The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

FDA Approval 52

FDA Approval Treatment FDA Hospitals 52

EG Life Sciences

FEBRUARY 15, 2023

It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively.

Drug Development 52

Drug Development FDA Approval Drugs Virus 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif., Outside the U.S.,

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

DECEMBER 12, 2020

“More than 100,000 in long-term care have died from this virus in the U.S. and our nursing homes are now experiencing the worst outbreak of new cases since last spring, with more than 2,000 residents succumbing to this virus each week.” When you don’t have that capacity, that means people will die.”

Vaccine 52

Vaccine FDA Approval FDA Nurses 52

The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes.

FDA Approval 52

FDA Approval FDA Vaccine Virus 52

Vial

DECEMBER 11, 2023

Hepatitis C virus (HCV) infection is a global health problem with complications that place a significant economic burden on national health systems. Despite advances in clinical research, there remain significant challenges as only 20% of HCV cases are diagnosed, and of these, only 15% receive treatment.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

Advarra

JANUARY 11, 2024

There are currently 16 FDA-approved immunomodulators: Nine checkpoint inhibitors Four cytokines Two adjuvants One small molecule with immunomodulatory properties One of the challenges of using immunomodulatory proteins is their potential impact on cytokine release and liver function.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. So far clinical trials have had mostly discouraging results. They shared the Nobel Prize in Chemistry in 2020.

FDA Approval 52

FDA Approval DNA Therapies Clinical Trials 52

The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

JANUARY 6, 2021

In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021. ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors.

Virus 52

Virus FDA Approval Clinical Trials Trials 52

The Pharma Data

SEPTEMBER 11, 2020

60,000 people across Britain may have been suffering from prolonged symptoms of coronavirus months after contracting the virus. Pascal Soriot, Chief Executive of AstraZeneca, said that the company’s vaccine could still be available this year, despite the clinical trials being paused after a participant became ill.

FDA Approval 52

FDA Approval Vaccine Clinical Trials FDA 52

The Pharma Data

JANUARY 29, 2021

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. Source: AstraZeneca .

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. Source: AstraZeneca.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

OCTOBER 28, 2020

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Based on this finding, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2. There was a 1.08

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. and globally.”.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

Cutting through the usual red tape and working with an intense sense of purpose, the partnership took a mere matter of weeks to set up its first four clinical trials. Therapeutics Clinical Working Group : Prioritizes therapeutic agents for testing within an adaptive master protocol strategy for clinical research.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

The Pharma Data

NOVEMBER 17, 2021

The precise mechanism of the drug against SARS-CoV-2 is not yet known, but researchers have hypothesized that it may prevent the virus from taking hold by interfering with an enzyme it requires to replicate. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot.

Virus 52

Virus Drugs Clinical Trials Medical Schools 52

The Pharma Data

JANUARY 6, 2021

The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world.

Vaccine 52

Vaccine Virus Clinical Trials Government 52

The Pharma Data

AUGUST 16, 2021

Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus. In the U.S.,

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

Vaccine 52

Vaccine Immune Response FDA FDA Approval 52

The Pharma Data

DECEMBER 3, 2020

Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

FEBRUARY 23, 2022

For laboratory workers: TBE vaccination is recommended for those with a potential exposure to the TBE virus (TBEV). Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S.

Vaccine 52

Vaccine FDA Approval Laboratories Virus 52

The Pharma Data

NOVEMBER 30, 2020

In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

FDA 52

FDA Clinical Trials Drugs Pharmaceutical Companies 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. The FDA has streamlined its recommendations for sponsors enrolling patients in clinical trials.

FDA 40

FDA Clinical Trials Vaccine Trials 40

The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. Director of the FDA’s Center for Biologics Evaluation and Research. The vaccine was 94.1% ModernaTX, Inc.

Vaccine 52

Vaccine FDA Clinical Trials FDA Approval 52

The Pharma Data

FEBRUARY 23, 2022

To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences San Francisco, CA using an FDA-approved standardized pseudovirus neutralization test (pVNT) against the D614G prototype virus. for efficacy, immunogenicity and safety compared to a placebo.

Vaccine 52

Vaccine Virus Trials Immune Response 52

The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. .

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Department of Health and Human Services under OT number: HHSO100201700020C. and Roche will develop, manufacture and distribute it outside the U.S.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Codon

MAY 18, 2023

link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. ” The clinical trial was halted and 69 others were investigated. link ) Yup, Elizabeth Holmes is going to prison.

DNA 52

DNA Engineering Therapies Virus 52

Codon

MAY 18, 2023

link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. ” The clinical trial was halted and 69 others were investigated. link ) Yup, Elizabeth Holmes is going to prison.

DNA 52

DNA Engineering Therapies Virus 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Hospitals 52

Hospitals Production Clinical Trials Therapies 52

The Pharma Data

OCTOBER 21, 2020

The pooled analysis examined 1,744 participants across 16 countries currently taking long-acting cabotegravir and rilpivirine as part of the regimen’s ongoing global clinical development programme of six studies, which includes the phase IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE clinical trials.

Clinical Development 52

Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

Vaccine 52

Vaccine Trials FDA Clinical Trials 52