FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide …

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FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide …

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Novartis acquires Arctos Medical, expanding optogenetics portfolio to bring gene therapies to patients with severe vision loss
  • Acquisition underscores Novartis commitment to using optogenetics-based therapies to restore vision to patients with advanced blindness
  • Novartis gains one pre-clinical optogenetic AAV gene therapy program and Arctos’ proprietary technology introducing a distinct mechanism of action
  • Technology joins growing portfolio being developed at Novartis for potential treatment of vision loss

Basel, September 21, 2021 — Novartis today announced that it has acquired Arctos Medical, adding a pre- …

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Novartis announces collaboration on HARMONIA, a Phase III, head-to-head trial evaluating Kisqali® vs. Ibrance®* in patients with HR+/HER2- advanced breast cancer

  • HARMONIA seeks to identify the best therapeutic option between Kisqali and Ibrance® for patients with aggressive HER2-enriched intrinsic subtype of HR+/HER2- advanced breast cancer (ABC)
  • HARMONIA is intended to test whether Kisqali changes tumor biology to enable a better response to endocrine-based therapy even within the more aggressive subtypes, improving the course of HR+/HER2- disease
  • Kisqali is unique as the only CDK4/6 inhibitor with proven overall survival benefit in all three pivotal trials, with …
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Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer

  • With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting2
  • Kisqali plus letrozole achieved median OS of over five years (63.9 months), a survival benefit of over 12 months vs. placebo plus letrozole in postmenopausal women (HR=0.76; p=0.004)2
  • Kisqali is the only CDK4/6 inhibitor with proven OS benefit across all …
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Novartis announces findings from a real-world study of alpelisib demonstrating clinical benefit in people with PIK3CA-Related Overgrowth Spectrum (PROS)

  • PROS is a spectrum of rare disorders caused by PIK3CA mutations and is characterized by atypical, visible overgrowths and anomalies in blood vessels, the lymphatic system and other tissues

  • At 24 weeks, 38% of patients achieved ≥20% reduction in the volume of the PROS lesions assessed in the primary endpoint analysis; no patients experienced disease progression or death
     
  • Alpelisib is the first potential treatment to specifically address the root cause of PROS conditions
  • EPIK-P1 study …
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Novartis reports positive health-related quality of life data for 177Lu-PSMA-617 radioligand therapy in patients with advanced prostate cancer at ESMO 2021

  • New quality of life data for 177Lu-PSMA-617 plus standard of care shows delay in worsening of health-related quality of life (HRQoL) and pain in heavily pre-treated patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to standard of care alone1
     
  • US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to 177Lu-PSMA-617; Submission to FDA and European Medicines Agency on track for 2H21
     
  • Novartis committed to …
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Photographer Captures Patients Around the World Persevering With ITP

“I can’t imagine my life without ITP—it has always been a part of me.” Daniela is a patient from Germany diagnosed with the rare platelet disorder at the age of 14. While she has since grown up, raised a family—and now enjoys traveling, hiking, and building memories with her husband and sons—she has also learned how to become the day-to-day manager of her own health and best handle her condition to live her life to the fullest.

ITP (immune thrombocytopenia) is a rare blood disorder in which there are too few clotting cells, or platelets, in the blood. Patients diagnosed with ITP may …

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Doing the right thing is good business

Can a pharmaceutical company do good and run a profitable business at the same time? Lutz Hegemann believes not only that it is possible, but also that this is exactly what society expects. In fact, reframing the definition of business success around doing the right thing, he says, is both motivating and liberating.

“In the past, what was seen as a distraction from the core business is now being seen as an enhancement of our business,” says Hegemann, Group Head of Corporate Affairs and Global Health at Novartis.

Hegemann began his medical career working with patients with …

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Toward regrowing cartilage

In a recent wildlife documentary, a shark bites off an octopus’s arm. The octopus hides for days and then reappears. Its tentacle has started to grow back.

Unlike octopuses, humans can’t regrow body parts. At least, not yet.

Novartis researchers are inspired by these wild survival artists. They are developing a treatment that has the potential to regrow cartilage in the knees of patients with osteoarthritis. Though not quite equivalent to the regenerative powers of wildlife, it’s an ambitious attempt to regenerate tissue. The approach is part of a wider effort at Novartis to …

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