-
AI Proteins Partners with Bristol-Myers Squibb to Develop Miniprotein-Based Therapeutics
•
US-based biotech AI Proteins, Inc. has entered into a research collaboration and option agreement with New York-headquartered Bristol-Myers Squibb (BMS; NYSE: BMY). This partnership allows BMS to explore and develop novel miniprotein-based therapeutics using AI Proteins’ advanced discovery platform. Agreement Terms and FinancialsUnder the terms of the agreement, AI Proteins…
-
Novatim Immune Therapeutics’ Y-0301 Receives FDA Clearance for Clinical Trials
•
China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd. has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its innovative drug candidate, Y-0301, a bispecific nanobody targeting MET and EGFR pathways. Y-0301: A Pioneering Bispecific NanobodyY-0301, the world’s first bispecific nanobody developed through Novatim’s…
-
HighField Biopharmaceutical’s HF50 Receives Tacit Clinical Approval from NMPA for HER-2 Positive Tumors
•
Hangzhou-based HighField Biopharmaceutical, a specialist in immuno-oncology biotech focused on targeted lipid-based therapies, has revealed that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its drug candidate HF50. This T-cell redirecting antibody fragment-anchored liposomes (TRAFsomes) product will be tested in clinical trials for HER-2…
-
Shenyang Hongqi Pharma Secures NMPA Approval for Pretomanid in TB Treatment
•
The National Medical Products Administration (NMPA) of China has officially approved pretomanid, developed by Shenyang Hongqi Pharmaceutical Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196). This approval marks a significant advancement in the treatment of drug-resistant tuberculosis (TB) patients. Innovative Mechanism of Action Pretomanid is…
-
Chongqing Zhifei Biological and GlaxoSmithKline Amend Distribution Agreement for Herpes Vaccine
•
China-based Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has entered into a supplementary exclusive distribution and co-promotion agreement with UK pharmaceutical major GlaxoSmithKline (GSK, NYSE: GSK), optimizing and adjusting the original deal concerning the recombinant herpes zoster vaccine. The revised agreement removes the original minimum procurement amount, allowing Zhifei Bio…
-
GSK plc Partners with Muna Therapeutics to Discover Alzheimer’s Disease Treatment Targets
•
GSK plc (NYSE: GSK) has announced a new partnership with Danish biotech firm Muna Therapeutics, following recent collaborations with Sino-US Duality Biologics and US biotech Rgenta Therapeutics. This latest alliance aims to identify and validate novel drug targets for the treatment of Alzheimer’s disease, leveraging insights from Muna’s MiND-MAP platform,…
-
Jiangsu Hengrui’s SHR-A2102 Earns Breakthrough Therapy Designation for Urothelial Carcinoma
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received breakthrough therapy designation (BTD) from the National Medical Products Administration of China for its pipeline candidate, SHR-A2102. The designation is in recognition of the molecule’s potential in treating locally advanced or metastatic urothelial carcinoma in patients who…
-
Roche’s Columvi Supplemental sBLA Accepted by FDA for Relapsed DLBCL Treatment
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its drug Columvi (glofitamab). Roche is seeking FDA approval for the use of Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the…
-
Teva Pharmaceutical to Divest Holdings in Teva Takeda Pharma to JKI
•
Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced its intention to sell all holdings in Teva Takeda Pharma Limited and its wholly owned subsidiary Teva Takeda Yakuhin Ltd. to JKI, a company established by a fund managed and operated by J-Will. This strategic move aligns with Teva’s Pivot to…
-
Eyebright Medical Technology Aims to Raise RMB 300 Million for Contact Lens Production Expansion
•
China-based ophthalmic medical device manufacturer, Eyebright Medical Technology Co., Ltd (SHA: 688050), has announced plans to raise up to RMB 300 million (USD 41.3 million) through a private placement of 3,787,878 shares. The capital raised will be allocated towards the construction project of a contact lens and injection mold processing…
-
Cambrex Partners with Eli Lilly to Enhance Clinical Development for Biotech Collaborators
•
US-based contract development and manufacturing organization (CDMO) Cambrex has reached an agreement with Eli Lilly & Co., (NYSE: LLY), to enhance the clinical development capabilities for the US giant’s biotech collaborators. This partnership aims to provide a comprehensive suite of services to support early-stage biotech innovation. Cambrex’s Role in Lilly…
-
Dewpoint Therapeutics Partners with Mitsubishi Tanabe Pharma to Develop ALS Treatment
•
US-based Dewpoint Therapeutics Inc. has entered into a strategic partnership with Japan-headquartered Mitsubishi Tanabe Pharma Corporation (MTPC) to enhance the development of Dewpoint’s novel TDP-43 small molecule condensate modulator (c-mod) for amyotrophic lateral sclerosis (ALS). This collaboration aims to address the mislocalization of the TAR DNA-binding protein 43 (TDP-43), a…
-
AstraZeneca’s Imfinzi Receives FDA Approval for Limited-Stage Small Cell Lung Cancer
•
UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has reported receiving a new indication approval from the US Food and Drug Administration (FDA) for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The approval is for the use of Imfinzi in treating adult patients with limited-stage small cell lung cancer (LS-SCLC)…
-
Eli Lilly & Co. Expands Wisconsin Manufacturing Facility with $3 Billion Investment
•
US pharmaceutical major Eli Lilly & Co. (NYSE: LLY) has announced the expansion of its manufacturing facility in Kenosha County, Wisconsin, with a substantial capital investment of USD 3 billion. This significant expansion, acquired earlier this year, is part of Lilly’s strategic plan to enhance its global parenteral (injectable) product…
-
Amgen Expands Biomanufacturing Footprint in North Carolina with Second Facility
•
US biotech company Amgen (NASDAQ: AMGN) has announced plans to construct a second drug substance manufacturing facility in Holly Springs, North Carolina, raising its total biomanufacturing investment in the region to USD 1.5 billion. This new plant, costing USD 1 billion, follows Amgen’s previously announced commitment of USD 550 million…
-
Merck Initiates Phase III MOVE-NOW Study for Lagevrio COVID-19 Antiviral
•
US pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced the commencement of the Phase III MOVE-NOW study for its oral antiviral COVID-19 medicine, Lagevrio (molnupiravir), in adults with COVID-19 who are at high risk for disease progression. This trial marks a significant step in the ongoing development and…
-
CDE Approves RinuaGene’s mRNA-Based RG002 for Clinical Study in Cervical Dysplasia
•
China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has indicated that the Category 1 drug RG002, developed by Suzhou-based mRNA therapeutics company RinuaGene, has been approved for clinical study in cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) associated with human papillomavirus (HPV) 16 and/or…
-
Burning Rock Ltd Reports Q3 2024 Financials with Revenue Growth and R&D Reduction
•
China-based medtech firm Burning Rock Ltd (NASDAQ: BNR) has released its financial results for the third quarter of 2024. The company reported Q3 revenues of RMB 128.6 million (USD 18.3 million), marking a year-on-year (YOY) increase of 0.8%. Research and development (R&D) expenses saw a significant decline of 41.3% YOY,…
-
Novavax to Sell Czech Manufacturing Facility to Novo Nordisk for $200 Million
•
US-based Novavax, Inc. (NASDAQ: NVAX) has reached an agreement to sell its manufacturing facility located in Bohumil, Czech Republic, to Denmark-based Novo Nordisk A/S (NYSE: NVO) for a total consideration of USD 200 million. The transaction involves the transfer of assets, including a 150,000-square foot state-of-the-art recombinant protein manufacturing facility,…
-
Eli Lilly’s Zepbound Outperforms Wegovy in SURMOUNT-5 Weight Loss Study
•
US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has revealed a positive readout from the open-label, randomized Phase III SURMOUNT-5 study. The study assessed the weight loss effects of Zepbound (tirzepatide) compared to Wegovy (semaglutide) in adult patients with obesity or overweight, who have at least one weight-related medical…
