Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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STAT News

OCTOBER 12, 2022

— Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem — and possible solutions.

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Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”.

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Pharmaceutical Technology

APRIL 24, 2023

Apellis Pharmaceuticals has received validation of its four marketing applications for intravitreal pegcetacoplan by regulatory authorities in Switzerland, the UK, Canada and Australia. The marketing applications are based on the data obtained from the Phase III OAKS and DERBY trials at 24 months.

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Pharmaceutical Technology

JULY 26, 2022

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health. No product is mentioned for help-seeking advertising.

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pharmaphorum

AUGUST 17, 2020

N o one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content. Engagement channels. Joanna Carlish.

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pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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Pharmaceutical Technology

APRIL 5, 2023

PRIME is an EMA scheme to support the development of medicines for rare diseases and conditions with high unmet need. The scheme also supported the development of thirteen treatments across several therapy areas last year. Breyanzi is a treatment for various lymphomas and Carvykti is an orphan medicine for multiple myeloma.

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Pharma Marketing Network

JULY 12, 2023

The pharmaceutical industry is facing a number of challenges, including increasing competition, rising costs, and changing regulations. In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. They are individuals with unique needs, concerns, and experiences.

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BioPharma Reporter

MAY 15, 2024

Abzena, an end-to-end CDMO for biologics and bioconjugates, will be presenting its latest AbZelect and AbZelectPRO cell line development (CLD) platforms and more at BIO 2024.

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BioTech 365

JULY 15, 2021

… Continue reading →

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XTalks

SEPTEMBER 12, 2022

Food and beverage companies across the supply chain must always be prepared for new regulatory developments in 2022 as they seek to bring new ingredients and products to market. New regulations are often reflective of the supply chain, food safety and consumer trends. Regulating Heavy Metals in Baby Food.

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XTalks

JULY 7, 2023

Earlier this week, the World Health Organization (WHO) released new guidelines that emphasized the critical role that marketers must play in safeguarding children’s health. The WHO underscored the need for tighter regulations to protect children from the adverse effects of food marketing.

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pharmaphorum

DECEMBER 9, 2021

If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments. The same principle applies to regulation,” she went on. Opportunities and pitfalls. ” Prerequisites for global competitiveness.

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Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

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Pharma Marketing Network

JULY 19, 2023

Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Finding the best commercial packaging suppliers in contract marketing.

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pharmaphorum

APRIL 23, 2021

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients.

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BioSpace

APRIL 27, 2021

Levitt has had extensive experience working with an interdisciplinary team of scientists, executives and lawyers to push a candidate to market. Previously chief regulatory counsel for Pfizer Inc.,

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Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA-Issued Guidances Offer Clarification on PREA, QIDP Designation, Post-Marketing Requirements, and More.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. GSK’s problems with Trelegy, developed in partnership with Innoviva, stem from the phase 3 CAPTAIN study , which reported findings in May 2019.

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Drug Discovery World

FEBRUARY 19, 2024

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year. antibody-drug conjugate [ADC] pipelines in some oncology settings).

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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Drug Discovery World

MARCH 30, 2023

According to data and analytics company Globaldata, the approval of LK101 injection sets the stage for exciting developments in the field. According to GlobalData’s Pharma Intelligence Center, there are currently four personalised cancer vaccines in clinical development in China.

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XTalks

JULY 20, 2023

A new deforestation regulation has finally come into effect in the European Union (EU) and it’s poised to send shockwaves through the world’s food system. Every food business should be aware of this monumental development, despite its lack of media coverage amidst other pressing issues.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Fierce Pharma

JUNE 16, 2023

In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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pharmaphorum

OCTOBER 28, 2022

The EU regulator has formally started an accelerated assessment of GSK’s RSV vaccine RSVPreF3 OA for older adults, with a decision now expected in the third quarter of next year – a timeline that could allow GSK to beat rival RSV shot developers, including Pfizer, to the European market.

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FDA Law Blog

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.

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