2022, Licensing and Packaging - Drug Discovery Digest

Vamorolone

New Drug Approvals

JULY 25, 2025

79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. “Drug Approval Package: Agamree” U.S. Shale, U.J. Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. Reeves, E.P. Hoffman, K. Nagaraju, J.M. Damsker, J.M.

FDA

FDA FDA Approval Treatment Clinical Trials

Unboxing AG-Grid: A Quick Start Guide for Angular Developers

Perficient: Drug Development

JULY 23, 2025

Grid is a popular package that simplifies grid implementation while offering extended functionalities such as sorting, filtering, editing, pagination, custom themes, and much more. In addition, you must set your license key to activate these features properly. file, import AgGridModule from the @ag-grid-community/angular package.

Packaging

Packaging Licensing Licensing

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

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

FDA Law Blog: Biosimilars

JANUARY 11, 2024

mL was approved on March 18, 2022. mL and 20 mg/0.4 mL for subcutaneous injection was approved on October 15, 2021; the supplement for 10 mg/0.2 Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively.

Biosimilars

Biosimilars FDA Production Marketing

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.

Drugs

Drugs Pharmacokinetics FDA Production

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

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

FDA

FDA Drugs Production Licensing

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

The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022. patients during the review of the NexoBrid Biologics License Application (BLA).

Clinical Trials

Clinical Trials Licensing Licensing FDA

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

Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

FDA

FDA Science Regulations Biosimilars

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

Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine?

FDA

FDA Science Regulations Production

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

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. See AgencyIQ’s analysis of these changes here. What’s next?

FDA

FDA Biosimilars Science Drugs

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

Agency IQ

JANUARY 26, 2024

In its 2022 annual report to Congress on drug shortages, the FDA notes that one method of mitigating a shortage – once the agency is aware of the shortage at all – is “reviewing requests for extensions of expiration dating.” What happens when a drug is not stored in its original container or within a licensed facility?

Science

Science FDA Production Packaging

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

Biosimilars

Biosimilars FDA Production Treatment

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. The latest update, announced this week, is known as the Spring 2023 Unified Agenda. Of those 51, just four are new to the Agenda, having never before been made public.

Regulations

Regulations FDA Science Production

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

Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

Clinical Trials

Clinical Trials Trials Science FDA

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. from 2021 to 2022, up to $625 million. Nature Biotechnology. Gene Therapy. Will Bedingfield.

DNA

DNA RNA Engineering Licensing

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Top-line results from the event-driven confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in H1 2022. Data from the Phase 2 monotherapy study in patients with KRAS G12C-mutated solid tumors other than NSCLC and CRC are expected in H1 2022. Tezepelumab.

Biosimilars

Biosimilars Production Treatment FDA

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

FDA

FDA FDA Approval Production Regulations

Codon Digest: Seeing Colors After Gene Therapy

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Two of these proteins are about 30% the size of Cas9 , and thus much easier to package into viruses for gene therapy. No longer.

Therapies

Therapies RNA DNA Engineering

Codon Digest: Seeing Colors After Gene Therapy

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Two of these proteins are about 30% the size of Cas9 , and thus much easier to package into viruses for gene therapy. No longer.

Therapies

Therapies RNA DNA Engineering

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

FDA

FDA Science Biosimilars Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Clinical Trials

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

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

The Fall 2022 edition was released in January 2023. The updated supplemental proposal from 2022 would add the DINP category to the list based on hazard concerns and an updated hazard assessment for the substances. EPA issued a proposal on April 1, 2022 (87 FR 19042). Decennial Census.

Regulations

Regulations Compliance Production Science

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

In March 2022, the FDA held a meeting with representatives from several states, the National Academy for State Health Policy, and HHS to help assist states with their respective SIP process. The May 2022 guidance didn’t make clear if this PIR must be submitted each and every time a shipment is expected.

FDA Approval

FDA Approval FDA Science Drugs

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

Therapies

Therapies Science FDA Production

Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would Require

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” In other words, a prescription written by a DEA-registered, state-licensed practitioner.

Regulations

Regulations Production Packaging Licensing

Deliberate Dysentery

Codon

JANUARY 21, 2024

A 2022 survey identified 284 human challenge trials that have been conducted since 1980. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. Sign up to receive articles from Asimov Press. Why are challenge trials becoming more popular?

Vaccine

Vaccine Trials Disease Treatment

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Science Production

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. Somatics, LLC , 2022 WL 989469 (9th Cir. April 1, 2022) (the companion case to this ). W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . .

Testimonials

Testimonials Doctors Production Laboratories

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

2022) (same result as to other COVID-19 vaccine). April 13, 2022) (available here ). 2022) (quoting this publication). “The 2022) (“Willful-misconduct claims may proceed only in the federal district court for the District of Columbia.”); Maglioli v. 247d-6d(b)(8). 25, 2023); Goins v. 3d 745, 753 (E.D. Franklin ). “[T]here

Vaccine

Vaccine FDA FDA Approval Production

PREP Act Immunity: Baghikian v. Providence Health & Servs.

Drug & Device Law

FEBRUARY 29, 2024

The other defendant manufactures a rheumatoid arthritis medicine, tocilizumab, but contracted with the federal government to conduct clinical trials regarding its use in treating COVID-19 leading to an Emergency Use Authorization in June 2021 and full approval for COVID-19 use in December 2022. 247d-6d(a)(2)(B). In Saldana v.

Government

Government Production FDA Clinical Trials

Two New Appellate COVID-Related Developments

Drug & Device Law

MAY 15, 2023

include[s] licensed health care professionals or other individuals who are authorized to prescribe, administer, or dispense a covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. 2022), the intermediate appellate decision that we discussed here. 2022); Pisano v.

Vaccine

Vaccine Pharmacy Hospitals Licensing

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

171, 212 (Fall 2022). Uber Technologies , 2022 Cal. March 22, 2022) (same); Shaff v. 2022), review denied (Cal. Uber , 2022 WL 2031868, at *2 (Cal. July 13, 2022) (similar language). 2022 WL 551701 (N.D. 3d , 2022 WL 16752071 (C.D. 2022 WL 16747282, at *9 (S.D. Meta Platforms, Inc.

Production

Production Trials International Government

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. Sanofi Pasteur Inc.

Testimonials

Testimonials Drugs FDA Vaccine

D. Arizona Precludes Pelvic Mesh Punitive Damages

Drug & Device Law

MARCH 16, 2022

2022 WL 604889 (D. Arizona March 1, 2022) – focuses on the regulatory status of the device. The pelvic mesh case of the week – McBroom v. Ethicon, Inc. We always knew it was an important issue, and McBroom provides yet another reason why that is so.

FDA

FDA Production Trials Government

Mixson Somewhat Mixed, But We’ll Take It

Drug & Device Law

NOVEMBER 1, 2022

16, 2022) (“ Mixson I ”), and Mixson v. 2022 WL 7581737 (N.D. 23, 2022) (“ Mixson II ”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results. 2022 WL 4364153, at *2. 2022 WL 4364153, at *2. Mixson I , 2022 WL 4364153, at *5. Bard, Inc. ,

Testimonials

Testimonials FDA FDA Approval Packaging

The Medical Device Labeling Exception for “Commonly Known” Hazards

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 2022 WL 970681 (N.D.

Testimonials

Testimonials Licensing Licensing FDA

Rezafungin

New Drug Approvals

MAY 14, 2025

Retrieved 27 December 2023. ^ “Drug Approval Package: Rezzayo” U.S. Epub 2022 Nov 25. 2022 Jan 18;66(1):e0139021. Rezafungin acetate shows potent antifungal activity against Candida spp. Aspergillus spp. , and Pneumocystis spp. SYN Hughes, D., Synthesis of echinocandin antifungal agent. 11,524,980 B2). PMC 11123963.

Pharmacokinetics

Pharmacokinetics FDA FDA Approval Treatment

Experts explore the future of iPSC-based cell therapies

Drug Target Review

FEBRUARY 19, 2025

If the data package (including safety) is well thought out and developed from the beginning, regulations can be a support to frame the development journey. Cedrone joined Catalent in 2022, bringing with him 18 years of experience in biotech, including key roles at Lysogene SA and Cellectis SA.

Therapies

Therapies Molecular Biology Regulations Packaging

Flurpiridaz F 18

New Drug Approvals

APRIL 27, 2025

This article incorporates text from this source, which is in the public domain. ^ “Drug Approval Package: Flyrcado Injection” U.S. 2022 Aug;24(8):987-994. Epub 2022 May 26. 2] 3D model ( JSmol ) Interactive image show SMILES show InChI Epub 2022 May 26. Food and Drug Administration (FDA). 27 September 2024.

FDA

FDA Clinical Trials FDA Approval Disease

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

Because of PEPFAR’s effectiveness, the United Nations (UN) set an ambitious goal in 2022 to end HIV transmission and eliminate AIDS-related deaths by 2030. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Half of the participants received lenacapavir, and the other half an injectable placebo.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Vamorolone

Unboxing AG-Grid: A Quick Start Guide for Angular Developers

Trending Sources

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

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

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

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

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

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

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

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

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

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

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

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

Codon Digest: Injected Gene Editors

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

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

Amgen Reports Second Quarter 2021 Financial Results

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Codon Digest: Seeing Colors After Gene Therapy

Codon Digest: Seeing Colors After Gene Therapy

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would Require

Deliberate Dysentery

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Unimpressed Learned Intermediaries Defeat Warning Causation

A Texas Mess

PREP Act Immunity: Baghikian v. Providence Health & Servs.

Two New Appellate COVID-Related Developments

How the Fifty States View Electronic Data as a “Product”

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

D. Arizona Precludes Pelvic Mesh Punitive Damages

Mixson Somewhat Mixed, But We’ll Take It

The Medical Device Labeling Exception for “Commonly Known” Hazards

Rezafungin

Experts explore the future of iPSC-based cell therapies

Flurpiridaz F 18

Making a “Miracle” HIV Medicine

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