Drug Development, Licensing and Therapies

Revolution Medicines Secures $2B Funding from Royalty Pharma for RAS(ON) Cancer Drug Development

The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

Drug Development

Drug Development Clinical Trials Therapies Drugs

From siloed data to breakthroughs: multimodal AI in drug discovery

Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

Drugs

Drugs Clinical Trials Drug Development Pharmaceuticals

Teva and Fosun Partner to Develop Novel Anti-PD1-IL2 Immunotherapy

The Pharma Data

JUNE 16, 2025

Teva and Fosun Pharma Forge Strategic Partnership to Develop and Commercialize Innovative Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology Teva Pharmaceutical Industries Ltd. This collaboration marks a significant step forward in global oncology drug development. and Shanghai Fosun Pharmaceutical (Group) Co.,

Therapies

Therapies Licensing Licensing Treatment

Toxicology transformed: Why accuracy now leads the way

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

International

International Laboratories Drugs Pharmacokinetics

Obesity care gets personalised: tailoring therapies with Phenomix

Drug Target Review

MARCH 4, 2025

Knowing a patients subtype or phenotype can be used to guide obesity treatments of all kinds, including drug therapy, devices, bariatric surgery and even diet and lifestyle interventions, Bagnall explains. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions.

Therapies

Therapies Treatment Clinical Trials Science

Spirulina’s role in shaping the future of preventative biologics

Drug Target Review

APRIL 14, 2025

By preventing infections before they occur, these drugs reduce the need for hospital treatments, including the costly intensive care unit (ICU) care that can burden healthcare systems. The spirulina-based platform Lumen Biosciences approach to drug development is radically different from traditional biopharmaceuticals.

Therapies

Therapies Marketing Drug Development Treatment

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. You can unsubscribe at anytime. Track funding rounds here. inhibitors.

Drugs

Drugs Clinical Trials Therapies Licensing

Navigating Regulatory Hurdles in Drug Development

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. One of the most significant challenges in drug development is global regulatory variability.

Drug Development

Drug Development Clinical Trials Compliance Drugs

Suzetrigine

New Drug Approvals

APRIL 2, 2025

This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. under nitrogen. 6 February 2025.

FDA

FDA Therapies Trials Treatment

The future of mental health treatment: Zelquistinel’s role

Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. This concept is crucial in early drug discovery because it challenges traditional methods of drug development, where the focus is often on the PK.

Treatment

Treatment Licensing Licensing Science

Why smarter financial planning could be key to clinical trial success

Drug Target Review

JULY 29, 2025

” This is why financial oversight is so important – without it, the success of a trial is jeopardised and the progress of drug development can be significantly hindered. Jennifer has been a licensed CPA (California) since July 2014. Meet Jennifer Kyle Jennifer Kyle is Co-founder and CEO of Condor Software, Inc.

Clinical Trials

Clinical Trials Trials Clinical Development Drug Development

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

SugarCone Biotech

JULY 6, 2025

They have interesting patterns of expression in different cancer indications; thus, diverse therapies for attacking these targets have been developed. This is an active drug development landscape with a lot of recent news. The leading program is the approved therapeutic zenocutuzumab developed by Merus N.V.

Drug Development

Drug Development Drugs Clinical Trials Therapies

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

GenAI and real-world data in pharma: 4 questions to fuel effective insights

BioPharma Drive: Drug Pricing

JULY 28, 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. Please select at least one newsletter.

Clinical Trials

Clinical Trials Therapies Science FDA

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

Ropotrectinib

New Drug Approvals

AUGUST 7, 2025

After undergoing currently approved targeted therapies, patients with tumors containing ROS1 and neurotrophic tyrosine kinase receptor (NTRK) gene fusions frequently acquire resistance mutations [88,89]. These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors.

FDA

FDA FDA Approval Production Treatment

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

Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Drive: Drug Pricing

JULY 18, 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. That data found similar risks including breast cancer, stroke and dementia.

Therapies

Therapies FDA Clinical Trials 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. Since the drug’s U.S. You can unsubscribe at anytime.

Drugs

Drugs Licensing Licensing Therapies

Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

BioPharma Drive: Drug Pricing

JULY 30, 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. Elsewhere, Apellis’ drug Empaveli gained a new indication from the FDA. You can unsubscribe at anytime.

Drugs

Drugs Clinical Trials FDA Therapies

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. drug production. You can unsubscribe at anytime. It’ll also boost investments in U.S.

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 Therapies 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. Alamy 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. You can unsubscribe at anytime.

Therapies

Therapies Licensing Licensing 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

Redefining commercial success in specialty lite with alternative channels

BioPharma Drive: Drug Pricing

JULY 28, 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. Please select at least one newsletter.

Specialty Pharmacies

Specialty Pharmacies Pharmacy Clinical Trials Therapies

Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP

BioPharma Drive: Drug Pricing

AUGUST 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. By BioPharma Dive staff • Updated July 2, 2025 Keep up with the story.

Marketing

Marketing Pharmacy Therapies Clinical Trials

Replimune drug rejected by FDA; Omega raises $647M biotech fund

BioPharma Drive: Drug Pricing

JULY 22, 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. The Food and Drug Administration on Tuesday rejected a melanoma drug developed by Replimune.

FDA

FDA Specialty Pharmacies Drugs Therapies

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Therapies FDA FDA Approval Treatment

Strengthening Warfighter Resiliency Using Broad-Spectrum or Host-Directed Therapies within the Rapid Acquisition and Investigation of Drugs for Repurposing (RAIDR) Program [Minireview]

ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development. Repurposing is one such method. CBRN MCMs).

Therapies

Therapies Licensing Licensing FDA Approval

Advancing neurological therapies with Dr Bruce Leuchter

Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Historically, what has limited investor interest in funding neurological and psychiatric therapies in development?

Therapies

Therapies Drug Development Disease Clinical Development

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

Treatment

Treatment Drugs Therapies FDA

Ambulero Raises Up To $5.5 Million from Orphinic ScientificMiami Cell and Gene Therapy Company Opens European Subsidiary To Advance Gene Therapy For Rare Vascular Disease

The Pharma Data

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. ,

Therapies

Therapies Disease Licensing Licensing

ViGeneron signs global collaboration agreement for ophthalmic gene therapy development

The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. .

Therapies

Therapies Virus Disease Licensing

6 Operational Considerations You Need To Know for Psychedelic Trials

Conversations in Drug Development Trends

OCTOBER 26, 2022

That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities. Certain licensing must be obtained. Raters and therapists are not the same. More guidance on safety considerations can be found, here.

Trials

Trials Clinical Trials Licensing Licensing

Corlieve Therapeutics SAS Closes Seed Financing to Develop Therapies for Severe Neurological Conditions

The Pharma Data

NOVEMBER 1, 2020

Corlieve is focused on developing novel therapeutics for severe neurological disorders. Corlieve’s lead program employs a novel AAV gene therapy approach for the treatment of refractory temporal lobe epilepsy (TLE), the most commonly diagnosed focal epilepsy in humans. Maryland , US), a leading gene therapy company.

Therapies

Therapies Science Treatment Disease

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).

Therapies

Therapies Engineering Production FDA

Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

Pharmaceuticals

Pharmaceuticals Pharmaceutical Companies Therapies 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

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. Noria) and PSMA Therapeutics Inc.

Small Molecule

Small Molecule Licensing Licensing Therapies

LyGenesis Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease, and also Closes $11 Million Convertible Debt Financing

The Pharma Data

DECEMBER 29, 2020

a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. Its drug development pipeline includes thymus, pancreas, and kidney regeneration.

Therapies

Therapies FDA Trials Disease

For the Children: Advancing the Cause of Pediatric Cancer Research

Crown Bioscience

MAY 4, 2021

Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids. Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval.

Research

Research Pharmaceutical Companies Licensing Licensing

The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

Treatment

Treatment FDA Clinical Trials Therapies

Looking for Opportunities to Accelerate Clinical Research in Rare Diseases

LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

Clinical Research

Clinical Research Disease Research Clinical Trials

Revolution Medicines Secures $2B Funding from Royalty Pharma for RAS(ON) Cancer Drug Development

From siloed data to breakthroughs: multimodal AI in drug discovery

Trending Sources

Teva and Fosun Partner to Develop Novel Anti-PD1-IL2 Immunotherapy

Toxicology transformed: Why accuracy now leads the way

Obesity care gets personalised: tailoring therapies with Phenomix

Spirulina’s role in shaping the future of preventative biologics

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

Navigating Regulatory Hurdles in Drug Development

Suzetrigine

The future of mental health treatment: Zelquistinel’s role

Why smarter financial planning could be key to clinical trial success

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

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

GenAI and real-world data in pharma: 4 questions to fuel effective insights

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

Ropotrectinib

Moderna COVID vaccine gets full approval for children

Panel urges FDA to remove warnings on hormonal menopause therapy

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

Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

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

Redefining commercial success in specialty lite with alternative channels

Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP

Replimune drug rejected by FDA; Omega raises $647M biotech fund

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

Strengthening Warfighter Resiliency Using Broad-Spectrum or Host-Directed Therapies within the Rapid Acquisition and Investigation of Drugs for Repurposing (RAIDR) Program [Minireview]

Advancing neurological therapies with Dr Bruce Leuchter

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

Ambulero Raises Up To $5.5 Million from Orphinic ScientificMiami Cell and Gene Therapy Company Opens European Subsidiary To Advance Gene Therapy For Rare Vascular Disease

ViGeneron signs global collaboration agreement for ophthalmic gene therapy development

6 Operational Considerations You Need To Know for Psychedelic Trials

Corlieve Therapeutics SAS Closes Seed Financing to Develop Therapies for Severe Neurological Conditions

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Trends in Pharmaceutical Mergers and Acquisitions

Sentiment & Themes Emerging From JPM 2024

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

LyGenesis Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease, and also Closes $11 Million Convertible Debt Financing

For the Children: Advancing the Cause of Pediatric Cancer Research

The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Looking for Opportunities to Accelerate Clinical Research in Rare Diseases

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