Pharma Leaders

MAY 8, 2023

In August 2022 the company submitted concizumab, an anti-tissue factor pathway inhibitor antibody, for regulatory approval for treatment of hemophilia A and B with inhibitors. Related Topics Novo Nordisk also said it is evaluating the content of the CRL and will work with the FDA to provide the requested data.

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FDA Manufacturing Patients 52

Pharmaceutical Technology

MAY 24, 2023

Streamlining the regulatory process, the AMP BGTC will also facilitate cost-efficient vector production to increase access for patients with rare and ultra-rare genetic diseases. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

JUNE 9, 2023

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

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Food and Drug Administration FDA Medical science Food 98

Pharma Leaders

JUNE 8, 2023

Under PDUFA VII, the agency agreed to create the program by December 2022 and then to report aggregate data on an annual basis starting June 30, 2024, including data sources, study designs and the types of regulatory requests. Related Topics

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Pharmaceutical Technology

DECEMBER 5, 2022

According to the deal, Incyte is entitled to receive an upfront payment from CMS, which will also make further potential payments on meeting development, regulatory and commercial milestones. Ruxolitinib cream is the first topical inhibitor of JAK to obtain approval in the US.

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Food and Drug Administration Healthcare Provider Food Patients 52

PharmaTech

FEBRUARY 23, 2023

We cover topics including regulatory compliance, manufacturer flexibility & supply chain risk and debate the supplier vs partner relationship and the importance of collaboration as we face a challenging future.

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Manufacturing 40

European Pharmaceutical Review

AUGUST 1, 2022

According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. In addition, searching for information from regulatory documents will be enhanced through the development of analytics tools and the development of standardised clinical trial protocols.

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Medicine Networking Electronics Healthcare 97

European Pharmaceutical Review

MAY 2, 2023

Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

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FDA Food and Drug Administration Medical Food 86

European Pharmaceutical Review

JUNE 26, 2023

The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. RWE shows efficacy of nirsevimab for infant RSV The post How can real-world evidence support regulatory decision making? appeared first on European Pharmaceutical Review.

Medicine 84

Medicine Safety Management Medical 84

Cesare Ferrari

JULY 15, 2023

Customer complaints Customer complaints is a hot topic in the medical device business for marketers, quality and regulatory people. You’ll have some surprises for examples new topics, and a totally different me when I return. Product flops Product flops are an incredibly good source of learning for product managers.

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Customer Relationship Management Relationship management CRM Medical 52

Pharmaceutical Technology

APRIL 27, 2023

Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections. Notably, this includes the reduction of regulatory data protection from eight years to six— a decision which will likely prove controversial.

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Pharma Marketing Medicine Medical 105

World of DTC Marketing

MAY 31, 2022

According to Google search statistics, “health” and “wellness” topics are among the top searches. Regulatory and legal requirements have made pharma websites read more like medical journals when the average reading level of most people is at an 8th-grade level. In both these areas, most pharma sites fail.

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Marketing Pharma Side effects Media 179

World of DTC Marketing

DECEMBER 16, 2020

3hree: As you finalize the objectives the next step is to prepare a discussion guide and get approval from your medical and regulatory people. 5ive: Ensure the ad board stays on topic. If you decide that you need an ad board the next question is to define the objective and get buy-in from team members.

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Physicians Marketing Pharma Medical 180

pharmaphorum

OCTOBER 12, 2022

Understand the latest regulatory requirements from regulatory experts surrounding medical devices and digital health. Steve Hoare, Quality, Regulatory Science & Safety Policy Director, The Association of the British Pharmaceutical Industry (ABPI). Blake Green, Director Regulatory Affairs, Amgen.

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Engineering Safety Consulting Medical 52

Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. QPS was established in 1995 to provide bioanalytical LC-MS/MS contract services.

Food and Drug Administration 52

Food and Drug Administration Management Food Pharmaceutical 52

Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. Topic sponsors are not involved in the creation of editorial content.

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Side effects Safety Government Pharmaceutical 85

Pharmaceutical Technology

NOVEMBER 14, 2022

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. There are only a handful of institutions that are able to make these cells, and getting regulatory support for this is also a challenge, he adds.

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Side effects Patients Manufacturing Safety 144

Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The most commonly reported adverse event in the trials is mild and transient instillation site irritation.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

European Pharmaceutical Review

DECEMBER 20, 2023

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) analysis (Source: L.E.K) What are the latest amendments?

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Biopharma Pharmaceutical Medicine Manufacturing 90

European Pharmaceutical Review

JANUARY 31, 2023

Across Part A and Part B , of which the approval was based on, 74 percent of patients were previously treated with swallowed topical corticosteroids. All patients had previously not responded to proton pump inhibitors.

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Medicine Safety Patients Pharmaceutical 93

Pharmaceutical Technology

MARCH 21, 2023

It has also received regulatory approvals in many countries to treat chronic rhinosinusitis with nasal polyposis (CRSwNP), asthma, eosinophilic esophagitis (EoE) or prurigo nodularis in different age groups. The regulatory approval is based on the data obtained from a Phase III trial.

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Safety Medicine 52

pharmaphorum

SEPTEMBER 28, 2022

This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and increased regulatory stringency, to the latest technologies in rapid microbiological testing methods and data integrity. Event Hashtag: #MicrobiologyEurope. Download the brochure at: [link].

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Pharmaceutical Management 52

Pharmaceutical Technology

MAY 22, 2023

Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing. The regulatory approval was supported by data from the GEM-1/2 and GEM-3 clinical trials. Topic sponsors are not involved in the creation of editorial content.

FDA 52

FDA Food and Drug Administration Patients Food 52

Pharma Leaders

JUNE 13, 2023

The FDA has “sufficient legal authority right now to require postmarket efficacy studies to verify clinical benefit and to impose expedited withdrawal more expansively than it has to date,” they write, “allowing [the agency] to avoid the current regulatory limbo between traditional and accelerated approval.” Related Topics

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FDA 40

Pharmaceutical Technology

MAY 2, 2023

CellReady will minimise Marker’s overhead by $11m per year, using Marker’s manufacturing, development, quality and regulatory affairs team. CellReady has also agreed to sign a long-term contract with Marker for conducting services including research and development, manufacturing and regulatory activity to promote clinical trials of Marker.

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Manufacturing Leads Management Pharmaceutical 52

pharmaphorum

JULY 19, 2022

Speaking during a Patients as Partners meeting, Ebony Dashiell-Aje, senior director of patient engagement and outcomes research at BioMarin Pharmaceuticals, said these small, informal, non-regulatory events helped the FDA “better understand what is most important” among specific patient groups. The rise of patient centricity. “We

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Patients FDA Education Consulting 98

Clarivate

NOVEMBER 17, 2021

In this episode of Conversations in Healthcare , Carolyn Hynes from AstraZeneca discusses the importance of regulatory intelligence. Moreover, being compliant with today’s regulations is not necessarily sufficient because the regulatory environment itself keeps evolving. Mike Ward: Celine, what’s your take on this topic?

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Pharma Healthcare Healthcare Specialization 52

Cesare Ferrari

DECEMBER 16, 2023

This is my last article of 2023, and I would like to re-share a few posts on important topics for medical sales and marketing professionals. Customer complaints Customer complaints are critical in the medical device business for marketers, quality and regulatory professionals. I do not consider realistic plans and planning useless.

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Medical sales Medical Sales Marketing 52

Pharmaceutical Technology

APRIL 5, 2023

It is also expected to help Caribou receive early and continual communication from the FDA during the regulatory review procedures. Topic sponsors are not involved in the creation of editorial content. The newly granted designation helps the firm accelerate the development and evaluation of CB-011.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Food 59

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. The addition of a topical gel to pharmacy shelves expands treatment options available to those with ED.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

APRIL 20, 2023

In addition to new regulatory functionalities, this feature may result in stronger and more durable protein expression. Topic sponsors are not involved in the creation of editorial content. Initially reported in 2011, CircRNA is a naturally occurring class of RNA.

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Engineering Leads Medicine Pharmaceutical 96

pharmaphorum

DECEMBER 2, 2022

(MSD) has just been launched in the US and Canada: ‘Never Miss’ leverages sport – as well as social media activity and an information website – as a way to help men understand their potential risk of developing prostate cancer, opening up the conversation about this sensitive topic: Never miss a game. Never miss a goal.

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Media Physicians Patients Medical 72

pharmaphorum

AUGUST 18, 2022

Whereas I see now, hopefully moving forward, those topics will still be present, obviously, but the focus is going to be much more on how they are used by patients –how are they integrated into daily life for the people who really need to use these in a real-world setting?”. “One

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Patients Marketing Healthcare Healthcare 82

Pharma Marketing Network

NOVEMBER 30, 2021

Coming in January; join the Pharma Marketing Network and industry experts for a fire-side talk on hot topics around what has changed and how to align your pharma marketing strategies accordingly. An overview of what you can expect: The impact of new legislative and regulatory changes: Which should you be concerned about.

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Marketing Pharma Networking Management 52

Pharmaceutical Technology

JULY 15, 2022

In March this year, the regulatory agency approved Spikevax for active immunisation to prevent Covid-19 in people aged six years and above. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Safety Pharmaceutical Management 105

Pharmaceutical Technology

MARCH 29, 2023

Regeneron Pharmaceuticals has collaborated with Sonoma Biotherapeutics to discover, develop and commercialise new regulatory T cell (Treg) therapies for autoimmune diseases. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Leads Engineering Pharmaceutical Patients 98

Pharma Marketing Network

NOVEMBER 30, 2021

On December 9th at 12:30 PM EST, join the Pharma Marketing Network and industry experts from Novartis, Boehringer Ingelheim, Karyopharm Therapeutics and more, for a fire-side talk on hot topics around what has changed and how to align your pharma marketing strategies accordingly.

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Marketing Pharma Networking Management 52