FDA Requires Black Box Warning for Pfizer Drug

Pfizer will be required to add a black box warning for Xeljanz, stating that patients who take it could experience a higher risk of blood clots or death.

Jul 31st, 2019

Xeljanz Box / Image: Pfizer

Xeljanz Box / Image: Pfizer

A recent Journal Sentinel article discussed a new addition to the packaging of Pfizer’s Xeljanz. The FDA is requiring its most severe warning for the higher-dose version of the drug used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The change comes five months after a clinical trial demonstrated a link to blood clots in the lungs and deaths. The FDA failed to take action on the drug and Pfizer under the leadership of former Commission Scott Gottlieb, who later took a job on the company’s board of directors.

Pfizer Inc.

The combination of Flexi-Cap and Booklet-Label blinds the vial and offers ample space for product information in several languages.

CSL Behring Uses Specialty Label System to Blind Vials for Clinical Trials

There are visible differences between the candidate and the placebo in this international Phase III trial. The blinding system combines a cap system that completely covers the vial with a booklet label for multilingual product information.

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Pharma Packaging Innovations

New webinar covers several unique packaging innovations to overcome challenges such as child resistance/senior friendly, on-the-go convenience, anti-counterfeiting and improved packaging functionality.

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CPhI Festival of Pharma 2020 in October

Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.

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Liveo Research Announces Capacity Expansion

Liveo Research announces 20,000 ton capacity expansion for coated barrier films to significantly expand pharma packaging business.

Monique Sprueill of Johnson & Johnson addresses supply chain management for ATMPs.

Innovative Therapies Demand Data and Risk Management in Supply Chain

Gene and cell therapies delivered to patients struggling for their lives further complicate an already complicated supply chain. Data and analytics throughout the process are essential to maintaining the integrity needed.

HDA Celebrates Manufacturers With 2020 DIANA Awards

Climate Change Interest Isn’t Ideology, It’s Economics

Economics is the new driver of climate change initiatives, according to Reusable Packaging Association. Attention to packaging selection and management can not only help reduce negative sustainability impacts, but also create new value streams.

Bormioli Pharma Invests in Type I Glass Vial Production for Injectable Medicines and Vaccines

Recent investments will allow Bormioli Pharma to better support pharmaceutical industry demand, especially during such unprecedented, challenging times.

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Collaboration Key to Tackling Drug Development Complexity

Rentschler Biopharma and Vetter team up with joint goal to simplify processes and optimize time-to-market.

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Covectra Enhances Drug Supply Chain Security

Automates management of resalable returns & DSCSA product verification compliance to protect consumers from counterfeit, contaminates or stolen drugs.

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Ready-to-Use and Development Services Grow with Injectables Market

Challenges around injectable products include regulatory requirements, pricing pressures, and an increasingly complex industry landscape.

A wide variety of process steps are required for the filling of vaccines – from washing and sterilizing the vials to filling and closing. All system components are tested and accepted as part of the CSPE approach at Optima in Schwaebisch Hall.

OPTIMA Supporting Catalent with New High-Speed Vial Filling Line for COVID-19 Vaccine Program

Fast track delivery of a complete filling solution under isolator

The GKF 2600, which was developed for the high-performance range, achieves an output of more than 110,000 capsules per hour with capsule size 00.

Pharma Contract Manufacturer Expands Large Batch Production to 110,000 Capsules Per Hour

Wiewelhove expands capsule filling line, enabling the company to fill pellets into capsules with the GKF 2600 from Syntegon Technology. Collaboration on special requests led to a smooth implementation.

Gregor Anderson, MD of Pharmacentric Solutions

Pharmapack Expert Recommends Holistic Approach to Sustainability

Encouragingly, the industry might be 30% along its sustainability journey, but greater interoperability is needed from materials to devices for next stage of development.

Peter Buczynsky, Vice President & General Manager of Pharmaworks blister packaging machinery with PPE face shield.

Packaging Industry fights Covid-19

ProMach company launches collaborative packaging industry effort to donate protective face shields

ACG has received a certification of compliance from Clean Label ProjectTM for its ACGcapsTM H+.

ACG Receives Certification for its ‘Clean Label’ Capsules

ACG is the first and the only capsule manufacturer at this time to receive the certification.

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Healthcare Market Equipment Investments Poised for Growth in 2021

Personal care and pharmaceuticals /medical devices are two markets that, not surprisingly, are holding their own and even expecting growth during COVID-19.

Syntegon Virtuelle Messe

Syntegon Unveils Sustainable, Intelligent Machine Design

Following a major corporate rebranding, the food and pharma packaging OEM launches its first virtual show as a platform to introduce new products and interact with customers.

Midol Before After[1]

Redesign Reverses Course to Reflect Modern Women

Midol®, the venerable OTC menstrual relief brand from Bayer, underwent a striking packaging redesign, reversing course on existing iconography, typography, and messaging.

The coronavirus pandemic is also set to boost the geriatric medicines market.

COVID-19 to Boost Market Prospects for the Global Geriatric Medicines Market

Report foresees positive growth in the geriatric medicines market at a CAGR of 6% from 2020 through 2026.

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The state-of-the-art coating line has increased kp’s local South American coating capacity by over 30%

Klӧckner Pentaplast Completes Major Pharma Capacity Expansion in Cotia, Brazil

Expansion provides additional coating capacity and reduces the site’s carbon footprint and overall energy consumption.

In Support of Customers’ Crisis Response, Groninger USA Extends Service to Weekends and Lowers Rates

To support the COVID-19 response, weekend services will help maximize production output and uptime for customers’ production support technicians and prepare for the upcoming catch-up rally.

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Take PDA's COVID-19 Survey in Pharmaceuticals

The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.

The semi-automatic RRA enables PCI to establish a flexible auto-injector assembly process with a minimum of downtime between batches.

Burgeoning Auto-Injector Market Demands Flexible Production Options

Injectable drug delivery is surging, and auto-injectors are helping patients self-administer more easily. PCI Pharma Services turned to an assembly machine from Syntegon Technology to provide the needed flexibility and scalability.

Glass-Like Plastic for Injectables

Day 2 Innovation Stage at PACK EXPO East in Philadelphia introduced a film from Japan that delivers same performance as glass for parenteral drugs.

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CPhI Japan to be Postponed on Request of Event Attendees

Rescheduling will ensure all stakeholders can take part in a successful exhibition and conference.

“The rebranding effort showcases our commitment to delivering tailored end-to-end systems that meet each customer’s unique set of challenges.”

TCP Reliable Announces Corporate Name Change to Integreon Global

Corporate name change demonstrates ongoing commitment to integrating technologies, expertise and capabilities offered by Integreon Global and its family of companies.

VR piqued the company’s interest because it seemed to be the only medium that could transcend boundaries in a remote way to enable both instruction and hands-on skill building focused on the “why.”

Machine-Agnostic VR Comes to Sterile Manufacturing Education

You’ve heard of OEMs offering augmented reality tools, but virtual reality has come to pharmaceutical processing training. How does improved critical thinking impact the bottom line?

Credence MedSystems, one of two winners in the “Best Innovation in Drug Delivery Device,” was chosen for its Connect™ Auto-Sensing Injection System, which incorporates real-time monitoring of critical injection data into a reusable ergonomic grip. The Credence app also measures and transmits injection progress in real-time, as well as providing users with reminders and instructions on how to use the auto-injector.

2020 Pharmapack Award Winners Announced

The Pharmapack Awards celebrate the latest innovations from packaging companies within the drugs, medical devices, health products and veterinary drugs sectors.

The vials offer a more attractive physical appearance (no burrs), uniform orifice/drug delivery, flexible closure design and printing capability, ability to mold with barrier materials vs. only one material, more uniform wall thickness, and reclosable features.

Lameplast: line of single, multidose containers and filling equipment at Pharmapack

Higher level of precision, functionality, and quality control with flexible closure design and printing capability as well as other features.

Enercon and Innovation decided on an out-of-the-box configuration: two sealers per line, configured at the two different bottle heights required.

Sealing Two Bottles Sizes on One Line

The Department of Veterans Affairs’ Consolidated Mail Outpatient Pharmacy (CMOP) needed a tailor-made system to safely seal two bottle sizes.

Sovereign implemented serialization and aggregation on all three configurations of packaging lines at once.

CDMO Speeds its Line with Open-Source L4 Serialization System

With the serialization deadline approaching, Sovereign Pharmaceuticals implemented open-source software that allows the company to make their own changes and improve packaging efficiency.