FDA Approval, Packaging and Vaccine - Drug Discovery Digest

Q&A: One scientist’s bold vision to make on-demand treatments routine for life-threatening rare genetic diseases

Broad Institute

JUNE 24, 2025

s specific mutation, creating a mouse model of the disease, determining the optimal base editor, performing extensive safety analyses, working with Danaher to manufacture the therapeutic, conducting toxicity studies, and securing FDA approval for the trial. This unprecedented feat required diagnosing K.J.’s

Treatment

Treatment Disease DNA 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

Such models will, in turn, make it much easier to invent the sorts of platform tools that Amodei asserts “drive >50% of progress in biology,” such as CRISPR and mRNA vaccines, because the creation of these tools ultimately derive from a deeper understanding of how cells work.

DNA

DNA RNA Molecular Biology Laboratories

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

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

FDA Approval

FDA Approval Vaccine FDA Treatment

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. This results in more fully packaged and intact capsids, which are essential for reducing manufacturing costs per dose and enhancing the effectiveness of gene therapies.

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.

FDA Approval

FDA Approval Treatment RNA FDA

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. The vote itself is not slated to take place until after 3 p.m.

Vaccine

Vaccine Immune Response FDA Virus

Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZeneca’s COVID-19 Vaccine

The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults.

Vaccine

Vaccine Virus Clinical Trials Government

ChEMBL 34 is out!

The ChEMBL-og

APRIL 16, 2024

71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA. University of Dundee: T. 1813 bioactivities in total have been added. The definition of a chemical probe has been amended to update the field MOLECULE_DICTIONARY.CHEMICAL_PROBE.

Clinical Trials

Clinical Trials FDA Cell Based Assays Compound Screening

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Promising new malaria vaccine for kids approved in Ghana. Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do?

Vaccine

Vaccine DNA Virus Engineering

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Promising new malaria vaccine for kids approved in Ghana. Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do?

Vaccine

Vaccine DNA Virus Engineering

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

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccine

Vaccine FDA Clinical Trials Disease

Dentitox Pro – Text Presentation

The Pharma Data

MAY 15, 2021

The product is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. After you fill in your information and confirm your package will be shipped for free right to your doorstep as soon as possible. Dentitox Pro is non-GMO and safe.

Production

Production Packaging Nurses FDA Approval

DermaPrime

The Pharma Data

MAY 16, 2021

Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. If you order the 3 bottles or 6 bottles package (which we highly recommend as we estimate that we will run out of stocks soon as this has happened before) you’ll also take advantage of a huge discount.

Production

Production Nurses FDA Approval Packaging

Met Slim Pro

The Pharma Data

MAY 13, 2021

After all my requirements were 100% met, we finally had the final product: Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards.Met Slim Pro capsules are non-GMO and safe. Safe: processed under strict sterile standards with regularly disinfected equipment.

Production

Production Packaging Doctors FDA Approval

AlphaZym Plus

The Pharma Data

MAY 13, 2021

Every capsule is manufactured in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. If you order the 3 bottles or 6 bottles package (which we highly recommend as we estimate that we will run out of stocks soon as this has happened before) you’ll also take advantage of a huge discount.

Production

Production Doctors FDA Approval Packaging

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

The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Data on these novel approvals is published throughout the year by both CDER and CBER.

FDA

FDA Biosimilars Science Drugs

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

The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. 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.

Government

Government Hospitals Virus Clinical Trials

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

We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Casirivimab and imdevimab injection is not FDA approved for any use. Source: Regeneron.

Therapies

Therapies FDA Clinical Trials Hospitals

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease.

Drugs

Drugs Regulations International Production

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

Packaging

Packaging Small Molecule Production FDA Approval

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).

FDA

FDA FDA Approval Production Regulations

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. Andreano E.

DNA

DNA RNA Engineering Licensing

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

Agency IQ

JANUARY 19, 2024

The FDA CRL cited inspection findings that arose from a “multi-sponsor inspection of a third-party, contract manufacturing organization” which involved the monoclonal antibody drug substance for lebrikizumab. The clinical package, safety and label were not affected. However, BeiGene announced that it is seeking approval in the U.S.

Biosimilars

Biosimilars FDA Production Treatment

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Casirivimab and imdevimab injection is not FDA approved for any use.

FDA

FDA Clinical Trials Hospitals Production

Beyond Steel Tanks

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Vaccine

Vaccine Engineering Production RNA

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

JANUARY 9, 2021

• Anthrax Vaccines. Anthrax vaccine revenues are expected to be at a more normalized annual level and continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, adjuvanted) under the Company’s existing contract with the Biomedical Advanced Research and Development Authority (BARDA).

Government

Government Vaccine Production Licensing

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval

FDA Approval FDA Production Treatment

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

Which Arthritis Painkiller Works the Fastest?

The Pharma Data

MAY 13, 2021

Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). You should apply the MindBody Matrix Pain Relief cream 3-4 times per day for the first week after you receive your package. It is FDA-registered and manufactured in the USA at an FDA approved plant.

Pharmacy

Pharmacy Doctors Production Therapies

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. are scheduled to receive a vaccine. If you are not sure about the type of immunization or vaccine, ask your healthcare provider.

Treatment

Treatment Therapies FDA FDA Approval

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. RINVOQ ® (upadacitinib) [Package Insert].

Treatment

Treatment Disease FDA Therapies

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. are scheduled to receive a vaccine. If you are not sure about the type of immunization or vaccine, ask your healthcare provider.

Treatment

Treatment FDA Therapies FDA Approval

Merck KGaA raises full-year forecast; Perlmutter’s new gig tackles ‘undruggable targets’

The Pharma Data

MAY 5, 2021

. White House will make unordered vaccine supply available to other states ( WaPo ). White House set to send vaccines abroad ( Politico ). cases, vaccinations continue to drop as White House sets new inoculation goal ( CNBC ). BD Taps Contract Packager for COVID-19 Test Kits ( MD+DI ).

Vaccine

Vaccine FDA FDA Approval International

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements.

Vaccine

Vaccine FDA FDA Approval Production

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

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. Preemption.

Testimonials

Testimonials Drugs FDA Vaccine

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. billion worth of doses — equivalent to 200,000 vaccines.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Q&A: One scientist’s bold vision to make on-demand treatments routine for life-threatening rare genetic diseases

A Visual Guide to Gene Delivery

Trending Sources

Levers for Biological Progress

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

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

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

Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZeneca’s COVID-19 Vaccine

ChEMBL 34 is out!

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon Digest: Ghana Approves A Better Malaria Vaccine

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

Dentitox Pro – Text Presentation

DermaPrime

Met Slim Pro

AlphaZym Plus

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

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

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

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

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

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

Codon Digest: Injected Gene Editors

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

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Beyond Steel Tanks

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

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

Which Arthritis Painkiller Works the Fastest?

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

Merck KGaA raises full-year forecast; Perlmutter’s new gig tackles ‘undruggable targets’

A Texas Mess

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

Making a “Miracle” HIV Medicine

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