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The US biosimilar market: Predictions for 2021

pharmaphorum

There is also current legislation in Congress (HR 8190) that aims to open the door to interchangeability within the biosimilar market – specifically starting with insulin products. If passed, HR 8190 would allow insulin biosimilar products to receive automatic interchangeability upon FDA approval.

Marketing 119
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Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

XTalks

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. What does this Approval Mean for Breast Cancer Patients? months in HR+/HER2- Patients The average five-year rate of survival is 30 percent in HR+/HER2- patients.

HR 52
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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

The Pharma Data

1 Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo (Hazard Ratio [HR] 0.70, 95% CI: 0.57 n=142) for placebo; Opdivo reduced the risk of disease recurrence or death by 45% (HR 0.55, 95% CI: 0.39 months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3 to 13.9]). to 0.86; P =0.0008).

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Janssen Announces Treatment with ERLEADA

The Pharma Data

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). ERLEADA ® received U.S.

HR 52
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Pfizer Responds to Research Claims

Pfizer

In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. Most of this work is conducted using computer simulations or mutations of the main protease–a non-infectious part of the virus.

Research 112
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Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicityEnhertu. 4.3] (HR=0.47; 95% CI 0.31-0.71) Related Articles: Enhertu (fam-trastuzumab deruxtecan-nxki) FDA Approval History. 0.88; p=0.0097) at a pre-specified interim analysis with a median OS of 12.5

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Janssen Presents Results from Phase 3 ACIS

The Pharma Data

months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001). 2 ERLEADA ® received U.S.

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