AllSci News
Novo Nordisk's denecimig maintains low bleeding rates in long-term hemophilia A extension study
Novo Nordisk (Nasdaq: NVO) reported interim data from the FRONTIER4 long-term extension study at the ISTH Congress in Paris this week, showing that...
Amydis secures USD 1.1m NIH award to develop retinal imaging for TDP-43 detection
Amydis, a La Jolla, California-based diagnostics company, has received a USD 1.1 million NIH R44 Phase II SBIR award from the National Institute on Aging to...
FDA issues second manufacturing-related CRL for Elevar-Hengrui HCC combination
New Jersey-based Elevar Therapeutics, a majority-owned subsidiary of HLB Co., Ltd., announced that the US FDA issued a Complete Response Letter (CRL)…
Acta restarts first-in-human development of likely Alzheimer's gamma-secretase modulator with streamlined Phase I study
Acta Pharmaceuticals has registered a Phase I first-in-human clinical trial of GSM-779690T, an investigational compound, in healthy adults. The randomized,...
Insilico Medicine expands CNS pipeline with CMS with USD 177m in new biobuck commitments
Insilico Medicine (HKEX: 03696) and China Medical System Holdings Limited (CMS, HKEX: 867; SGX: 8A8) have announced an additional drug development collaboration…
Antengene pockets USD 60m from UCB as it pivots to monetizing proprietary TCE platform
Antengene Corporation Limited (HKEX: 6996) has confirmed receipt of the USD 60 million upfront payment from UCB under their worldwide exclusive license...
FDA expands Keytruda-Padcev combo to all muscle-invasive bladder cancer patients regardless of cisplatin eligibility
The US FDA approved both Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), as perioperative…
Tarsus bets USD 565 million to displace Betadine in intravitreal injection prep
Irvine, California-based Tarsus Pharmaceuticals, Inc. (Nasdaq: TARS) has acquired iRenix Medical, Inc., a privately held clinical-stage ophthalmic...
FDA grants fast-track status to Arialys’ first-in-class anti-NMDA receptor encephalitis therapy
La Jolla-based Arialys Therapeutics announced receipt of US FDA Fast Track Designation for ART5803, a humanized monovalent monoclonal antibody designed to block…
Sanofi’s Sarclisa Escena becomes first anticancer drug approved for on-body injector delivery
Sanofi has received US FDA approval for Sarclisa Escena (isatuximab-irfc), a subcutaneous formulation of its anti-CD38 antibody delivered via an automated on-body…
Rani secures PegBio as client for oral delivery platform to advance metabolic disease pipeline
China-based PegBio Co., Ltd. (HKEX: 2565) and San Jose, California-based Rani Therapeutics Holdings, Inc. (Nasdaq: RANI) announced a research and development collaboration…
Leads Biolabs wins NMPA priority review for first-ever EP-NEC treatment opamtistomig
China-based Nanjing Leads Biolabs Co., Ltd. (HKEX: 09887) announced that China’s National Medical Products Administration (NMPA) has accepted its biologics license application…
LEO Pharma extends Adtralza into younger children with positive pediatric safety data
Denmark-based LEO Pharma A/S has reported positive results from the Phase II TRAPEDS-1 trial, a pediatric study evaluating tralokinumab (Adbry/Adtralza) in...
Cue Bio secures USD 50m to advance autoimmune pipeline after three-fold valuation jump
Boston-based Cue Biopharma, Inc. (Nasdaq: CUE) announced a USD 50 million private placement to fund clinical development across its immunological disorders...
Hansoh's B7-H3 antibody-drug conjugate achieves first-ever Phase III overall survival win in small-cell lung cancer
Hansoh Pharma's ARTEMIS-008 has delivered what the field has not seen before: the first Phase III overall survival benefit for a B7-H3-targeted...
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