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Clinical

Evommune Reports Phase 2a EVO301 Data in Moderate to Severe Atopic Dermatitis

Evommune disclosed results from a phase 2a clinical trial evaluating its IL-18–targeting fusion protein, EVO301, in patients with moderate...
Regulatory

FDA Rejects REGENXBIO’s RGX-121 Gene Therapy for Hunter Syndrome, Requests New Study

The U.S. Food and Drug Administration (FDA) has issued a complete response letter rejecting REGENXBIO’s application for accelerated approval...
Clinical

Eli Lilly Discontinues Three Clinical-Stage Programs Including Prevail Gene Therapy

Eli Lilly has discontinued three clinical-stage drug candidates as it awaits an FDA approval decision for its oral GLP-1...
Regulatory

Pfizer EU Tafamidis Patent Withdrawal

Pfizer withdrew European patent EP3191461B1 during a hearing with the European Patent Office. The patent covered certain crystalline solid...
Commercial

Iambic and Takeda Enter Multiyear AI Drug Discovery Partnership Valued at Over $1.7 Billion

Privately held biotechnology company Iambic Therapeutics announced on Monday...
Regulatory

FDA Issues Complete Response Letter for Subcutaneous Saphnelo Application

AstraZeneca said the U.S. Food and Drug Administration has...
Clinical

CagriSema Shows Greater Blood Sugar and Weight Reduction Than Semaglutide in Phase 3 Trial

Novo Nordisk reported phase 3 trial results showing that its investigational combination therapy CagriSema achieved greater reductions in blood...
Clinical

Sanofi Reports Divergent Phase III Results for Venglustat in Gaucher and Fabry Diseases

Sanofi has reported mixed Phase III clinical trial outcomes for venglustat, an oral glucosylceramide synthase inhibitor being studied for...
Clinical

GSK Returns WVE-006 Rights to Wave Following Phase Ib/IIa AATD Results

GSK has decided to return rights to WVE-006, an RNA editing oligonucleotide developed by Wave Life Sciences for alpha-1...
Commercial

AstraZeneca commits $15 billion investment in China to advance radioconjugates and cell therapy innovation

AstraZeneca has outlined plans to invest $15 billion in...
Commercial

AstraZeneca and CSPC Sign Up to $18.5 Billion Ex-China Weight Management Collaboration

AstraZeneca has entered into a wide-ranging collaboration with Hong...
Clinical

Quince Therapeutics’ Phase 3 eDSP Trial Fails to Meet Endpoints in Ataxia-Telangiectasia

Quince Therapeutics said its experimental therapy that delivers steroids through patients’ own red blood cells did not demonstrate efficacy...
Regulatory

FDA Places Regenxbio Gene Therapies on Clinical Hold Weeks Before Approval Decision

The U.S. Food and Drug Administration (FDA) has placed two Regenxbio gene therapy programs on clinical hold, just weeks...
Manufacturing

Cellares Raises $257 Million Series D to Expand Global Cell Therapy Manufacturing

Cellares has raised $257 million in a Series D financing round as it advances plans to support clinical cell...
Commercial

BMS Terminates Two Mid-Stage and Four Early-Stage Clinical Initiatives

During an R&D Day presentation, Bristol Myers Squibb (BMS)...
Commercial

Kroger Health Joins Hands With Performance Kitchen to Provide Medically Tailored Food

Kroger Health, a division of the Kroger Company, has...

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Information Technology

Chugai and Gero Partner to Develop Antibodies for Age-Related Diseases Using AI

Chugai Pharmaceutical has entered into a research collaboration with Singapore-based Gero to develop antibody-based...
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J&J MedTech presents the first Ottava surgical robot clinical cases

Johnson & Johnson MedTech successfully conducted the initial clinical use of Ottava surgical robot...
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Wisp Launches Weight Care Vertical for Women with Hormonal Imbalances

Common conditions in women such as PCOS, menopause, and endometriosis often lead to hormonal...
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PicnicHealth Launches New Service Bringing Observational Clinical Trials to the Virtual Realm

Health technology company PicnicHealth has launched a new product, Virtual Site, which allows researchers...
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Regulatory

Regulatory

FDA Rejects REGENXBIO’s RGX-121 Gene Therapy for Hunter Syndrome, Requests New Study

The U.S. Food and Drug Administration (FDA) has issued...
Clinical

Eli Lilly Discontinues Three Clinical-Stage Programs Including Prevail Gene Therapy

Eli Lilly has discontinued three clinical-stage drug candidates as...
Regulatory

Pfizer EU Tafamidis Patent Withdrawal

Pfizer withdrew European patent EP3191461B1 during a hearing with...
Commercial

Lilly Acquires Orna to Enter In Vivo CAR-T Development for Autoimmune Diseases

Eli Lilly has agreed to acquire Orna Therapeutics in...

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Clinical

Evommune Reports Phase 2a EVO301 Data in Moderate to Severe Atopic Dermatitis

Evommune disclosed results from a phase 2a clinical trial...
Editorial Team -
Manufacturing

Recipharm Commissions Bengaluru Facility for Nonbacterial Beta-Lactam Tablet Manufacturing

Swedish contract development and manufacturing organization (CDMO) Recipharm has...
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Clinical

Eli Lilly Discontinues Three Clinical-Stage Programs Including Prevail Gene Therapy

Eli Lilly has discontinued three clinical-stage drug candidates as...
Editorial Team -

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