Clinical Development, Licensing and Packaging

Clinical Development

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Packaging

Royalty Pharma and Revolution Medicines Sign Funding Deals Worth Up to $2 Billion

The Pharma Data

JUNE 24, 2025

Royalty Pharma and Revolution Medicines Forge $2 Billion Strategic Funding Pact to Accelerate Global Development of RAS Cancer Therapies Royalty Pharma plc, a prominent funder of innovation in the biopharmaceutical industry, announced a transformative agreement with Revolution Medicines, Inc., securing a funding package of up to $2 billion.

Clinical Development

Clinical Development Packaging Therapies Treatment

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.

RNA

RNA Drugs Therapies Licensing

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Trending Sources

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

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Most Popular A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups Gene therapy faces fresh uncertainty as two more top FDA officials depart FDA to speed reviews for drugs supporting ‘national interests’ A startup banks $66M to pursue ‘inclusive precision medicine’ Library resources Survey Report Pharma's AI and RWD (..)

Treatment

Treatment Drugs Therapies FDA

Advancing neurological therapies with Dr Bruce Leuchter

Drug Target Review

FEBRUARY 1, 2024

In other cases, well-established biomarker profiles enable patient enrichment strategies in early-stage clinical development. Provided that existing clinical data are compelling, the disease areas we can consider are unlimited. The organizing principle is the data package. Is the mechanistic rationale bona fide?

Therapies

Therapies Drug Development Disease Clinical Development

Gilead Exercises Options to Three Arcus Biosciences Clinical-Stage Programs and Adds Research Collaboration

The Pharma Data

NOVEMBER 18, 2021

Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.

Research

Research Clinical Development Small Molecule Packaging

Biopharma Money on the Move: December 2 – 8

The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.

RNA

RNA Therapies Disease Protein Expression

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

The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

Clinical Trials

Clinical Trials FDA Trials Production

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

Hospitals

Hospitals Virus Production Clinical Trials

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

Hospitals

Hospitals Production Clinical Trials Virus

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production

Production Trials Treatment Disease

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” said David Weinreich, M.D.,

Virus

Virus Trials Clinical Trials Production

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S.

Vaccine

Vaccine FDA Clinical Trials Disease

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). R&D: Up-front payments related to license and collaboration agreements. (85).

Production

Production Trials FDA FDA Approval

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

Hospitals

Hospitals Trials Clinical Trials Production

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.

Vaccine

Vaccine Virus Immune Response Trials

Cidara stock soars as antiviral drug succeeds in flu study

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. Influenza A virus" [Micrograph]. Retrieved from Flickr.

Drugs

Drugs Virus Therapies FDA

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

The Pharma Data

APRIL 27, 2021

For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions.

Vaccine

Vaccine Clinical Trials Licensing Licensing

Top drug official at FDA reportedly set to exit next month

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Ned Pagliarulo Lead Editor post share post print email license A sign for the Food and Drug Administration is seen outside of the agency's headquarters on July 20, 2020 in White Oak, Maryland.

FDA

FDA Drugs Therapies Licensing

Pharma’s wins and losses in the budget bill

BioPharma Drive: Drug Pricing

JUNE 12, 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 Pharma’s wins and losses in the budget bill Key pharma reforms are up in the air as Republicans battle over their mammoth legislation that includes significant healthcare spending cuts.

Small Molecule

Small Molecule Packaging Therapies Pharmacy

Drug Discovery Digest

Royalty Pharma and Revolution Medicines Sign Funding Deals Worth Up to $2 Billion

Lexeo to help launch spinout around RNA drugs for the heart

Trending Sources

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

Advancing neurological therapies with Dr Bruce Leuchter

Gilead Exercises Options to Three Arcus Biosciences Clinical-Stage Programs and Adds Research Collaboration

Biopharma Money on the Move: December 2 – 8

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

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

Cidara stock soars as antiviral drug succeeds in flu study

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

Top drug official at FDA reportedly set to exit next month

Pharma’s wins and losses in the budget bill

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