The Pharma Data

JUNE 22, 2025

Throughout the 26-week study period, the investigational therapy was well-tolerated. Additionally, no participants developed neutralizing antibodies to Mim8—a key concern with biological therapies that could undermine long-term efficacy.

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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. Thus, these drugs best complement, rather than replace, healthy lifestyle interventions.

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The Pharma Data

JUNE 12, 2025

Foundation, explained during the EULAR 2025 presentation: “IgG4-related disease is a progressive, immune-mediated condition with a significant unmet patient need. This design was meant to enable clinician-researchers to gauge the ability of rilzabrutinib to control disease activity after the withdrawal of standard therapy.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Drug Target Review

JUNE 11, 2025

Drug development faces significant challenges: long timelines, high costs , complex processes and low probabilities of success (PoS), exacerbated by the shift towards more complex molecules, biologics and cell and gene therapies, hindering patient access to vital treatments. Navigating the AI revolution: a roadmap for pharma’s future.

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The Pharma Data

JULY 2, 2025

per share and brings Inozyme’s promising late-stage therapeutic candidate, INZ-701, into BioMarin’s growing pipeline of innovative enzyme therapies. BioMarin, a recognized leader in the development of therapies for genetic conditions, believes that INZ-701 has the potential to become a first-in-class treatment for this serious disease.

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The Pharma Data

JUNE 22, 2025

The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C., The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.,

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The Pharma Data

JUNE 6, 2025

Sanofi Highlights Robust Pipeline of Innovations in Rare Blood Disorders at ISTH 2025 Sanofi is poised to take center stage at the 33rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), set to be held in Washington, D.C., from June 21 to 25, 2025. and EU, in late 2024 as the first therapy of its kind.

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The Pharma Data

JUNE 18, 2025

“As our science has advanced, so has the need for tighter alignment across Research and Development to ensure that we continue to scale our impact and transform the lives of patients across a growing number of diseases,” Greenstreet stated.

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RNA Clinical Development Science Disease 40

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. “My passion for science drew me to DARPin technology, and I was eager to contribute to the development of new DARPin therapies.”

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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 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. A Closer Look at the PHOENYCS GO Study The PHOENYCS GO study enrolled patients with moderate-to-severe SLE who were receiving standard-of-care (SOC) therapies.

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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. President and Chief Executive Officer of Intellia Therapeutics.

Treatment 40

Treatment Therapies Licensing Licensing 40

Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a clinical-stage private biopharma company developing therapies for neurological and psychiatric diseases.

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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. Global Head of R&D. “We

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Research Clinical Development Clinical Trials Engineering 40

The Pharma Data

JUNE 12, 2025

The data, presented at the annual European Alliance of Associations for Rheumatology (EULAR 2025) congress in Barcelona, Spain, show that dapirolizumab pegol resulted in significant and clinically meaningful improvements in disease activity while addressing a major symptom that profoundly impacts patients’ daily lives — fatigue.

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The Pharma Data

JUNE 23, 2025

These pivotal findings were unveiled at the 85th Scientific Sessions of the American Diabetes Association (ADA) and were concurrently published in The New England Journal of Medicine , underscoring the significant promise of MariTide in the growing field of anti-obesity therapies.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Many thanks to Michelle Levine and Maurizio Fazio for their editorial advice.

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Small Molecule Trials Therapies Disease 143

New Drug Approvals

MAY 15, 2025

A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinical development as an anti-inflammatory therapeutic. 16 April 2025. Retrieved 3 May 2025. New Drug Therapy Approvals 2023 (PDF). 29 March 2023. January 2024.

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FDA Approval FDA Treatment International 62

The Pharma Data

JANUARY 19, 2021

The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is based in Suzhou and Shanghai, China.

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 52

Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

PPD

NOVEMBER 30, 2023

Nearly half of the group predicted that 90% of their trials will include decentralized elements by 2025. This fundamental step will create more efficacious therapies by developing and researching their effects in a more inclusive population.

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Clinical Trials Trials Clinical Research Drug Development 98

The Pharma Data

JULY 27, 2021

AbbVie (NYSE: ABBV) and Calico Life Sciences today announced an extension of their leading-edge collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer. This is the second extension of the collaboration originally established in 2014.

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Disease Science Therapies Production 52

LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us. These goals were believable and achievable.

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Clinical Trials Trials Disease Treatment 81

The Pharma Data

NOVEMBER 26, 2020

The EGM resolved to approve the Board of Directors’ previous resolution on October 27, 2020 on a directed issue of 29,395,311 new shares and 14,697,655 new warrants of series 2020/2025, both to CASI Pharmaceuticals, Inc. per share during the period from and including 27 November 2020 up to and including 27 November 2025.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. This harmonization aims to enhance the efficient use of resources, reduce duplication in HTA submissions and address inequities in patient access to innovative therapies.

Regulations 52

Regulations Pharmaceutical Companies Pharmaceuticals International 52

BioPharma Drive: Drug Pricing

JUNE 24, 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.

RNA 227

RNA Drugs Therapies Licensing 227

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. We expect 2021 will mark a number of key clinical and commercial milestones. COPENHAGEN, Denmark, Jan. Morgan Healthcare Conference. “In ?. .

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The Pharma Data

NOVEMBER 10, 2020

Billion by 2025. Phase1b/2 clinical study to be conducted in the United States and several European countries. This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. billion by 2025, according to Grand View Research 1.

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Clinical Trials Science Disease Trials 40

The Pharma Data

DECEMBER 12, 2020

Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . In contrast, AstraZeneca’s capabilities in genomics, precision medicine and oligonucleotides can be leveraged to develop medicines targeting less-frequent diseases.

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Regulations International Disease Small Molecule 75

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. Each target and each therapeutic modality induces varying degrees of clinical efficacy, as well as causing toxicities.

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Drug Development Drugs Clinical Trials Therapies 56

The Pharma Data

JULY 2, 2025

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. 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. risk score of 9 or greater. Source link

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Trials FDA Licensing Licensing 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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Immune Response Drugs Therapies Drug Development 52

The Pharma Data

JUNE 16, 2025

BioMarin Boosts Enzyme Therapy Business with Inozyme Acquisition BioMarin Pharmaceutical and Inozyme Pharma today announced that BioMarin has entered into a definitive agreement to acquire Inozyme for $4.00 per share in an all-cash transaction valued at approximately $270 million in total consideration. This is where INZ-701 comes in.

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The Pharma Data

JUNE 13, 2025

Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), its flagship anti-PD-1 therapy, for the treatment of adult patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] of 1 or greater) as determined by an FDA-approved test.

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The Pharma Data

JUNE 20, 2025

The new recommendation supports the use of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union (EU). Food and Drug Administration (FDA) already approved darolutamide in combination with ADT for mHSPC in June 2025.

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Trials Therapies Treatment Pharmaceutical Companies 40

The Pharma Data

JANUARY 15, 2021

Enhertu previously received Priority Review and Breakthrough Therapy Designation (BTD) in the U.S. About the Enhertu Clinical Development Program. for the treatment of patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.

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