Novo Nordisk scored a pair of double wins the last couple years with the approval of two different forms of semaglutide, the company’s newest blockbuster product line. Now, Novo is setting aside a serious pile of cash to take its manufacturing ops into the future as the company looks to level up.
Novo will invest roughly $2.58 billion (DKK 17 billion) to greatly expand its manufacturing footprint at its central hub in Kalundborg, Denmark, with three new facilities and the expansion of a fourth on the way, the company said this week.
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Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Australian firm CSL paid a steep price earlier this week for Vifor Pharma and its pipeline of iron and kidney drugs. Looking to ensure it starts its next phase as battle-ready as possible, Vifor will now dump its ‘non-core’ manufacturing business as it slims down before the merge.
Vifor Pharma will offload its finished drug manufacturing wing to Swiss CDMO CordenPharma in a deal designed to streamline the biotech’s business as it awaits regulatory approval for a $11.7 billion buyout by CSL announced earlier this week.
Pfizer CEO Albert Bourla (Evan Vucci, AP Images)
The Covid-19 pandemic has been an extremely profitable time for Pfizer, and the massive drugmaker is using that leverage to advance its portfolio writ large. Now, Pfizer’s emerging gene therapy biz will have some new elbow room as it continues to grow in the coming years.
Pfizer this week opened a $68.5 million gene therapy manufacturing facility in Durham, North Carolina, as part of a multi-year, $800 million plan to outfit its next-gen therapeutics business, the company said Wednesday.
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Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
Eli Lilly, Gilead, Thermo Fisher and other industry groups and nonprofits like BIO and USP are seeking some slight changes and more clarity from the International Council of Harmonisation on its new guidance related to continuous manufacturing.
The guidance, known as Q13, focuses on continuous manufacturing and its potential to lower manufacturing costs and reduce the physical footprint of manufacturing facilities compared to traditional batch manufacturing, according to USP. Continuous manufacturing also may improve quality control, lower the variability in manufactured products, and provide enhanced flexibility in production quantity and utilization of manufacturing lines.
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Hilleman Laboratories is opening a vaccine and biologics development hub in Singapore to aid the company’s journey to develop affordable vaccines against infectious diseases.
A 30,000-square-foot site will go up at 138 Depot Road in Biopolis at a brand new R&D center at the Biopolis industrial park. The project will cost around $58 million with a two-year buildout expected.
The manufacturing site will supply clinical trial materials for up to Phase II development, and the R&D facility will be working on candidate selection, design, the manufacturing process development, and preclinical studies. The two locations will work together to provide concept-to-Phase II services.
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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https://endpts.com/buoyed-by-semaglutide-success-novo-nordisk-uncorks-plans-for-2-58b-manufacturing-expansion-in-denmark/
