XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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pharmaphorum

FEBRUARY 25, 2021

Earlier this month Chiesi and Protalix reported results from another trial called BRIDGE which showed a decrease in patients with moderately or fast progressing kidney disease following the switch from Replagal.

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Drugs Bioavailability Antibody Marketing 80

pharmaphorum

JANUARY 29, 2021

While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable. Along with tanezumab and AK1780, Lilly is also developing LY3016859, an antibody that blocks two different cellular targets (TGF alpha and epiregulin), in phase 2 for chronic pain.

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The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. 1-4 The U.S. . Almirall S.A.’s

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Delveinsight

FEBRUARY 16, 2021

Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, a protein. However, now the duo has reported positive primary results from the phase 3 EV-301 trial comparing Padcev to chemotherapy and are positive about receiving FDA affirmation. Maribavir is an orally bioavailable anti-CMV compound.

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Session Type: Clinical Trials Plenary Session.

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Delveinsight

SEPTEMBER 8, 2021

There are several SLE therapies in the pipeline that are under investigation in different phases of clinical trials for the treatment of Systemic Lupus Erythematosus. Anifrolumab produced a significant response when compared to placebo in the TULIP-1 and TULIP-2 trials. The average annual drug cost is USD 38,000 per year.

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