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DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

. “Serious infections in children can be difficult to treat and the impact of ABSSSI among children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” said Margaret Burroughs, medical director, infectious diseases, AbbVie. Use in Specific Populations.

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FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

This real-world cohort includes more than 1,400 women with HR+, HER2- mBC with any extent of visceral disease. Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. 2,3 In the U.S.,

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S., The full U.S.

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together. It remains under review by the FDA. www.lilly.com?and?www.lilly.com/news.?P-LLY.

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BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

This trial is a multicenter, randomized, double-blind, placebo-controlled, ascending, dose-finding, adaptive Phase 2 study designed to evaluate the safety, pharmacokinetics and efficacy of BXCL501 in intensive care unit patients experiencing agitation associated with delirium, including COVID-19 patients.

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Stoke Therapeutics Announces Presentations Related to the Company’s Work to Advance STK-001, the First Potential New Medicine to Target the Underlying Cause of Dravet Syndrome at the American Epilepsy Society (AES) 2020 Annual Meeting

The Pharma Data

The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease. The primary endpoints are safety, tolerability and pharmacokinetic (PK) profile of STK-001 in Dravet syndrome patients. BEDFORD, Mass.–(

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2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.