Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. Natural health product vs. regulated drug In Winning Combination Inc. In its August 16, 2023 decision in Le-Vel Brands, LLC v.

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XTalks

NOVEMBER 23, 2021

The expansion will include a new 30,000-square-foot building that will be able to produce 160 million doses of an mRNA vaccine per year, and up to 70 million prepared and packaged fill finish doses for commercial distribution annually. Additional production would be performed at other facilities for final packaging.

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pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

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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.

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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. Mira Nabulsi, MJ , is a multimedia editor and webinar moderator at Xtalks.

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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.

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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.

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XTalks

MAY 9, 2023

A clinical trial manager is responsible for overseeing the planning, conduction and completion of clinical trials in accordance with applicable regulations, guidelines and protocols. Ensuring compliance with applicable regulations, guidelines and ethical principles. What Does a Clinical Trial Manager Do?

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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.

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Cloudbyz

JANUARY 27, 2021

Understand global regulatory implications Federal laws and regulations heavily govern clinical trials. For example, the regulations for governing trials in the US and EU allow electronic submission of clinical trial reports (with few exceptions), but this might not be the case in other countries. Package Installation.

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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.

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Drug Discovery World

SEPTEMBER 26, 2022

Improvements in technology and changes to worldwide regulations in life sciences has led to an increase in the availability of clinical data. Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. . Global efforts .

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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 ).

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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. for a 2-pen package (0.6 & 1.2 for a 3-pen package (1.8 mg doses), or $815.27 NovoMix is also known as Novolog Mix.

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pharmaphorum

APRIL 11, 2022

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. Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We

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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.

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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.

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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. As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5.

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XTalks

NOVEMBER 27, 2020

It includes a cardiovascular measurements package and pulsed wave doppler to allow for the rapid diagnosis of cardiac conditions. Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators. which can be downloaded through the Apple App Store and Google Play.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Another immediate benefit is improved batch-to-batch consistency — something regulators are expected to tighten the rules on in coming years. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp. 1] BioNews. Hemophilia News Today.

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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. About the author.

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Pharma Business Blog

MARCH 15, 2023

The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS. • Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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XTalks

NOVEMBER 25, 2021

Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. The levetiracetam injection (USP 500 mg per 5 mL) is packaged in a single-dose 5 mL vial. Levetiracetam injection is used for the treatment of certain types of seizures.

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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.

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Pharma in Brief

DECEMBER 3, 2020

Health Canada has published a proposal titled “ Consultation on amending the Food and Drug Regulations ( FDR ) to expedite access to COVID-19 drugs ”. In the fall of 2021, regulatory amendments to the Medical Device Regulations ( MDR ) are expected take effect and remain in force for 2 years. . Drugs and Vaccines.

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XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13

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XTalks

AUGUST 29, 2022

They regulate the maturation and growth of immune cells and play an important role in immune mediation. The company also described how packaging multiple cytokines within a single nanoparticle can boost the efficacy of their medicines in treating solid tumors. Cytokines are signaling proteins produced by immune cells.

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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.

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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?

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XTalks

FEBRUARY 10, 2023

It is important to have a comprehensive Product Development Plan (PDP) that is developed early and in collaboration with regulators and the non-clinical, manufacturing, clinical operations and logistics teams. Integrate clinical workflow considerations in the packaging and handling design of the investigational product (IP).

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The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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pharmaphorum

AUGUST 16, 2021

These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages. With this close working relationship, we are fully aware of changes to all regulations and our platform reflects this up-to-date view.

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Drug Discovery World

JULY 18, 2023

Current research is focused on designing CRISPR-enhanced CAR T cells that are resistant to immunosuppressive cytokines such as transforming growth factor-β (TGF-β) 2 , programmed cell death protein (PD-1) 3 , or other negative T cell regulators 4 (CTLA-4, LAG-3, and TIM-3), thus improving anti-tumour functions.

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XTalks

JANUARY 24, 2024

This disparity can be attributed to various factors, including the lack of government regulation on drug prices and the complex web of negotiations between drug manufacturers, insurers and pharmacy benefit managers. ” If authorized, Sanders said these would be the first subpoenas issued by the HELP Committee since 1981.

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XTalks

SEPTEMBER 14, 2020

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.

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