Pharma manufacturing sees wave of investments in Europe

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Over the past three months, the pharma sector has seen a string of investments in manufacturing facilities, especially in Europe. While the European economy lost momentum in 2023 owing to a high cost of living, weak external demand, and monetary tightening, the prospects for growth remain stronger with the EU GDP growth forecast to improve to 1.3% in 2024, according to the European Commission. As economic prospects improve in 2024, major pharma companies are doubling down on investments in European manufacturing infrastructure and jobs to meet strong global demand. While the sector regains momentum, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed concerns about a proposed overhaul of pharma rules from the European Commission, which it worries could harm future investments in the region. For the time being, major pharma companies including Novo Nordisk, Eli Lilly…
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AbbVie launches Produodopa in the EU to treat Parkinson’s

AbbVie (NYSE: ABBV) recently announced the launch of its Parkinson’s disease drug Produodopa (foslevodopa/foscarbidopa) in the European Union.

Produodopa is for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement). It’s indicated for use when combinations of Parkinson’s medicinal products have not given satisfactory results.

North Chicago, Illinois–based Abbvie described Produodopa as the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations. The continuous delivery of Produodopa provides levodopa 24 hours a day. According to AbbVie, this could help patients by extending the period when symptoms are well-controlled, often referred to as “On” time.

“People living with Parkinson’s disease experience daily challenges and uncertainty, especially as th…

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Moderna resizes its manufacturing footprint for a post-pandemic era

Moderna (NASDAQ:MRNA) is progressing on efforts to resume revenue growth in 2025 — even as COVID-19 vaccine sales decline now that the virus is endemic versus a pandemic.

During a presentation at the JP Morgan Healthcare Conference this week, Moderna CFO Jamey Mock noted that the company took a charge of $1.6 billion during the second half of 2023 as it resized its manufacturing footprint.

Meanwhile, the company is betting on a diverse pipeline that relies on its mRNA platform. The company enters 2024 with 45 therapeutic and vaccine programs, including nine in late-stage development. Key highlights include:

Respiratory syncytial virus (RSV) vaccine: Moderna expects regulatory approvals starting in the first half of this year for its vaccine to prevent RSV-associated lower respiratory tract disease and acute respiratory disease in adults 60 and up. The company says it will have the only pre-filled syringe product available at launch and has worked to genera…
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Novartis opens new radioligand therapy manufacturing facility in Indianapolis

Novartis today announced the expansion of its radioligand therapy (RLT) manufacturing capabilities with a new facility in Indianapolis.

The Basil, Switzerland–based pharma giant said it has received FDA approval for commercial manufacturing in Indianapolis of its RLT therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat advanced metastatic prostate cancer.

The new 70,000-square foot facility in Indianapolis is the second of its kind for the company in the U.S. and Novartis’ largest globally.

The Indianapolis site, strategically situated in the U.S., is designed from scratch for RLT production. It promises to substantially increase supply to meet growing demands, especially in the U.S. and potentially Canada, subject to approval. The facility is equipped for future expansion, including fully automated lines — a first for the radiopharmaceutical industry.

“The intricate process of providing RLTs to patients within hours of producti…

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Report: Pharma kicks off year with drug price hikes

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Reuters reports that a number of big-name drugmakers, including Pfizer, Sanofi and Takeda plan to raise drug prices to start the year.

According to the report, the price hikes apply to more than 500 drugs. Excluding different doses and formulations, the reach extends to more than 140 brands of drugs. Reuters said healthcare research firm 3 Axis Advisors analyzed data that uncovered these increases.

This move comes just weeks after the Biden Administration signaled its intent to target the pricing of dozens of prescription drugs. The Administration announced a strategy under the Inflation Reduction Act to focus on 48 Medicare Part B drugs that have raise…

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Kentucky’s $42 million ibogaine research proposal could face hurdles

[Photo by Karolina Grabowska from Pexels]

In the battle against the opioid crisis, Kentucky made waves earlier this year by proposing to allocate $42 million to investigate ibogaine May 31, 2023, a potentially risky psychedelic that can curb opioid withdrawal and cravings. The state’s Opioid Abatement Advisory Commission has recently selected Attorney General-elect Russell Coleman’s appointment of Christopher Evans as the new executive director, marking a possible shift in the state’s strategy in evaluating ibogaine.

While not dismissing ibogaine outright, Coleman has signaled plans to focus more comprehensively on opioid use disorder prevention. Coleman also appointed a new executive director, Christopher Evans, a veteran of the Drug Enforcement Administration (DEA).

A more conservative approach in tackling opioid use disorder would be in line with a view of some medical experts, who have que…

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FDA taking hands-off approach in enforcing medication promotion on TikTok

Social media has become the new wild west for questionable prescription drug marketing. According to an investigation by Bloomberg Law, TikTok has emerged as a hotbed for inappropriate and potentially dangerous promotion of medications from self-dubbed influencers without any medical expertise.

Drugs featured prominently include Novo Nordisk’s bestselling GLP-1 drug Ozempic and Pfizer’s migraine medication Nurtec ODT. Promotion of the drugs often omit mentions of possible risks or side effects. Influencers on TikTok have also promoted medications such as Ozempic solely for dramatic weight loss purposes.

One young TikTok user promoting Wegovy demonstrates on the platform how she injects the medication and advises her nearly 20,000 followers on how to get started on the drug

Some influencers on the platform have ties  to pharmaceutical companies.

Other TikTok videos promote steroids, unproven supplements, and other medications to teenagers looking f…

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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…

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Pfizer and AstraZeneca top annual pharma future-readiness rankings

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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, …

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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…

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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…

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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…
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