XTalks

MARCH 25, 2021

Sydney writes about various food industry topics, including safety and regulation, grocery and foodservice, innovation and sustainability. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences. 3. A Podcast to Help Food Industry Professionals Stay Informed.

Life Science 95

Life Science HR Branding Production 95

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

pharmaphorum

FEBRUARY 12, 2021

The life sciences industry has an important role in the Irish economy, with sectors such as biologics booming across the country. With an attractive corporate tax rate and the youngest workforce in the EU, Ireland continues to be a popular destination for life science companies to settle.

Life Science 124

Life Science Botox Pharma Packaging Regulation 124

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

Regulation 52

Regulation Manufacturing Medicine Drugs 52

The Pharma Data

OCTOBER 26, 2020

Novasep provides cost-effective and sustainable manufacturing solutions for the life sciences industries. Novasep also offers Fill & Finish services for viral vectors, attenuated and live viruses, mAbs, plasmids and other biologics, from formulation to packaging. www.sensorion-pharma.com. About Novasep.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries.

Sales 52

Sales Insulin FDA Approval Drugs 52

Drug Discovery World

SEPTEMBER 26, 2022

A report by the medical charity LifeArc 1 puts the timeframe for a therapy brought to market through repurposing methods at anywhere from one to three years. This is a stark contrast to the often decade-long projects that pharmaceutical companies undertake to bring a drug to market. Global efforts .

Drugs 52

Drugs Genome Genomics Clinical Trials 52

pharmaphorum

APRIL 11, 2022

The wearable market was starting to proliferate, and people were starting to ask questions. There was a huge opportunity for regulators to leverage real-world evidence and patient-reported outcomes data, captured through wearables, in addition to traditional clinical data. How can this data be incorporated into clinical trials?”.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

Pharma in Brief

AUGUST 3, 2023

Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature.

Production 52

Production Drugs Manufacturing Clinical Trials 52

Pharma in Brief

SEPTEMBER 1, 2022

These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments ) and accompanying changes to the Board’s Guidelines. A reduced package of Amendments comes into force. In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board ( PMPRB ).

Medicine 59

Medicine Packaging Packaging Sales 59

Intouch Solutions

DECEMBER 9, 2021

Content strategy ensures that brand claims and messages are packaged such that users actually want to see them. Our process to actively build link profiles takes into account the caution and care necessary for even the most regulated brands. Life-sciences companies ought to have the most high-ranking content about health online.

Branding 52

Branding Engineer Life Science Marketing 52

Drug Discovery World

JULY 11, 2022

David Lewandowski, Business Director of Cell & Gene Therapy at Azenta Life Sciences, explains how efficient sample management can help to work efficiently and bring therapies to market faster. David Lewandowski is the Business Director of Cell & Gene Therapy at Azenta Life Sciences. Regulatory requirements.

Gene Therapy 52

Gene Therapy Gene Development Production 52

pharmaphorum

NOVEMBER 24, 2022

While many production environments across all verticals must remain hygienic for product integrity, the standards that regulate pharmaceutical cleanrooms are more stringent – with unique industry-specific standards governing their use. Meeting strict standards. Enter cleanrooms-on-demand…. Solving industry challenges. The future of COD.

Manufacturing 97

Manufacturing Pharma Packaging Packaging Packaging 97

Pharmaceutical Technology

FEBRUARY 3, 2023

Cell culture challenges The viral vectors used in the gene therapies currently on the market are produced in adherent human embryonic HEK-293 cell culture. Another immediate benefit is improved batch-to-batch consistency — something regulators are expected to tighten the rules on in coming years. 1] BioNews. Hemophilia News Today.

Genome 244

Genome Genomics Medicine Gene Therapy 244

Pharma in Brief

DECEMBER 3, 2020

Health Canada has now begun the consultation process to transition drugs, vaccines and medical devices that were authorized under the interim orders to a more permanent market authorization under the relevant regulatory regime. require market authorization holders to meet post-marketing regulatory requirements; and.

Vaccination 98

Vaccination Vaccine Drugs Manufacturing 98

XTalks

MARCH 28, 2024

In a statement announcing the approval and describing the mechanism of action of the drug, Merck said Winrevair improves the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH, reversing vascular and right ventricle remodeling. The PAH market was valued at $7.3 billion in 2032.

FDA Approval 81

FDA Approval Clinical Trials Clinical Trials Trials 81

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Drug Discovery World

AUGUST 10, 2023

In this article, Amplexor asks some of the company’s closest industry partners and BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and explore some of the most prominent themes and priorities seen throughout 2023.

Production 98

Production Life Science Development Manufacturing 98

XTalks

AUGUST 29, 2022

They regulate the maturation and growth of immune cells and play an important role in immune mediation. XTALKS WEBINAR: Patient-Reported Outcomes as Endpoints in Oncology Trials and Marketing Claims: An FDA/EMA Perspective. Cytokines are signaling proteins produced by immune cells.

Clinical Trials 95

Clinical Trials Clinical Trials Trials Drugs 95

The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

Production 52

Production Manufacturing Vaccination Vaccine 52

Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. Business: Where is the money? When it comes to something as volatile and irregular in terms of regulation as psilocybin, funding is a key component if the field is to expand and progress. So, where is the money?

Medicine 52

Medicine Clinical Trials Clinical Trials Regulation 52

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. ECONOMIC IMPACT: Canada.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92