Clinical Trials, Drug Development and Licensing

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

Licensing

Licensing Licensing Drugs Biosimilars

Why smarter financial planning could be key to clinical trial success

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. As the pharmaceutical and biotech industries continue to evolve, clinical trials become more complex, and the importance of robust financial oversight has never been clearer.

Clinical Trials

Clinical Trials Trials Clinical Development Drug Development

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

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

The Pharma Data

JUNE 24, 2025

For Revolution Medicines, the funding not only provides critical financial runway but also preserves full strategic autonomy—a rare combination in the biotechnology landscape where promising young companies often trade developmental control for capital through licensing or acquisition.

Drug Development

Drug Development Clinical Trials Therapies Drugs

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

Biotech leader champions targeted cancer treatments and diversity

Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. Personally, I went from working in licensing and business development in big pharma straight to being a CEO. Gender diversity is a hot topic in pharmaceutical and biotech drug development.

Treatment

Treatment Small Molecule Clinical Trials Trials

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

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. Recommended Reading Investors are waking up to Centessa’s sleepiness drug By Jacob Bell • Sept. Can they keep it?

Drugs

Drugs Clinical Trials Therapies Licensing

Obesity care gets personalised: tailoring therapies with Phenomix

Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data.

Therapies

Therapies Treatment Clinical Trials Science

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. 5] The company announced in July 2024 that the FDA had accepted a new drug application for suzetrigine. [11] 6 February 2025. 85 (1): 1119.

FDA

FDA Therapies Trials Treatment

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

SugarCone Biotech

JULY 6, 2025

It follows that HER3-targeting therapies have emerged as a class of anti-cancer treatments designed to treat various tumors that have developed resistance to EGFR or HER2-directed therapies or have emerged due to a NRG1 gene fusion. This is an active drug development landscape with a lot of recent news.

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

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. You can unsubscribe at anytime. Sanofi’s $9.1 Sanofi’s $9.1

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

By Jacob Bell • July 1, 2025 Kendall Davis/BioPharma Dive Tracker 10 clinical trials to watch the rest of 2025 Expected readouts in obesity, lung cancer and AATD headline a series of study results that could give the biotechnology sector a boost. You can unsubscribe at anytime. inhibitors. inhibitors. Registered in England and Wales.

Clinical Trials

Clinical Trials Therapies Science FDA

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

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. You can unsubscribe at anytime. and European drugmakers.

Disease

Disease Licensing Licensing Therapies

Moderna COVID vaccine gets full approval for children

BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. You can unsubscribe at anytime.

Vaccine

Vaccine FDA Therapies Licensing

Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. You can unsubscribe at anytime. You can unsubscribe at anytime. inhibitors. inhibitors.

Therapies

Therapies FDA Clinical Trials Licensing

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

BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. 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

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval The Hong Kong-based CSPC will receive $120 million from Madrigal under the deal.

Drugs

Drugs Clinical Trials FDA Therapies

Private equity firms back PCI Pharma in bet on drug production

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

Production

Production Drugs Therapies Clinical Trials

Organon drug for endometriosis falls short in mid-stage study

BioPharma Drive: Drug Pricing

JULY 2, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

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

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials

Clinical Trials Drugs Therapies Licensing

Incyte replaces CEO Hoppenot with dealmaker Meury

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory.

Therapies

Therapies Licensing Licensing Vaccine

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

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. You can unsubscribe at anytime. Registered in England and Wales.

Therapies

Therapies FDA Treatment Licensing

Redefining commercial success in specialty lite with alternative channels

BioPharma Drive: Drug Pricing

JULY 28, 2025

By Jacob Bell • July 1, 2025 Kendall Davis/BioPharma Dive Tracker 10 clinical trials to watch the rest of 2025 Expected readouts in obesity, lung cancer and AATD headline a series of study results that could give the biotechnology sector a boost. You can unsubscribe at anytime. inhibitors. inhibitors. Registered in England and Wales.

Specialty Pharmacies

Specialty Pharmacies Pharmacy Clinical Trials Therapies

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

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.

FDA

FDA Specialty Pharmacies Drugs Therapies

6 Operational Considerations You Need To Know for Psychedelic Trials

Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. 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.

Trials

Trials Clinical Trials Licensing Licensing

MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

Clinical Trials

Clinical Trials FDA Trials Production

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials

Clinical Trials Pharmacy Clinical Pharmacology FDA

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials

Clinical Trials Trials Treatment Pharmaceuticals

Predictive Oncology partners with the world’s largest funder of cancer research to launch PEDAL™

Predictive Oncology

MARCH 17, 2023

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8

Research

Research Clinical Trials Licensing Licensing

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials

Trials Clinical Trials Regulations FDA

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. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.

Treatment

Treatment Drugs Therapies FDA

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. Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles.

Therapies

Therapies Drug Development Disease Clinical Development

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

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ).

Animal Testing

Animal Testing Biosimilars Cell Based Assays Clinical Trials

Inmagene Biopharmaceuticals closed $21 million Series B financing, making the total raised to date over $40 million

The Pharma Data

NOVEMBER 8, 2020

The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. Inmagene is a leading drug development company focused on immunology-related therapeutic areas. SHANGHAI , Nov. To date, Inmagene has raised over $40 million financing.

Clinical Trials

Clinical Trials Licensing Licensing Drug Development

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

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. The post The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment appeared first on Worldwide Clinical Trials. In June 2023, the U.S.

Treatment

Treatment FDA Clinical Trials Therapies

AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

Licensing

Licensing Licensing Pharmacokinetics Clinical Trials

Sanofi Keeps on Rolling With Biond Biologics Partnership

The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Keitma/Shutterstock.

Immune Response

Immune Response Clinical Trials Licensing Licensing

Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1].

Drugs

Drugs Disease Drug Development Clinical Trials

Gilead Sciences and Gritstone Announce Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure

The Pharma Data

JANUARY 31, 2021

Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. This press release features multimedia.

Vaccine

Vaccine Science Clinical Trials Licensing

A Closer Look At Our On-Site Compounding Pharmacies

Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials 24/7 monitoring of temperature and humidity.

Compounding Pharmacies

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply

The Scientific Singularity: Our Vision for The Future of Research with IP-NFTs

Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ How will IP-NFTs enable drug development in the future?

Research

Research Licensing Licensing Science

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Why smarter financial planning could be key to clinical trial success

Trending Sources

From siloed data to breakthroughs: multimodal AI in drug discovery

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

Toxicology transformed: Why accuracy now leads the way

Biotech leader champions targeted cancer treatments and diversity

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

Obesity care gets personalised: tailoring therapies with Phenomix

Navigating Regulatory Hurdles in Drug Development

Suzetrigine

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

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

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

6 Operational Considerations You Need To Know for Psychedelic Trials

MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Predictive Oncology partners with the world’s largest funder of cancer research to launch PEDAL™

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

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

Advancing neurological therapies with Dr Bruce Leuchter

Looking for Opportunities to Accelerate Clinical Research in Rare Diseases

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Inmagene Biopharmaceuticals closed $21 million Series B financing, making the total raised to date over $40 million

Trends in Pharmaceutical Mergers and Acquisitions

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

AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

Sanofi Keeps on Rolling With Biond Biologics Partnership

Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

Gilead Sciences and Gritstone Announce Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure

A Closer Look At Our On-Site Compounding Pharmacies

The Scientific Singularity: Our Vision for The Future of Research with IP-NFTs

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