Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

Vaccine 111

Vaccine Trials Disease Virus 111

The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). 1 OSTRO involved 413 patients in Europe and North America.

FDA 52

FDA Licensing Licensing Trials 52

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The Evolving Regulatory System Regulatory frameworks play a pivotal role in shaping the pharmaceutical M&A landscape.

Pharmaceuticals 69

Pharmaceuticals Pharmaceutical Companies Marketing Therapies 69

The Pharma Data

JANUARY 17, 2021

Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO.

Marketing 52

Marketing Engineering Therapies Disease 52

The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology. Transaction Terms.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

LifeSciVC

JANUARY 25, 2024

Testing drugs that make it into clinical trials has its own specific challenges. Designing trials to show safety and efficacy in people and doing it in a way that complies with all the regulatory and ethical guidelines is where many drugs fail. Importantly, we were also able to publish the underlying work in high-quality journals.

Science 70

Science Clinical Trials Trials Medical Schools 70

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Clinical Trials 40

The Pharma Data

AUGUST 5, 2020

A separate post hoc analysis demonstrated that nearly 9 out of 10 patients experienced no evidence of disease activity in the second year of treatment 4. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

Trials 52

Trials Treatment Disease Production 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D., .

Trials 52

Trials Treatment Therapies Clinical Trials 52

New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. At Roche, palovarotene was evaluated in more than 800 individuals including healthy volunteers and patients with chronic obstructive pulmonary disease (COPD). [7] 17 September 2018.

FDA 52

FDA Clinical Trials Pharmaceuticals Treatment 52

The Pharma Data

JULY 22, 2021

The estrogen receptor is a well-known disease driver in most breast cancers. ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial). and a disease control rate (DCR) of 86.2%

FDA 52

FDA Clinical Trials Trials Treatment 52

The Pharma Data

NOVEMBER 8, 2020

The New Drug Application (NDA) for the drug is based on data from four Phase III trials in pediatric patient populations from the age of 6 to 17 years, two Phase II trials, several Phase I trials, a long-term open label extension study, preclinical testing, and drug manufacturing data. This is under Priority Review.

FDA 52

FDA Trials Pharmaceuticals Pharmacokinetics 52

New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., 2018 ; Ding et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., 2017 ; Ilievski et al.,

Small Molecule 62

Small Molecule DNA Disease Trials 62

The Pharma Data

JANUARY 13, 2021

With the recent announcement that the RATIONALE 303 trial met its primary endpoint of overall survival at its interim analysis, three Phase 3 trials of tislelizumab in NSCLC have achieved a positive outcome at interim analysis,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Production 52

Production Trials Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 10, 2020

The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. . STOCKHOLM , Nov. in the brain.

Pharmaceutical Companies 40

Pharmaceutical Companies Disease Treatment Pharmaceuticals 40

The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., 1 Lederman, S. 175:1091-1101 (1992) 2 Karpusas, M et al.,

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 2, 2020

Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups. About Achondroplasia. In the U.S.,

Drugs 40

Drugs FDA Pharmaceuticals Treatment 40

The Pharma Data

AUGUST 19, 2021

1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Interstitial Lung Disease/Pneumonitis 7.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

APRIL 23, 2021

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have limited treatment options and a poor prognosis. and a disease control rate of 55.6% (95% CI; 45.7-65.1). and 90.9% (95% CI; 73.7,

Therapies 52

Therapies Treatment Licensing Licensing 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 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

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. In contrast, people with sickle cell disease commonly receive red blood cell transfusions to alleviate vaso-occlusive pain crises. The results of the trial are expected at the end of 2024. In the U.S., million units transfused.

Production 133

Production Clinical Trials Trials Therapies 133

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Clinical Trials Government 40

The Pharma Data

NOVEMBER 4, 2020

Previously they had recommended use of VASCEPA for treating patients with established cardiovascular disease. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 commercial team. “In million and $8.9 million and $5.7 million and $1.1

Production 40

Production FDA Trials Licensing 40

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Human γδ TCR repertoires in health and disease. Trends Immunol 39(6):446-459 (2018).

Therapies 105

Therapies Engineering Molecular Biology Immune Response 105

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. “Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Reese, M.D.,

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

JULY 8, 2021

Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials. The BLA was based on results from the PATHFINDER clinical trials programme, including results from the pivotal NAVIGATOR Phase III trial.

Treatment 52

Treatment FDA Clinical Trials Trials 52

Agency IQ

OCTOBER 6, 2023

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). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Virus Vaccine Pharmacokinetics 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.,

Vaccine 52

Vaccine FDA Approval FDA Disease 52

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. NYSE:PFE) today announced that the U.S.

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

NOVEMBER 17, 2020

Fast Track Designation (FTD) is an FDA process meant to facilitate the development and review of drugs for serious disease and to fill unmet medical need. Accelerated Approval is for drugs for serious diseases that filled an unmet medical need and can be approved based on a surrogate endpoint. Food and Drug Administration (FDA).

FDA 52

FDA Licensing Licensing Therapies 52

The Pharma Data

OCTOBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. The dosing regimen in the Phase 3 is the same as in the pilot trial.

Treatment 40

Treatment Trials Production Disease 40