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 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

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and may lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19. CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

DECEMBER 2, 2020

The drug is a small-molecule inhibitor of the S. ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services.

Licensing 52

Licensing Licensing DNA Vaccine 52

The Pharma Data

APRIL 27, 2021

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. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

DrugBank

AUGUST 15, 2024

This first-in-class reversible small molecule inhibitor targets specific mutations in the EGFR and HER2 genes, which are known to drive tumor growth in several types of cancer. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

Drug Development 81

Drug Development Clinical Trials Drugs Therapies 81

The Pharma Data

OCTOBER 25, 2020

Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The vaccine candidate is called “spike ferritin nanoparticle” (SpFN) and uses ferritin—“attaching a certain type of spike protein to a polymerized version of ferritin,” according to the organization.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

DECEMBER 9, 2020

With the expected Emergency Use Authorization (EUA) of Pfizer – BioNTech and Moderna ’s COVID-19 vaccines providing hope that the COVID-19 pandemic will soon be resolved, 2021 is going to need a new primary healthcare campaign. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc.,

Marketing 52

Marketing Small Molecule Disease Pharmaceuticals 52

The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

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

DECEMBER 20, 2020

CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19. The technology used for the CureVac vaccine is similar to that utilized by Pfizer-BioNTech and Moderna. Russia’s Sputnik V COVID-19 vaccine demonstrated 91.4% Here’s a look.

Vaccine 52

Vaccine Trials Therapies Small Molecule 52

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Codon

APRIL 2, 2023

mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read How well do different antibodies, created by people who got two or three doses of the COVID-19 mRNA vaccine, fight off new viral variants, such as BA.4 Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

JANUARY 18, 2021

Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD , COVI-AMG , COVI-SHIELD , Gene-MAb , COVI-MSC and COVI-DROPS ; and diagnostic test solutions, including COVI-TRACK , COVI-STIX and COVI-TRACE. for the treatment of post-herpetic neuralgia.

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Vaccine 52

Vaccine Production FDA Disease 52

The Pharma Data

MARCH 4, 2021

We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). Ovid’s most advanced pipeline programs include OV935 (soticlestat) in collaboration with Takeda and OV101 a ?-selective

Treatment 52

Treatment Clinical Trials Pharmaceutical Companies Trials 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

Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

Vaccine 52

Vaccine Clinical Trials Hospitals 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. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

Vaccine 52

Vaccine Clinical Trials Trials Licensing 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

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

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

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Licensing 52

Licensing Licensing Vaccine FDA 52

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

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

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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

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. billion related to certain license and collaboration agreements, and certain other items. Non-GAAP EPS of $1.74 COVID-19 Research Highlights.

Vaccine 40

Vaccine Trials Treatment Therapies 40

The Pharma Data

JUNE 24, 2021

Effort is part of the companies’ recent pledge of two billion doses to ensure global equitable access to the vaccine. The government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and lower middle-income countries and organizations that support them. This press release features multimedia. Our partnership with the U.S.

Government 52

Government Vaccine Clinical Trials Licensing 52

Codon

APRIL 16, 2023

These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study. It turns out that one skin microbe, called S. epidermidis , can actually trigger tumor-specific T cells.

Engineering 52

Engineering DNA RNA Science 52