FDA Approval, Packaging and Production

WuXi Biologics Unveils WuXiHigh™ 2.0 for Ultra-Concentrated Biologics

The Pharma Data

JULY 2, 2025

Currently, more than 20% of FDA-approved monoclonal antibodies (mAbs) fall into this category, reflecting a growing industry trend. High viscosity , aggregation risks , and stability issues often complicate both upstream and downstream processes, including manufacturing, packaging, and storage. WuXiHigh™ 2.0: WuXiHigh™ 2.0:

FDA Approval

FDA Approval Packaging Production FDA

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

A Visual Guide to Gene Delivery

Codon

JULY 28, 2025

Casgevy , the first FDA-approved CRISPR-based therapy, is also an ex vivo gene therapy; it aims to cure sickle cell disease by editing a patient’s blood-producing stem cells so they generate functional fetal hemoglobin, then returning these corrected cells to the bloodstream.

Immune Response

Immune Response DNA Therapies Virus

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

They engineered genetically-encoded RNA exporters, based on viruses, that package and secrete RNA molecules in protective nanoparticles, allowing non-destructive monitoring of those RNA molecules in real-time. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease.

DNA

DNA RNA Molecular Biology Laboratories

Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. Explain the FDA Approval Process Many patients are unaware of the rigorous approval process generic drugs must undergo. What Are Generic Drugs?

Drugs

Drugs FDA Doctors Trials

Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). In 2023, the FDA approved a 2.7

FDA Approval

FDA Approval Pharmacokinetics Packaging FDA

New gene delivery vehicle shows promise for human brain gene therapy

Broad Institute

MAY 16, 2024

But FDA-approved forms of the most commonly used vehicle for packaging and delivering these therapies to target cells, adeno-associated viruses (AAVs), aren’t able to efficiently cross the blood-brain barrier at high levels and deliver therapeutic cargo.

Therapies

Therapies FDA Approval Engineering Disease

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

Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

The Pharma Data

OCTOBER 30, 2020

To increase demand for products during the novel coronavirus pandemic, the US Food and Drug Administration (FDA) has already approved at-home testing and investigated the effectiveness of malaria pills and other antiviral drugs to treat Covid-19 9. FDA approves first treatment for Covid-19. Source link.

FDA Approval

FDA Approval Vaccine FDA Treatment

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog: Biosimilars

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

Government

Government Small Molecule FDA Approval Regulations

Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products

Agency IQ

JULY 26, 2024

FDA finalizes guidance on electronic submissions for OTC products FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. Read AgencyIQ’s explainer on the CARES Act here.

FDA

FDA Production Regulations Packaging

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The overall development strategy for GT123 was to include a complete CMC package.

Drugs

Drugs Clinical Pharmacology Packaging Small Molecule

Release of ChEMBL 33

The ChEMBL-og

JUNE 13, 2023

This fresh release comes with a few new data soures and also some new features: we added bioactivity data for understudied SLC targets from the RESOLUTE project and included a flag for Natural Products and for Chemical Probes. An an annotation for the ACTION_TYPE of a measurement was included for approx. 270 K bioactivities.

FDA Approval

FDA Approval Pharmacokinetics International Production

New insights into the role of viral capsids in gene therapy safety

Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

Therapies

Therapies Virus DNA Compliance

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? A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting?

Packaging

Packaging FDA Trials Regulations

FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

FDA

FDA Production FDA Approval Regulations

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

SEPTEMBER 20, 2023

NASDAQ:VRPX) (“Virpax”), a company specializing in developing non-addictive products for pain management, PTSD, central nervous system (CNS) disorders, and viral barrier indications, to conduct nonclinical studies in support of their development of quaternary ammonium palmitoyl glycol chitosan (GCPQ, under the trade name of AnQlar™). “We

Virus

Virus Clinical Pharmacology Drugs FDA Approval

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. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Sigilon Therapeutics .

RNA

RNA Therapies Disease Protein Expression

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

The Premier Consulting Blog

APRIL 15, 2024

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

FDA

FDA Pharmacokinetics Laboratories FDA Approval

DNA Barcodes Could Streamline Search for New Drugs to Combat Cancer

NIH Director's Blog: Drug Discovery

MARCH 8, 2016

Instead of the black, printed stripes of the Universal Product Codes (UPCs) that we see on everything from package deliveries to clothing tags, they used short, unique snippets of DNA to label cells. A little more than a decade ago, researchers began adapting a familiar commercial concept to genomics: the barcode.

DNA

DNA Drugs Small Molecule FDA Approval

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

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

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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

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

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

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

BioPharma Drive: Drug Pricing

JULY 21, 2025

The past few years have seen multiple high-profile FDA approvals for AAV-based therapeutics, with a series of regulatory decisions in the pipeline for 2025. Scaling up from bench to production scale requires significant process development and optimization to achieve consistent quality and yield from batch-to-batch.

Therapies

Therapies Clinical Trials FDA Production

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV. . US Approval January 2021. John’s wort (Hypericum perforatum).

FDA Approval

FDA Approval Treatment RNA FDA

Dentitox Pro – Text Presentation

The Pharma Data

MAY 15, 2021

Product Name: Dentitox Pro – Text Presentation. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Dentitox Pro is non-GMO and safe.

Production

Production Packaging Nurses FDA Approval

ChEMBL 34 is out!

The ChEMBL-og

APRIL 16, 2024

A significant effort has been made to correctly map the drug form of the EMA data by manually inspecting different EMA sources of information, such as the Product Information (Annex I: Summary of Product Characteristics and Annex III: Labelling and Package Leaflet) and/or Assessment Report, where available.

Clinical Trials

Clinical Trials FDA Cell Based Assays Compound Screening

DermaPrime

The Pharma Data

MAY 16, 2021

Product Name: DermaPrime. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. DermaPrime Plus capsules are non-GMO and safe.

Production

Production Nurses FDA Approval Packaging

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” MoCRA amends the FD&C Act by expanding the FDA’s authority over cosmetics, adding new definitions and requirements for manufacturers and importers of cosmetics.

Production

Production FDA Compliance Regulations

Met Slim Pro

The Pharma Data

MAY 13, 2021

Product Name: Met Slim Pro. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. ClickBank is the retailer of products on this site.

Production

Production Packaging Doctors FDA Approval

AlphaZym Plus

The Pharma Data

MAY 13, 2021

Product Name: AlphaZym Plus. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. AlphaZym Plus capsules are non-GMO and safe.

Production

Production Doctors FDA Approval Packaging

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

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

Science

Science FDA Production Packaging

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

The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Government

Government Hospitals Virus Clinical Trials

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

AUGUST 6, 2020

NEW YORK–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance. SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS. FIRST HALF PRODUCT REVENUE HIGHLIGHTS.

Production

Production International Licensing Licensing

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

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. 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).

FDA

FDA Biosimilars Science Drugs

Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. A critical vote is set to take place today amongst those on a U.S.

Vaccine

Vaccine Immune Response FDA Virus

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

Agency IQ

JUNE 16, 2023

FDA’s is generally consistent from edition to edition , will each edition consisting primarily of holdovers from previous editions. The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation.

Regulations

Regulations FDA Science Production

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

The Pharma Data

FEBRUARY 25, 2022

The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA).

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

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

FDA Science Regulations Production

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of our antibody cocktail. Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Schleifer, M.D.,

Therapies

Therapies FDA Clinical Trials Hospitals

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). The Company commenced delivery of REGN-COV2 drug product under the agreement during the third quarter of 2020. Business Highlights.

Production

Production Trials FDA FDA Approval

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. driven by the write-off of $1.5

Biosimilars

Biosimilars Production Treatment FDA

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

Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

Biosimilars

Biosimilars FDA Production Treatment

WuXi Biologics Unveils WuXiHigh™ 2.0 for Ultra-Concentrated Biologics

Vamorolone

Trending Sources

A Visual Guide to Gene Delivery

Levers for Biological Progress

Educating Patients about Generic Drugs: Strategies for Success

Limited Evidence for Nalfmefene

New gene delivery vehicle shows promise for human brain gene therapy

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

Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

Release of ChEMBL 33

New insights into the role of viral capsids in gene therapy safety

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

FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Biopharma Money on the Move: December 2 – 8

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

DNA Barcodes Could Streamline Search for New Drugs to Combat Cancer

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

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

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

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Dentitox Pro – Text Presentation

ChEMBL 34 is out!

DermaPrime

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Met Slim Pro

AlphaZym Plus

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

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

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

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

Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

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

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

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Amgen Reports Second Quarter 2021 Financial Results

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

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