Clinical Trials

10 Oct 2019
- Clinical Trials
- Human Trials
Dermira begins phase 3 programme to assess lebrikizumab in patients with moderate-to-severe atopic dermatitis

By PBR Staff Writer

Dermira, a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, announced dosing of the first patient in a Phase 3 study evaluating the safety and efficacy of lebrikizumab in adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis, the most common form of eczema.
09 Oct 2019
Clinical Trials
Human Trials
IDEAYA announces first patient dosing of IDE196 for solid tumors outside of uveal melanoma

By PBR Staff Writer

IDEAYA Biosciences has dosed its first patient with cutaneous melanoma harboring a GNAQ or GNA11 (GNAQ/11) mutation, a key milestone for evaluating Protein Kinase C (PKC) inhibitor IDE196 in solid tumors outside of metastatic uveal melanoma (MUM) as part of IDEAYA's ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions".
09 Oct 2019
Clinical Trials
Human Trials
Hoth Therapeutics completes phase 1 of in-life dose escalation study for treating Eczema

By PBR Staff Writer

Hoth Therapeutics, a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, announced that they have completed Phase I of their In-Life dose escalation study.
01 Oct 2019
Clinical Trials
Human Trials
RESTORE-IMI 2 phase 3 study of Merck’s RECARBRIO in HABP/VABP meets primary endpoint

By PBR Staff Writer

Merck, known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 RECARBRIO (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) RESTORE-IMI 2 trial met its primary endpoint.
30 Sep 2019
Human Trials
Clinical Trials
Clover Biopharmaceuticals doses first patient in Phase I study of SCB-313 in China for malignant ascites

By PBR Staff Writer

Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, announced that the first patient was dosed in another Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in China for the treatment of cancer patients with malignant ascites.
30 Sep 2019
Clinical Trials
Human Trials
Tagrisso is only first-line treatment for EGFR-mutated NSCLC to deliver median overall survival of over three years

By PBR Staff Writer

AstraZeneca announced overall survival (OS) results from the Phase III FLAURA trial of Tagrisso (osimertinib) in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
30 Sep 2019
Clinical Trials
Human Trials
GSK’s niraparib meets PFS goal in phase 3 PRIMA trial

By PBR Staff Writer

GlaxoSmithKline (GSK) said that a phase 3 trial called PRIMA has demonstrated its polymerase (PARP) inhibitor Zejula (niraparib) to have significantly improved progression free survival (PFS) in women with first-line platinum responsive advanced ovarian cancer.
27 Sep 2019
Clinical Trials
Human Trials
Samsung Bioepis announces phase 3 results of SB8, Bevacizumab biosimilar candidate, at ESMO 2019 Congress

By PBR Staff Writer

Samsung Bioepis Co announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
27 Sep 2019
Clinical Trials
Human Trials
Noveome Biotherapeutics initiates trial evaluating intranasal delivery of ST266 targeting optic nerve and brain

By PBR Staff Writer

Noveome Biotherapeutics, a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, announced initiation of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in patients diagnosed with intraocular hypertension who have not yet developed optic nerve damage.
26 Sep 2019
Clinical Trials
Human Trials
Incyte announces first patient treated in phase 3 trial program evaluating Ruxolitinib cream in patients with vitiligo

By PBR Staff Writer

Incyte announced that the first patient has been treated in the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream as a monotherapy for adolescent and adult patients (age ≥12 years) with vitiligo.

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Gerresheimer

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Clinical Trials

Dermira begins phase 3 programme to assess lebrikizumab in patients with moderate-to-severe atopic dermatitis

IDEAYA announces first patient dosing of IDE196 for solid tumors outside of uveal melanoma

Hoth Therapeutics completes phase 1 of in-life dose escalation study for treating Eczema

RESTORE-IMI 2 phase 3 study of Merck’s RECARBRIO in HABP/VABP meets primary endpoint

Clover Biopharmaceuticals doses first patient in Phase I study of SCB-313 in China for malignant ascites

Tagrisso is only first-line treatment for EGFR-mutated NSCLC to deliver median overall survival of over three years

GSK’s niraparib meets PFS goal in phase 3 PRIMA trial

Samsung Bioepis announces phase 3 results of SB8, Bevacizumab biosimilar candidate, at ESMO 2019 Congress

Noveome Biotherapeutics initiates trial evaluating intranasal delivery of ST266 targeting optic nerve and brain

Incyte announces first patient treated in phase 3 trial program evaluating Ruxolitinib cream in patients with vitiligo

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