Pharmaceutical Processing World Archives - Page 4 of 64

Nordson Medical unveils Pharma+ tubing retainers

Pharma+ tubing retainers [Image courtesy of Nordson Medical]

NEWS RELEASE: Nordson Medical unveils Pharma+ tubing retainers: a breakthrough in fluid transfer efficiency

Loveland, Colorado – November 29, 2023 – Nordson Medical, a Nordson company (Nasdaq: NDSN), is proud to announce the launch of Pharma+ tubing retainers, a revolutionary addition to their product portfolio that promises to redefine excellence in fluid transfer applications. These advanced tubing retainers have been meticulously engineered to address the critical challenges faced by professionals in the biopharmaceutical and high-pressure medical sectors, offering a comprehensive solution for leak-free fluid transfer.

The Pharma+ tubing retainers introduce a groundbreaking feature — a patent-pending lead-in ramp that creates complete 360° compression, ensuring a secure fit over hose barbs. This cutting-edge design eliminates potential leak poin…

Pfizer restructuring push hits Ireland

After encountering a significant drop in demand for its COVID-19 products, Pfizer announced a significant restructuring aimed at ultimately saving $3.5 billion globally. The initiative continues with cost-cutting efforts in Ireland where the company plans to consolidate offices and eliminate jobs. The pharmaceutical giant, which was the biggest in the world in 2022, recently announced it will relocate employees from its Citywest office in Dublin to its larger Ringsend facility. The company did not specify an exact number of layoffs. This comes just weeks after Pfizer cut 100 jobs at its Newbridge plant.

Pfizer said it would≥ move all employees from Citywest to the larger Ringsend site to “enable growth and investment in our Irish manufacturing network.” Additionally, the company plans to bolster its Grange Castle biotech facility, which manufactures vaccine and biologic ingredients. Pfizer has biotech and pharmaceutical manufacturing sites in Dublin, Cork,…

Forecast 2024: Pharma industry grapples with regulatory hurdles and AI opportunities

[Johnathan/Adobe Stock]

Heading into 2024, the pharma industry finds itself in uncharted waters. On the one hand, the sector’s commitment to R&D investment and innovation output is likely to remain strong, with tools based on AI, automation and real-world data promising more streamlined drug candidate optimization. Additionally, the pharma sector is typically resilient in economic downturns. Financial stability in 2024 is likely to be elusive. While Goldman Sachs remains largely upbeat, analysts at UBS forecast significant economic headwinds for the U.S., including the looming threat of a recession, but characterize the pharma sector as “defensive” — along with software, staple goods, electric utilities, reinsurance and defense companies.

Several factors, however, could complicate matters. First, the pharma sector continues to grapple with increased regulatory burdens from the Inflation Reduction Act (IRA),…

Senators urge action on Beyfortus supply as RSV threat looms

Beyfortus (nirsevimab), along with vaccines, is one of the latest weapons against RSV.

Approved on July 17, 2023, AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) occupies a unique niche as a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor for neonates and infants. With RSV rates surging, the drug quickly fell into a shortage. The CDC and FDA recently made available more than 77,000 additional doses of Beyfortus. Meanwhile, Senate Democrats Tammy Duckworth, Kirsten Gillibrand, Ron Wyden, Ed Markey, Richard Blumenthal, Jon Ossoff, and Elizabeth Warren pushed AstraZeneca and Sanofi for action regarding the supply shortage.

Unprecedented demand

Facing criticism for the supply shortfall, Sanofi noted it had encountered “higher than anticipated demand” and said it had an “aggressive supply plan” in place to exceed past performance of pediatric vaccine launches. AstraZeneca also noted…

Navigating the new regulatory terrain pharma companies face with IRA and 340B

[Image courtesy of Adobe Stock]

The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals to allow Medicare to negotiate drug prices for the first time and imposing rebates on drug price increases that outpace inflation. Additionally, the 340B Drug Pricing Program, which was created in 1992, is a U.S. federal government program that aims to allow healthcare organizations to offer affordable prescription drugs to underserved and low-income populations. In 2021, 340B backed entities purchased $43.9 billion worth of covered outpatient drugs under the program.

To get a clearer sense of how the indu…

Revolutionizing Pharma Sustainability: Grundfos Solutions for Optimizing Efficiency

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AstraZeneca faces profitability dip in Q3 2023 despite revenue bump; bets big on obesity

Cambridge, UK–based AstraZeneca continued its strong growth trajectory in Q3 2023, expanding its cardiometabolic and obesity pipeline with a focus on GLP-1 receptor agonists. In particular, AstraZeneca has a licensing agreement with Eccogene for ECC5004, a potential oral GLP-1RA for obesity and cardiometabolic conditions, represents the company’s strategic focus on this emerging therapeutic area, which Lilly and Novo Nordisk currently dominate.

Pascal Soriot, CEO of the company noted he was “excited” about the acceleration of the company’s cardiometabolic and obesity pipeline with the licensing agreement for ECC5004, “a potential best-in-class oral GLP-1RA.”

ECC5004 has an oral formulation, in contrast to Novo Nordisk’s Wegovy (semaglutide) and the recently approved Lilly’s Zepbound (tirzepatide), which are injectables. This oral GLP-1 receptor agonist could potentially improve patient compliance and accessibility in treating obesity and type 2 diabetes. While …

Commitment to operational efficiency and partnerships yield dividends for Teva

Teva’s strategy to boost its operational efficiency and tap strategic partnerships seems to be paying off. In its Q3 earnings report, Teva announced that global revenues were up to $3.9 billion, marking a 7% rise from the previous year’s third quarter. Factors fueling the growth include the robust performance of their specialty medications, Austedo and Ajovy, as well as a strong showing from their generics portfolio. However, despite these promising stats, investors appear to be cautious. Teva’s stock is down almost 8% so far this year, currently trading at $8.77.

For Austedo, Sven Dethlefs, the company’s head of North America commercial, noted that the company has seen growth for the extended-release version of the drug. In an earnings call, Dethlefs said the company has seen “a significant number of new prescribers that have never prescribed Austedo before that now start prescribing Austedo XR.” He added that the demand for the …

Transparency-Rx promises reform in the PBM landscape

Image from https://torange.biz/medications-big-money-19928

Pharmacy benefit managers (PBMs) have recently emerged as a punching bag with the pharma trade group PhRMA accusing such orgs of driving up drug prices. Now, an alliance of PBMs known as Transparency-Rx has emerged, promising a reform initiative in a digital campaign attempting to put pressure on rival PBMs. This coalition’s efforts could reshape drug pricing dynamics, with potentially significant consequences for pharma companies, which may potentially need to adapt to a market with more straightforward and possibly more stringent pricing structures.

Transparency-Rx pushes for PBM reform

Transparency-Rx, comprising PBMs such as AffirmedRx, Liviniti and SmithRx, claim they can generate major per-prescription savings. In doing so, they aim to differentiate themselves from the “big three” PBMs, which include CVS Caremark, Express Scr…

Pfizer’s $3.5B cost-cutting strategy hits Peapack site in New Jersey

After news emerged regarding Pfizer’s plans to close sites in North Carolina, the company is adding New Jersey to the list. The company expects its Peapack facility to cease operations in early 2024.

A Worker Adjustment and Retraining Notification(WARN) Notice notes that 791 workers could potentially be cut from its Somerset County corporate office. The company hasn’t released an official tally, and notes that the “vast majority” of workers at the New Jersey site to be re-assigned to the company’s New York headquarters with another portion transitioning to the company’s site in Parsippany.

Peapack closure part of Pfizer’s $3.5 billion cost-savings plan

To respond to weak demand for its COVID-19 therapies, Pfizer has announced a $3.5 billion cost-cutting drive, aiming to save at least that figure by the end of 2024. It will incur a one-time cost of $3 billion in the process.

The 595,000 Peapack site is situated on 130-acres in the Borough o…

FDA warns against compounded oral ketamine for psychiatric disorders

[3D model of Ketamine from Wikimedia Commons]

In recent years, interest in the use of oral ketamine has surged for mood disorders, thanks to the marketing efforts of companies like Mindbloom, Better U, Nue Life and Joyous. FDA released a statement describing the risks involved in taking compounded oral ketamine, noting that the dissociative anesthetic is not FDA approved for any psychiatric disorder.

Compounded oral ketamine risks

The agency specifically warned against the use of compounded ketamine without proper medical oversight, warning that sedation, dissociation, and vital sign changes “may put patients at risk for serious adverse events.”

The FDA’s warning included several considerations related to the use of compounded ketamine for psychiatric disorders, including its potential for abuse and misuse. The agency also noted that ketamine use could lead to psychiatric events, given its associa…

Pfizer to close Durham and Morrisville, North Carolina facilities amid major restructuring effort

In a strategic initiative to streamline operations, Pfizer said it would close facilities in Durham and Morrisville, North Carolina. The company aims to cut at least $3.5 billion in costs.

The company now employs more than 80,000 people worldwide, with roughly 4,000 based in North Carolina.

The closures will not affect Pfizer’s two largest facilities in North Carolina — Sanford and Rocky Mount. The Rocky Mount facility, which specializes in producing injectable medicines for hospitals, employs approximately 3,200 people and has recently resumed operations after a tornado damaged it in July. The Durham Clinical Manufacturing Facility, on the other hand, opened in December 2021. The company initially planned for the facility to create 50 jobs and relocate 40 employees from Chapel Hill. The exact number of people employed at the facility at the time of the announcement remains unclear.

The company has lowered its full-year revenue guidance to $58.0 to $61.…