The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

Drug Discovery World

SEPTEMBER 6, 2022

Cell and gene therapies are not only transforming the way diseases are treated but are also aiming to cure entirely new patient populations. New applications and indications are being researched daily with the hope to address a wide array of rare and chronic diseases that have long been thought incurable. billion raised.

Therapies 130

Therapies Clinical Trials Production Disease 130

Drug Discovery World

APRIL 14, 2023

Dr Schon is applying his broad expertise from lead discovery to manufacture in order to progress differentiated, safe and developable bi-specific therapeutic ADC candidates to clinical development. We may have to explore disease complexity and signaling cascades more critically before entering costly and long clinical trial.

Drug Development 130

Drug Development Drugs Clinical Trials Therapies 130

Drug Discovery World

MARCH 7, 2023

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials.

International 246

International Science Pharmaceuticals DNA 246

The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

Science 52

Science Production Treatment FDA 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

Clinical Trials 52

Clinical Trials Trials Disease Hospitals 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% The CDD will sponsor and manage KWF-supported trials.

Drugs 148

Drugs Science Molecular Biology Clinical Trials 148

The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. The company’s success is based on its rich R&D portfolio with a focus on diseases with high unmet medical need. More than 60 million patients worldwide suffer from this disease, approx.

Research 52

Research Clinical Trials Treatment Production 52

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Accessed April 2021].

Biosimilars 40

Biosimilars Clinical Development Production Government 40

The Pharma Data

JANUARY 19, 2021

With this kind of a start, 2021 may be scorching. The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. It is now in a Phase I/IIa trial for adult NSCLC with EGFRex20ins mutations.

Small Molecule 52

Small Molecule Laboratories Trials Immune Response 52

Drug Discovery World

JULY 2, 2024

OECD data places Switzerland second in the world for biotechnology R&D intensity 1 , and in 2021, the country had the seventh largest share of the global biotech market 2. The centre currently has 58 pharma/biotech assets that are in pre-clinical development, alongside 29 that are being tested in clinical trials.

Science 148

Science Drugs Clinical Trials Licensing 148

The Pharma Data

MARCH 23, 2021

Data presented at ENDO 2021 demonstrate clinically relevant weight loss, without weight regain, in people treated with semaglutide 2.4 Bagsværd, Denmark, 23 March 2021 – New results from the STEP phase 3a clinical trial programme demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4

Trials 52

Trials Clinical Trials Treatment Disease 52

The Pharma Data

JANUARY 14, 2021

15, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX) (NASDAQ – CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021 , which will take place between 1pm and 5pm CET. STOCKHOLM , Jan.

Clinical Trials 40

Clinical Trials Hospitals Disease International 40

The Pharma Data

AUGUST 15, 2021

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. AstraZeneca is working with its partner FibroGen, Inc.

Disease 52

Disease Treatment FDA Clinical Trials 52

The Pharma Data

SEPTEMBER 6, 2021

The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”.

Trials 52

Trials Clinical Trials International Treatment 52

The Pharma Data

JANUARY 10, 2021

The DMC approved the proposal to open the expansion cohort at the highest dose in advance of unblinding data from the first three cohorts of the study, which is expected to take place in early 2021. 1, we believe it has the potential to be best-in-disease which may result in improved safety and efficacy over other biologics in the class.

Clinical Trials 52

Clinical Trials Pharmaceuticals Trials Treatment 52

The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck. About Molnupiravir.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

JANUARY 3, 2021

. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. The Company expects to enroll the first subject in the first half of 2021 and provide preliminary safety and biomarker data in the second half of 2021.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. About Krabbe Disease.

Disease 40

Disease FDA Treatment Clinical Trials 40

Drug Discovery World

OCTOBER 4, 2022

This year’s event will cover some of the most exciting advancements in areas spanning screening, automation, high content imaging, disease models, cell and gene therapies and how innovation is being driven through partnerships and collaborations. In 2021, levels of investment hit an all-time high at $22.7 billion, compared to $19.9

Drugs 130

Drugs Therapies Clinical Trials Cell Based Assays 130

The Pharma Data

JANUARY 20, 2021

20, 2021 /PRNewswire/ — INOVIO Pharmaceuticals, Inc. The offering is expected to close on or about January 25, 2021 , subject to customary closing conditions. PLYMOUTH MEETING, Pa. , Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 All of the shares are being sold by INOVIO. About INOVIO.

DNA 40

DNA Immune Response Disease Clinical Trials 40

The Pharma Data

APRIL 8, 2021

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. About KEYNOTE-564. In the U.S.

Therapies 52

Therapies Disease Research Laboratories Trials 52

The Pharma Data

JUNE 25, 2021

First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting. 41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; KENILWORTH, N.J.–(BUSINESS

Disease 52

Disease Therapies Treatment Medical Schools 52

The Pharma Data

JULY 12, 2021

Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

FDA Approval 52

FDA Approval Disease FDA Treatment 52

Drug Discovery World

JULY 11, 2022

These challenges exist across the translation cycle from early research to clinical trials, manufacturing, and ultimately reimbursement. The complexities of sample management can significantly extend the timelines for clinical trials. 2021, February 23). Regulatory requirements. Conclusion. About the author.

Therapies 130

Therapies Clinical Trials Production Trials 130

Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By 2021, the number of PPD employees exceeded 30,000 globally, and Thermo Fisher Scientific Inc.

Clinical Trials 52

Clinical Trials Clinical Research Laboratories Trials 52

The Pharma Data

JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JANUARY 25, 2021

– January 26, 2021) – NervGen Pharma Corp. The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. Vancouver, British Columbia–(Newsfile Corp. Dr.

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

The Pharma Data

JANUARY 13, 2021

14, 2021 11:00 UTC. PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. study centers.

Small Molecule 52

Small Molecule Trials Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 8, 2021

Data from the analyses were presented at the American Society of Nephrology (ASN)’s Order Week 2021 in two oral donations and two late- breaking bills. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52

The Pharma Data

DECEMBER 18, 2020

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).

Disease 52

Disease FDA FDA Approval Science 52

Drug Discovery World

MAY 16, 2023

Investment landscape In 2023, Matthieu de Kalbermatten, CEO of CellProthera, looks forward to presenting the final safety and efficacy results of the company’s Phase II clinical trial, and for moving into Phase III. Entering pivot trials with a low-throughput, high-cost, highly variable, paper-based process is no longer acceptable.

Therapies 130

Therapies Clinical Trials Marketing Production 130

LifeSciVC

JANUARY 16, 2024

recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Additional trials (e.g., Join the club.

Small Molecule 139

Small Molecule Trials Therapies Disease 139

The Pharma Data

JULY 18, 2021

VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.

Disease 52

Disease Immune Response Vaccine FDA Approval 52