XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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XTalks

DECEMBER 20, 2021

It has also applied for regulatory licensing in the UK, European Union (EU), Australia, Singapore, India, United Arab Emirates (UAE), New Zealand and Japan. Covovax is a recombinant protein-based vaccine and can be regarded as a more “traditional” vaccine as it isn’t genetic-based like mRNA or viral vector vaccines.

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Vaccination Vaccine Manufacturing Protein 96

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

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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.

Immune Response 52

Immune Response Licensing Licensing Sales 52

pharmaphorum

AUGUST 24, 2020

With the ink barely dry on a deal to develop Dragonfly’s lead cancer immunotherapy, Bristol-Myers Squibb’s business development team has agreed to buy Canadian biotech Forbius and its pipeline of drugs for cancer and fibrotic diseases. BMS seems to be interested mainly in AVID200’s potential in cancer, however, at least initially.

Immune Response 59

Immune Response Antibody Drugs Licensing 59

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

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Vaccination Vaccine Immune Response Trials 111

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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Vaccination Vaccine Protein Immune Response 52

pharmaphorum

DECEMBER 15, 2020

Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3. GBS is responsible for nearly half of all life-threatening infections in newborns. The post Minervax raises €47.4m

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 52

Delveinsight

JANUARY 21, 2021

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The combination appears to work by activation of the tumour-suppressing protein p53, they announced. The gene TP53 produces the protein p53, a known tumour suppressor.

Research 52

Research Protein Clinical Trials Clinical Trials 52

The Pharma Data

MAY 27, 2022

The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immune response after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.(1-5). About AstraZeneca.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., The Phase III will have overall survival as the primary objective and may include a specific patient population.

Trials 52

Trials Immune Response HR Clinical Development 52

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Vaccination Vaccine Protein Immune Response 111

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

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Vaccination Vaccine Immune Response Licensing 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.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

DECEMBER 23, 2020

Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. 74% had measurable cellular responses at the 1.0 mg dose group demonstrated cellular responses. The 1.0 mg and 2.0 mg dose group and 84% demonstrating neutralizing antibodies in the 2.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. This is particularly important in developing countries, where access to cold-chain is limited,” said Channon. There are other theoretical advantages as well.

Licensing 119

Licensing Licensing Vaccination Vaccine 119

The Pharma Data

MARCH 25, 2022

” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing COVID-19. W911QY-21-9-0001.

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

pharmaphorum

SEPTEMBER 2, 2020

Jounce will lead development of JTX-1811 through IND clearance, after which Gilead will have the sole right to develop the drug. Results presented for the drug at ASCO 2018 showed only one partial response out of seven gastric cancer patients given vopratelimab, and two partial responses when the drug was paired with Opdivo.

Licensing 65

Licensing Licensing Antibody Immune Response 65

The Pharma Data

DECEMBER 20, 2020

We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. “We NEW YORK, Dec. 21, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc.

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

XTalks

MAY 2, 2024

The Prescription Drug User Fee Act (PDUFA) date is the deadline that the FDA sets for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. Alexion, AstraZeneca Rare Disease is serving as a licensing partner of BridgeBio’s affiliate, Eidos Therapeutics, Inc.,

Drugs 52

Drugs FDA Approval Sales Vaccination 52

Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. It has been developed using the company’s recombinant nanoparticle technology. In the Phase II trials, adult participants received a single Nuvaxovid booster dose six months after their initial two-dose vaccine doses.

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Vaccination Vaccine Immune Response Protein 147

pharmaphorum

JULY 18, 2022

“It is programmed and coded for the production of the full-length spike protein of the coronavirus. It then elicits an immune response against that spike protein. When you have mucosal immunity, the immunoglobulins called IgAs start neutralising the virus at the point of entry. The inhalant version.

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Vaccination Vaccine Development Immune Response 133

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. vice president of immunology development at Lilly. “Lebrikizumab is a specific inhibitor of IL-13 that offers robust binding affinity and high bioavailability. Almirall S.A.’s

Dermatology 40

Dermatology Trials Bioavailability Medicine 40

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Seronegative patients (n=217) had much higher viral loads than those who had already developed their own antibodies (seropositive) to SARS-CoV-2 at the time of randomization. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

XTalks

SEPTEMBER 17, 2020

While the table lists acceptable surrogate endpoints for trials of more common conditions, such as asthma, type 2 diabetes and various cancer types, the document also provides key information to developers of certain rare disease therapies. Dietary changes, including restriction of salt and animal protein, are also recommended.

Trials 98

Trials Gene Hormones Clinical Trials 98

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

Vaccination 52

Vaccination Vaccine Genetic Engineering Protein 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. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%

Antibody 40

Antibody Trials Production Clinical Trials 40

Drug Discovery World

SEPTEMBER 6, 2022

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . Thompson says that the development of Covid-19 vaccines, which used mRNA technology, resulted in wider acceptance for cell and gene therapies. . “On

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.

Development 40

Development Clinical Development Clinical Trials Clinical Trials 40

The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. Business Development/Other Developments. Research and development expenses increased 20 percent to $1.673 billion, or 24.8 on a non-GAAP basis.

Antibody 52

Antibody Sales Production Development 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” patients under an Emergency Use Authorization, and we also continue a robust clinical development program.”

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

JUNE 26, 2021

The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

MAY 31, 2022

billion in potential development milestones, to get its hands on the ASP3772 shot, which recently claimed a breakthrough designation from the FDA for the treatment of pneumococcal disease in older adults. The biotech says this can stimulate both B cell (antibody) and T cell immune responses with a single shot.

Vaccination 52

Vaccination Vaccine Bacterium Sales 52