Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. How are disease targets selected for challenge trials?

Vaccine 132

Vaccine Trials Disease Virus 132

The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% There was a 1.08 REGN-COV2 was well tolerated in the trial. high dose, 1.6% low dose; 2.3%

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

MARCH 8, 2021

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

OCTOBER 25, 2020

The UK government’s COVID-19 Vaccine Taskforce and a contract research company called Open Orphan announced a $13 million (£10 million) plan to test investigational COVID-19 vaccines in volunteers who are then intentionally exposed to SARS-CoV-2, the virus that causes COVID-19. They will require regulatory and ethical approval.

Vaccine 52

Vaccine Clinical Trials Trials Virus 52

The Pharma Data

NOVEMBER 17, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. COVID-19 Vaccine AstraZeneca is known as Vaxzevria in Europe. About AstraZeneca. United Nations.

Vaccine 52

Vaccine Virus Clinical Trials Licensing 52

The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues. WARNINGS AND PRECAUTIONS.

Treatment 52

Treatment Clinical Trials Therapies Drugs 52

The Pharma Data

APRIL 1, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. 18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. About ZUMA-3. Grade 3 CRS in 18% of patients.

Virus 52

Virus Treatment Therapies FDA 52

The Pharma Data

DECEMBER 28, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

Compliance 52

Compliance Licensing Licensing Virus 52

The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” IMPORTANT SAFETY INFORMATION: Events of anaphylaxis have been reported. A slightly lower frequency of reactogenicity events was associated with greater age.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. Have chronic kidney disease. Have immunosuppressive disease. cardiovascular disease, OR. chronic obstructive pulmonary disease/other chronic respiratory disease. sickle cell disease, OR. Have diabetes.

Hospitals 52

Hospitals Production Clinical Trials Virus 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. and Roche will develop, manufacture and distribute it outside the U.S.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Drug Discovery World

SEPTEMBER 6, 2022

This area of medicine, which turns our own bodies into agents of combat to fight disease, has quickly become one of the most promising fields in treating deadly diseases such as cancer, central nervous system disorders and even musculoskeletal conditions. . billion, compared to $19.9 Tuyen Ong, MD, CEO, Ring Therapeutics. .

Therapies 130

Therapies Clinical Trials Vaccine Disease 130

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. Have chronic kidney disease. Yancopoulos , M.D.,

Government 52

Government Hospitals Virus Production 52

The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. No serious adverse events were reported in this study and the vaccine candidate was well-tolerated. and Mexico, and Phase 1/2 studies in Australia and the U.S.

Vaccine 52

Vaccine Clinical Trials Virus Government 52

The Pharma Data

OCTOBER 29, 2020

The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). In the Phase 2 portion, the most common adverse event was upper respiratory tract infection which occurred in 17.9%, 11.1% INDIANAPOLIS , Oct. versus placebo).

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. Adverse Events.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

JULY 21, 2021

We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at [link].

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 29, 2020

It is important to remember that while the virology results from this analysis of hospitalized patients were robust, the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage. cardiovascular disease, OR. chronic obstructive pulmonary disease/other chronic respiratory disease.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

JANUARY 18, 2021

Utilizing drug delivery platform technologies, BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV).

Pharmacy 40

Pharmacy Regulations Compliance Licensing 40

The Pharma Data

MARCH 2, 2021

Bayer is a main sponsor of the event, which invites scientists and industry leaders to discuss the latest achievements and developments in horticulture. It is licensed for commercial use by Ecología y Protección Agricola (EPA) in Valencia and provides 400 days of pest control. Bayer is the main sponsor of the SHE2021 congress.

Production 52

Production International Licensing Licensing 52

The Pharma Data

DECEMBER 19, 2020

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Moderna COVID-19 vaccine in people 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. .–( BUSINESS WIRE )– Moderna, Inc., AUTHORIZED USE.

Vaccine 52

Vaccine Long-Term Care Facilities FDA Licensing 52

The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Government 52

Government Long-Term Care Facilities Hospitals Treatment 52

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain. LONDON and BOSTON, Jan.

Science 40

Science Virus FDA Approval Treatment 40

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

DECEMBER 20, 2020

We see great promise in delivering psychedelic-based medicines to treat various diseases and disorders and look forward to unveiling clinical study designs,’’ he continued. For further information please visit www.abetterlifepharma.com.

Production 52

Production Compliance Clinical Trials Licensing 52

The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate. Download this exclusive report here.

Vaccine 52

Vaccine Immune Response Government RNA 52

The Pharma Data

JUNE 24, 2021

This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.:

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 22, 2021

Number of patients with events. Serious adverse events (SAEs) were largely related to COVID-19 and occurred in 1.1% All patients in this analysis had at least one risk factor, including obesity (58%), age 50 years (51%) and cardiovascular disease, including hypertension (36%). Patients with ? Risk reduction. p<0.0001).

Virus 52

Virus Clinical Trials Trials FDA 52

The Pharma Data

SEPTEMBER 12, 2020

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. About BioNTech.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

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. Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance.

Vaccine 52

Vaccine Clinical Trials Disease Therapies 52

The Pharma Data

DECEMBER 14, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumors to treat specific types of cancer.

Bioethics 40

Bioethics Clinical Research Regulations Compliance 40

The Pharma Data

NOVEMBER 20, 2020

Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Progeria and Progeroid Laminopathies are separate and distinct ultra-rare, genetic, premature aging diseases that accelerate mortality in young patients. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. TNX-801 , live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 42% (n=8) had a CR or sCR.

Production 40

Production Trials Treatment Pharmaceuticals 40