pharmaphorum

APRIL 26, 2022

Compared to a ‘critical organ’ that had been largely ignored, companies working to develop microbiome-based therapies believe there is untapped potential in the area. Ben Hargreaves speaks to companies that are developing therapies not just in gastrointestinal conditions but also in broader areas, such an immuno-oncology.

Containment 115

Containment Development Production Immune Response 115

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. President of Research and Development, Novavax.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

DECEMBER 28, 2020

.” The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Any forward-looking statements contained in this release speak only as of its date. About Moleculin Biotech, Inc. .

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

Delveinsight

DECEMBER 13, 2020

Due to hepatitis C, most people develop cirrhosis, or scarring of the liver, before liver cancer; about 5–25% of patients with chronic hepatitis C develop cirrhosis over 10–20 years. Research and development in Hepatitis. Frequent side effects and average sustained viral response (SVR) was observed with IFNa treatment.

Genotype 52

Genotype FDA Approval DNA Drugs 52

XTalks

AUGUST 17, 2020

Immunotherapy continues to be a burgeoning field, with immune-based therapies being among the leading treatments being developed in oncology and autoimmunity. Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses. Nature by Design.

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

DECEMBER 11, 2020

company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”. “We

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. With the world watching, the biopharmaceutical community got to work.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. Jansen, Ph.D., Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

Vaccination 52

Vaccination Vaccine FDA Approval Containment 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. INTERCHANGEABILITY.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Seronegative patients (n=217) had much higher viral loads than those who had already developed their own antibodies (seropositive) to SARS-CoV-2 at the time of randomization. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

hAd5 Vaccine Seeks to Develop Immune Memory The hAd5-COVID-19 vaccine candidate is a novel, engineered, second-generation human adenovirus serotype 5 vaccine. Because it delivers both the S and N proteins, the vaccine has the potential to enable recipients to develop immune “memory”, promoting long-lasting immunity to SARS-CoV-2.

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” patients under an Emergency Use Authorization, and we also continue a robust clinical development program.”

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. Therapeutic product development is a long process, but we’re making great progress. 28, 2020 13:00 UTC. CARLSBAD, Calif.–(

Manufacturing 52

Manufacturing Production Development Clinical Trials 52

Drug Discovery World

MAY 11, 2023

However, the increased complexity and diversity involved in the development and manufacturing of gene therapies and vaccines can cause challenges when it comes to determining the quality of the final product, particularly around the detection of impurities. In the case of therapeutics, the aim is usually to avoid patients’ immune responses.

Production 52

Production Gene Protein Vaccination 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 The information contained in this release is as of July 19, 2022. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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. Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

AUGUST 17, 2021

development lead, gastrointestinal cancers, Bristol Myers Squibb. 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. Waxman, M.D., On March 25, 2011, the U.S.

Immune Response 52

Immune Response Trials Medicine FDA Approval 52

Pfizer

OCTOBER 20, 2022

“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

Vaccination 40

Vaccination Vaccine Containment Immune Response 40

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

pharmaphorum

NOVEMBER 2, 2021

Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed. The BiTE platform is an innovative technology designed to engage the immune system against numerous stages and types of cancers.

Antibody 52

Antibody Immune Response Production Engineer 52

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

APRIL 11, 2021

vice president, thoracic cancers development lead, Bristol Myers Squibb. 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. About CheckMate -816.

Trials 52

Trials Immune Response Genome Genomics 52

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

JUNE 30, 2021

development lead, gastrointestinal cancers, Bristol Myers Squibb. Efficacy outcome measures included objective response rate (ORR) as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response (DOR). Waxman, M.D.,

Trials 52

Trials Genome Genomics Containment 52

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. We developed TG4001, a viral based vaccine against the HPV E6 and E7 antigens. 27, 2020 06:30 UTC. Christophe Le Tourneau, M.D.,

Vaccination 52

Vaccination Vaccine Trials Containment 52

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. Rare Blood Disorder.

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

JULY 23, 2021

For the past three and a half years, Opdivo monotherapy has been an important option that physicians have relied on to address this need and is currently the most commonly used therapy in the post-sorafenib setting,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

“We support the FDA’s efforts to evaluate accelerated approvals across the industry as an important element of how the agency ensures the integrity of the accelerated approval program,” said Ian M. development lead, gastrointestinal cancers, Bristol Myers Squibb. “In Waxman, M.D.,

Trials 52

Trials Hormones Genome Genomics 52

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) The companies will share the development costs. Ugur Sahin, M.D.,

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

AUGUST 11, 2020

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. Waxman, M.D.,

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “We We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. Waxman, M.D.,

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98