The Pharma Data

JUNE 9, 2025

The Week 26 data from the COACH Trial now show that TransCon hGH may further enhance these benefits. COACH Trial Overview The COACH Trial is a prospective, Phase 2, open-label, proof-of-concept study designed to evaluate the efficacy, safety, and tolerability of the combination therapy. mg/kg/week) during the trial.

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SugarCone Biotech

JUNE 19, 2025

Two large and randomized clinical trials, IMpower-133 and CASPIAN, showing statistically significant improvements in outcomes when chemotherapy was combined with atezolizumab or durvalumab, respectively, in the first-line treatment of ES-SCLC. This Phase 3 trial compared tarlatamab with chemotherapy as second-line treatment.

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Drug Target Review

JULY 8, 2025

As Vice President of Oncology Early Development (OED) at AbbVie , she leads the charge on translating bold scientific ideas into real-world impact – and she’s doing it with a focus on some of the most tenacious cancers out there. Her team sits right at the edge of innovation, where discovery science meets clinical execution. “The

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Drug Target Review

JUNE 28, 2025

DARPin therapeutics were a prominent theme at AACR 2025 , with Molecular Partners presenting a trio of preclinical programmes spanning radiopharmaceuticals and immune cell engagers. ” With an IND filing and first-in-human trials expected in 2025, MP0712 is moving steadily towards clinical evaluation.

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SugarCone Biotech

JUNE 27, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and Her3 June 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and Her3 are compelling tumor antigens to target with cancer therapeutics. As we’ll see, ASCO 2025 was a breakout conference for B7-H3-targeted therapies. That trial is in second-line NSCLC.

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Alta Sciences

JUNE 6, 2025

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. This can result in failed runs and wasted reagents.

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Alta Sciences

MARCH 4, 2025

Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD pmjackson Tue, 03/04/2025 - 20:10 Many of my colleagues and I are members of the Cross-Company Abuse Liability Council (CCALC), where I have been a co-chair for the past seven years, and a member for 15.

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). National Primate Research Centers (NPRCs) Annual Report, 2021. Bailey J, et al.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

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BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting.

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The Pharma Data

JULY 2, 2025

FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S. alone, more than 36,000 new diagnoses and approximately 12,000 deaths are anticipated in 2025.

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The Pharma Data

JUNE 26, 2025

BeOne Medicines Showcases Bold Vision and Expansive Oncology Pipeline at 2025 R&D Day BeOne Medicines Ltd., a global oncology-focused biopharmaceutical company, delivered a comprehensive update to investors today during its highly anticipated Research and Development (R&D) Day.

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Alta Sciences

JULY 7, 2025

ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs pmjackson Mon, 07/07/2025 - 21:31 New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS).

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SugarCone Biotech

JULY 6, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and HER3 July 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and HER3 are compelling tumor antigens to target with cancer therapeutics. This is an active drug development landscape with a lot of recent news. regulatory application in NSCLC.

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BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. Sanofi’s $9.1

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LifeSciVC

JUNE 12, 2025

2025 holds to be a transformative year for us, with the potential for multiple milestones to come to fruition, with the biggest value inflection being the interim clinical data from our lead asset KRRO-110, a potential best in class compound for patients with Alpha-1 antitrypsin deficiency (AATD). Over the last 4.5

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease.

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Perficient: Drug Development

MARCH 17, 2025

Perficients Clinical Trial Data Collaboration Solution , d eveloped in partnership with a top-five life sciences leader , is a great example of how we bring fresh ideas and game-changing transformative business outcomes for our client.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. By Jonathan Gardner • Updated April 9, 2025 Keep up with the story.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

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BioPharma Drive: Drug Pricing

JULY 2, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

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BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. Track funding rounds here.

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BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Can they keep it?

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Conversations in Drug Development Trends

APRIL 29, 2025

Unfortunately, this years event, scheduled for February 27-28, 2025, in Washington, DC, was abruptly postponed less than one week before it began. Thats why Worldwide Clinical Trials was committed to ensuring the rare disease community still had a space to share knowledge, resources, and support on Rare Disease Day 2025.

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FDA Law Blog: Drug Discovery

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L.

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Codon

JULY 14, 2025

Drugs developed in Eichengrün’s laboratory were tested at Bayer’s pharmacological laboratory, led by Heinrich Dreser. Dreser had the right to veto any drug going to clinical trials, so this is where the story of aspirin could have ended. ” Asimov Press (2025). Cite: Harrison, S. million).

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Conversations in Drug Development Trends

APRIL 28, 2025

Following the American College of Cardiology (ACC) conference 2025, Worldwide Clinical Trials hosted a post-meeting webinar, On the Cutting Edge of Cardiovascular Discovery Learnings from ACC 2025 and Future Perspectives. As a result, regulatory assessment is ongoing and the FDA granted orphan drug designation in March 2025.

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Quanticate

SEPTEMBER 13, 2024

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

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H1 Blog

DECEMBER 11, 2024

In this edition, our CEO and co-founder, Ariel Katz, along with Regional VP of Trial Landscape, Ryan Brown, share their top predictions for 2025. Drug Policy There will be significant changes in clinical trials & drug development due to the Inflation Reduction Act.

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H1 Blog

OCTOBER 30, 2023

The application of AI in the life sciences sector has the potential to revolutionize many aspects of research, development, and patient care. By 2025, we can anticipate pretty significant shifts as AI continues to advance and integrate into various processes within the healthcare ecosystem.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

By Ned Pagliarulo, Jacob Bell and Julia Himmel • Updated June 17, 2025 Spencer Platt via Getty Images Facing ‘uncertainty on steroids,’ biotech dealmakers tread more cautiously Experts say market turmoil has made it harder for buyers and sellers to agree on price, which can be an especially imposing obstacle to large acquisitions.

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Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), On Demand Start Date Wed, 02/12/2025 - 15:00

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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