2023 and Licensing - Drug Discovery Digest

Tofersen

New Drug Approvals

MAY 17, 2025

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] 25 April 2023. Archived from the original on 8 May 2023. Retrieved 10 June 2023. 25 April 2023. Archived from the original on 25 April 2023. Retrieved 25 April 2023.

FDA Approval

FDA Approval FDA Treatment Clinical Trials

Protein degraders: chasing undruggable targets

BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Crews, in 2023, helped launch Halda Therapeutics , which is testing a spin on induced proximity by getting one protein to “smother” the other.

Targeted Protein Degradation

Targeted Protein Degradation Small Molecule Disease Therapies

Vamorolone

New Drug Approvals

JULY 25, 2025

10] Vamorolone was approved for medical use in the United States in October 2023, [11] [10] and in the European Union in December 2023. [2] Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 2] Vamorolone was approved for medical use in the European Union in December 2023.

FDA

FDA FDA Approval Treatment Clinical Trials

Elacestrant

New Drug Approvals

MAY 9, 2025

2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 8 February 2023.

FDA

FDA Pharmacokinetics Therapies Treatment

Gepirone

New Drug Approvals

JUNE 11, 2025

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4]

FDA

FDA FDA Approval Treatment Clinical Trials

Inavolisib

New Drug Approvals

APRIL 25, 2025

Retrieved 21 September 2023. Retrieved 21 September 2023. Retrieved 21 September 2023. ^ April 2023). Retrieved 21 September 2023. Retrieved 21 September 2023. World Health Organization (2023). PMID 36455032. S2CID 254149451. ^ “CID 124173720, Inavolisib” PubChem. 1 October 2024.

FDA

FDA FDA Approval Therapies Trials

Zilucoplan

New Drug Approvals

JUNE 15, 2025

11] Zilucoplan was approved for medical use in the United States in October 2023, [6] [12] in the European Union in December 2023, [7] and in Australia in July 2024. [1] 11] Zilucoplan was approved for medical use in the United States in October 2023, [6] [12] in the European Union in December 2023, [7] and in Australia in July 2024.

FDA

FDA Treatment Clinical Trials Production

Orforglipron’

New Drug Approvals

JULY 2, 2025

then was licensed to Lilly in 2018. [1] 1] [3] Clinical trials The results of Phase I safety and Phase II ascending-dose clinical trials enrolling people with obesity or type 2 diabetes were published in 2023. [4] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] Sidik S (2023).

Small Molecule

Small Molecule Clinical Trials Trials Pharmacokinetics

Pirtobrutinib

New Drug Approvals

MAY 8, 2025

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 27 January 2023.

FDA Approval

FDA Approval FDA Therapies Trials

Leniolisib

New Drug Approvals

MAY 15, 2025

5] Leniolisib was approved for medical use in the United States in March 2023. [5] 5] Leniolisib was approved for medical use in the United States in March 2023. [5] 29 March 2023. Retrieved 20 June 2023. 24 March 2023. Retrieved 24 March 2023. Duggan S, Al-Salama ZT (July 2023). 24 March 2023.

FDA Approval

FDA Approval FDA Treatment International

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. Sanofi’s $9.1 Sanofi’s $9.1

FDA

FDA Drugs Therapies Science

Fitusiran

New Drug Approvals

APRIL 11, 2025

April 2023). . “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75” WHO Drug Information. hdl : 10665/331046. Further reading Srivastava A, Rangarajan S, Kavakli K, Klamroth R, Kenet G, Khoo L, et al. doi : 10.1182/blood.2024027008. 2024027008. PMID 40053895. 401 (10386): 14271437.

Clinical Trials

Clinical Trials FDA FDA Approval Trials

Suzetrigine

New Drug Approvals

APRIL 2, 2025

1] [2] Clinical data Pronunciation /suztrdin/ soo-ZE-tri-jeen Trade names Journavx Other names VX-548 AHFS / Drugs.com Journavx License data US DailyMed : Suzetrigine Routes of administration By mouth Drug class Na v 1.8 August 2023). World Health Organization (2023). It exerts its action on dorsal root ganglion. [3]

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

Bristol Myers Squibb (BMS) licensed rights to iza-bren in 2023 and they and partner Sysimmune/Biokin have sponsored clinical studies across cancer indications without limiting these to settings of EGFR resistance or of NRG1 fusion.

Drug Development

Drug Development Drugs Clinical Trials Therapies

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

BioPharma Drive: Drug Pricing

JULY 16, 2025

Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025. For Sarepta, the layoffs reflect, in part, uncertainty around the future of Elevidys, its gene therapy for Duchenne muscular dystrophy.

Therapies

Therapies FDA Clinical Trials Licensing

FDA to ask Sarepta to stop shipping Duchenne gene therapy

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Elevidys was approved by the FDA in 2023 as the first gene therapy for Duchenne, a genetic disorder that results in progressive muscle weakening and typically early death.

Therapies

Therapies FDA Clinical Trials Licensing

Crinecerfont

New Drug Approvals

APRIL 18, 2025

18 October 2023). 2023 Oct 30;70(10):945-957. Epub 2023 Jun 29. . “Crinecerfont Lowers Elevated Hormone Markers in Adults With 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia” The Journal of Clinical Endocrinology & Metabolism. 107 (3): 801812. doi : 10.1210/clinem/dgab749. PMC 8851935. PMID 34653252.

FDA

FDA FDA Approval Drugs Trials

PIMICOTINIB

New Drug Approvals

JULY 7, 2025

History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 6] The U.S.

Small Molecule

Small Molecule Clinical Trials Licensing Licensing

Landiolol

New Drug Approvals

APRIL 19, 2025

Landiolol was approved for medical use in Japan in 2002, [10] [11] in Canada in November 2023, [1] and in the United States in November 2024. [12] 20 November 2023. This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] 2 July 2024. PMID 37185629.

FDA

FDA Clinical Trials Treatment Trials

Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

MARCH 24, 2025

Houck In August 2023, the U.S. Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state licensed practitioner. By Larry K.

Regulations

Regulations Testimonials Licensing Licensing

Lexeo to help launch spinout around RNA drugs for the heart

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. The company has faced some bumps along the way, including a smaller-than-projected IPO in 2023.

RNA

RNA Drugs Therapies Licensing

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

BioPharma Drive: Drug Pricing

JULY 9, 2025

Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. In 2023, the New Jersey-based company scooped up Prometheus Biosciences for $10.8 logo displayed on the exterior of their research facility in San Francisco, Calif., Alamy Merck & Co. In 2021, Merck agreed to pay $11.5

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. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury. Prior to those posts, Meury was chief commercial officer at Allergan.

Therapies

Therapies Licensing Licensing Vaccine

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023 edition at special discounted prices. Special preorder and launch pricing discounts will be valid through April 3, 2023.

Pharmacy

Pharmacy Specialty Pharmacies Licensing Licensing

New Technology Could Predict Your Teen Driver's Risk for a Crash

Drugs.com

OCTOBER 17, 2023

16, 2023 -- When your teen gets a driver’s license, you'll likely have mixed emotions. MONDAY, Oct. While you’re off the hook for carpools, it’s scary to think about your baby behind the wheel. Now, a new video game technology.

Licensing

Licensing Licensing

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

thought leadership

JANUARY 26, 2024

The FDA's  Biologics License Application (BLA)  approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the approvals, their numbers, and the trends they reveal unveils a dynamic landscape in biologics.

FDA

FDA Licensing Licensing Therapies

Nine Key Takeaways from Dreamforce 2023

Perficient: Drug Development

SEPTEMBER 19, 2023

Users can interact with the assistant in natural language, and it can offer additional actions beyond user queries, such as automatically completing tasks, providing recommendations, and answering questions. Free Data Cloud and Tableau Licenses Perhaps the biggest announcement to come out of Dreamforce, Salesforce is providing free Data Cloud (..)

Licensing

Licensing Licensing Production Marketing

Analysis Life Sciences: What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Fill out the form to read the full article.

FDA

FDA Science Licensing Licensing

Inconsistent uptake of US Federal Child and Adult Care Food Program means children lack access to nutritious food

SCIENMAG: Medicine & Health

NOVEMBER 6, 2023

Ann Arbor, November 6, 2023 – Current participation rates in the US federal Child and Adult Care Food Program (CACFP) by licensed child care centers point to program underutilization and unequal access, according to the first nationwide analysis of data on CACFP participation in the American Journal of Preventive Medicine, published by Elsevier.

Licensing

Licensing Licensing

Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 About Juyou Bio – Technology Co. Juyou Bio-Technology Co.,

Licensing

Licensing Licensing Production Engineering

NIH 2023 Data Management and Sharing Policy: What you Need to Know

Advarra

FEBRUARY 28, 2023

In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized Data Management and Sharing (DMS) policy , effective January 25, 2023. What is the 2023 NIH Data Management and Sharing Policy? The NIH data sharing principles are not new.

Research

Research Licensing Licensing Regulations

Sentiment & Themes Emerging From JPM 2024

LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Join the club.

Small Molecule

Small Molecule Trials Therapies Disease

Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023-24 edition at special discounted prices. pharmaceutical distribution industry.

Pharmaceuticals

Pharmaceuticals Pharmacy Biosimilars Licensing

Accelerate Cloud Migration with AWS OLA

Perficient: Drug Development

SEPTEMBER 3, 2024

In the wake of VMware’s recent license cost increase under Broadcom’s new pricing model, many enterprises are facing the pressing need to reevaluate their IT strategies. Licensing is a critical yet often overlooked factor in cloud migration decisions.

Licensing

Licensing Licensing

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). 21 December 2023. 22 December 2023. Ionis Pharmaceuticals.

Clinical Trials

Clinical Trials FDA Clinical Pharmacology FDA Approval

Real-World Data for Cardiovascular Disease Research

Fierce BioTech

JULY 12, 2023

With so many sources of data, both in-house and licensed, we know it can be hard to sort through it all and analyze what you need to answer your research questions. Real-World Data for Cardiovascular Disease Research These days, top-tier biopharma companies are using real-world data (RWD) to power their cardiovascular disease research.

Disease

Disease Research Licensing Licensing

7 “Make or Break” Factors for Emerging Biopharma Companies

Fierce BioTech

DECEMBER 13, 2023

7 “Make or Break” Factors for Emerging Biopharma Companies This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. cbroadwell Wed, 12/13/2023 - 13:04 Blue Matter Consulting Resource Type eBook BlueMatterConsulting_250x190.png

Licensing

Licensing Licensing Science Production

Palopegteriparatide

New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 4] Palopegteriparatide was approved for medical use in the European Union in November 2023. [2] 4] Palopegteriparatide was approved for medical use in the European Union in November 2023. [2]

FDA

FDA International Trials FDA Approval

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. But could it be a busy month for rulemaking?

FDA

FDA Science Regulations Production

Iptacopan

New Drug Approvals

DECEMBER 16, 2023

2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. 1] Iptacopan was approved by the US Food and Drug Administration (FDA) for the treatment of adults with paroxysmal nocturnal hemoglobinuria in December 2023. [2] 5 December 2023. . 5 December 2023.

FDA

FDA Small Molecule FDA Approval Treatment

Motixafortide

New Drug Approvals

SEPTEMBER 20, 2023

1] Motixafortide was approved for medical use in the United States in September 2023. [2] 1 Motixafortide was approved by the FDA in September 2023, in combination with filgrastim, for use in stem cell mobilization prior to autologous stem cell transplant in patients with multiple myeloma. 4 September 2023. 4 September 2023.

FDA Approval

FDA Approval FDA International Clinical Trials

Optimizely Configured Commerce Spire CMS Enhancement

Perficient: Drug Development

JANUARY 18, 2024

The following list contains the allowed license types of 3rd party NPM packages: MIT Apache-2.0 The following list contains the allowed license types of 3rd party NPM packages: MIT Apache-2.0 Now, Configured Commerce lets partners and clients to install and use third-party NPM packages as needed within Spire CMS.

Packaging

Packaging Licensing Licensing Production

Capivasertib

New Drug Approvals

DECEMBER 24, 2023

3] In November 2023, capivasertib was approved in the United States for people with hormone receptor-positive, human epidermal growth factor receptor 2 -negative breast cancer when used in combination with fulvestrant. [3] 16 November 2023. . 16 November 2023. Archived from the original on 20 November 2023. June 2023).

FDA Approval

FDA Approval FDA Production Therapies

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] Retrieved 18 October 2023. Bayer M (2 May 2023). April 2023).

FDA

FDA FDA Approval International Pharmacokinetics

Tofersen

Protein degraders: chasing undruggable targets

Trending Sources

Vamorolone

Elacestrant

Gepirone

Inavolisib

Zilucoplan

Orforglipron’

Pirtobrutinib

Leniolisib

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

Fitusiran

Suzetrigine

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

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

FDA to ask Sarepta to stop shipping Duchenne gene therapy

Crinecerfont

PIMICOTINIB

Landiolol

Schedule III Marijuana Would Still Be Regulated Marijuana

Lexeo to help launch spinout around RNA drugs for the heart

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

Incyte replaces CEO Hoppenot with dealmaker Meury

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

New Technology Could Predict Your Teen Driver's Risk for a Crash

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

Nine Key Takeaways from Dreamforce 2023

Analysis Life Sciences: What We Expect the FDA to do in June 2023

Inconsistent uptake of US Federal Child and Adult Care Food Program means children lack access to nutritious food

Crescita Announces Licensing Agreement for Pliaglis; in China

NIH 2023 Data Management and Sharing Policy: What you Need to Know

Sentiment & Themes Emerging From JPM 2024

Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Accelerate Cloud Migration with AWS OLA

Eplontersen

Real-World Data for Cardiovascular Disease Research

7 “Make or Break” Factors for Emerging Biopharma Companies

Palopegteriparatide

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Iptacopan

Motixafortide

Optimizely Configured Commerce Spire CMS Enhancement

Capivasertib

Etrasimod

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