Licensing, Packaging and Production - Drug Discovery Digest

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

The Pharma Data

JUNE 24, 2025

securing a funding package of up to $2 billion. The synthetic royalty component involves payments to Royalty Pharma based on future net product sales of daraxonrasib, once approved and commercialized. The agreement is structured around two key financial components: a synthetic royalty agreement valued at up to $1.25

Clinical Development

Clinical Development Packaging Therapies Treatment

Vamorolone

New Drug Approvals

JULY 25, 2025

Finally, the acetate group is cleaved under basic conditions to give crude Vamorolone, which was recrystallized from iPrOH to obtain the pure product. The product was filtered off, washed with H 2 O (3 x 0.5 The product was filtered off, washed with H 2 O/MeCN 4:1 (2 x 0.5 and DMAP (16.1 g, 0.132 mmol, 0.10 HCI (950 mL, 0.95

FDA

FDA FDA Approval Treatment Clinical Trials

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

Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., The drug product is packaged and shipped as a solid powder.

Production

Production Efficacy & Potency Packaging Drugs

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

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

Therapies

Therapies FDA FDA Approval Treatment

Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

JULY 10, 2025

These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,

FDA

FDA Packaging Production Drugs

Optimizely Configured Commerce Spire CMS Enhancement

Perficient: Drug Development

JANUARY 18, 2024

Install third-party NPM Packages Installing third-party NPM Packages in Optimizely Configured Commerce Spire CMS is a new functionality included in Optimizely’s most recent release. Optimizely uses the Workspaces feature of NPM to link the blueprint packages and the Spire package.

Packaging

Packaging Licensing Licensing Production

Similarity Search and Some Cool Pandas Tricks

Practical Cheminformatics

SEPTEMBER 12, 2021

In this example, we'll be using the chemfp package by Andrew Dalke. Chemfp is a great package. If you're using it for production drug discovery, you should buy a license. Chemfp has both free and paid tiers. With the free tier, you can perform similarity searches on smaller datasets, like the one we're using here.

Packaging

Packaging Licensing Licensing Production

Nine Key Takeaways from Dreamforce 2023

Perficient: Drug Development

SEPTEMBER 19, 2023

This solidifies that Salesforce is leading the charge in AI, and Perficient is leaning into the partnership to bring innovative solutions to our clients. We learned about new Salesforce capabilities and technologies, heard new product announcements, and connected with peers and clients from across industries.

Licensing

Licensing Licensing Production Marketing

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Medicinal products authorized through the centralized procedure in the E.U. s official exit from the E.U. as of January 1, 2021.

Packaging

Packaging Licensing Licensing Regulations

Introduction to Sitecore Content Serialization

Perficient: Drug Development

AUGUST 2, 2023

As If we configure any one of the above tools in the Sitecore instance, then all developers need to use the same tool also, we need to configure the same tool in all the lower environments along with production. It also provides functionality to create a packager for later/future deployments.

Licensing

Licensing Licensing Packaging Production

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

BioPharma Drive: Drug Pricing

JUNE 23, 2025

The black and gray market risks Ben warned about the proliferation of counterfeit GLP-1 drugs in unregulated markets, posing significant dangers to patients who might unknowingly use ineffective or harmful products.

Treatment

Treatment Drugs Therapies FDA

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

The Premier Consulting Blog

NOVEMBER 16, 2022

One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product.

FDA

FDA Production Packaging Licensing

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. patients with renal, hepatic, or cardiovascular concerns).

Drugs

Drugs Pharmacokinetics FDA Production

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

Biosimilars

Biosimilars FDA Production Marketing

Noema Pharma raises CHF54 million in Series A financing round led by Sofinnova Partners and Polaris Partners

The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. Financing will advance the development of four clinical – stage product candidates. Highly experienced team leverages latest scientific discoveries in neuroscience.

Licensing

Licensing Licensing Packaging Production

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

The Pharma Data

JANUARY 13, 2021

These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), (..)

Clinical Trials

Clinical Trials FDA Trials Production

Q&A: The IND Journey Phase I – Navigating Success

Advarra

JULY 19, 2022

Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? At what point does the drug substance become a drug product? Could you please confirm?

Packaging

Packaging FDA Trials Regulations

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

NOVEMBER 5, 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 Trials Clinical 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

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Hospitals

Hospitals Virus Production Clinical Trials

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. The products are used to treat substance use disorder, opioid use disorders and chronic insomnia, respectively. Sigilon Therapeutics .

RNA

RNA Therapies Disease Protein Expression

The Regulatory Binder Checklist For Clinical Trial Sites

Advarra

JUNE 14, 2024

Protocol and amendments Purpose: To document revisions of trial-related documents during the trial Documents: Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments Informed consent documents Purpose: (..)

Clinical Trials

Clinical Trials Trials Compliance FDA

MediWound Completes Enrollment Stage of its NexoBrid Phase 3 Pediatric StudyTop-line Data is Expected in the Second Half of 2021

The Pharma Data

OCTOBER 27, 2020

patients during the review of the NexoBrid Biologics License Application (BLA). Vericel holds an exclusive license for North American commercial rights to NexoBrid. NexoBrid is currently an investigational product in the United States. On June 29, 2020, a biological license application (BLA) was submitted to the U.S.

Clinical Trials

Clinical Trials Licensing Licensing FDA

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

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Hospitals

Hospitals Production Clinical Trials Virus

Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Agency IQ

JANUARY 12, 2024

Industry wants its products reviewed quickly, efficiently and predictably. The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies that submit marketing applications to the agency for certain human drug and biological products. Without sufficient resources, the FDA is unable to do so.

FDA

FDA Drugs Production Licensing

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

FDA

FDA Science Regulations Production

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

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production

Production Trials Treatment Disease

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

Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. 1 Noyce RS, et al. 2018) PLoS One.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

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

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Virus

Virus Trials Clinical Trials Production

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Title Type Date Received by OIRA Legal Deadline Expedited Program for Serious Conditions –Accelerated Approval of Drugs and Biologics Draft Guidance July 9 Yes Conducting Clinical Trials With Decentralized Elements Draft Guidance July 25 Yes Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft (..)

FDA

FDA Science Regulations Biosimilars

From bench to batch: AAV manufacturing for the next-generation of gene therapies

BioPharma Drive: Drug Pricing

JULY 21, 2025

Scaling up from bench to production scale requires significant process development and optimization to achieve consistent quality and yield from batch-to-batch. Yet, many developers struggle to achieve consistent AAV production at the scale needed to reach their milestones.

Therapies

Therapies Clinical Trials FDA Production

(1) Every Morning 12,342+ People Use This "3-Letter Timing Hack" That 92% of Women Have No Idea Exists

The Pharma Data

MAY 15, 2021

Product Name: (1) Every Morning 12,342+ People Use This "3-Letter Timing Hack" That 92% of Women Have No Idea Exists. That’s why you’re making the right choice by ordering your discount package of LumaSlim on the next page…. Just order your discount package on the next page now… Still here? It isn’t for sale. .

Production

Production Packaging Medical Schools Science

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.”

Regulations

Regulations FDA Science Production

Scaling Phage Therapy

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs

Drugs FDA Licensing Licensing

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

Vamorolone

Trending Sources

Private equity firms back PCI Pharma in bet on drug production

Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

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

Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

Optimizely Configured Commerce Spire CMS Enhancement

Similarity Search and Some Cool Pandas Tricks

Nine Key Takeaways from Dreamforce 2023

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Introduction to Sitecore Content Serialization

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

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

Noema Pharma raises CHF54 million in Series A financing round led by Sofinnova Partners and Polaris Partners

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

Q&A: The IND Journey Phase I – Navigating Success

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

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

Biopharma Money on the Move: December 2 – 8

The Regulatory Binder Checklist For Clinical Trial Sites

MediWound Completes Enrollment Stage of its NexoBrid Phase 3 Pediatric StudyTop-line Data is Expected in the Second Half of 2021

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

Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

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

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

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

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

From bench to batch: AAV manufacturing for the next-generation of gene therapies

(1) Every Morning 12,342+ People Use This "3-Letter Timing Hack" That 92% of Women Have No Idea Exists

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Scaling Phage Therapy

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

DrugBank adds ASHP data to knowledgebase, improving user experience and data reliability

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

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

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

Novartis announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients with SMA

Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance

Animals Need Drugs Too, But Not Without CVM Approval

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