Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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European Pharmaceutical Review

DECEMBER 13, 2022

Patient-centred pharmaceutical packaging: are we there yet? DRUG DEVELOPMENT. Arnaud Robert and Brendan O’Callaghan, Sanofi. Giana Carli Lorenzini, Technical University of Denmark. REGULATORY INSIGHT. Interchangeability of biosimilars in the EU – the industry impact. Marie Manley and Chris Boyle, Sidley Austin LLP.

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Express Pharma

JANUARY 17, 2025

Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.

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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. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.

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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.

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European Pharmaceutical Review

JULY 14, 2023

However, extensive capital investment and complex infrastructure is necessary for carrying out in-house filling of biologics and small molecules, which can be a challenge for drug developers with limited finances and capacity constraints. The global aseptic fill finish market Which packaging container type has the highest share?

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European Pharmaceutical Review

MARCH 21, 2024

What is patient centricity and why is it an important consideration in drug development? Insights obtained from patients are used to better understand the impact of the disease on their daily life, and to carefully design all stages of drug product manufacture: from clinical studies to package design.

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Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

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Express Pharma

AUGUST 6, 2024

In this video: Dr Vivek Kumar Jha, CTO, Cilicant & Komal Bhavsar, AGM – Business Development (Pharma), Cilicant Topic: Innovations in active packaging Key Highlights: [1] Innovation in active packaging is required to support latest approaches to drug development. [2]

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Pharmaceutical Technology

JULY 25, 2022

The drug developers will use artificial intelligence based on the acquired data from these devices and from the healthcare providers, allowing them to create and provide personalized treatments maybe even in predictive ways later on,” he explains.

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Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

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Express Pharma

SEPTEMBER 20, 2023

In this video: Dhairy Sharma, Technical Sales, CILICANT Topic: Role of active packaging in drug development Key Takeaway: ACCUFLIP from Cilicant regulates Equilibrium Relative Humidity (ERH) within a specific range in order to protect medications from over-desiccation.

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Express Pharma

JUNE 16, 2023

In this video: Dhairy Sharma, Technical Sales, CILICANT Topic: Role of active packaging in drug development Key Takeaway: ACCUFLIP from Cilicant has been designed to regulate Equilibrium Relative Humidity (ERH) within a specific range in order to protect medications from over-desiccation.

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Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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European Pharmaceutical Review

SEPTEMBER 15, 2023

Catalent: Case Management Services for Cell/Gene Therapies Cipla: Digital Innovation at Cipla Global Supply Chain Thermo Fisher Scientific: mySupply Platform Packaging Bilcare Limited: Elite PVC-free Compact Barrier Coldform Blister GASPOROX AB: AutoMAP Pharma IMA S.p.A.:

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European Pharmaceutical Review

JUNE 5, 2023

Article: NDMA: a recall trigger for the drug development industry … The recent discovery of small-molecule nitrosamine impurities in marketed drugs, starting with N -nitrosodimethylamine (NDMA) in batches of Valsartan in 2018, has led to significant regulatory response, the paper noted. It was observed that 41.4

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Express Pharma

OCTOBER 9, 2023

The researchers also identified three proteins that are needed for the virus to carry out the invasion and have in turn synthesised molecules (potential drugs) that can target one of the proteins, potentially leading to new treatments for AIDS. “

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pharmaphorum

MAY 4, 2022

Our expert industry thought leaders will present case studies and updates to the industry’s approach to injectable delivery for novel drug products. Furthermore, our speakers will be assessing the key considerations for primary packaging and CMC approaches to injectable device development. Primary Packaging material designers.

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European Pharmaceutical Review

MARCH 15, 2023

It binds to chromatin, which is the braid of DNA and protein packaging within the nucleus; it summons large protein complexes to join it. Menin is a critical part of the cell’s epigenetic mechanism for switching gene activity on and off. The complexes tighten or loosen the coils of DNA, changing gene activity level at that site.

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Pharmaceutical Business Review

NOVEMBER 3, 2023

The services include drug product formulation development, clinical and commercial drug product manufacturing, and packaging from facilities that are located in Whippany, New Jersey, in the US, and Mirabel, Quebec, in Canada.

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Express Pharma

AUGUST 13, 2023

The researchers also identified three proteins that are needed for the virus to carry out the invasion and have in turn synthesised molecules (potential drugs) that can target one of the proteins, potentially leading to new treatments for AIDS. “We

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PharmaState Academy

MARCH 7, 2024

a) Enhancing Packaging Aesthetics b) Monitoring Process Compliance c) Maximizing Production Speed d) Optimizing Sales Strategies Analytics monitors process compliance, ensuring adherence to regulatory guidelines and maintaining product quality standards.

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Express Pharma

MARCH 16, 2025

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. First, advanced research and development (R&D) and biologics will be critical. Regulatory bodies in the U.S.

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FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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Syner-G

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

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Syner-G

SEPTEMBER 20, 2023

By: Mayuri Mutha, Senior Manager, CMC Development & Project Management Joseph Sclafani PhD, Director, CMC Development & Project Management Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization.

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European Pharmaceutical Review

JUNE 24, 2022

But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.

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pharmaphorum

NOVEMBER 22, 2022

The company focuses on so-called ‘undruggable’ targets – those that have defied the efforts of drug developers using conventional treatment approaches.

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pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. VivoSense software is developed specifically for analysis of data from wearable sensors”, explains Tabakin. “The This brings us to VivoSense.

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European Pharmaceutical Review

FEBRUARY 7, 2023

Launch of the EU pharmaceutical package The European Commission plans to commence initiatives relating to the European Pharmaceutical Strategy (strategy) with the publication of the revised EU pharmaceutical package scheduled during the first quarter of 2023.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The company focuses on small molecule, oral liquid, and solid dose products, providing formula development, method development, cleaning verification methods, tech transfer, pilot studies, commercial scale-up, and packaging.

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Viseven

AUGUST 15, 2024

The traditional model of drug development and healthcare delivery is undergoing a seismic shift, with patient engagement emerging as a critical factor in achieving better health outcomes and driving innovation. This change is further driven by major regulatory bodies emphasizing Patient-Focused Drug Development (PFDD).

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Pharmaceutical Technology

NOVEMBER 24, 2022

We talked to Iain Shaw, Senior Director of 14 C Enabled Drug Development, and Eleanor Row, Executive Director of Commercial, at Quotient Sciences, a drug development and manufacturing accelerator. How does your unique Synthesis-to-Clinic® offering streamline the drug development process? Conclusion.

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pharmaphorum

DECEMBER 9, 2021

After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families. “I I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

US Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; June 2020. Available from: [link]. Available from: [link].

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The companies offer various solid dose products and services including, but not limited to, formulation and analytical development, manufacturing capabilities, technology transfer and scale-up, quality and regulatory support, commercial manufacturing, packaging, and warehousing.

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