The Pharma Data

OCTOBER 26, 2020

FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Eli Lilly halted a separate study of its LY-COV555 antibody against COVID-19 in hospitalized patients. FDA Actions. Days after the U.S. Other Industry News.

Vaccine 52

Vaccine FDA Approval FDA Clinical Trials 52

The Pharma Data

NOVEMBER 18, 2020

.” Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, “In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. ” Presentation number: 397P / Poster: ID 680.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.

Vaccine 52

Vaccine Immune Response Disease Clinical Trials 52

The Pharma Data

JANUARY 17, 2021

The primary endpoint of the study was composite of time to first occurrence of heart failure hospitalization or cardiovascular death. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. The NDA was built on data from the Phase III VICTORIA trial.

FDA 52

FDA Small Molecule Immune Response Hospitals 52

The Pharma Data

MARCH 29, 2022

Spinner, MD, Consulting Physician Infectious Diseases and Pandemic Officer at the University Hospital Rechts der Isar and adjunct teaching professor at the Technical University of Munich, Munich, Germany, said: “Increasing COVID-19 cases, driven by the highly-transmissible BA.2 1-3 Evusheld was generally well-tolerated in the trial.

Vaccine 52

Vaccine Virus Immune Response Government 52

The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania.

DNA 40

DNA Vaccine Immune Response Clinical Trials 40

The Pharma Data

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). The Phase 3 portion of this trial continues in non-hospitalized patients. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. placebo; p=0.024).

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

Vaccine 52

Vaccine Clinical Trials Disease Trials 52

Codon

JULY 14, 2024

In contrast, people with sickle cell disease commonly receive red blood cell transfusions to alleviate vaso-occlusive pain crises. 2 And while transfusions are among the safest procedures in medicine, there is still a very slight risk of transmission of infectious diseases and adverse immune reactions. In the U.S.,

Production 133

Production Clinical Trials Trials Therapies 133

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Limitations of Authorized Use.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

OCTOBER 18, 2020

Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. We believe our drug candidate has the potential to inhibit a key proinflammatory pathway linked to some of the worst effects of the disease.”

Immune Response 40

Immune Response Hospitals Virus Treatment 40

The Pharma Data

JUNE 26, 2021

In line with our global leadership and our 7 0-year history of pro tecting people with influenza v accine s , w e will always focus on developing product s that demonstrate protection beyond flu , as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

AUGUST 3, 2021

The company announced plans to submit donanemab for Alzheimer’s disease and tirzepatide for type 2 diabetes to regulatory authorities by the end of 2021. announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses.

Production 52

Production Marketing Research Government 52

Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. At best, the corporations with the best models released weak versions to the public under non-commercial licenses.

Engineering 125

Engineering Virus DNA Therapies 125

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Limitations of Authorized Use.

FDA 40

FDA Clinical Trials Hospitals Government 40

The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

Vaccine 52

Vaccine FDA Approval FDA Disease 52

Codon

FEBRUARY 13, 2024

alone, according to the Centers for Disease Control and Prevention. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. 4 But the same barriers still exist today.

Therapies 118

Therapies Virus DNA Clinical Trials 118

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. “Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Reese, M.D.,

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. ARCA biopharma enrolled the first patients in ASPEN-COVID-10, its Phase IIb trial of rNAPc2 for hospitalized COVID-19 patients.

Vaccine 52

Vaccine Trials Small Molecule Therapies 52

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. Their cone cells, which are responsible for color vision, don’t work like normal. There’s a TV show where a bunch of doctors are walking through a hospital corridor. In response, the U.S. a lower risk of immune responses.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. Their cone cells, which are responsible for color vision, don’t work like normal. There’s a TV show where a bunch of doctors are walking through a hospital corridor. In response, the U.S. a lower risk of immune responses.

Therapies 52

Therapies RNA DNA Engineering 52

The Pharma Data

OCTOBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. NEW YORK, Oct.

Treatment 40

Treatment Trials Production Disease 40

The Pharma Data

NOVEMBER 9, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. 6,7 Approximately 10% of asthma patients have severe asthma.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

MARCH 11, 2021

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

Vaccine 52

Vaccine Clinical Trials Hospitals Licensing 52

The Pharma Data

FEBRUARY 8, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

APRIL 27, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the first quarter, Rare Disease sales increased 4.4% up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Net sales (€ million). Change at CER.

Vaccine 52

Vaccine Production FDA FDA Approval 52