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?

FDA Approval 89

FDA Approval Gene Genetics Protein 89

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 protein subunit vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccination 96

Vaccination Vaccine Manufacturing Protein 96

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

AUGUST 15, 2021

About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S., is developed using a master ‘seed’ virus that is similar to the TBE virus found in nature. More than 45 years of experience with the Pfizer TBE vaccine exist outside the U.S.,

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 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.

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Vaccination Vaccine Immune Response Medicine 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

Vaccination 52

Vaccination Vaccine Immune Response Licensing 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. INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. Department of Defense.

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 6, 2021. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. CEO and Co-founder of BioNTech. “We

Manufacturing 52

Manufacturing Vaccination Vaccine 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 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. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We The information contained in this release is as of August 20, 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials 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

SEPTEMBER 9, 2020

We would like to thank the European Commission for its commitment and confidence in our development efforts,” said Albert Bourla, Chairman and CEO, Pfizer. “We Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end in Europe and across the world. CEO and Co-founder of BioNTech.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 4, 2021

. Kiromic’s deep understanding of the tumor micro environment (TME) and the tumors’ escape and masking mechanisms led to development of a promising platform for chimeric antigen receptor therapy (CAR-T). We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

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 This press release contains forward-looking statements. NEW YORK, Dec. Kenilworth, N.J.,

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As 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. Jansen, Ph.D., Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

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

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

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

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 The information contained in this release is as of July 19, 2022.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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 Development Production 52

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The information contained in this release is as of July 8, 2022. have completed a primary series.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. The information contained in this release is as of July 8, 2022.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

JUNE 26, 2021

We’ve all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines ”, said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “ The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JANUARY 31, 2021

Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 9, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We We are encouraged by the data thus far and confident in our progress towards developing a safe and effective vaccine candidate to help address this current pandemic.”. producing CD8+ T cell responses, which is thought to promote an anti-viral effect.

Vaccination 52

Vaccination Vaccine RNA Clinical Trials 52

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. Senior Vice President and Head of Vaccine Research & Development, Pfizer.

Vaccination 52

Vaccination Vaccine FDA Approval Containment 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. Patients will be infused intravenously with a single dose of EB05 or placebo. Edesa Biotech, Inc.

Immune Response 40

Immune Response Antibody Regulation Development 40

Pfizer

OCTOBER 20, 2022

“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

Vaccination 40

Vaccination Vaccine Containment Immune Response 40

The Pharma Data

DECEMBER 20, 2020

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. BT-001 is our fourth program in clinical development. LUND, Sweden and STRASBOURG, France , Dec. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. About BioInvent.

Trials 52

Trials Antibody Clinical Trials Clinical Trials 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.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

executive vice president of Research and Development at Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Reese , M.D.,

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

SEPTEMBER 15, 2020

(NYSE: PFE) provided an extensive overview of pipeline advances and shared updates on the Company’s efforts to battle the COVID-19 pandemic on multiple fronts, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

The Pharma Data

DECEMBER 21, 2020

executive vice president of Research and Development at Amgen. 4 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below). AstraZeneca continues to lead development and Amgen continues to lead manufacturing. Reese , M.D.,

Trials 40

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