Drug Patent Watch

JANUARY 9, 2025

Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. A: First, try to address issues through open communication and your established governance structure. Assessing Your Technical Needs Every drug is unique, and so are its manufacturing requirements.

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The Pharma Data

OCTOBER 30, 2020

A three-way agreement between Takeda , Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW) plans to bring mRNA-1273, Moderna’s Covid-19 vaccine candidate, to Japan. Takeda and Moderna join forces to expand Covid-19 vaccine supply in Japan. Source link.

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Agency IQ

AUGUST 25, 2023

As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. years for fluoropolymers used in food and feed packaging for industrial and professional use, to 1.5 Under the current proposal, the transitions would range from 13.5

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Agency IQ

AUGUST 4, 2023

government to ensure that, in the wake of Brexit, Northern Ireland continues to receive critical supplies such as food and medicines. government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. only” label can be affixed anywhere on the packaging.

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Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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The Pharma Data

JUNE 18, 2023

These include implementing small-scale regional or state-wide programmes on improving access to morphine for medical use with a package of essential services and products for palliative care that is formulated according to the WHO Model List of Essential Medicines and the WHO Essential Package of Palliative Care.

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FDA Law Blog: Biosimilars

JUNE 12, 2023

Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”

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Perficient: Drug Development

DECEMBER 20, 2023

With on-prem AEM installations, you could have a separate repository for each tenant website, where you would just install a separate code package for each tenant (be it manually in the Package Manager or via a CI/CD pipeline in a tool of your choice). It will install code packages for each of the submodules.

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Perficient: Drug Development

SEPTEMBER 19, 2023

Ultimately, this will reduce the cost and complexity of moving and copying data while keeping security, governance, and trust standards. Databricks Salesforce and Databricks are expanding their partnership to allow for seamless merging of data from Data Cloud with external Databricks Lakehouse Platform data.

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Perficient: Drug Development

JULY 20, 2023

If you’re leading the industry, your company is taking an assertive approach to security strategies and governance of data and technical infrastructure across the entire organization and throughout the whole life cycle of the customer.

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Agency IQ

JULY 13, 2023

Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21 st Century Cures Act , sought to add to, tweak and/or amend the U.S. The House PAHPRA reauthorization package does include some interesting provisions. public health emergency preparedness and response infrastructure.

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The Pharma Data

JANUARY 13, 2021

These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), (..)

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. With the ambiguity of the statutory text, FDA looked at the plain language, context, and the structure and purpose of the statute—including both parties’ positions on those points.

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DrugBank

JANUARY 22, 2025

This reduces reliance on finite fossil fuels and optimizes reaction conditions to reduce energy consumption and waste generation, promoting resource conservation and proper environmental governance.    An example of applying green chemistry to pharmaceutical manufacturing is the burgeoning field of biocatalysis.

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Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. However, Maine (and some other states) have more broadly focused on banning all intentionally added PFAS in products after a certain date.

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The Pharma Data

NOVEMBER 5, 2020

Food and Drug Administration (“FDA”) will grant an Emergency Use Authorization (“EUA”) for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such (..)

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The Pharma Data

JANUARY 5, 2021

From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction. This includes Certificates to Foreign Governments from the U.S. and internationally. and internationally.

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Agency IQ

JULY 12, 2024

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Agency IQ

APRIL 12, 2024

Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Heated debates on the most contentious issues resulted in a compromise text for each legislation in March The proposal package , consisting of one directive and one regulation, was finally released in April 2023. citizens; 2.

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The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. CMS has created a checklist to assist sponsors in submitting a complete package. CMS will review each complete submission within approximately 30 days of receipt.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

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Agency IQ

SEPTEMBER 15, 2023

SEP 11, 2023 10:49 PM CDT Regulatory background Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration ( 21 CFR 701.3 ).

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The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration (“FDA”) with respect to a potential Emergency Use Authorization (“EUA”) for REGN-COV2, and possible regulatory approval of REGN-COV2; whether the FDA will grant an EUA for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; (..)

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The Pharma Data

SEPTEMBER 1, 2020

Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally. In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic. link] Accessed July 2020.

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Agency IQ

MAY 3, 2024

It aims to: strengthen ECHA governance and adapt it to its future role, as well as to streamline the working methods of ECHA bodies and make their financing more sustainable. food packaging, kitchen and tableware and food processing equipment). EU food safety policy includes rules on food contact materials (e.g.,

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Agency IQ

AUGUST 18, 2023

This framework is anchored in the Classification, Labeling, and Packaging Regulation (CLP) (1272/2008/EC), the bloc’s definitive legislation on classifying substances and mixtures. varies based on government agency. European Union The E.U. Currently, the CLP is aligned with parts from the sixth and seventh revised editions of the GHS.

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The Pharma Data

JUNE 25, 2021

Government.” government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. It is packaged in a ready-to-use liquid formulation in 10-dose vials. efficacy against the B.1.351

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Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

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Agency IQ

AUGUST 30, 2024

CAD and CMRD) are coming to a close this month (CLP is the acronym for Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures; CAD and CMRD stand for chemical agents directive and carcinogens, mutagens, reprotoxic substances directive, respectively).

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Agency IQ

JULY 28, 2023

Vermont has prohibited the manufacture, supply, and distribution of food packaging, rugs and carpets, ski wax, and water resistant treatments with intentionally added PFAS. The relevant sections of Vermont’s Act 36 (2, 3, and 4) become effective July 1, 2023.

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Agency IQ

JUNE 7, 2024

European Commission issues EU-wide rules on pesticide ingredients The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU.

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The Pharma Data

OCTOBER 14, 2020

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

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Agency IQ

AUGUST 2, 2024

It aims to: strengthen ECHA governance and adapt it to its future role, as well as to streamline the working methods of ECHA bodies and make their financing more sustainable. food packaging, kitchen and tableware and food processing equipment). EU food safety policy includes rules on food contact materials (e.g.,

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Agency IQ

JANUARY 4, 2024

The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments.

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Agency IQ

JUNE 7, 2024

Europe replaced the three directives with two regulations – the medical device regulation (MDR; Regulation (EU) 2017/745) encompasses active implantable and general medical devices; diagnostics, including companion diagnostics are governed a separate IVD regulation (IVDR; Regulation (EU) 2017746).

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (the “FDA”) for casirivimab and imdevimab will remain in effect and whether the EUA is revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; the likelihood, timing, and scope of possible regulatory approval and commercial (..)

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The Pharma Data

DECEMBER 5, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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