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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Packaging Biosimilars Drug Development 98

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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Dosage Pharmaceutical Manufacturing Packaging Drug Development 104

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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Packaging Labelling Pharmaceutical Manufacturing Documentation 40

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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Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

Express Pharma

MARCH 7, 2024

In fact, BMS has just announced a $100 million investment in Hyderabad for a new facility which will expand the company’s global drug development, IT and digital capabilities. Indian pharma will have to re-set its goalposts in response to such transitions.

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Drug Development Packaging Vaccines 111

Express Pharma

MAY 10, 2023

However, this philosophy isn’t just relegated to guiding the practices of medical professionals and drug developers. It extends all the way down to the healthcare sector’s expectations for every component, instrument, and process orbiting the development and manufacture of medicine—especially parenteral drugs.

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Packaging Dosage Labelling Immunity 97

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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Packaging Compounding Drug Development 98

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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Drug Development Packaging Labelling Pharmaceutical Companies 98

European Pharmaceutical Review

MAY 26, 2023

The UK Chancellor has announced a £650 million life sciences growth package (Life Sci for Growth) to help deliver the Science and Technology framework through reforming regulation, boosting investment and driving up talent and skills.

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Packaging Vaccines Drug Development 105

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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Packaging Drug Development 110

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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Health and Personal Care Stores Packaging Drug Development 114

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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Biosimilars Drug Pricing Packaging Labelling 130

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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Packaging Drug Development 52

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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Packaging Drug Development 52

Express Pharma

AUGUST 20, 2023

Even generics giant Teva Pharmaceuticals – a potential beneficiary of the reform – echoed the innovative drug developers’ preference for a voluntary licensing scheme. Several responses drew attention to the question of defining emergency situations, which remains vague in the legislation.

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Packaging Vaccines Drug Development 98

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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Biosimilars Packaging Labelling Drug Development 130

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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Packaging Drug Development 119

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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Drug Development Packaging 98

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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Packaging Communication Drug Development 111

European Pharmaceutical Review

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Another 563 new nanomedicines were under clinical trial or in other stages of drug development. Yet in 2021, 100 nanomedicines had been marketed. Tanzini et al. Significance of Annex 1–2022 for implementing Pharma 4.0

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Process Improvement Packaging Vaccines Drug Development 95

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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Packaging Drug Development 52

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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Packaging Chemotherapy Drug Development 105

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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Packaging Drug Development 59

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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Packaging Communication Drug Development 98

pharmaphorum

MAY 27, 2022

However, if considered early in the drug development plan, compliance is by no means insurmountable and would be offset by the benefits of digital healthcare tools for patient engagement. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. About the interviewees.

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Packaging Generic Medicine Communication Hospitals 80

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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Packaging Drug Development Pharmaceutical Manufacturing 64

pharmaphorum

FEBRUARY 28, 2022

Featured 2022 Speakers Include: Sriman Banerjee, Head of Packaging Development & Commercial Device Engineering, Takeda. Amin Sedighiamiri, Associate Director, Device Development, AstraZeneca. Engineer II, Technical Development, Biogen. Drug-delivery developers. Primary Packaging material designers.

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Packaging Vaccines Drug Development 52

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.

Biosimilars 98

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

OCTOBER 12, 2022

Microneedle Device Developers. Transdermal Delivery Developers. Microarray Patch Developers. Primary Packaging Material Designers. Secondary Packagers. Smart Device Developers. Training Device Developers. Drug Developers. Transdermal Drug Product Developers.

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Packaging Vaccines Drug Development 40

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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Packaging Drug Development Documentation 64

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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Documentation Drug Development Packaging 59

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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Drug Development Documentation Dosage Packaging 59

pharmaphorum

APRIL 11, 2022

Delivering value for patients doesn’t start and end in our R&D labs; actions can be implemented across all stages of the drug development lifecycle to encourage and embrace a pro-innovation environment. The role of innovation in value-based healthcare.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

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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