Pave the way to high productivity with continuous manufacturing for pharma

Continuous manufacturing in the pharmaceutical industry is increasing as more manufacturers realize the benefits of the technology. But no two manufacturers are the same, which is why support from the Siemens Smart Manufacturing Solution for Pharmaceuticals helps advance the strategies of your operations.

Learn how a pharmaceutical product that previously took 1-2 months in production can now be finished after two days

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Takeda wins approval for eosinophilic esophagitis drug Eohilia

Takeda announced this week that it received FDA approval for its Eohilia (budesonide oral suspension) therapy.

This makes Eohilia the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). Takeda plans to offer it in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

Eohilia, a corticosteroid, is indicated for 12 weeks of treatment in patients 11 years and older with EoE. Developed specifically for EoE, the novel formulation of budesonide confers thixotropic properties, according to a news release. This allows for more free flow when shaken, returning to a more viscous state when swallowed.

Takeda picked up approval on the back of efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies.

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal…

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Catalent cuts 300 jobs ahead of acquisition by Novo Holdings

Catalent said this week that it reduced its headcount by approximately 300 employees as part of a restructuring effort.

The company confirmed the workforce reduction in its 10-Q quarterly report, filed on Feb. 14. This also coincides with preparations for an acquisition as Novo Holdings agreed to buy the leading pharmaceutical CDMO for $16.5 billion earlier this month.

In connection with the headcount slash, Catalent incurred cumulative employee-related charges totaling approximately $12 million. Those are primarily associated with cash severance programs through Dec. 31, 2023.

The company says that it adopted plans to reduce costs, consolidate facilities and optimize infrastructure during the fiscal year ended June 30, 2023. During the three months ended Dec. 31, 2023, it extended those plans to reduce costs and headcount in its Biologics and Pharma and Consumer Health segments.

In October 2023, the company committed to closing operations at a Sa…

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AbbVie is expanding its Singapore biologics plant

AbbVie (NYSE: ABBV) recently announced that it will spend $223 million to expand its Singapore biologics manufacturing facility.

Construction will commence immediately, with the facilities coming online in 2026. The added facilities will create 100 new jobs at the plant, boosting total employment to more than 500 positions in manufacturing, quality assurance, supply chain, engineering and administration roles, according to AbbVie.

AbbVie said the investment strengthens its global manufacturing network and supports its growing pipeline in treatment areas such as immunology and oncology. The Singapore expansion will add 24,000 liters of biologics drug-substance capacity to AbbVie’s global network, supporting current projects and emerging immunology and oncology compounds within AbbVie’s pipeline.

The company has invested $740 million in acquiring, modernizing and expanding its Singapore facility over the past 10 years.

“This expans…

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Eicos Sciences’ FDA-approved Aurlumyn promises to drastically reduce frostbite amputations

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Imagine scaling a mountain only to later lose digits or an entire hand to the unforgiving ravages of frostbite. For climbers, explorers, adventurous backcountry skiers, and even those caught in unexpected winter storms, severe cold exposure carries a devastating risk — amputation. Today,  thanks to a potentially landmark FDA approval, the prospect of losing one’s extremities to frostbite becomes slightly less chilling.

Novel indication for iloprost

Eicos Sciences’s Aurlumyn, containing the active ingredient iloprost, offers a novel approach to treating severe frostbite. Iloprost, a synthetic version of a naturally occurring substance known as prostacyclin, targets two key problems. First, it addresses cold-induced blood vessel construction by widening them to restore essential blood flow to the affected tissues. Second, it prevents blood clots from forming, which can further block circulation…

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AstraZeneca invests $300 million to establish new cell therapy manufacturing facility in Maryland

AstraZeneca facility in Maryland

Maryland Governor Wes Moore announced that AstraZeneca would invest $300 million to construct a new manufacturing facility in Rockville, a city with roughly 70,000 inhabitants that is about 17 miles from Washington, D.C. The facility will focus on cell therapies for cancer treatment. The 84,000 square-foot facility, slated for completion in 2026, will enable global clinical trials and commercial supply of AstraZeneca’s CAR-T cancer therapies. AstraZeneca estimates the plant to create 150 new high-skilled jobs.

Incentives played a role in new plant

To support AstraZeneca’s new manufacturing facility in Rockville, Maryland, the state and county are providing financial incentives, including a $500,000 conditional loan from the Maryland Department of Commerce’s Advantage Maryland program and a $100,000 conditional grant from Montgomery County’s Economic Developm…

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Sanofi offers a year of salary to employees facing cancer, critical illnesses

French pharma giant Sanofi launched a new global program aimed at providing financial, social and emotional assistance to employees diagnosed with cancer or other critical illnesses.

Dubbed “Cancer & Work: Acting Together,” the program guarantees continued salary and benefits for up to one year for affected staff regardless of role or location. It also incorporates flexible work options to help employees balance treatment with their responsibilities.

“The last thing you want to be thinking about when diagnosed with cancer is work,” said Natalie Bickford, Sanofi’s Chief People Officer, in a statement. “I am delighted that Sanofi has gone further, guaranteeing job security and salary continuation for at least a year after diagnosis.”

Program offers more than financial support

In addition to the financial safeguards, the program provides access to trained volunteer employees who have dealt with cancer themselves and can offer advice and support. Psychol…

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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…

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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…

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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…

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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 …

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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…

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