Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

Production 190

Production Trials Development Clinical Trials 190

Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. PRIME is an EMA scheme to support the development of medicines for rare diseases and conditions with high unmet need.

Development 130

Development Drugs Medicine Production 130

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020. Meeting Package Due.

Production 230

Production Packaging Packaging Development 230

XTalks

SEPTEMBER 24, 2020

In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

Regulation 94

Regulation Hormones Containment Packaging 94

Camargo

OCTOBER 20, 2021

The regulatory strategy for developing such products needs to be well-designed and should factor in both adaptability and the manufacturing process to minimize overall program risk. However, not every combination product can be classified so easily, and the OCP must follow certain work-flows and regulations to reach a decision.

Production 206

Production Regulation Drugs Development 206

pharmaphorum

JUNE 10, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry. Request business program via the link. .

Packaging 52

Packaging Packaging Manufacturing Pharma Packaging 52

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

Regulation 97

Regulation Marketing Sales Branding 97

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

Pharma Mirror

FEBRUARY 6, 2024

By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments.

Production 100

Production Packaging Packaging Clinical Research 100

Pharmaceutical Technology

JUNE 19, 2023

Regulations can be challenging, with ever-changing rules. For example, the UK Government has recently announced a series of new measures that will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), representing the biggest overhaul in UK clinical trial regulations in over 20 years.

Medicine 130

Medicine Production Packaging Packaging 130

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

Manufacturing 105

Manufacturing Pharma Packaging Packaging Packaging 105

XTalks

APRIL 24, 2023

Dutch food and biotechnology company Corbion recently developed a new system to help bakers determine how long their products can stay mold-free naturally. The natural mold inhibitor is just the latest in Corbion’s wide range of offerings, which include food innovations, specialty ingredients and packaging products.

Packaging 98

Packaging Packaging Production Development 98

XTalks

SEPTEMBER 22, 2020

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. The Velco-like device pierces the packaging and the food via silk microneedles that suck in material through capillary action.

Contamination 98

Contamination Scientist Development Bacterium 98

Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

Packaging 40

Packaging Packaging Production Manufacturing 40

pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

Production 98

Production Regulation Manufacturing Packaging 98

Camargo

JANUARY 12, 2022

The latter are intended to facilitate early discussions of novel questions and unique challenges in early development (i.e., Receipt of Background Package. prior to filing an Investigational New Drug [IND] application). Response Time. calendar days). Meeting Scheduling or Written Response Time. At the time of the meeting request.

Production 169

Production Gene Therapy Packaging Packaging 169

XTalks

MAY 9, 2024

She discusses some of the latest developments in technology that businesses are adopting to remove PFAS from their products and processes. Cally starts off by explaining what PFAS chemicals are and why they are so prevalent in the food industry. Subscribe to the Xtalks Food Podcast to never miss a new episode.

Packaging 103

Packaging Packaging Production Development 103

Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

Manufacturing 130

Manufacturing Sales Packaging Packaging 130

XTalks

APRIL 15, 2025

Anthea Cherednichenko, MPH, MBA Vice President Hematology Franchise Head Takeda Cell and Gene Therapies: Transformations and Challenges One of the most exciting developments in rare diseases has been the emergence of cell and gene therapies, particularly in hemophilia, says Cherednichenko.

Trials 52

Trials Clinical Trials Clinical Trials Gene Therapy 52

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

Regulation 45

Regulation Production Cosmetics Sales 45

Camargo

JULY 30, 2021

I’ve been in the pediatric arena since 1976, and in those days, I was going to develop my career in pediatric oncology, specifically acute lymphocytic leukemia (ALL). In 1981, I got my doctorate degree in Clinical Pharmacology, but more importantly, my research was heavily involved in neonatal medicine, developing drugs there.

Clinical Research 226

Clinical Research Research Gene Therapy Drugs 226

Cloudbyz

MARCH 3, 2023

This can make it challenging to ensure compliance with the latest regulations and guidelines. To address this challenge, mid-size CROs should invest in regulatory expertise and keep abreast of the latest regulations and guidelines. Larger CROs may offer more attractive compensation packages and career advancement opportunities.

Compliance 98

Compliance Branding Packaging Packaging 98

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow. Meeting strict standards.

Manufacturing 98

Manufacturing Pharma Packaging Production Packaging 98

pharmaphorum

DECEMBER 20, 2021

Aptar continues to look for valuable partnerships to develop and expand its portfolio, and Sai relays the importance of synergies between digital health applications and Aptar’s heritage when considering such collaborations. Sai has 20 years of product development and business strategy experience in the pharmaceutical industry.

Packaging 75

Packaging Packaging Engineer Development 75

FDA Law Blog

JULY 22, 2024

s John W.M. s John W.M.

Cosmetics 59

Cosmetics Compliance Production Regulation 59

Camargo

JANUARY 19, 2021

When developing a novel therapy, sponsors can modify certain aspects of their CMC execution as clinical testing progresses. CMOs are subject to cGMP regulations, so they have standard operating procedures they must follow. In this post, we will highlight those requirements that seem to be the most misunderstood. CMC Considerations.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

Pharmaceutical Technology

MAY 23, 2023

While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. Adjustments to orphan drug exclusivity The proposed reform also detrimentally affects the exclusivity periods for orphan drug developers.

Marketing 130

Marketing Medicine Manufacturing Drugs 130

XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast is focused on improving its products and packaging vis-à-vis reducing emissions.

Packaging 64

Packaging Packaging Production In-Vitro 64

pharmaphorum

AUGUST 20, 2020

BioMarin previously agreed with the FDA on a data package necessary to support approval, but the company said the regulator has introduced a new recommendation for two years of safety and efficacy data. The company said the new recommendation was not raised at any time during development or review.

Gene Therapy 64

Gene Therapy Drugs Regulation Gene 64

The Pharma Data

JULY 11, 2021

In a previously-published Phase 2 study evaluating patients with UC, mirikizumab down-regulated several gene transcripts associated with inflamed mucosa and up-regulated gene transcripts correlated with healthy mucosa and markers of functional healing after 12 weeks, as defined by clinical disease indices of endoscopy and histology.

Regulation 52

Regulation Gene Gene Expression Packaging 52

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

pharmaphorum

FEBRUARY 12, 2021

Rory Mullen, head of biopharma at Ireland’s economic development agency IDA Ireland tells pharmaphorum why business is blossoming in the Emerald Isle. UK’s withdrawal from the EU has also created opportunities for Ireland, according to Mullen, with pharma packaging and distribution services such as Central Pharma opening Irish operations.

Life Science 124

Life Science Botox Pharma Packaging Regulation 124

XTalks

DECEMBER 1, 2021

Not only can the PD100 ensure produce is safe to eat, but it can also help users develop better fruit and vegetable washing habits over time. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? It comes equipped with a wireless charging station and lasts for six hours per charge.

Contamination 98

Contamination Packaging Packaging Regulation 98

XTalks

JULY 11, 2024

They help regulate muscle contractions, including the heartbeat and are vital for nerve function. Brands are also developing targeted products for different activity levels and specific needs, further expanding the market. As more people recognize the benefits of these nutrients, the popularity of electrolyte beverages has surged.

Branding 105

Branding Marketing Production Packaging 105

pharmaphorum

MAY 4, 2022

The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. Assess developments in primary packaging and CMC considerations for injectable devices.

Drug Delivery 52

Drug Delivery Packaging Packaging Engineer 52

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. Some specific tasks that a clinical trial manager may be responsible for include: Developing and managing trial timelines, budgets and resources.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59