pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. . Project Patient Voice .

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Pharmaceutical Technology

JUNE 15, 2023

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.

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FDA Law Blog: Biosimilars

MARCH 7, 2024

As another example, both documents note the possibility that if FDA has safety information relevant to an ongoing study, it may request that the sponsor confirm that the DMC is aware of that safety data and is taking it into consideration, or “request that the sponsor arrange for FDA to communicate with, or even meet with, the DMC.”

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Express Pharma

MAY 24, 2023

The day concluded with the delegates solving an exciting case study by Tahseen Rana on the drug development process while dealing with the pandemic and timelines! Check out their LinkedIn page and event website for more updates! The second day of the conference was theme-based, i.e. Retro or Bollywood.

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pharmaphorum

NOVEMBER 1, 2021

Patient centricity isn’t a box ticking exercise – it’s a mindset that has to run the entire length of the drug development pathway. One example of patient centricity in action at Boehringer Ingelheim is how the company has changed its clinical trial communications policies, she said.

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Pharmaceutical Technology

JUNE 6, 2025

wants to ensure the ensuing the US does not lag behind other countries in drug development. We want to make sure we are getting rid of the regulatory impediments [that stop drugs getting to market],” RFK Jr stated. We may still continue to send you service-related and other non-promotional communications.

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Express Pharma

AUGUST 9, 2024

2] Clear roles and responsibilities and precise communication will help bridge the gap between R&D, manufacturing and supply chain, and aid the process of tech transfer, making it effective and faster. [3] 3] Peptides drug development has seen significant progress. Hence, automating is the need of the hour. [4]

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Putting Patients First Blog

JANUARY 22, 2025

2025 Health Leadership Conference takes on The Future of Leadership January 22, 2025 By: Leah Poffenberger, Senior Manager, Communications Leadership health care often comes with unique challenges in an ever-changing ecosystem.

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Pharma Marketing Network

MARCH 18, 2025

Unlike other industries, pharma marketers must understand drug development, regulatory requirements, and clinical trial data to craft effective messaging. Attending these events can keep you updated on emerging trends and best practices. What role does omnichannel marketing play in pharma?

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Pharmaceutical Technology

JANUARY 22, 2023

Nicklas Westerholm, the CEO and president of orphan drug developer Egetis Therapeutics, says disease awareness amongst paediatric neurologists and endocrinologists is low for MCT8 deficiency. The FDA will weigh the concerns and benefits of this drug before its PDUFA date in October. compared to 38.5% on placebo.

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FDA Law Blog: Biosimilars

JANUARY 12, 2025

The new draft guidance , Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics , is intended to replace much of the 2014 Guidances discussion of the topic. in Duchenne Muscular Dystrophy).

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European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developing drugs.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. Anti-obesity therapeutic landscape.

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Pharmaceutical Technology

NOVEMBER 2, 2022

Acting as a go-between for pharma and physicians, medical science liaisons (MSLs) are responsible for communicating necessary information about new medicines to healthcare professionals and key opinion leaders (KOLs). Traditionally, these detailed scientific discussions took place in person. Participant management can also be a problem.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. Anti-obesity therapeutic landscape.

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Pharmaceutical Technology

FEBRUARY 28, 2023

First established in 2008, Rare Disease Day is observed every 28 February, with events set up across more than 100 countries in 2023 to unite the world in raising awareness. On leap years, the event is observed on 29 February – the rarest date in the calendar. Orphan drug development is expanding Change is happening.

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Viseven

JANUARY 4, 2023

From the early beginning of the world’s digitalization, the mainstream media taught us that artificial intelligence is a super complicated mechanism that is supposed to cover human existence hurdles, explain the universe’s secrets, start or prevent a global cataclysm, and other significant events. Drug Development and Discovery.

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ID Stewardship

JUNE 6, 2023

Hospital pharmacists can utilize AI to identify appropriate drug alternatives, adjust dosages, and monitor medication effectiveness, leading to improved patient outcomes and reduced adverse events. AI can assist in language translation, improving communication with non-native speakers.

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Pharmaceutical Technology

OCTOBER 26, 2022

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. Managing drug supply in the midst of unexpected and changing circumstances can be overwhelming.

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT.

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pharmaphorum

APRIL 19, 2022

They’ve also begun attending US-based events like JP Morgan, to start to make the connections that will help them sell and develop their products on a global scale. “In I think the most important thing is making a good team and also good communication within that team is very important. Moving to the global stage. Conclusion.

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Pharmaceutical Technology

MAY 23, 2023

In February, Centessa presented additional data from the Phase IIa Serpin PC study (NCT04073498) at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), showing that there were no treatment-related adverse events observed. Please check your email to download the Report.

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Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development.

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Pharmaceutical Technology

JANUARY 26, 2023

RoslinCT also works in conjunction with the Scottish Universities Life Science Alliance, with Skills Development Scotland playing an important role in furthering capabilities. “We We are all aligned and in frequent communication with each other. It certainly drives things in the right direction,” adds Brownfield.

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Pharmaceutical Technology

NOVEMBER 28, 2022

To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Precision Medicine: Streamlining Treatments and Drug Development. Free Whitepaper. Please check your email to download the Whitepaper.

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pharmaphorum

JUNE 25, 2021

But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In That’s a huge communication challenge. The average UK patient only stays on their statins for a month. Think about that.

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FDA Law Blog: Biosimilars

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. FDA strongly encourages sponsors to discuss plans for a waiver early in the planning stages of the study or development program.

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Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). The price of progress: funding and financing Alzheimer’s disease drug development. Translational Medicine Communications, 4(18). autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L.,

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Pharmaceutical Technology

FEBRUARY 20, 2023

The event was also attended by representatives of the Wuxi Government and members of the executive team for both parties. We are delighted to deepen our partnership with Teddy Lab that will enable us to build on existing knowledge and increase services within China to support customers with their global drug development programmes.

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PharmaShots

APRIL 3, 2023

events/100 patient-yrs.) The results also showed a reduction in risk of hospitalization for any cause with 14% relative risk reduction (24.8 vs 10%) The companies will discuss the findings with regulatory authorities, initiate a P-III study in adjuvant melanoma in 2023 & expand to additional tumor types, incl.

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Express Pharma

OCTOBER 31, 2024

She highlighted that while the GCC was initially set up for cost savings in drug development, the focus has shifted to harnessing India’s vast talent pool, particularly in the scientific and medical fields, in an interview with Viveka Roychowdhury India seems to have become a hub for pharma GCCs. With a long gestation period.

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FDA Law Blog: Biosimilars

OCTOBER 28, 2024

The Guidance provides a listing of domains for such assessment as pertains to general concerns ( e.g. , quality of life, physical health) and neurodevelopmental concerns ( e.g. , sensory, motor, cognition, communication). The Guidance is written carefully to communicate that these determinations are all very case-specific.

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STAT

JANUARY 24, 2025

The daylong, in-person event would instead take place virtually and last roughly 90 minutes.  On Wednesday, the day before it was set to begin, they received a surprising message: Due to a temporary ban on official travel for Department of Health and Human Services staff, its government backers would no longer attend in person.

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