SugarCone Biotech

JUNE 19, 2025

For these patients, clinical onset means severe symptoms and a rapid decline in overall health. Typical treatment has been chemotherapy and radiotherapy with an initially high overall response rate (ORR) but then rapid recurrence followed by poor prognosis. 4 patients (33%) had grade 4 adverse events.

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The Pharma Data

JUNE 23, 2025

This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit. Both data sets now provide foundational insight into the design and direction of Amgen’s upcoming Phase 3 MARITIME clinical development program.

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The Pharma Data

JUNE 12, 2025

The data were revealed during an oral presentation (S137) at the 2025 European Hematology Association (EHA) Congress in Vienna, reflecting ongoing progress in developing new treatment options for patients battling this aggressive hematologic malignancy.

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The Pharma Data

JUNE 15, 2025

The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc.

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The Pharma Data

JUNE 26, 2025

The encouraging data builds on the foundation established by earlier studies and further strengthens the clinical case for MR-141 as a potential non-invasive, once-daily ophthalmic solution for millions affected by the age-related decline in near vision. According to the company, MR-141 met its primary endpoint with statistical significance.

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Trials Clinical Trials Treatment Licensing 40

The Pharma Data

JUNE 11, 2025

(NASDAQ: BIIB) presented comprehensive new findings from their Phase 3 PHOENYCS GO clinical trial evaluating dapirolizumab pegol (DZP) at the 2025 Annual Congress of the European Alliance of Associations for Rheumatology (EULAR) in Barcelona, Spain. Treatment-Emergent Adverse Events (TEAEs) : Occurred in 82.6% in the SOC group.

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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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DrugBank

JUNE 18, 2025

As clinical development progresses, pharmaceutical companies must submit periodic updates to regulatory agencies, reporting on patient safety data, adverse events, and protocol modifications. This application is the foundation for obtaining approval to proceed with Phase I human trials.

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DrugBank

JULY 14, 2025

Understanding the pharmacokinetics and pharmacodynamics of each drug in these complex regimens is critical to ensure safe and effective treatment.    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

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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The Pharma Data

JULY 2, 2025

and Canada, has announced a significant regulatory milestone for its pulmonary arterial hypertension (PAH) treatment, WINREVAIR™ (sotatercept-csrk). Importantly, the treatment effect emerged early in the course of therapy and continued to increase over time. Despite existing therapies, many PAH patients remain at substantial risk.

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Trials FDA Licensing Licensing 52

SugarCone Biotech

JULY 6, 2025

HER3 plays a pivotal role in activating downstream signaling pathways through heterodimerization with other receptors like HER2 and can mediate resistance to therapies targeting EGFR and HER2, making it a compelling target for novel treatments in cancers that rely on oncogenic signaling via those related growth factor receptors.

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Drug Development Drugs Clinical Trials Therapies 56

The Pharma Data

JUNE 13, 2025

FDA Approves KEYTRUDA® (Pembrolizumab) for Perioperative Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma Merck known as MSD outside the United States and Canada, recently announced that the U.S. Among these patients, the median event-free survival was 59.7 0.89; p = 0.00140). 0.89; p = 0.00140).

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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

Spencer Platt via Getty Images The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. You can unsubscribe at anytime. Condulis, for instance, predicts Vykat could reach $2.5 © 2025 TechTarget, Inc.

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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. Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

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PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

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Clinical Trials Trials Clinical Development Disease 52

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance recommends, when feasible/ethical, the use of a placebo/sham concurrent control, active concurrent control, or dose-ranging concurrent control, as opposed to no-treatment concurrent control or external control, though no guidance is offered as to when such controls are feasible or ethical.

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PPD

SEPTEMBER 16, 2024

ML is also used to identify predictors of response to a therapy or risk for adverse events (AEs) that can be used to inform value-based contracting or treatment strategies intended to minimize “wasted” use of a drug. Ready to learn more about convergence of real-world data and technology for clinical trials?

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

This shift raises ethical questions around prioritizing supply for diabetes patients versus those seeking treatment for obesity or cosmetic weight loss. You can unsubscribe at anytime. The balance is complex, as obesity carries its own serious health risks. TechTarget, Inc.s registered office is 275 Grove St. Newton, MA 02466.

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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. Aflibercept is a key treatment in ophthalmology.

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Biosimilars Clinical Development Production Government 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. Kimberly Smith, M.D., About the long-acting regimen of cabotegravir and rilpivirine.

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Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

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Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

MAY 16, 2022

Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). There is no cure for HIV or AIDS. About Lenacapavir.

Treatment 52

Treatment FDA Science Therapies 52

PPD

OCTOBER 17, 2024

In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches. They also need to have the medical competencies to manage adverse events often associated with these therapies. Factoring in cultural dynamics is key to enabling new therapy treatment success.

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The Pharma Data

JANUARY 17, 2021

a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma.

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Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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Treatment Therapies Clinical Development Cell Biology 98

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I

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Treatment FDA Clinical Trials Drugs 52

The Pharma Data

MARCH 7, 2022

Astellas”) today announced topline results from the Phase 3 SKYLIGHT 4™ clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.

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Treatment Clinical Trials Trials Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 11, 2021

Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal. mg injection is approved for the treatment of adults with obesity or overweight in the US and UK, as an adjunct to diet and exercise. Once-weekly semaglutide 2.4

Treatment 52

Treatment Disease Clinical Trials Trials 52

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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Treatment FDA Approval Pharmacokinetics FDA 52

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

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Clinical Trials Trials FDA Regulations 105

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 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. About Sandoz.

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Biosimilars Clinical Development Production Government 40

The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.

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Therapies Treatment Clinical Trials FDA 52

Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

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Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.

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Clinical Trials Trials Treatment FDA 52