PPD

NOVEMBER 4, 2024

Increasing complexity of clinical trials rounds out the list of the top challenges facing sponsors in 2024, driven by factors such as enrollment of hard-to-find patient populations , compliance with complex regulatory requirements and innovative therapies that require complex protocols.

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The Pharma Data

NOVEMBER 23, 2020

CMTI) has received 60+ red light therapy (RLT) modules for initial photonics testing and product fabrication. View original content to download multimedia: [link]. FRISCO, Texas , Nov. 24, 2020 /PRNewswire/ — Curtis Mathes Corporation (OTC: TLED) subsidiary, Curtis Mathes Therapeutics, Inc.

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The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Nightware is not a standalone therapy for PTSD.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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The Pharma Data

SEPTEMBER 15, 2020

Download Your Copy. We respect your privacy, by clicking “Download Your Copy” you will receive our e-newsletter, including information on Podcasts, Webinars, event discounts, online learning opportunities and agree to our User Agreement. Balance risk and innovation in regulation using new digital-therapy products.

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The Pharma Data

DECEMBER 22, 2020

Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy. Outside of Japan , Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. , ” About Rakuten Medical, Inc.

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Drug Channels

MAY 22, 2023

WHAT YOU WILL LEARN As expensive specialty therapies come to dominate drug spending, pharmaceutical manufacturers are paying a growing share of patents’ out-of-pocket costs for these prescriptions. Or, download this spreadsheet and email your registrants’ information to Tamra Feldman ( admin@drugchannels.net ).

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PPD

MARCH 26, 2024

Backed by a 25-year legacy of FSP support for clinical and marketed products, we know what it takes to deliver customized solutions tailored to the unique needs of each client, providing much-needed resource flexibility, reliability and continuity. Stay ahead of the competition with the latest FSP insights and trends.

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The Pharma Data

JANUARY 9, 2021

(NASDAQ: BMRN) today announced positive topline results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. This is the largest global Phase 3 study to date for any gene therapy in any indication, with 134 participants.

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Drug Channels

OCTOBER 19, 2020

You can download the complete agenda here. Download the agenda to plan your sessions and wrap up your week armed with critical updates and valuable takeaways. Visit www.informaconnect.com/trade-channel for further details and to register. Visit www.informaconnect.com/trade-channel for further details and to register.

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Drug Channels

MAY 9, 2022

Emily Phillips, Reimbursement, Patient Advocate, & Government Affairs Leader Melissa Beatty, Director, Patient Services and Reimbursement, CTI Bio Pharma Chad Bower, Executive Director, Field Reimbursement & Oncology Solutions, US Market Access, Daiichi Sankyo, Inc. Download the full agenda and save your seat today!

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Drug Channels

NOVEMBER 8, 2020

You can download the complete agenda here. Visit www.informaconnect.com/trade-channel for further details and to register. Drug Channels readers will save $200 off the standard rate when they use code KTP933 and register prior to November 20th.*. Stuart Parker, Senior Director, Trade Relations, Mayne Pharma And more!

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Perficient: Drug Development

AUGUST 20, 2023

Virtual Therapists and Chatbots Online platforms and apps offering virtual therapy sessions or AI-driven chatbots provide accessible and immediate support to individuals who may find traditional therapy challenging or expensive.

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Perficient: Drug Development

AUGUST 8, 2023

Here are some ways to provide support: Speech Therapy Speech therapy is a specialized field that plays a crucial role in helping individuals overcome speech disabilities and communication challenges.

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The Pharma Data

JANUARY 20, 2021

The first target market for CureLab Veterinary’s patented DNA therapeutics will be to treat cancer in dogs and cats. “Receiving market authorization through the USDA approval process is cost efficient and relatively fast. View original content to download multimedia: [link]. BOSTON , Jan. About CureLab Oncology.

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The Pharma Data

DECEMBER 27, 2020

C-RAD offers a specific version of its Catalyst System for use in proton and particle therapy – Catalyst PT. “There is a trend within radiation therapy towards high precision treatments. STOCKHOLM , Dec. The other sites will follow in 2021 and 2022. About C-RAD.

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PPD

JUNE 17, 2024

For example, a company bringing its first gene therapy candidate to market but lacking key expertise in running a gene therapy trial can start with an FSO model and transition to FSP arrangements as their internal expertise and experience grows.

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The Pharma Data

DECEMBER 9, 2020

10, 2020 /PRNewswire/ — Swedish Orphan Biovitrum AB (publ) (Sobi ) (STO: SOBI) today announced that a Marketing Authorization Application for emapalumab has been accepted for review in China. In the US, emapalumab is the first therapy approved by the US Food & Drug Administration (FDA) for primary HLH. STOCKHOLM , Dec.

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Drug Channels

AUGUST 14, 2021

In such a fluid year for medication access and affordability, join influential stakeholders as they innovate on copay program design and operations, identify key trends in market access, patient affordability and the future of the drug pricing and analyze the impact of cost sharing on out of pocket costs and high deductible health plans.

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The Pharma Data

OCTOBER 20, 2020

CureLab intends to receive market approval for commercialization in the GCC region. The GCC market is lucrative, and the tax policies in Dubai are attractive. View original content to download multimedia: [link]. ” About Elenagen CureLab’s lead product, Elenagen , is a DNA encoding gene called p62/SQSTM1. .”

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Drug Channels

OCTOBER 26, 2020

You can download the complete agenda here. Download the agenda to plan your sessions and wrap up your week armed with critical updates and valuable takeaways. Drug Channels readers will save $300 off the standard rate when they use code GNB425 and register prior to October 30th.*.

Government 40

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The Pharma Data

NOVEMBER 4, 2020

The aim is to sign 1-2 new license agreements per year, with focus on orthopedic and dental implants, as well as different types of products for the urinary tract, blood stream and airways for the global market. We now have a broader base and better market coverage in Europe , the Middle East , India , Southeast Asia and China.

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The Pharma Data

NOVEMBER 3, 2020

m (-), including US launch of the scientifically proven digital therapies deprexis® and vorvida®. These changes in prioritization have been made to ensure we have all the resources needed to secure a successful launch of the digital therapies and to ensure OX124 development is finalized and meet FDA’s requirement.

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PPD

OCTOBER 2, 2024

To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.

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Clinical Trials Clinical Development Clinical Research Trials 52

The Pharma Data

JANUARY 7, 2021

The ADSs have been approved for listing on The Nasdaq Global Market and are expected to begin trading on January 8, 2021 under the ticker symbol “GRCL “ The offering is expected to close on January 12, 2021 subject to the satisfaction of customary closing conditions. SUZHOU and SHANGHAI, China , Jan.

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The Pharma Data

JANUARY 13, 2021

The 17,000-square-meter site includes 6,500 square meters of lab space and one KUBio modular facility, and will enable quick ramp-up of antibody development services and manufacturing, which are urgently needed to respond to market needs for biologics, including mAbs and other complex proteins, in and for China , and the rest of the world.

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The Pharma Data

DECEMBER 1, 2020

IsoPlexis’ Single-Cell Intracellular Proteome solution has been recognized for its impact on the development of better targeted and edited therapies and its potential to innovate and accelerate medical research. MEDIA CONTACT: Jon Chen VP of Marketing info@isoplexis.com. BRANFORD, Conn. , BRANFORD, Conn. ,

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Therapies Disease Science Research 52

The Pharma Data

DECEMBER 14, 2020

The global GBM treatment market is projected to reach $3.3 representing the largest market. The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O 6 -alkylguanine DNA alkyltransferase (MGMT).

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Clinical Trials DNA Drugs Therapies 52

The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. About ImaginAb. ImaginAb Inc. Source link.

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The Pharma Data

SEPTEMBER 11, 2020

a clinical AI analytics platform, has partnered with iNDX.Ai , a data analytics and translation research platform, to launch a Covid-19 command center to accelerate research and development programs for therapies to prevent and treat Covid-19. Saama Technologies, Inc. , Source link.

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The Pharma Data

NOVEMBER 24, 2020

In prostate cancer there is currently no other therapy available for patients to prevent cancer recurrence. Currently, these patients undergo only surveillance and have no access to preventive therapy. Only when patients are diagnosed with recurring and now metastatic cancer, are they again eligible for therapy such as hormone therapy.

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The Pharma Data

NOVEMBER 15, 2020

Cytiva provides FlexFactory bioprocessing upstream and downstream solutions for Clover to accelerate GMP facility development and shorten time to market. Additionally, Clover is leveraging its in-house GMP biomanufacturing capabilities to support large-scale production of its biologic therapies. SHANGHAI , Nov.

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The Pharma Data

JANUARY 13, 2021

At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA. MindMed Co-CEO J.R. About MindMed.

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The Pharma Data

JANUARY 31, 2021

An issue of SEK denominated senior unsecured callable floating rate bonds in the amount up to SEK 500 million , under a framework of SEK 1,000 million and with a tenor of four years (the “New Bonds”) may follow, subject to, inter alia, market conditions. CONTACT: This information was brought to you by Cision [link].

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The Pharma Data

DECEMBER 29, 2020

HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company was officially included into the Shenzhen-Hong Kong Stock Connect program (the “Hong Kong Stock Connect”). Ascentage Pharma (6855.HK)

Clinical Development 52

Clinical Development FDA Regulations Clinical Trials 52

Perficient: Drug Development

SEPTEMBER 26, 2023

While traditional therapies and interventions have proven beneficial, technology, particularly brain training apps, offers a new dimension of support. Challenges Faced by Individuals with Cognitive Disabilities Living with a cognitive disability can present numerous challenges for individuals and their families.

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