") today announced CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) develop...

April 28, 2025 | News

Primo Biotechnology Secures PIC/S GMP and GDP Certifications, Strengthening Global Position in Nuclear Medicine

Primo Biotechnology Co., Ltd. ("Primo") proudly announces that its Taoyuan pharmaceutical facility has successfully passed inspection by Taiwan Food and Dr...

April 25, 2025 | News

Lotte Biologics Seals First ADC Manufacturing Deal to Launch Full-Scale US Production

Lotte Biologics has announced the signing of its first official contract manufacturing agreement at its newly expanded antibody-drug conjugate (ADC) produc...

April 25, 2025 | News

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