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

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

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

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

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 BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within 3 days after the infection. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,

Vaccine 52

Vaccine Clinical Trials RNA 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. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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 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

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 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

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

The Pharma Data

MARCH 29, 2022

Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S.

Vaccine 52

Vaccine Small Molecule FDA Therapies 52

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

DrugBank

AUGUST 15, 2024

Additionally, industry partners bring a wealth of experience in drug development and commercialization strategies, essential for translating scientific discoveries into marketable products that can reach patients worldwide.

Drug Development 99

Drug Development Clinical Trials Drugs Therapies 99

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. Could it come from the field of neuroscience? Tranquis Therapeutics.

Marketing 52

Marketing Small Molecule Disease Pharmaceuticals 52

Codon

APRIL 30, 2023

Also, last week’s digest had an error: The country that approved the malaria vaccine was Ghana. Vaccines (basically little fat bubbles filled with mRNA and some dissolvable polymers) were physically printed onto microneedle patches using a robot. The patches have little spikes that help push the vaccines through the skin.

Vaccine 52

Vaccine DNA Engineering RNA 52

Codon

APRIL 30, 2023

Also, last week’s digest had an error: The country that approved the malaria vaccine was Ghana. Vaccines (basically little fat bubbles filled with mRNA and some dissolvable polymers) were physically printed onto microneedle patches using a robot. The patches have little spikes that help push the vaccines through the skin.

Vaccine 52

Vaccine DNA Engineering RNA 52

Agency IQ

JUNE 9, 2023

However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs. The guidance contains recommendations for small molecule drugs, as well as any biological products that fall within CDER’s purview.

FDA 40

FDA Science Small Molecule Immune Response 40

Drug Target Review

DECEMBER 21, 2023

mRNA biology has become widely recognised as a new “drug mine” RNAi drugs are in the market and mRNA vaccines, initially developed for Covid-19, are already in trials for cancer. All of these are novel targets to be explored in small molecule drug discovery as well as for improving the efficacy of mRNA vaccines.

Disease 106

Disease Small Molecule Vaccine Drugs 106

The Pharma Data

DECEMBER 4, 2021

. “Pfizer’s goal with AWS is to expedite the processes for drug discovery and development in ways that can ultimately enhance patient experiences and deliver new therapies to market. Pfizer has an extensive collection of documents that contain valuable data from a variety of drug development processes.

Drug Development 52

Drug Development Small Molecule Synthetic Chemistry Drugs 52

The Pharma Data

MARCH 28, 2022

Dupixent is now a market leader and more than 400,000 patients with certain types of atopic dermatitis (AD), asthma and chronic rhinosinusitis with nasal polyposis have been treated globally. A broad Phase 1 clinical program of small molecules and biologics. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Small Molecule 52

Small Molecule Clinical Development Disease Science 52

The Pharma Data

MARCH 18, 2022

Today marks a major milestone for EUROAPI, a leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients* (API), as Sanofi’s Board of Directors unanimously proposed, on March 17th, to submit to its shareholders the distribution of circa 58% of the share capital of EUROAPI.

Small Molecule 52

Small Molecule Marketing Pharmaceuticals Regulations 52

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. Amanda Conti, AgencyIQ What kind of biologic products entered the market? Industry has historically struggled to fulfill (or be incentivized to fulfill) post-market requirements (PMRs) in general.

FDA 52

FDA Biosimilars Science Drugs 52

The Pharma Data

FEBRUARY 25, 2022

Under the terms of the agreement, Pfizer has commercialization rights to rimegepant in markets outside of the U.S. CGRP Receptor Antagonism Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. Biohaven continues to lead research and development globally and retains the U.S.

Treatment 52

Treatment Small Molecule FDA Approval Therapies 52

The Pharma Data

FEBRUARY 25, 2022

They have the ability to help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

PerkinElmer

JANUARY 21, 2021

Using drugs that are already on the market was the quickest path forward to evaluate these compounds and possibly help patients now because novel drug development typically takes years. The next focus for the team is to identify similar small molecules to the 25 hits they uncovered and then try to improve the potency of each.

Treatment 52

Treatment Small Molecule Drugs Virus 52

The Pharma Data

OCTOBER 1, 2021

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Great Britain marketing authorization for CIBINQO earlier this month. CIBINQO (abrocitinib) is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. About CIBINQO ® (abrocitinib).

Clinical Trials 52

Clinical Trials Small Molecule Trials Treatment 52

The Pharma Data

MARCH 4, 2021

“Ovid may benefit significantly, but without the obligation to commit the substantial capital needed over the coming years as soticlestat completes pivotal trials and, if successful, enters the global market. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. selective GABA A receptor agonist.

Treatment 52

Treatment Pharmaceutical Companies Clinical Trials Trials 52

The Pharma Data

MARCH 13, 2022

In connection with the acquisition, Arena’s shares of common stock will be delisted from the Nasdaq Global Select Market on or about March 11, 2022. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

The Pharma Data

MARCH 29, 2022

With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars.

Trials 52

Trials Small Molecule Disease Biosimilars 52

The Pharma Data

JANUARY 18, 2021

With the deteriorating COVID-19 situation around the world, there is a clear need for new treatment options for elderly patients, or patients with co-morbidities, who are expected to continue to be at high risk of developing severe respiratory manifestations requiring hospitalization, even while vaccines are being rolled-out.”.

Small Molecule 52

Small Molecule Hospitals Treatment Clinical Trials 52

The Pharma Data

MARCH 29, 2022

The small molecule was developed by Drs. ” However, the spray should be used in combination with other drugs already on the market, he says, as the compound is an entry inhibitor, blocking entry of the virus to cells while other drugs reduce replication. 2 around the world.”

Virus 52

Virus Small Molecule Research Clinical Trials 52

Codon

MARCH 20, 2023

Marine biofilm engineered to produce current in response to small molecules. How cell-free processes could speed up vaccine development. 5 strategies for biotech startups to outlast a market downturn. 🏭 Industry SpyBiotech receives more than $4 million to develop vaccine platform. DeWinter MA. Klingler F.

Virus 52

Virus RNA Engineering Small Molecule 52

The Pharma Data

OCTOBER 26, 2020

The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the same patient population with a decision anticipated in the second half of 2021. Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. About Abrocitinib.

FDA 40

FDA Clinical Trials Trials Therapies 40

Drug Target Review

MARCH 1, 2024

Here, we wanted to ask whether delivery to lymph nodes was important for allowing vaccines to (1) coordinate the expansion and functional qualities of tumour-specific TCR-T cells and (2) more broadly promote immune activation which could contribute to improved anti-tumour effect. Dr Haqq holds multiple patents and publications.

Immune Response 106

Immune Response Therapies Vaccine Small Molecule 106

The Pharma Data

JANUARY 6, 2021

This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. “ The United States is the world’s biggest market for biopharmaceuticals.

Packaging 52

Packaging Small Molecule Production FDA Approval 52