Novartis announces tislelizumab helped extend median overall survival in first-line advanced esophageal cancer 

Novartis (NYSE:NVS) has announced that chemotherapy plus tislelizumab, a humanized monoclonal antibody directed against PD-1, improved overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the Phase 3 RATIONALE 306 study.

The survival benefits were seen in patients regardless of PD-L1 status.

The benefits were consistent across patient subgroups in the study.

In the study, the combination of tislelizumab and chemotherapy resulted in median overall survival of 17.2 months compared to 10.6 months in patients receiving chemotherapy plus placebo.

Investigators concluded that the combination of chemotherapy and tislelizumab cut the risk of death by 34%.

Tislelizumab was first developed by BeiGene. Novartis paid $650 million for rights to the drug. The company also stands to pay up to $1.55 billion in potential milestone payments.

Novarti…

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Novartis mulls sale of $25 billion Sandoz generics arm

On the heels of announcing a restructuring plan that would do away with approximately 8,000 positions, Novartis AG (NYSE:NVS) is reportedly considering spinning off its Sandoz generics arm.

The company is likely to make a final decision by the end of the year, according to Bloomberg.

Given the sluggish state of the economy, Novartis is likely to pursue spinning off its generics business.

The roots of Sandoz stretch back to 1886 as a die maker known as Kern & Sandoz. The company began manufacturing a fever-reducing drug known as antipyrin in 1895, expanding production to encompass ergotamine for migraines by the 1920s.

The Sandoz business unit is worth approximately $25 billion.

In October 2021, Novartis announced that it had begun a strategic review of its Sandoz business unit.

“We continue to view Sandoz as having the potential to be the leading generics company in the world, driven by its biosimilars’ presence and s…

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Novartis to cut up to 8,000 positions

AG (NYSE:NVS) has announced a restructuring plan that will result in up to 8,000 layoffs internationally, including 1,400 in Switzerland. The cuts would equate to 7.4% of its workforce.

Novartis currently has approximately 108,000 employees.

The Basel, Switzerland–based company aims to save approximately $1 billion in operating expenses by 2024.

In April, Novartis hinted that such a change was coming with the description of a “new organizational structure” that would “accelerate growth, strengthen pipeline and increase productivity.”

The restructuring could hit the company’s Basel operations the hardest, according to the German language paper Tages-Anzeiger.

The restructuring initiative also will integrate the company’s pharmaceuticals and oncology business divisions into an Innovative Medicines (IM) business.

Furthermore, the company intends to decouple its U.S. operations from international comme…

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Novartis temporarily halts production of two radioligand therapy medicines

Novartis (NYSE:NVS) announced that it had voluntarily stopped the production at radioligand therapy plants in Ivrea, Italy and Millburn, New Jersey, over possible quality concerns.

In a statement, the company explained it had made the decision “out of an abundance of caution due to potential quality issues identified in its manufacturing processes.”

As a result, it will stop the distribution of Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide in the U.S. and Canada, and Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

The company plans to investigate further before resuming the production of the two radioligand therapies.

The company anticipates having some supply of the two drugs in the next six weeks.

In the meantime, the company can continue distributing Lutathera in Europe and Asia from a site in Zaragoza, Spain. Novartis, however, acknowledges that the supply of the drugs may be limited.

The compan…

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Novartis reveals positive Phase 3 data for tislelizumab plus chemotherapy in esophageal cancer

The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study.

The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the combination therapy against chemotherapy as a monotherapy.

Novartis noted that the study focusing on first-line ESCC follows on the heels of FDA and EMA accepting tislelizumab in a second-line context.

The company is optimistic that the drug could treat a variety of solid tumors.

To date, tislelizumab has been the subject of more than 200 clinical studies.

Novartis licensed rights to the drug from BeiGene in February 2021 for $650 million upfront plus another $1.55 billion in potential milestone payments.

The Swiss company noted that it would collab…

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FDA approves Novartis’ Vijoice for to treat rare PROS genetic diseases

Novartis announced that it received FDA approval for its Vijoice (alpelisib) PIK3CA-Related Overgrowth Spectrum (PROS) treatment.

Basel, Switzerland-based Novartis said in a news release that Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowth in blood vessel anomalies.

FDA approval followed real-world evidence from the EPIK-P1 retrospective chart review study demonstrating the success of Vijoice in reducing target lesion volume and the improvement in PROS-related symptoms and manifestations. At week 24, 27% of patients (10/37) achieved a confirmed a response to treatment, defined as 20% or greater reduction in the sum of PROS target lesion volume.

Nearly three-quarters of patients (74%) with imaging at baseline and week 24 showed some reduction in target lesion volume, while patients reported improvements in pain (90%), fatigue (76%), vascular malformation (79%), limb asymmetry (69%) and dissem…

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Novartis’ Sandoz, Ares Genetics seek better antibiotics deployment

Sandoz, a Novartis division, announced today that it extended and expanded a strategic collaboration agreement with Ares Genetics.

Basel, Switzerland-baed Sandoz’s collaboration with Ares, aimed at driving innovation to develop solutions in the fight against antimicrobial resistance (AMR), was extended through January 31, 2025.

According to a news release, the companies agreed to an extension of an existing master services agreement in recognition of the importance of surveillance data in informing better prescribing and use of antibiotics as a central part of the global AMR response strategy.

In 2016, details were released from the 2014 Review on Antimicrobial Resistance (AMR), commissioned by the UK government to address the concern that superbugs, resistant to current antibiotics, could eventually evolve to the point that the drugs are no longer effective. New Atlas reported at the time that, if such issues aren’t addressed, the AMR found that s…

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Novartis partners with Carisma Therapeutics on manufacturing HER2-targeted CAR-M cell therapy

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors.

Carisma is headquartered in Philadelphia.

As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris Plains, New Jersey.

Novartis anticipates clinical manufacturing to begin in 2023.

Get the full story from our sister site, Drug Discovery & Development. 

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Novartis partners with Carisma Therapeutics on manufacturing HER2-targeted CAR-M cell therapy

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors.

Carisma is headquartered in Philadelphia.

As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris Plains, New Jersey.

Novartis anticipates clinical manufacturing to begin in 2023.

Novartis has worked to expand its contract manufacturing business. Last year, the company announced that it had an agreement with BioNTech (Nasdaq:BNTX) to fill COVID-19 vaccine vials in Europe.

Novartis has also helped Roche (SWX:ROG) manufacture the arthritis drug Actemra.

In 2017, Novartis became the first company to win FDA approval for a gene therapy with the authorization of Kymriah (tisagenlecleucel) for some pediatric and young adult patients with a form of acute lymphob…

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Novartis to offer Ukraine-based humanitarian aid

Novartis (NYSE:NVS) is joining a growing number of pharma companies in supporting humanitarian efforts in Ukraine.

The company recently announced an initial donation of $3 million to support Ukrainian humanitarian assistance initiatives at the International Red Cross and Red Crescent Movement, Save the Children and International Rescue Committee.

Bayer and Roche have announced similar initiatives.

Novartis also said it would offer ongoing financial support and donations of medicines to Ukrainians.

The company also criticized the war in a statement and pushed for a peaceful resolution.

Pharmacies in Ukraine have reported shortages of some medicines.

Novartis remains hopeful this war will reach a peaceful solution as soon as possible.

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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Novartis to pay up to $1.5 billion to acquire Gyroscope Therapeutics

Novartis (NYSE:NVS) has entered into an agreement to acquire U.K.-based Gyroscope Therapeutics, which specializes in ocular gene therapy company.

The acquisition would add GT005, an investigational gene therapy for geographic atrophy, to its pipeline.

Geographic atrophy is an eye-sight-threatening condition occurring in some patients with dry age-related macular degeneration.

Dry AMD is the most common cause of vision loss in individuals over 55.

GT005 is the subject of three active clinical trials.

Last year, Gyroscope Therapeutics won Fast Track designation from FDA for GT005.

As part of the deal, Novartis will pay $800 million upfront and up to $700 million in further milestone payments.

The acquisition is subject to customary closing conditions.

In November, London-based Gyroscope announced that it had received an investment from Sanofi worth up to $60 million.

 

 

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