pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

Vaccine 89

Vaccine Vaccination Recombinant DNA Technology Trials 89

pharmaphorum

JUNE 28, 2022

Shares in Sutro rocketed in pre-market trading in the wake of the announcement, rising more than 50% before slipping back slightly to a 30% increase at the time of writing. The biotech has the option to share costs and profits for developing and commercialising the three product candidates in the US.

Antibody 105

Antibody Immune Response Gene Therapy Drugs 105

pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

Immune Response 72

Immune Response Trials Vaccination Vaccine 72

XTalks

JULY 31, 2024

Related: Pfizer’s Newly Approved Litfulo to Take on Eli Lilly’s Olumiant in Growing Alopecia Market So, what is alopecia areata? Alopecia areata occurs when the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp, face and sometimes other body parts.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

pharmaphorum

APRIL 9, 2021

The cytokine release prompts T-cells so they can translate that first innate immune response into a long-lasting adaptive immune response. The quality of the science led us to really focus on key mechanisms and pathways in innate immunity.”. “The That’s what is most exciting about all this,” says Mahjoubi.

Immune Response 122

Immune Response Development Trials Clinical Trials 122

Delveinsight

AUGUST 4, 2021

Similarly, genetics, immune response, and environmental factors also influence the occurrence of Neurological Conditions. Several therapies have been approved in the Epilepsy Market. and Neurimmune are actively working in the Alzheimer’s Therapeutics Market. Parkinson’s Disease. Multiple Sclerosis.

Marketing 98

Marketing Genetics Development Clinical Development 98

pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. ” Vaxzevria added almost $4 billion to its revenues last year, including $1.8

Vaccine 52

Vaccine Vaccination Development Immune Response 52

Pharma Marketing Network

DECEMBER 21, 2020

A herculean effort will be required from pharmaceutical marketers of all stripes, but particularly those in the promotional medical education (promo med-ed) space, to address the many challenges. Here are 5 considerations when developing a communications strategy for a novel genetic medicine. #1. Am J Bioeth. 2017;17(11):31-39.

Genetics 52

Genetics Medicine Gene Therapy Marketing 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.

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

pharmaphorum

FEBRUARY 25, 2021

Pandion ’s lead candidate PT101 has completed a phase 1a clinical trial backing its safety and tolerability, and is due to start a phase 1a/2b study in ulcerative colitis and a phase 2 trial in systemic lupus erythematosus before the end of the year.

Clinical Trials 71

Clinical Trials Clinical Trials Immune Response Trials 71

pharmaphorum

JANUARY 31, 2022

The COVID-19 vaccines were brought to market faster than any other vaccines in history. Better access to high-quality data makes informed decision-making easier and promotes innovation in vaccine development. Partly as a result of these developments, vaccine innovation has grown by leaps and bounds in just the past year.

Vaccine 97

Vaccine Vaccination Development Marketing 97

pharmaphorum

SEPTEMBER 8, 2021

Kadmon claimed approval for Rezurock (belumosudil) in July as a treatment for chronic graft versus host disease (GVHD) – a common and often fatal complication that can follow a bone marrow transplant and which occurs when the donated cells mount an immune response against the transplant recipient’s tissues and organs.

Drugs 52

Drugs Sales Immune Response Marketing 52

pharmaphorum

JANUARY 25, 2021

The company – known as MSD outside North America – said that although the vaccines were well tolerated, the immune responses seen were weaker than natural immunity and those reported for other SARS-CoV-2 vaccines.

Vaccine 52

Vaccine Vaccination Immune Response Development 52

The Pharma Data

OCTOBER 14, 2020

Orphan drug designation qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing, up to seven years of marketing exclusivity for the orphan indication and waiver of certain FDA fees. About APX005M. Binding of APX005M to CD40 on antigen presenting cells (i.e.,

Immune Response 40

Immune Response Drugs Antibody Clinical Trials 40

The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The country is its second-largest market, behind the U.S., That has changed.

Vaccine 52

Vaccine Vaccination Antibody Licensing 52

The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech. About FixVac. About BioNTech.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

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.

Vaccine 52

Vaccine Vaccination Immune Response Containment 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

Vaccine 52

Vaccine Vaccination Immune Response Protein 52

XTalks

SEPTEMBER 21, 2023

The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc., announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

The Pharma Data

OCTOBER 27, 2020

Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com. Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations.

Sales 52

Sales Immune Response Clinical Development Development 52

The Pharma Data

AUGUST 17, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Immune Response 52

Immune Response Trials Medicine FDA Approval 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 1 as compared to the companies’ current COVID-19 vaccine.

Vaccine 100

Vaccine Vaccination Medicine Clinical Trials 100

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

XTalks

AUGUST 18, 2021

Of important note is the aberrant immune response that occurs in patients with COVID-19, including the intensive release of cytokines (cytokine storm), which can make a patient infected with SARS-CoV2 more susceptible to contracting a bacterial respiratory infection. Addressing AMR has to become a priority again.”.

Development 105

Development Bacteria Drugs Vaccination 105

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.

Vaccine 81

Vaccine Vaccination Clinical Trials Clinical Trials 81

Pfizer

JULY 8, 2022

In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021.

FDA Approval 102

FDA Approval Vaccine Vaccination Clinical Trials 102

The Pharma Data

JANUARY 19, 2021

The company’s focus is on the development, manufacture, marketing and sale of licorice products, oxytetracycline products, traditional Chinese medicine derivatives, heparin, sausage casing, and fertilizers. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

In-Vitro 52

In-Vitro Production Trials Manufacturing 52

The Pharma Data

JANUARY 20, 2021

Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, today announced the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50

DNA 40

DNA Containment Immune Response Sales 40

Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5)

Vaccine 85

Vaccine Vaccination Clinical Trials Clinical Trials 85

Roots Analysis

OCTOBER 30, 2023

Considering the potential of these therapies, several industry stakeholders are actively engaging in the development of such therapeutics. The support from venture capitalists and big pharmaceutical companies will continue to drive the development of circular RNA therapeutics and RNA therapeutics market growth over the forecast period.

RNA 40

RNA Vaccine Vaccination Development 40

Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN?

Vaccine 52

Vaccine Vaccination RNA Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Crohn’s Disease Therapeutics Market Size $4.7 Phase1b/2 clinical study to be conducted in the United States and several European countries. Recently, we also successfully demonstrated that nasally administered Foralumab is not only well-tolerated, but also produced desirable immunological responses.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

SEPTEMBER 8, 2021

3,4 Acapatamab engages PSMA on cancer cells and CD3 on T cells, inducing T-cell activation, proliferation and target cell lysis to prompt a cancer-fighting immune response. Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRAS G12C inhibitor. In the U.S.,

Trials 52

Trials Clinical Trials Clinical Trials Clinical Development 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

Licensing 52

Licensing Licensing Vaccine Vaccination 52

The Pharma Data

JANUARY 4, 2021

Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. “We believe Prof.

In-Vivo 40

In-Vivo Development Immune Response Big Data 40

The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

Vaccine Vaccination Manufacturing Clinical Trials 52