PM360

DECEMBER 14, 2023

Moderna Joins CEPI Pandemic Preparedness Mission After making its debut in the pharma market during the COVID-19 pandemic, Moderna is preparing for the next pandemic. The pharma company has joined the Coalition for Epidemic Preparedness Innovations (CEPI) in a partnership that aims to shorten vaccine development timelines down to 100 days.

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Pharmaceutical Technology

DECEMBER 12, 2022

The data, which is collated from the GlobalData Pharma Intelligence Center’s Deals Database and PharmSource reports on these outsourcing relationships, provides a glimpse of not only the different players involved in the pharma supply value chain, but also the nature of the contracts that link them.

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Pharmaceutical Technology

JULY 7, 2022

There is a lot of excitement that we could be at the start of a new era for the biopharmaceutical industry, with the hope of delivering revolutionary healthcare for previously unaddressed diseases finally becoming a reality.

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Clarivate

JANUARY 8, 2024

FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. The year 2024 is shaping up to be the best of times and the worst of times for the pharma industry,” said Henry Levy, President, Life Sciences & Healthcare at Clarivate. Granted U.S.

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Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

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European Pharmaceutical Review

DECEMBER 21, 2022

This US pathway offers early-phase benefits, including greater FDA collaboration. This US pathway is usually leveraged at later stages in drug development and permits sponsors to use surrogate endpoints to get faster FDA approval. She has held diverse roles within CROs as well as with large and small pharma. Priority review.

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MedCity News

OCTOBER 27, 2022

Earlier this year, the FDA approved the biotech’s first rare disease drug, a treatment for a type of anemia. Agios Pharmaceuticals sold royalties to an approved cancer drug to get immediate cash to support its new focus on rare diseases.

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Clarivate

NOVEMBER 13, 2023

More recently, the FDA has developed the Patient Focused Drug Development (PFDD) Guidance Series, which provides sponsors with guidance on how to collect and submit patient experience data in medical product development for regulatory decision making. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

Patients 52

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Clarivate

MAY 24, 2022

The consortium aims to promote awareness for rare diseases within the healthcare community and general public, address the impending issue of drug availability and improve the quality of life of rare disease patients. Multinational pharmas seek entry for their products. 3] Rare Diseases at FDA [online]. [4] References. [1]

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PM360

SEPTEMBER 15, 2022

But battling information asymmetry is one of the best ways to address the ongoing inequities in our healthcare system. But to shift the industry’s approach to healthcare, all stakeholders must move the efforts, attention, and education necessary to find a common ground and ensure that the patients’ interests are always driving development.

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PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. Patients want to know other patients are involved in what pharma is doing. Learn how pharma is involving them. They want to hear about those patients’ experiences.

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Patients Pharma Education Media 59

Clarivate

APRIL 4, 2024

That’s a problem for patients, in whom treatment safety and efficacy can sometimes vary by ethnicity, as well as developers, who are under increasing pressure from regulators like FDA to demonstrate how their products stand to impact diverse populations. Such insights aid in gauging the market demand for newly developed medications.

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Electronics Patients Medical FDA 52

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

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FDA Food and Drug Administration Patients Biopharma 207

Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. By end of year, as many as ten adalimumab biosimilars could be on the U.S. biologics market and reduce prescription drug costs.

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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

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Food and Drug Administration Patients Side effects Medicine 52

Clarivate

NOVEMBER 10, 2022

The evidence standards that a COA must meet to support key clinical trial endpoints have become increasingly stringent in recent decades, following the introduction of the United States Food and Drug Administration (FDA) Patient Reported Outcomes (PRO) draft guidance in 2006, followed by the full guidance in 2009.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Clarivate

NOVEMBER 23, 2021

Recently, Mike Ward, Head of Thought Leadership, Life Sciences and Healthcare at Clarivate spoke with Oriol Serra (at the time of recording Mr. Oriol Serra was Head of Site Intelligence & Site Selection at Pfizer) and Simon Andrews, Vice President of RWD Engagements and Innovations at Clarivate, on the topic.

Patients 52

Patients Recruitment Management Healthcare 52

European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

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Manufacturing Food and Drug Administration Biopharma Marketing 76

Clarivate

NOVEMBER 14, 2023

Figure 1: Timeline of GLP-1 RA development [9] , [10] Abbreviations: EMA, European Medicines Agency; US FDA, United States Food and Drug Administration. Since then, two GLP‑1 RAs requiring only once-daily injection have become available, followed by three which require only once-weekly injection (Figure 1). [7] What’s next in diabetes?

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Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Learn more about our healthcare market intelligence solutions. Key ESMO findings. References. [1]

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Clarivate

MARCH 17, 2022

Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Ahead of the meeting, the FDA highlighted nonclinical findings (i.e., We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Clarivate

NOVEMBER 8, 2022

Beyond these household names there is an entire world of innovator companies – plucky startups and well-resourced large pharmas alike – looking to leverage this emerging technology to treat and even cure a wide variety of diseases. . Cargene Biopharma Inc., DTx Pharma Inc., Aro Biotherapeutics , a Philadelphia, U.S.

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Clarify Health

MAY 19, 2020

After FDA-approval comes the last critical mile of this journey: bringing the product to market. There is also a looming, time-sensitive reality that biopharma companies face once their products hit the market: they need to recoup the costs of development as quickly as possible before drug patents expire and generics threaten sales.

Biopharma 52

Biopharma Physicians Marketing Prescription 52

Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

Pharmaceutical Technology

MARCH 21, 2023

In this month’s edition, which covers events from late January to early March, manufacturing contract-related data from GlobalData’s PharmSource reports and news from GlobalData’s Pharma Intelligence Center have been collated to identify stakeholders at the center of new developments.

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Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. FDA expands approval labels.

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