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Regulatory

FDA Cites Pinnacle Biologics Over Promotional Videos for Photofrin Cancer Therapy

The U.S. Food and Drug Administration (FDA) has issued an untitled letter to Pinnacle Biologics, stating that promotional videos...
Insights

Top 10 AI Applications Transforming Pharmaceutical Market Access

Executive Summary Market access has become one of the most strategically important functions within the pharmaceutical industry. Securing regulatory approval...
Insights

The Future of Scientific Engagement in an AI-Driven World

Executive Summary Scientific engagement is undergoing one of the most significant transformations in its history. For decades, scientific exchange in the...
Clinical

cAMPfield Plans Mid-Stage Ulcerative Colitis and Crohn’s Disease Trials for Prifemilast

cAMPfield Therapeutics is preparing to advance prifemilast, an oral phosphodiesterase type 4 (PDE4) inhibitor, into mid-stage clinical testing for...
Clinical

Merck Reports Positive Phase 3 Result for Tulisokibart in Ulcerative Colitis

Merck has reported positive results from the ATLAS-UC induction-only...
Insights

Top 10 Data Architecture Challenges in Modern Pharma Organizations

Executive Summary Data has become one of the most valuable...
Insights

The Next Evolution of Decentralized Clinical Trials

Executive Summary Decentralized clinical trials (DCTs) emerged as one of the most significant innovations in clinical research over the past...
Regulatory

Despite a mid-stage miss, Mirum and Incyte strengthen the case for approval in uncommon bone disease

Incyte and Mirum Pharmaceuticals are taking a step closer to approval of their investigational pill for fibrodysplasia ossificans progressiva...
Clinical

Phase 3 Lagoon Trial Misses Survival Goal for Jazz’s Zepzelca in Second-Line Small Cell Lung Cancer

Jazz Pharmaceuticals said its phase 3 Lagoon trial evaluating Zepzelca as a second-line treatment for metastatic small-cell lung cancer...
Clinical

Novartis Reports Positive Phase 1/2 Results for Del-Brax in FSHD

Novartis has reported positive topline results from the Phase...
Insights

Is Pharma Ready for the Age of Autonomous Work?

Executive Summary For years, pharmaceutical organizations have focused on automating...
Manufacturing

Following Navacaprant’s disappointing late-stage results, Neumora will fire thirty-five percent of its employees

Neumora announced that its two studies evaluating navacaprant in MDD (Koastal-2 and Koastal-3) were not statistically significant on their...
Regulatory

FDA Approves Welireg-Keytruda Combination for Adjuvant Treatment of Clear Cell Renal Cell Carcinoma

Merck & Co. has received U.S. FDA approval for a combination of Welireg and Keytruda as an adjuvant treatment...
Clinical

Caribou Gets CAR-T Boost Ahead of Phase 3 Trial

Caribou Biosciences has reported that its CAR-T cell therapy candidate achieved a median progression-free survival (PFS) of 17.1 months,...
Commercial

Gilead Sciences Secures Exclusive Rights in $848 Million Deal with Compugen for Innovative Cancer Therapy

Gilead Sciences has concluded a significant transaction with Compugen,...
Commercial

Umoja Biopharma Secures $100 Million Series C Funding for Cell Therapy Advancements

Umoja Biopharma has successfully closed a $100 million Series...

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Commercial

Information Technology

Alnylam Inks $2B Agreement With Inceptive to Change sIRNA Design With AI Leader

Alnylam has entered into a partnership with the scientist instrumental in developing the technology...
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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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Regulatory

Insights

Top 10 AI Applications Transforming Pharmaceutical Market Access

Executive Summary Market access has become one of the most...
Insights

The Future of Scientific Engagement in an AI-Driven World

Executive Summary Scientific engagement is undergoing one of the most...
Clinical

cAMPfield Plans Mid-Stage Ulcerative Colitis and Crohn’s Disease Trials for Prifemilast

cAMPfield Therapeutics is preparing to advance prifemilast, an oral...
Clinical

Definium’s LSD Formula Delivers Stunning Late-Stage Results

Definium Therapeutics has released topline phase 3 results for...

Research & Development

Market Access

Manufacturing

Novartis Names Texas as Site For RadioPharma Production Facility

Novartis is moving quickly to outline how radiopharmaceutical manufacturing...
Manufacturing

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

Cellares has raised $257 million in a Series D...

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The Future of Scientific Engagement in an AI-Driven World

Executive Summary Scientific engagement is undergoing one of the most...
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