2025, Licensing and Therapies - Drug Discovery Digest

Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

JULY 9, 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. billion in 2025, giving the industry a glimpse of radiopharmaceuticals’ sales potential. subsidiary EMD Serono Inc.,

Drugs

Drugs Clinical Development Therapies Clinical Trials

From siloed data to breakthroughs: multimodal AI in drug discovery

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. The Rise of Multimodal Language Models in Drug Development (2025).

Drugs

Drugs Clinical Trials Drug Development Pharmaceuticals

Protein degraders: chasing undruggable targets

BioPharma Drive: Drug Pricing

JULY 8, 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. Drugmakers are working to coopt this process with targeted therapies. You can unsubscribe at anytime.

Targeted Protein Degradation

Targeted Protein Degradation Small Molecule Disease Therapies

Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

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

Treatment Therapies Licensing Licensing

Suzetrigine

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] 1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 6 February 2025. 6 February 2025. under nitrogen.

FDA

FDA Therapies Trials Treatment

2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Broad Institute

MAY 21, 2025

Merkin Prize in Biomedical Technology for developing chimeric antigen receptor (CAR) T-cell therapy, a groundbreaking form of personalized cancer immunotherapy that turns T cells into tumor killers and has led to durable remissions in tens of thousands of patients with previously incurable blood cancers.

Therapies

Therapies FDA Approval Engineering Immune Response

Fitusiran

New Drug Approvals

APRIL 11, 2025

2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] Fitusiran was approved for medical use in the United States in March 2025. [2] Society and culture Legal status Fitusiran was approved for medical use in the United States in March 2025. [2] 26 March 2025. Retrieved 2 April 2025.

Clinical Trials

Clinical Trials FDA FDA Approval Trials

Otsuka’s Sibeprenlimab Shows Significant Proteinuria Reduction in Phase 3 IgAN Trial

The Pharma Data

JUNE 6, 2025

Otsuka Unveils Promising Phase 3 Results for Sibeprenlimab in IgA Nephropathy, Marking Significant Proteinuria Reduction and Advancing a Novel APRIL-Targeted Therapy Otsuka Pharmaceutical Development & Commercialization, Inc., in those receiving placebo—further underscoring the tolerability of this investigational therapy.

Trials

Trials Treatment Therapies FDA

Taletrectinib

New Drug Approvals

JUNE 29, 2025

Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4 , Taletrectinib adipate FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer AB-106, DS-6051a 405.5 1] Taletrectinib was approved for medical use in the United States in June 2025. [3] April 2025. Retrieved 14 June 2025.

International

International FDA Clinical Trials Treatment

Inavolisib

New Drug Approvals

APRIL 25, 2025

3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3] Retrieved 17 April 2025. January 2025.

FDA

FDA FDA Approval Therapies Trials

Takeda to seek approval of new kind of narcolepsy drug after study data

BioPharma Drive: Drug Pricing

JULY 14, 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. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting.

Drugs

Drugs Clinical Trials Therapies Licensing

Tofersen

New Drug Approvals

MAY 17, 2025

Retrieved 17 April 2025. ^ “Qalsody- tofersen injection” DailyMed. Jump up to: a b New Drug Therapy Approvals 2023 (PDF). It is administered as an intrathecal injection. [3] 3] Tofersen was approved for medical use in the United States in April 2023, [3] [6] and in the European Union in May 2024. [4] 3 November 2006.

FDA Approval

FDA Approval FDA Treatment Clinical Trials

Jazz Pharma Gets EU Nod for Ziihera in Advanced HER2+ Biliary Cancer

The Pharma Data

JULY 2, 2025

A Groundbreaking Step in HER2-Targeted Therapy for BTC The EC’s decision was primarily driven by results from the Phase 2b HERIZON-BTC-01 trial , the largest of its kind in this population. May 2025 : China’s National Medical Products Administration (NMPA) issued conditional approval for the same indication. In the U.S.,

Therapies

Therapies Trials Medical Schools Pharmaceuticals

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

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. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials.

FDA

FDA Drugs Therapies Science

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

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. These results are notable given the poor response of NRG1 fusion driven cancers to chemo- and immuno-therapies. months (see [link] ).

Drug Development

Drug Development Drugs Clinical Trials Therapies

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

JULY 2, 2025

Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. risk score of 9 or greater.

Trials

Trials FDA Licensing Licensing

Vor, with new CEO, changes course to target autoimmune disease

BioPharma Drive: Drug Pricing

JUNE 26, 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. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival.

Disease

Disease Licensing Licensing Therapies

Crinecerfont

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] Retrieved 25 January 2025. New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. 1 October 2024.

FDA

FDA FDA Approval Drugs Trials

Leniolisib

New Drug Approvals

MAY 15, 2025

16 April 2025. Retrieved 3 May 2025. New Drug Therapy Approvals 2023 (PDF). Deprotection of the Boc group in DCM/TFA, followed by coupling with propionyl chloride in the presence of sodium bicarbonate in DCM at room temperature for 1 h gives the final compound 7 (leniolisib) a 76% yield. 29 March 2023. Retrieved 20 June 2023.

FDA Approval

FDA Approval FDA Treatment International

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

BioPharma Drive: Drug Pricing

JULY 16, 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. Some Wall Street analysts predicted sales might top $2 billion in 2025. You can unsubscribe at anytime.

Therapies

Therapies FDA Clinical Trials Licensing

Moderna COVID vaccine gets full approval for children

BioPharma Drive: Drug Pricing

JULY 10, 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. Kennedy Jr., who has pushed for policy changes around mRNA vaccines in particular.

Vaccine

Vaccine FDA Therapies Licensing

Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

JULY 10, 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. By Jonathan Gardner • Updated April 9, 2025 Keep up with the story. You can unsubscribe at anytime.

Drugs

Drugs Licensing Licensing Therapies

Lexeo to help launch spinout around RNA drugs for the heart

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

RNA Drugs Therapies Licensing

Landiolol

New Drug Approvals

APRIL 19, 2025

New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. . ^ Jump up to: a b “Novel Drug Approvals for 2024” U.S. 1 October 2024.

FDA

FDA Clinical Trials Treatment Trials

Private equity firms back PCI Pharma in bet on drug production

BioPharma Drive: Drug Pricing

JULY 14, 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. It’ll also boost investments in U.S. drug production.

Production

Production Drugs Therapies Clinical Trials

Organon drug for endometriosis falls short in mid-stage study

BioPharma Drive: Drug Pricing

JULY 2, 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.

Clinical Trials

Clinical Trials Drugs Licensing Licensing

Merck to buy Verona and its lung drug in $10B deal

BioPharma Drive: Drug Pricing

JULY 9, 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. Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co.

Clinical Trials

Clinical Trials Drugs Therapies Licensing

Incyte replaces CEO Hoppenot with dealmaker Meury

BioPharma Drive: Drug Pricing

JUNE 26, 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. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury.

Licensing

Licensing Licensing Therapies Vaccine

FDA takes major step to ease access to CAR-T therapy

BioPharma Drive: Drug Pricing

JUNE 27, 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. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements.

Therapies

Therapies FDA Treatment Licensing

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

JUNE 27, 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. By Delilah Alvarado • May 13, 2025 Keep up with the story. You can unsubscribe at anytime.

Vaccine

Vaccine FDA Therapies Licensing

2025 Gynecology Licensing Trends Report: 150+ Deals by Company, Therapy & Tech

The Pharma Data

JULY 3, 2025

Comprehensive Report Reveals Key Trends in Gynecology Collaboration and Licensing Deals from 2016 to 2025 Gynecology Collaboration and Licensing Deals report offers a deep dive into the evolving landscape of partnerships in women’s health, providing unparalleled insights into over 150 strategic deals executed globally between 2016 and 2025.

Licensing

Licensing Licensing Therapies Science

The rise of GLP-1 drugs: Transforming weight loss treatment

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.

Treatment

Treatment Drugs Therapies FDA

Avacta Announces License Agreement With POINT Biopharma Inc.

The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

Licensing

Licensing Licensing Therapies Pharmaceutical Companies

Acoltremon

New Drug Approvals

JUNE 26, 2025

Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. 29 May 2025. 28 May 2025.

FDA

FDA Clinical Trials Small Molecule FDA Approval

Bactiguard maintains clear growth strategy and updates financial targets

The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ — Bactiguard presents updated financial targets for 2025 in connection with the company’s financial report for the third quarter of 2020. We have several interesting licensing projects ongoing and see new, exciting business opportunities. STOCKHOLM , Nov. Profitability.

Licensing

Licensing Licensing Production Marketing

Sentiment & Themes Emerging From JPM 2024

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. recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Join the club.

Small Molecule

Small Molecule Trials Therapies Disease

ELRIG Announces USA Forum on Neuroimmunology in Drug Discovery

Elrig

APRIL 29, 2025

Rahway NJ USA) research facility in the Longwood medical area of Boston, Massachusetts, on 24 June 2025. She serves as the Director of Business DevelopmentSearch and Evaluation at AstraZeneca, focusing on licensing and collaboration opportunities for drug candidates targeting respiratory and immunology indications. Swarna holds a Ph.D.

Drugs

Drugs Science Clinical Trials Laboratories

Resolutions at the Extraordinary General Meeting in BioInvent on November 27, 2020

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

Clinical Trials Licensing Licensing International

Levacetylleucine

New Drug Approvals

APRIL 30, 2025

New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. ^ “Novel Drug Approvals for 2024” U.S. 1] [2] Levacetylleucine is a modified version of the amino acid leucine. [1] 1] It is the L -form of acetylleucine. 25 September 2024.

FDA

FDA FDA Approval Disease Trials

Navigating the Challenges and Opportunities of the PICO Framework in the New EU HTA Regulation

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

Regulations Pharmaceutical Companies Pharmaceuticals International

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA

FDA Trials Therapies Regulations

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

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. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

Clinical Trials

Clinical Trials Clinical Development Small Molecule Trials

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

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 . Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need. Dedicated rare disease unit to be headquartered in Boston.

Regulations

Regulations International Disease Small Molecule

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

FEBRUARY 4, 2021

AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). AbbVie and Frontier Medicines, Corp.,

Production

Production Clinical Trials International Small Molecule

Actithera draws new investors to radiopharma drug pitch

From siloed data to breakthroughs: multimodal AI in drug discovery

Trending Sources

Protein degraders: chasing undruggable targets

Intellia Reports Positive 3-Year Phase 1 Data for Lonvo-z in Hereditary Angioedema

Suzetrigine

2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Fitusiran

Otsuka’s Sibeprenlimab Shows Significant Proteinuria Reduction in Phase 3 IgAN Trial

Taletrectinib

Inavolisib

Takeda to seek approval of new kind of narcolepsy drug after study data

Tofersen

Jazz Pharma Gets EU Nod for Ziihera in Advanced HER2+ Biliary Cancer

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

Vor, with new CEO, changes course to target autoimmune disease

Crinecerfont

Leniolisib

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

Moderna COVID vaccine gets full approval for children

Soleno sales of new Prader-Willi drug rise faster than expected

Lexeo to help launch spinout around RNA drugs for the heart

Landiolol

Private equity firms back PCI Pharma in bet on drug production

Organon drug for endometriosis falls short in mid-stage study

Merck to buy Verona and its lung drug in $10B deal

Incyte replaces CEO Hoppenot with dealmaker Meury

FDA takes major step to ease access to CAR-T therapy

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

2025 Gynecology Licensing Trends Report: 150+ Deals by Company, Therapy & Tech

The rise of GLP-1 drugs: Transforming weight loss treatment

Avacta Announces License Agreement With POINT Biopharma Inc.

Acoltremon

Bactiguard maintains clear growth strategy and updates financial targets

Sentiment & Themes Emerging From JPM 2024

ELRIG Announces USA Forum on Neuroimmunology in Drug Discovery

Resolutions at the Extraordinary General Meeting in BioInvent on November 27, 2020

Levacetylleucine

Navigating the Challenges and Opportunities of the PICO Framework in the New EU HTA Regulation

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

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