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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.

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Healthcare Watch October 2023

PM360

HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Only 15% of prescribers think the drugs come at reasonable cost to patients or have decent insurance coverage eligibility. Three quarters of U.S.

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Curavit’s crystal ball – how will 2023 drive meaningful changes in clinical research

pharmaphorum

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

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Healthcare Watch April 2023

PM360

Patient Pages: How Healthcare Costs Affect Insured Patients Today A new study shows an insured American with an employer-sponsored health insurance plan can expect to spend more than $320,000 (including insurance premiums and out-of-pocket costs) during his/her adult lifetime.

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FDA accepts resubmission of Ardelyx’s NDA for XPHOZAH

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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FDA approval for Janssen’s prostate cancer treatment

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

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US FDA accepts Optinose’s sNDA for chronic rhinosinusitis therapy Xhance

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.