Fierce BioTech

JULY 25, 2023

How combining datasets from multiple sources can inform and improve commercial strategies Hundreds of rare disease treatments have entered the market over the past decade—thanks largely to a combination of government incentives, strong urging from patient advocacy groups and advances in cell and gene therapies.

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PPD

FEBRUARY 10, 2025

By harnessing the full range of innovative technologies and taking advantage of an FSP partners extensive skills and experience, sponsors are able to bring their therapies to market more quickly and within budget even in the face of complicated global regulations and widely fluctuating workloads.

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The Pharma Data

NOVEMBER 5, 2020

“We are pleased to announce the commercial launch of Hydroxychloroquine Sulfate tablets in the U.S.through our marketing partner,” stated Ashok Barot , Chairman, Aavis Pharmaceuticals. annual market size for Hydroxychloroquine Sulfate Tablets, 200 mg was approximately US$237 million (IQVIA MAT June 2020 ). YARDLEY, Pa.

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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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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

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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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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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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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

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

SEPTEMBER 25, 2023

Focusing on tailoring treatments to individual patients based on genetic, lifestyle and environmental factors, precision medicine offers more targeted and effective therapies while minimizing side effects. Successful market access and product update stems from valuable RWD and RWE regarding a product’s safety, effectiveness and value.

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PPD

SEPTEMBER 27, 2023

Biopharma and biotech companies can overcome these common challenges by partnering with a clinical research organization that integrates data usage, leverages new technologies and embraces innovative approaches to advance clinical trials and quickly bring therapies to market.

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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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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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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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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

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

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

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

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.*.

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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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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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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

DECEMBER 17, 2020

“We are pleased with the expeditious review and approval of our market authorization application for Buvidal by Swissmedic and that patients with opioid dependence in Switzerland will now have access to an effective long-acting treatment,” says Fredrik Tiberg , PhD, President & CEO of Camurus. LUND, Sweden , Dec.

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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

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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The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. View original content to download multimedia: [link].

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The Pharma Data

OCTOBER 19, 2020

. “Innovation in cancer treatment is realized through collaboration, and the physicians and researchers at Emory’s Winship Cancer Institute have consistently shown their commitment to developing novel cancer therapies using this collaborative approach,” said Chadi Nabhan , M.D., Europe , Asia and other international markets.

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The Pharma Data

DECEMBER 28, 2020

Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Mr. Weild is a globally recognized leader in capital formation and capital markets structure. ” The new directors are: Raphael (“Rafi”) Hofstein, Ph.D.

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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

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

MAY 6, 2021

myDiabby Healthcare and Roche – to advance connected solutions and streamline care for people living with diabetes in markets outside of the United States. View original content to download multimedia: [link]. Glooko Inc. “People with diabetes need access to all of the key information about their condition. ©Lilly USA , LLC 2021.

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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

NOVEMBER 1, 2020

For Product Enquiries and How to Order: All BD SARS-CoV-2 diagnostic products have regulatory authorizations in the markets where they are sold. View original content to download multimedia: [link]. The SARS-CoV-2 assay has been available in the United States since July through an Emergency Use Authorization by the U.S.

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