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).

Vaccination 52

Vaccination Vaccine Immune Response Medicine 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.

Vaccination 111

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

Vaccination 52

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

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

The Pharma Data

MARCH 25, 2022

Evusheld has also been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19. People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.

Antibody 52

Antibody In-Vivo Medicine Vaccination 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. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

GPS has previously been shown to invoke multi-epitope, broad cross-reactivity along the full-length of the WT1 protein, suggestive of epitope spreading, and immunologically mediated cancer cell destruction, which are hallmarks of an effective cancer vaccine. Kenilworth, N.J., About SELLAS Life Sciences Group, Inc.

Life Science 52

Life Science Immune Response Trials Clinical Trials 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. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Antibody 40

Antibody Trials Production Clinical Trials 40

Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

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

The Pharma Data

DECEMBER 17, 2020

To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

Antibody 52

Antibody Medicine Production Trials 52

XTalks

SEPTEMBER 17, 2020

In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval. The tumor secretes adrenocorticotropic hormone (ACTH), which stimulates cortisol production. What Is a Surrogate Endpoint?

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Every day, Pfizer.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

– Revenue from all key products grew in the quarter and 2021 year-to-date. whose proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity. The company announced the acquisition of Protomer Technologies Inc.,

Antibody 52

Antibody Sales Production Development 52

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.

Vaccination 133

Vaccination Vaccine Development Immune Response 133

Drug Discovery World

SEPTEMBER 6, 2022

With the sector looking strong it would be easy to think of the cell & gene sector as being resilient to challenge but this is never the case in pharma: fierce competition can result in fluctuating valuations for listed companies and the regulatory hurdles of pharma means that many companies won’t ever see their product reach the bedside. .

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

pharmaphorum

MAY 31, 2022

In February, the company reacquired full rights to the shot from Astellas, which paid $10 million upfront to license the vaccine in 2017, clearing the way for GSK’s acquisition. The biotech says this can stimulate both B cell (antibody) and T cell immune responses with a single shot. billion in sales last year.

Vaccination 52

Vaccination Vaccine Bacterium Sales 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. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Delveinsight

DECEMBER 3, 2020

Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Bayer has made a cell and gene therapy platform to assist its growing pipeline of advanced therapy medicinal products.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

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. Schleifer, M.D.,

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 18, 2020

” EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients.

Immune Response 40

Immune Response Antibody Regulation Production 40

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.

Development 40

Development Clinical Development Clinical Trials Clinical Trials 40

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. Schleifer , M.D.,

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

JUNE 18, 2021

PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]). pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on immune responses.

Vaccination 52

Vaccination Vaccine FDA Approval Containment 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. About TNX-1800.

Vaccination 40

Vaccination Vaccine Development Medicine 40

Pfizer

OCTOBER 20, 2022

PREVNAR 20® is Pfizer’s next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

Vaccination 40

Vaccination Vaccine Containment Immune Response 40

The Pharma Data

SEPTEMBER 15, 2020

20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Vaccination 52

Vaccination Vaccine Gene Therapy Trials 52

The Pharma Data

DECEMBER 15, 2020

Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. The protein may be involved in such conditions, and a CRP test may be used to find or monitor conditions that cause inflammation. These include inflammatory bowel disease, lupus or rheumatoid arthritis.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

DECEMBER 20, 2020

It is an optimized, non-chemically modified mRNA that codes for the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. 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.

Trials 52

Trials Gene Therapy Vaccination Vaccine 52

The Pharma Data

APRIL 27, 2021

up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Globally, diagnosis of the disease and product awareness remain impacted by the COVID-19 environment. . Cardiovascular and Established Rx Products. Net sales (€ million).

Sales 52

Sales Vaccination Vaccine Medicine 52

Pfizer

NOVEMBER 2, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection. INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85