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. About Sandoz.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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The Pharma Data

OCTOBER 26, 2020

Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. The forward-looking statements contained in this press release reflect Synlogic’s current views with respect to future events. The conference ID number for the call is 8557525.

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Alta Sciences

AUGUST 18, 2023

Don’t miss out: [link] Event End Date Thu, 10/26/2023 - 12:00 Event Start Date Thu, 10/26/2023 - 12:00 Weight 1

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Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

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Drug Target Review

AUGUST 24, 2023

Infiltration of immune cells into tissues follows a cascade of events, namely rolling, activation, adhesion and transmigration, which are mediated by different molecules. How does GDF-15 impact the tumour microenvironment and the infiltration of T cells into the tumour?

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PPD

OCTOBER 17, 2024

They also need to have the medical competencies to manage adverse events often associated with these therapies. Finding experienced experts to facilitate the drug development process from beginning to end is difficult, making training programs the ideal solution to expand advanced therapy development to more remote areas.

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LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement. Source link.

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The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests.

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec. Contact: Tauriga Sciences, Inc.

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The Pharma Data

APRIL 28, 2022

In the trial, there was no statistical difference in estimated hypoglycaemia rates, and no severe hypoglycaemia events were observed for people treated with insulin icodec. The rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) were 0.73 events per patient-year exposed to insulin degludec.

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The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. SINGAPORE, Oct. The company expects to share further details in early 2021.

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). and whether a molecule’s pharmacology can help to mitigate safety risk.

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The Pharma Data

MARCH 18, 2021

The most common adverse events were gastrointestinal. Across all groups, 5–14% of people discontinued any trial treatment due to adverse events. The study met its primary endpoint, demonstrating that all regimens were well tolerated over 24 weeks.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. About Moderna. View source version on businesswire.com: [link].

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Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? Also known as a clinical event committee (CEC), EAC members evaluate a clinical event in the context of the protocol and the individual participant’s medical information.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Source link.

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The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

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The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

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The Pharma Data

JUNE 28, 2021

It was studied specifically in patients who have experienced a recent worsening heart failure event, meaning a recent hospitalization for heart failure or the use of intravenous diuretics, in order to reduce the risk of further worsening events. Verquvo (vericiguat) was approved by the U.S.

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The Pharma Data

SEPTEMBER 6, 2021

In the study, eliapixant demonstrated a positive benefit-risk profile, with the vast majority of adverse events considered mild or moderate. Discontinuation of the study due to adverse events occurred in 8% of patients treated with eliapixant. These results will guide us to advance our clinical development strategy of eliapixant.”.

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DrugBank

SEPTEMBER 26, 2024

For instance, Inflectra , a biosimilar of Remicade, underwent a comprehensive clinical development program, including a Phase III trial demonstrating comparable efficacy and safety to the reference product in patients with rheumatoid arthritis.

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The Pharma Data

OCTOBER 27, 2020

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. View original content to download multimedia: [link]. Source link.

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The Pharma Data

APRIL 24, 2023

“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

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The Pharma Data

DECEMBER 3, 2020

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. We are proud to be partnered with Clover in our endeavors to develop a safe and effective COVID-19 vaccine that will be readily accessible around the world to combat this ongoing pandemic.”.

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The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. population will have obesity. About Boehringer Ingelheim.

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The Pharma Data

AUGUST 31, 2021

Teva will continue to lead the clinical development and regulatory process and be responsible for commercialization of this candidate treatment, with MedinCell eligible for development milestones, royalties on net sales and future commercial milestones. About Schizophrenia.

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The Pharma Data

OCTOBER 14, 2020

Live Webcast : accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or with this link: [link]. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. Domestic Dial-in Number : (866) 913-8546. International Dial-in Number: (210) 874-7715.

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The Pharma Data

JANUARY 10, 2021

There were no serious adverse events related to treatment and no clinically significant injection site reactions. The approval was received following a review by the DMC of blinded safety data from all three dose cohorts of the MAD study. ASLAN004 was found to be well tolerated at all dose levels. Source link.

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The Pharma Data

JANUARY 19, 2021

The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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The Pharma Data

JANUARY 7, 2021

a clinical-stage biopharmaceutical company, today announced that Xiaodong Yang , M.D., President and Chief Executive Officer, will participate in two upcoming virtual investor healthcare conferences: The Solebury Trout Virtual Management Access Event being held January 6 – 15, 2021. SAN CARLOS, Calif. , About Apexigen.

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The Pharma Data

JUNE 7, 2023

Grade 3 or greater treatment-related adverse events (TRAEs) occurred in 31% of patients receiving doublet therapy and 58% of patients receiving triplet therapy. Across treatment cohorts, there were 27 interstitial lung disease (ILD) or pneumonitis events adjudicated as drug-related by an independent committee.

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The Pharma Data

DECEMBER 16, 2020

“Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. These statements relate to future events, future expectations, plans and prospects. and 2 trials planned by our sublicensee WPD in Poland. . .

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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