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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The Pharma Data

JUNE 12, 2025

Safety Profile Consistent with Previous Studies : The safety profile of rilzabrutinib was well-understood from previous trials, with no new safety signals. We look forward to further evaluating rilzabrutinib in subsequent phases of its clinical development.” Fast Track and Orphan Drug Designations from FDA The U.S.

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Disease Clinical Development Treatment Medical Schools 40

The Pharma Data

JUNE 12, 2025

The trial evaluated 125 patients with relapsed or refractory AML, as well as those who were newly diagnosed but ineligible for intensive chemotherapy — all with KMT2A-rearrangements or NPM1 mutations. Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine.

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The Pharma Data

JUNE 15, 2025

The most frequently reported adverse events during follow-up were infusion-related reactions (IRRs), which were predominantly grade 1 (mild) and resolved without further complications. This trial is no longer enrolling, and additional enrollment details will be provided in future announcements.

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The Pharma Data

JUNE 26, 2025

a global oncology-focused biopharmaceutical company, delivered a comprehensive update to investors today during its highly anticipated Research and Development (R&D) Day. With more than 40 clinical and commercial-stage assets in active development, BeOne Medicines is demonstrating a scale of ambition matched by few in the field.

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Research Clinical Development Clinical Trials Engineering 40

The Pharma Data

JUNE 11, 2025

Dapirolizumab Pegol Demonstrates Promise in Phase 3 SLE Trial, Showing Improvements in Fatigue and Disease Activity at EULAR 2025 UCB (Euronext Brussels: UCB) and Biogen Inc. The latest data from the PHOENYCS GO trial reinforce the potential of dapirolizumab pegol to improve disease outcomes in people with moderate-to-severe SLE.

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DrugBank

JUNE 18, 2025

Developing a new drug takes an average of 10–15 years and costs upwards of $2 billion, yet the majority of drug candidates fail before reaching regulatory approval. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

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Drug Target Review

MARCH 17, 2025

Event-driven pharmacology Donello highlights the growing recognition of synaptic plasticity’s crucial role in the biology of depression. “We call this phenomenon ‘event-driven pharmacology.” This means the PD effects of synapse-targeted drugs can significantly outlast their PK.

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Treatment Licensing Licensing Science 52

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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DrugBank

JULY 14, 2025

Drug-drug interactions (DDI) are a significant concern in clinical trials, where the safe and effective administration of drugs to patients is crucial.   Challenges in Managing Drug-Drug Interactions in Clinical Development Predicting and managing DDI in clinical trials is one of the most complex challenges in drug development.

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Clinical Development Pharmacokinetics Drugs Clinical Trials 52

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Ibtrozi was approved based on a pair of trials showing response rates of 90% and 85%, respectively, in patients who hadn’t previously received another tyrosine kinase inhibitor. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. You can unsubscribe at anytime. © 2025 TechTarget, Inc.

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The Pharma Data

JULY 2, 2025

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. label of WINREVAIR based on compelling new evidence from the Phase 3 ZENITH trial. risk score of 9 or greater.

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Trials FDA Licensing Licensing 52

SugarCone Biotech

JULY 6, 2025

Of course the larger markets would be in non-NRG1 fusion cancers where HER3 is overrexpressed but Partner Therapeutics does not appear to be supporting additional clinical trials. This is where the rest of the drug development field comes in. regulatory application in NSCLC. This will lead to near-term approval in NPC.

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The Pharma Data

JUNE 13, 2025

The approval is supported by data from KEYNOTE-689, a pivotal Phase 3 trial that evaluated KEYTRUDA in this patient population. Furthermore, for patients whose tumors fell into the PD-L1 CPS 1 or greater subgroup, the improvement in event-free survival was even more pronounced. 0.89; p = 0.00140). months (95% CI, 37.9–not

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FDA Approval Treatment FDA Therapies 40

The Pharma Data

JUNE 19, 2025

Grifols’ BT524 Fibrinogen Therapy Shows Promise in Phase 3 Trial Published in The Lancet’s eClinicalMedicine Grifols , a globally recognized healthcare company and a leader in the production of plasma-derived therapies, has marked a significant advancement in the treatment of acquired fibrinogen deficiency (AFD).

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Therapies Trials Clinical Trials Medical Schools 40

BioPharma Drive: Drug Pricing

JULY 10, 2025

The drug’s clearance came after an unusual clinical development journey and, in the ensuing months, has swelled Soleno’s market value past $4 billion amid optimism about the drug’s sales prospects. You can unsubscribe at anytime. Condulis, for instance, predicts Vykat could reach $2.5 billion in worldwide yearly sales at its peak.

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PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. When the study started, the industry already knew that semaglutide could reduce the risk of adverse cardiovascular events in overweight or obese patients with diabetes.

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Clinical Trials Trials Clinical Development Disease 52

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Dive Insight: Lexeo is developing treatments for heart conditions, such as cardiomyopathy associated with Friedreich’s ataxia and plakophilin-2 arrhythmia. Trade Deficit NBC News Outside groups organize to form unbiased, independent vaccine panel View all Events 07 JUL Webinar | 10 a.m. You can unsubscribe at anytime.

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RNA Drugs Therapies Licensing 219

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations. The staggering interval should be long enough to monitor for acute and subacute adverse events based on observations in animal studies or previous human experience with related products.

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PPD

SEPTEMBER 16, 2024

Real-world data paired with machine learning is a game changer in drug development RWD is becoming increasingly important in influencing the drug development landscape, particularly when used to develop the natural history and patient journey through disease.

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Clinical Development Clinical Trials Clinical Research Drug Development 98

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Trials FDA Regulations 105

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Clinical Development Vaccine Clinical Trials Immune Response 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. © 2025 TechTarget, Inc. or its subsidiaries. All rights reserved. TechTarget, Inc.s

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Treatment Drugs Therapies FDA 130

The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) announced today that Gökhan Batur, Chief Executive Officer, will take part in a panel discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on Thursday, January 7 from 8:00AM Eastern Standard Time. Investors can pre-register for the event here.

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Clinical Development Trials Treatment Research 52

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. You should not place undue reliance on these statements.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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Therapies Clinical Trials Clinical Research Trials 97

Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex. All key questions to consider and address before the therapy even leaves the lab.

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Clinical Trials Trials FDA Therapies 52

The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

Clinical Development 52

Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

SEPTEMBER 6, 2021

In the study, eliapixant demonstrated a positive benefit-risk profile, with the vast majority of adverse events considered mild or moderate. Discontinuation of the study due to adverse events occurred in 8% of patients treated with eliapixant. These results will guide us to advance our clinical development strategy of eliapixant.”.

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Trials Clinical Trials Treatment International 52

The Pharma Data

APRIL 28, 2022

Novo Nordisk today announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from daily insulin. events per patient year exposed to once-weekly insulin icodec and 0.27

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Trials Clinical Trials Treatment Clinical Development 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

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Clinical Trials Trials Pharmacokinetics FDA 83

LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Additional trials (e.g.,

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Small Molecule Trials Therapies Disease 143

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. In addition to the ongoing clinical studies, Merck has conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir. “We

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The Pharma Data

JANUARY 10, 2021

There were no serious adverse events related to treatment and no clinically significant injection site reactions. The approval was received following a review by the DMC of blinded safety data from all three dose cohorts of the MAD study. ASLAN004 was found to be well tolerated at all dose levels. Source link.

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Clinical Trials Pharmaceuticals Trials Treatment 52

The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. 14, 2021 11:00 UTC. President and CEO of Knopp. study centers.

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