Pharmaceutical Processing World Archives - Page 4 of 64

In latest move, Biden targets 48 medications that have outpaced inflation

[Image courtesy of Biden for President]

In the latest move targeting Big Pharma, the Biden Administration has signaled its intent to target the pricing of dozens of prescription drugs. In a recently announced Fact Sheet, the Administration announced a strategy under the Inflation Reduction Act to focus on 48 Medicare Part B drugs that have raised prices faster than inflation. This initiative requires pharma firms to pay rebates to Medicare, which could translate to savings of $1 to $2,786 per dose for beneficiaries. The administration notest that it estimates more than 750,000 seniors to use the medications the act covers.

The Inflation Reduction Act is the backbone of Biden’s drug pricing policy, mandating rebates from pharma firms if their prices increase outpace inflation. The legislation also gives Medicare the ability to negotiate the price of a number of drugs. The law also includes a significant cap on o…

Pfizer and AstraZeneca top annual pharma future-readiness rankings

[See Less/Adobe Stock]

As 2023 draws to a close, the pharma industry finds itself at an inflection point. On the one hand, stubbornly high inflation rates, a dearth of talent, supply chain hurdles, and a more challenging regulatory climate threaten profitability. But on the other, the rapid advances in areas ranging from cell and gene therapy and IT technology offer new opportunities for efficiency gains and innovation.

Pfizer, AstraZeneca and Lilly come out on top in future-readiness

Against that backdrop, Pfizer, AstraZeneca and Lilly round out the top three rankings in terms of future-readiness, according to an analysis from IMD. In its annual ranking, Pfizer advanced from second to first place, Eli Lilly moved up from seventh to third place, and Novo Nordisk rose from 13th to seventh. While Pfizer has had something of a rough year, missing its revenue projections as demand for Paxlovid and Corminaty slides, …

Roche enters red-hot metabolic disease market with Carmot Therapeutics acquisition

Swiss pharma giant Roche had a limited presence in metabolic disease, but the firm has agreed to take over obesity drug developer Carmot Therapeutics for $2.7 billion, rivaling the dominance of next-gen obesity drug developers Novo Nordisk and Eli Lilly.

Carmot had been a rising star in biotech, attracting significant funding, including a $150 million Series E financing round in May 2023. The startup, having raised almost $385 million in total funding, had even flirted with an initial public offering (IPO) under the ticker CRMO., a rarity in the current climate.

CT-388 a valuable asset

Carmot’s lead asset is CT-388, a once-weekly injectable dual GLP-1/GIP receptor agonist for obesity, which has shown upbeat weight loss results in a phase 1b study. In the study, participants experienced more than 8% weight loss at 4 weeks. The drug candidate also appeared to be well-tolerated. In the study, The therapy demonstrated substantial weight loss compared to other…

Novo Nordisk to boost GLP-1 capacity with €2.1 billion investment in France

Novo Nordisk announced last week that it plans to invest approximately 16 billion Danish kroner €2.1 billion in GLP-1 drug production.

The company plans to expand its Chartres, France, production site for its current and future product portfolio within serious chronic diseases. This investment significantly increases the capacity of the manufacturing site. It adds aseptic production and finished production processes and extends its current quality control laboratory.

Denmark-based Novo Nordisk’s investment doubles the footprint of the existing plant. It began construction projects and expects finalization between 2026 and 2028, with more than 500 new jobs set to come along with it.

The company said its investment ups the capacity for GLP-1 products and will help it meet future demands for innovative medicine.

GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a glucagon-lik…

Biden’s supply chain plans include made-in-America medicines

President Joe Biden [Image courtesy of the White House]

The Biden administration recently announced efforts to strengthen the pharmaceutical supply chain, mitigate shortages of essential medicines, and expand domestic manufacturing.

The new efforts are part of an overall package of initiatives to boost U.S. supply chains that the White Houe announced on Nov. 27. Securing the country’s supply of medicines and lowering prices have been an important priority for Biden since he took office nearly three years go. The goal is to increase access to essential medicines and medical products.

The latest round of actions include:

Invoking the Defense Production Act to broaden the Department of Health and Human Services’ (HHS) authorities to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that the president deems essential to the national def…

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 …