The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

JULY 18, 2021

VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.

Disease 52

Disease Immune Response Vaccine FDA Approval 52

The Pharma Data

OCTOBER 25, 2020

We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co.,

Vaccine 52

Vaccine Clinical Development RNA Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Glenn, M.D., and globally.”. and globally.”.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. The company’s success is based on its rich R&D portfolio with a focus on diseases with high unmet medical need. More than 60 million patients worldwide suffer from this disease, approx.

Research 52

Research Clinical Trials Treatment Production 52

The Pharma Data

MAY 6, 2021

Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Drug Discovery World

OCTOBER 4, 2022

This year’s event will cover some of the most exciting advancements in areas spanning screening, automation, high content imaging, disease models, cell and gene therapies and how innovation is being driven through partnerships and collaborations. In 2021, levels of investment hit an all-time high at $22.7 Cell and gene therapies.

Drugs 130

Drugs Therapies Clinical Trials Cell Based Assays 130

The Pharma Data

JANUARY 20, 2021

20, 2021 /PRNewswire/ — INOVIO Pharmaceuticals, Inc. The offering is expected to close on or about January 25, 2021 , subject to customary closing conditions. PLYMOUTH MEETING, Pa. , Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 All of the shares are being sold by INOVIO. About INOVIO.

DNA 40

DNA Immune Response Disease Clinical Trials 40

The Pharma Data

OCTOBER 28, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., Forward-Looking Statements.

Vaccine 40

Vaccine Government Clinical Trials RNA 40

The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021. billion doses by the end of 2021. CEO and Co-founder of BioNTech.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

AUGUST 20, 2020

times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 billion doses by the end of 2021. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. Jansen, Ph.D.,

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

The Pharma Data

DECEMBER 1, 2020

has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. The distribution of the vaccine in the U.K. View the full release here: [link].

Vaccine 40

Vaccine Clinical Trials Trials Production 40

The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8%

Drugs 147

Drugs Science Molecular Biology Clinical Trials 147

The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

The Pharma Data

APRIL 27, 2021

All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

Vial

MARCH 1, 2024

Recent and significant activities among these top CROs based in the US include the acquisition of Pharmaceutical Product Development (PPD), a global industry leader in clinical development and analytical services, by Thermo Fisher Scientific Inc. launched a PV platform for clinical research registries.

Clinical Trials 52

Clinical Trials Clinical Research Laboratories Trials 52

The Pharma Data

DECEMBER 1, 2020

Described earlier this year in a submission available on the bioRxiv preprint server , a systematic study of five antigen designs was completed along with evaluation of vaccine response in mice. HR2-presenting I3-01v9 1c-SA p NP vaccine candidate elicited the strongest neutralizing antibody response (7-fold higher than S2P alone).

Vaccine 40

Vaccine Clinical Trials Clinical Development Trials 40

The Pharma Data

JANUARY 13, 2021

GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. Lederman added, “We believe the development risk of TNX-1500 is mitigated by previous clinical data and extensive preclinical science with ruplizumab.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

SEPTEMBER 28, 2021

10) and who haven’t received prior chemotherapy for metastatic disease. Overall survival data from KEYNOTE-355 are going to be presented at the ecu Society for Medical Oncology (ESMO) Congress 2021 on Sept. The CHMP’s recommendation will now be reviewed by the ecu Commission for marketing authorization within the European Union.

Research Laboratories 52

Research Laboratories Clinical Research Treatment Disease 52

The Pharma Data

MAY 26, 2023

since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. These real-world studies also have shown that PAXLOVID is effective amongst both vaccinated and unvaccinated high-risk patients.(6,7,8,9,10) More than 11.6

FDA Approval 40

FDA Approval FDA Hospitals Vaccine 40

The Pharma Data

DECEMBER 14, 2020

a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod. STOCKHOLM , Dec. About Cyxone.

FDA 52

FDA Clinical Trials Clinical Development Packaging 52

The Pharma Data

JANUARY 11, 2021

11, 2021 (GLOBE NEWSWIRE) — MediciNova, Inc. , commented, “We believe that this investment will meaningfully accelerate MediciNova’s drug development in the pipeline and could lead to unleashing its highest potential in value. LA JOLLA, Calif., MediciNova, Inc. For more information on MediciNova, Inc.,

Clinical Trials 52

Clinical Trials Trials Small Molecule Vaccine 52

The Pharma Data

JANUARY 3, 2021

The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil. NEW YORK and LONDON, Jan. Dr. .

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

The Pharma Data

JANUARY 24, 2021

25, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Given that we have already treated patients with StemVacs, and we have filed an Investigational New Drug (IND) application for this product, we are excited in its development prospects.” OCEANSIDE, Calif., ir@tsoimail.com.

International 52

International Laboratories Therapies Treatment 52

The Pharma Data

DECEMBER 9, 2020

We look forward to developing and advancing our differentiated pipeline of novel therapeutics in carefully selected disease areas.”. The first project under the agreement will support a multi-center international clinical study involving patients with neovascular age-related macular degeneration (nAMD).

Therapies 52

Therapies International Disease Research 52

The Pharma Data

APRIL 29, 2022

We designed the clinical development program for PAXLOVID to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. Additional details on the study are available on clinicaltrials.gov (NCT05047601).

FDA 52

FDA Trials Treatment Virus 52

The Pharma Data

DECEMBER 20, 2020

In the first study, a phase 1/2 ‘basket’ trial of GPS in combination with the checkpoint inhibitor pembrolizumab (Keytruda), which is conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., More mature clinical and immunobiological data are expected to be announced by the end of the second quarter of 2021.

Immune Response 52

Immune Response Clinical Trials Therapies Trials 52

The Pharma Data

JUNE 26, 2021

“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

FDA 40

FDA Treatment Clinical Trials Virus 40

Drug Discovery World

JUNE 26, 2023

Although the concept of using mRNA to make therapeutics or vaccines has been around for decades, it took the urgency of a global pandemic for it to become a reality. Now, there are many mRNA-based therapeutics in clinical development and mRNA cancer vaccines have been promised by 2030.

Vaccine 130

Vaccine Virus Clinical Trials Trials 130

The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. The FDA has granted V181, the company’s investigational dengue vaccine in Phase 1 development, Fast Track designation.

Vaccine 40

Vaccine Trials Licensing Licensing 40

The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52