Pharmaceutical Processing World Archives - Page 3 of 64

BD lays off 111 at biotech reagent plant in California

BD recently informed California’s Employment Development Department that it will relocate its Biosciences division’s reagent manufacturing and R&D operations in San Jose.

The Life Sciences tech giant is laying off 111 workers due to the relocation to other BD sites, according to its WARN letter dated Dec. 12, 2023. The layoffs have been taking place in waves: March 2023, December 2023 and September 2024. All affected employees have received at least 60 days written notice, opportunities to positions elsewhere in BD, and outplacement assistance. Those in full-time roles are receiving severance.

Remaining operations at Qume Drive in San Jose will move to nearby Montecito and Milpitas, with the entire San Jose facility closed by the end of September 2024.

The BD layoffs in San Jose come at the same time that the biotech sector continues to shed jobs. Factors behind the downsizing include not just economic uncertainty but also regulatory shif…

Oncology deals return to center stage as miopharma M&A remains strong in 2024

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In the first few weeks of 2024, oncology remained a central focus area for M&A deals. Two major acquisitions, Johnson & Johnson’s purchase of Ambrx Biopharma and Merck & Co.’s acquisition of Harpoon Therapeutics, both focus on the segment. The trend is long-standing and was also apparent in 2023, as E&Y has noted. Merck was also active in 2023, bagging Prometheus for $11B.

2024 pharma M&A trends: Strategic expansions beyond oncology

But a number of therapeutic areas are also in the mix. Sanofi kicked off the yera by scooping up rare disease biotech Inhibrx for $1.7 billion. The crown jewel is Inhibrx’s INBRX-101, a potential treatment for alpha-1 antitrypsin deficiency, an inherited disorder that can cause lung and liver disease. Phase 1 data is positive.

In the generics space, Sun Pharma finally finalized its long-sought deal for generic specialist Taro…

Lantheus announces a new CEO

Lantheus Holdings’ incoming CEO Brian Markison [Image courtesy of Lantheus]

Radiopharmaceutical-focused Lantheus Holdings (NASDAQ: LNTH) announced today that current board chair and industry veteran Brian Markison will become the company’s CEO, effective March 1.

Markison succeeds Mary Anne Heino, who is retiring from Lantheus’ corner office after leading the company for nine years. Heino will serve as board chair after March 1. Board member Julie McHugh will become lead independent director effective immediately.

“Brian is perfectly suited to lead Lantheus as the company enters its next growth phase. He has held the chair role for more than 10 years and in that role has overseen company strategy. He knows our exceptional executive team well and brings decades of leadership experience as the CEO of public companies with development, commercialization and manufacturing expertise, includin…

Bayer plans significant job cuts as it restructures

Bayer recently announced that it is embarking on a comprehensive restructuring plan with significant staff reductions.

The Germany-based pharma giant’s management aims to enhance operational performance through a new model called “Dynamic Shared Ownership” (DSO). This strategic change aims to reduce hierarchies, eliminate bureaucracy, streamline structures, and accelerate decision-making processes.

The new model, however, will come at the expense of the jobs of many managerial employees. The layoffs will take place in a decentralized manner through 2025, which means that Bayer cannot initially quantify the size. Bayer has committed to no compulsory redundancies until the end of 2026.

As of the end of 2022, Bayer had more than 101,000 employees, with about a fifth in Germany.

Bayer’s CEO Bill Anderson, who took the helm in June 2023, has emphasized a focus on internal reorganization. This approach delays any break-up plans …

Bora Pharmaceuticals is buying generics maker Upsher-Smith

[Image courtesy of Bora Pharmaceuticals]

Bora Pharmaceuticals announced that its board approved the acquisition of Upsher-Smith Laboratories for up to $210 million.

Minnesota-based Upsher-Smith features a diversified portfolio of 48 generic products. It has manufacturing facilities in Plymouth and Maple Grove, Minnesota. Taipei, Taiwan-based Bora called the company a reliable partner with solid manufacturing capabilities, a robust distribution network and established commercial relationships.

According to a news release, Upsher-Smith’s Minnesota facilities can commercialize a broad range of dosage forms. Those include oral solid, powders and liquid, plus packaging. Through the acquisition, Bora says it gains capacity to support its CDMO business and completes its capabilities in the U.S. market.

Upsher-Smith also offers significant opportunities for Bora’s commercial Rx business, called…

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…

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…

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…

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…

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…

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…

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…