The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . Our ambition is to develop life-changing treatments for patients.

Small Molecule 52

Small Molecule Disease Immune Response Licensing 52

The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . It is being developed for the treatment of solid tumors. Keitma/Shutterstock.

Immune Response 52

Immune Response Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Expected to enroll 415 participants; interim results expected in Q3 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. gammadelta T cells link innate and adaptive immune responses. Normality sensing licenses local T cells for innate-like tissue surveillance. References Fichtner A, Ravens S, Prinz I. Cells 9(40):800 (2020).

Therapies 105

Therapies Engineering Molecular Biology Science 105

The Pharma Data

JUNE 26, 2021

We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

OCTOBER 6, 2021

It is also licensed under the brand name Efluelda ® in Europe where it is indicated for adults aged 60 and older. The study assesses the safety profile and immune response when COVID-19 mRNA investigational booster vaccine (100 mcg dose) and high-dose quadrivalent influenza vaccine are administered simultaneously.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech

Vaccine 52

Vaccine Immune Response FDA Licensing 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. Title: OBI-833 was safe and immunogenic, without treatment-related SAEs, in a Phase 1 dose-escalation trial. 9:00 – 20:00 Eastern Time.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

JANUARY 31, 2021

While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. “We This press release features multimedia. View the full release here: [link]. Terms of the Agreement.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

The Pharma Data

DECEMBER 15, 2020

The human monoclonal antibody targets specific immune plasma cells. Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The researchers regulated the abnormal immunological memory processes found in these patients.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

New Drug Approvals

DECEMBER 16, 2023

3 Additionally, iptacopan has the benefit of targeting factor B, which only affect the alternative complement pathway, leaving the classic and lectin pathway untouched for the body to still mount adequate immune responses against pathogens. of patients experienced a sustained hemoglobin improvement without transfusions respectively.

FDA 62

FDA Small Molecule FDA Approval Treatment 62

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 antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. About INOVIO.

DNA 40

DNA Vaccine Clinical Trials Immune Response 40

The Pharma Data

JUNE 23, 2025

Vertex and Ono Pharmaceutical Forge Strategic Partnership to Develop and Commercialize Povetacicept in Japan and South Korea In a move that underscores the growing international collaboration in advancing treatment for autoimmune and kidney-related diseases, Vertex Pharmaceuticals Incorporated and Ono Pharmaceutical Co.,

Pharmaceuticals 40

Pharmaceuticals Disease Therapies Clinical Development 40

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

JULY 23, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g.,

Vaccine 52

Vaccine Government Immune Response FDA 52

The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer?BioNTech BioNTech COVID-19 Vaccine. BioNTech COVID-19 Vaccine.

Vaccine 52

Vaccine Clinical Trials Trials FDA 52

The Pharma Data

AUGUST 16, 2021

AD, also known as atopic eczema, is a chronic inflammatory skin disorder caused by skin barrier dysfunction and dysregulation of the immune response. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. About Atopic Dermatitis.

Trials 40

Trials Clinical Trials Small Molecule Disease 40

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

OCTOBER 28, 2020

. “We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% There was a 1.08

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. 1 Noyce RS, et al.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN?

Vaccine 52

Vaccine Clinical Trials RNA Trials 52

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.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. 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.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

DECEMBER 21, 2020

“The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. Detailed results from the SOURCE trial will be presented at a future medical meeting.

Trials 40

Trials Production Clinical Trials Therapies 40

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies 138

Therapies Virus DNA Clinical Trials 138

Drug Target Review

OCTOBER 10, 2024

In the context of preclinical research, using healthy cells to study disease-specific mechanisms, cell-cell interactions, and immune responses can result in faulty data, missed therapeutic targets, and unanticipated immune responses. Subsequently, these preclinical shortcomings translate into significant clinical risks.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Licensing 52

Licensing Licensing Therapies Engineering 52

The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.

Virus 52

Virus Immune Response Disease Clinical Trials 52

The Pharma Data

APRIL 26, 2022

STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting. Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020.

Immune Response 52

Immune Response Trials Treatment Disease 52

The Pharma Data

AUGUST 15, 2021

anaphylaxis) to any component of TICOVAC Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TICOVAC Some individuals with altered immunocompetence may have reduced immune responses to TICOVAC TICOVAC contains albumin, a derivative of human blood.

FDA Approval 52

FDA Approval Vaccine FDA Virus 52

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. Many patients with severe asthma have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.(2,6,9)

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

MAY 15, 2023

5 GSK’s MenABCWY vaccine candidate combines the antigenic components of licensed meningococcal vaccines, Bexsero and Menveo. Bexsero is used as the comparator for the MenB immune responses induced by the MenABCWY vaccine in the trial, which is both the phase III trial for MenABCWY and confirmatory trial for Bexsero in the US.

Vaccine 40

Vaccine Immune Response Licensing Licensing 40