PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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The Pharma Data

MAY 8, 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. Disclaimer. About Sandoz.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

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Drug Target Review

JANUARY 8, 2024

Jerry has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development, and global commercialisation of more than a dozen FDA-approved drugs with multiple successful exits. a commercial stage pharmaceutical company. acquired by Teva Pharmaceuticals in 2014.

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The Pharma Data

DECEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “The executive vice president of research and development. “We About Lexicon Pharmaceuticals.

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Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

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The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. 22, 2021 12:00 UTC.

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Broad Institute

NOVEMBER 2, 2023

Our joint goal is to bring innovation to cancer patients by building a robust, sustainable pipeline in oncology,” said Dominik Ruettinger, Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG.

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The Pharma Data

DECEMBER 1, 2020

01, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. About Allena Pharmaceuticals Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders.

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The Pharma Data

JANUARY 3, 2021

03, 2021 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceutical company traded on the Stock Exchange of Hong Kong (1477.HK),

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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. Disclaimer. About Sandoz.

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The Pharma Data

JANUARY 10, 2021

Dr. Ken Kobayashi, CMO, ASLAN Pharmaceuticals, commented: “The emerging safety profile of ASLAN004 has allowed us to move directly into the expansion cohort at the highest dose, 600mg weekly, based on blinded safety data, accelerating the completion of the study. SINGAPORE, Jan. Media and IR contacts. Forward looking statements.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. SAN JOSE, Calif. ,

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. About Eloxx Pharmaceuticals. Eloxx Pharmaceuticals, Inc. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. SOURCE: Eloxx Pharmaceuticals, Inc. WALTHAM, Mass., Conference ID : 9467336. Source link.

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The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.). ET ) to discuss the results and next steps in clinical development of BI-1206. About CASI Pharmaceuticals. CASI Pharmaceuticals, Inc. SOURCE CASI Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 15, 2020

. ASLAN appoints neurologist Professor Gavin Giovannoni as a scientific advisorto establish clinical development strategy in multiple sclerosis. Following an internal strategic review and noting changes in the AML treatment landscape, ASLAN will be focusing the future development of ASLAN003 in autoimmune disease.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. About CNS Pharmaceuticals, Inc. SOURCE CNS Pharmaceuticals, Inc. .

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DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. This has sparked the development of a new approach to treating neuropsychiatric disorders.

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Drug Target Review

FEBRUARY 10, 2025

Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies. My focus has always been on advancing novel medicines from research to clinical development. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

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The Pharma Data

JANUARY 26, 2021

27, 2021 /PRNewswire/ — Armata Pharmaceuticals , Inc. About Armata Pharmaceuticals, Inc. Media Contacts: At Armata: Steve Martin Armata Pharmaceuticals, Inc. SOURCE Armata Pharmaceuticals, Inc. . .

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Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Armata Pharmaceuticals , Inc. Patrick , Chief Executive Officer of Armata Pharmaceuticals. About Armata Pharmaceuticals, Inc. Media Contacts: At Armata: Steve Martin Armata Pharmaceuticals, Inc. . .

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The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. 5, 2020 11:00 UTC. LEXINGTON, Mass.–(

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Sygnature Discovery

JANUARY 26, 2024

Leveraging years of experience, we efficiently advance your compounds through preclinical studies and reduce risks as you move into clinical development. Our talented team of scientists can assist you in crafting robust pre-clinical development strategies.

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The Pharma Data

JANUARY 24, 2021

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures. About Citius Pharmaceuticals, Inc. CRANFORD, N.J. ,

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The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. He also previously served as Global CMO at Taiho Pharmaceutical Company, Ltd. He also held roles at Onyx Pharmaceuticals, Millennium Pharmaceuticals, Roche and Bristol-Myers Squibb.

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. In other words, it’s a sweeping application across the industry.

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New Drug Approvals

MAY 15, 2025

A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinical development as an anti-inflammatory therapeutic. World Health Organization (2016). hdl : 10665/331020. World Health Organization (2017). hdl : 10665/330984.

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The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link].

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan.

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The Pharma Data

NOVEMBER 1, 2020

02, 2020 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (‘China Grand Pharma’) for Telix’s portfolio of Molecularly-Targeted Radiation (‘MTR’) products. .

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The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product).

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Conversations in Drug Development Trends

APRIL 15, 2024

Worldwide Clinical Trials recently conducted a comprehensive research study, where we included 140 key industry-decision makers from biotech and pharmaceutical companies of all sizes. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

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The Pharma Data

DECEMBER 3, 2020

He also served as CFO at Aralez Pharmaceuticals Inc. Prior to UroGen, Pfreudschuh was the CFO of Sucampo Pharmaceuticals Inc., Monti has served as president and CEO of Pherin Pharmaceuticals. Bradshaw most recently served as CSO for Arrowhead Pharmaceuticals. and spent 11 years at Sanofi in a variety of financial roles.

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