Licensing, Pharmacokinetics and Vaccine

Navigating Regulatory Hurdles in Drug Development

DrugBank

JUNE 18, 2025

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review.

Drug Development

Drug Development Clinical Trials Compliance Drugs

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read How well do different antibodies, created by people who got two or three doses of the COVID-19 mRNA vaccine, fight off new viral variants, such as BA.4 Andreano E. Nature Communications. Ricciardi M.J. Science Translational Medicine.

DNA

DNA RNA Engineering Licensing

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

FDA

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). Pfizer Inc. NYSE: PFE) today announced that the U.S.

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

APRIL 14, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Government

Government Hospitals Long-Term Care Facilities Treatment

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

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients. Use in Specific Populations.

FDA Approval

FDA Approval Treatment RNA FDA

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. BioNTech – Germany’s BioNTech and partner Pfizer secured authorization from the European Medicines Agency for its COVID-19 vaccine.

Licensing

Licensing Licensing Vaccine Drugs

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.

Vaccine

Vaccine Therapies Trials Clinical Trials

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Treatment

Treatment Hospitals Long-Term Care Facilities Virus

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly.

Therapies

Therapies Hospitals Treatment FDA Approval

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

JULY 23, 2021

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.

Treatment

Treatment Virus Clinical Trials Pharmaceuticals

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together. patients who recovered from COVID-19. .

Hospitals

Hospitals Treatment Trials Long-Term Care Facilities

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Hospitals

Hospitals Trials Long-Term Care Facilities Treatment

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

Trials

Trials Virus Vaccine Pharmacokinetics

Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

The Pharma Data

MARCH 26, 2021

Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines. GSK Commitment to Tackling COVID-19.

Treatment

Treatment FDA Vaccine Trials

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. A lifelong HIV vaccine would be ideal, but developing one has proved difficult. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Drug Discovery Digest

Navigating Regulatory Hurdles in Drug Development

Codon Digest: Injected Gene Editors

Trending Sources

FDA Action Alert: MacroGenics and Amgen

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

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

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

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

Making a “Miracle” HIV Medicine

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