Eye on FDA

APRIL 13, 2022

The recipient of the letter was Bausch Health Companies and it was in regard to two different communications vehicles – one a “DTC video” that appeared on Lifetime TV’s The Balancing Act – and the other the efficacy webpage of the healthcare professional website. There are a couple of things of note.

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Pharmaceutical Technology

JUNE 19, 2025

billion from 2021 to 2025 year-to-date. Large pharmaceutical companies such as AbbVie, Lilly, Roche and Takeda have demonstrated strong interest in licensing innovator oligonucleotides for CNS indications, accounting for 63% of licensing deals between 2021 and 2025 year-to-date. ASOs accounted for more than half ($3.54

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pharmaphorum

MARCH 16, 2022

Future onsite-and-online conferences present significant decision-making challenges to the pharmaceutical industry, amply demonstrated by the sponsored symposia options, shown in Figure 5, which were available at the 2021 EAACI hybrid conference. Figure 5 Sponsored symposia options at the EAACI hybrid congress 2021.

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Pharmaceutical Technology

JANUARY 20, 2023

In a 2021 GlobalData poll 3 , environmental issues were viewed as the most important area that pharma needs to address, according to 43% of respondents. While using high-capacity aircraft and minimal packaging reduces weight and increases capacity for vital products by using fewer flights.

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European Pharmaceutical Review

APRIL 2, 2025

AI-based optic systems, for example, can enhance defect screening in manufacturing by scanning for packaging defects. Nature Communications. AI is playing an increasing role in sustainable development 15 and green chemistry by optimizing chemical processes to minimize environmental impact. cited 2025Feb]. Available from: [link] 15.

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FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

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European Pharmaceutical Review

JANUARY 25, 2024

7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Eurostat (2022) “How many citizens had basic digital skills in 2021?” percent as EU average with some Member States as high as 25 percent).

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pharmacy mentor

MARCH 12, 2023

34.7million views of our Google Adverts for pharmacies since 2021. Automation , (think Prescription Collection Machines , Dispensing Robots and Packaging Machines) significantly decreases the admin, and therefore long-term expenditure on Rx work. billion UK Prescriptions Dispensed in 2022 ( NHSBSA ).

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Pulses

AUGUST 31, 2023

2021:55-77. Cross reality (XR): Challenges and opportunities across the spectrum. Innovative learning environments in STEM higher education: Opportunities, challenges, and looking forward. Onime C, Uhomoibhi J, Wang H, Santachiara M. A reclassification of markers for mixed reality environments. Campus-wide information systems.

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Viseven

JUNE 12, 2023

Surprisingly, nearly half of all clinical trials conducted in the world in 2021 had locations in APAC. Suyoung went to the conference to share her insights on how pharma companies can switch from traditional communication to personalized customer journeys and increase brand awareness using solutions by Viseven.

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Proxsys Rx

AUGUST 28, 2024

billion in 340B savings from just five companies’ restrictive policies in 2021 alone.” Five companies — Merck, Sanofi, Astra Zeneca, Novartis and Eli Lilly — whose average gross profit margin in 2021 was over 71%. One almost has to wonder if there was a higher force at work in 2021, balancing the scales of justice.

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European Pharmaceutical Review

JUNE 24, 2022

Following initial consultations in 2021, we expect the publication of the proposal for changes to the EU’s pharmaceutical legislation and potential adoption by the European Commission (EC) by December 2022. It is too early to say because we have not seen the whole package of measures yet. London: Dolon Ltd; 2021. References.

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Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity. Catalent Inc has been tasked with the solid dose manufacturing for the drug.

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Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.

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RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

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Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164).

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Please check your email to download the Webinar.

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ID Stewardship

NOVEMBER 29, 2023

In 2021 I enrolled in a Master’s for Microbiology and cell science at the University of Florida and I am expecting to complete it in December of 2024. Not being afraid to communicate with people has been important to my success. I think that is where I do my best work I. I have found a lot of my guests through social media.

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pharmaphorum

NOVEMBER 27, 2022

Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication. Better communication with traceable data. Automated systems allow suppliers to maintain complete traceability over their processes and communicate in the most effective way possible.

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pharmaphorum

JULY 22, 2021

We found that strong and open channels of communication were imperative. The company remained in close and frequent communication with regulatory agencies to accelerate procedures for the evaluation and authorisation of the clinical trials. We found that strong and open channels of communication were imperative” .

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Pharmaceutical Technology

FEBRUARY 3, 2023

Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. Uniquely, a group of eight independent companies and users of robotic workcells, aggregated their data from 2018- 2021, to assess the performance of innovative aseptic filling technology and help drive modern regulatory standards. 1] BioNews. Hemophilia News Today.

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Pharmaceutical Technology

DECEMBER 8, 2022

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. Free Whitepaper. By Datwyler.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. The question is whether rising inflation levels and major global events will allow for development and innovation.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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European Pharmaceutical Review

APRIL 14, 2025

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Technology For the technical operation of a web of sites, systems must enable them to all share data and communicate with each other.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

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Pharmaceutical Technology

APRIL 21, 2023

Nevertheless, Narcan represents a life-saving treatment option that is free of prescription barriers and will be key in managing a drug epidemic that resulted in the deaths of more than 106,000 people in America in 2021. “We 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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Pharmaceutical Technology

MARCH 7, 2023

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. billion in 2021, which is expected to reach $15.77 Recent analysis valued the market [i] at USD 8.5

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Pharmaceutical Technology

DECEMBER 15, 2022

Kenilworth, NJ, US) is investing $500 million in its Singapore facilities, including setting up a secondary packaging facility and building an inhaler production plant. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Additionally, Merck & Co. Free Report.

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Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. One of the most common use cases is Internet of Things (IoT) sensors placed on containers and packaging to track humidity and temperature in real-time. This made the procurement process more expensive, time-consuming, and ridden with errors.

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Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. A drug with a recent approval extension in the US, though not the UK, was Supernus Pharmaceuticals’ Qelbree (viloxazine extended-release capsules). ADHD treatments were in the political crosshairs in the US recently.

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RX Note

FEBRUARY 23, 2023

Teaching - A selfless effort driven by passion Ideation - Dream big, start small Perspectives - How we viewed the world Work is Work - Do not take things too personal Knowledge is Not Free - The sad truth Communication - Food for thought Phone Addiction - Reflection on living Forget - Why I create notes?

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Pharmaceutical Technology

JUNE 10, 2025

It was the highest total IPO value raised since 2021, with the rebound driven by US Federal Reserve interest rate cuts. “Additionally, Trump’s recent tariff announcement on imports from Canada, Mexico, and China has led to increased market volatility, potentially delaying IPOs as investors await the countries’ responses to the tariffs.”

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