pharmaphorum

AUGUST 4, 2022

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. Harness technology.

Development 98

Development In-Vitro Manufacturing Compliance 98

The Pharma Data

MARCH 29, 2022

Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure.”. 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S.

In-Vitro 52

In-Vitro FDA Approval Drugs Manufacturing 52

Pfizer

AUGUST 15, 2022

I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. In addition, to meet U.S.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

In-Vitro 52

In-Vitro Contract Manufacturing Manufacturing Development 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 In-Vivo Protein In-Vitro 52

Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

Pharmaceutical Technology

AUGUST 26, 2008

” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy. .” ” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy. “Biotechnology has exploded across the industry. .

Antibody 130

Antibody Licensing Licensing Production 130

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death.

Antibody 52

Antibody Medicine Production In-Vitro 52

Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

Drugs 110

Drugs Licensing Licensing Production 110

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing 40

Licensing Licensing Drugs Manufacturing 40

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

MARCH 26, 2021

Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. About the VIR-7831 Clinical Development Programme.

Antibody 52

Antibody Trials Vaccination Vaccine 52

The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

Trials 52

Trials Antibody Vaccination Vaccine 52

The Pharma Data

JUNE 25, 2021

While COVID-19 vaccination efforts have been successful, there is still a significant need for prevention and treatment options for certain populations, including those unable to be vaccinated or those who may have an inadequate response to vaccination.”. The PROVENT trial will give us more clarity in this patient population.

Trials 52

Trials Antibody In-Vitro Medicine 52

The Pharma Data

JANUARY 24, 2021

Gritstone Oncology , based in Emeryville, California, announced that it is advancing development of its own second-generation vaccine against COVID-19. Brilacidin has shown in vitro to be have antiviral properties against different SARS-CoV-2 strains and other human coronaviruses. Read on to see. COVID-19-Related.

Trials 52

Trials Allergies In-Vitro Antibody 52

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 per share amounts).

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

MAY 26, 2023

Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines. Research into genetic medicines like mRNA vaccines and gene therapies, as well as gene-editing treatments and novel cancer therapies, have driven increased demand for DNA.

DNA 130

DNA Manufacturing Gene Gene Therapy 130

XTalks

NOVEMBER 20, 2020

A new type of test based on detection of activated T cells may prove to have greater utility in determining whether someone has had a COVID-19 infection compared to a traditional antibody test. The cell-based tests are designed to identify specific T cells that are activated in response to a pathogen — which in this case would be SARS-CoV-2.

Antibody 98

Antibody Immune Response Protein In-Vitro 98