The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Ovarian Cancer – July 6, 2020

July 6, 2020

BI-1808 / BioInvent; Keytruda (pembrolizumab) / Merck (MSD)
BioInvent Submits a CTA for a Phase I/IIa trial of BI-1808, A First-in-class Anti-TNFR2 Antibody for the Treatment of Patients With Solid Tumors and CTCL (PRNewswire) – Jun 30, 2020 – “BioInvent International AB…announces it has submitted a clinical trial application (CTA) to begin a Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2), as a single agent and in combination with KEYTRUDA® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL)…The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with KEYTRUDA® in patients with ovarian cancer, non-small cell lung cancer and cutaneous T cell lymphoma….It will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.”

 

Keytruda (pembrolizumab) / Merck (MSD); Lenvima (lenvatinib) / Eisai, Merck (MSD)
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) (clinicaltrials.gov) – Jul 2, 2020 – P2; N=600; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; N=180 –> 600; Trial completion date: Apr 2022 –> Feb 2024; Trial primary completion date: Apr 2022 –> Feb 2024

 

Zepzelca (lurbinectedin) / PharmaMar, Jazz
Zepzelca: Newly added patent in Orange Book (Orange Book) – Jul 3, 2020 – Expiry on December 13, 2024

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Weekly Top News – IBD – July 6, 2020

July 6, 2020

Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima SC Including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis (Businesswire) – Jun 28, 2020 – “Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis….’Remsima SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab and takes significantly less time than the current intravenous formulation, thereby reducing the time patients need to be in medical settings with infusion administrations,’ said Professor Walter Reinisch….Celltrion has completed its application process for patent protection for the Remsima SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia.”

 

MORF-057 / Morphic Therap
Morphic Therapeutic Presents Positive Preclinical Data Supporting Development of MORF-057 in Inflammatory Bowel Disease at Digestive Disease Week 2020 (GlobeNewswire) – Jun 29, 2020 – “The data presented at DDW demonstrate that MORF-057 successfully targets the integrin α4β7 with high potency and selectivity. These studies recapitulate results from previous in vitro and in vivo models of increasing complexity and bolster the emerging profile of MORF-057 by demonstrating saturation of α4β7 in non-human primate receptor occupancy studies…IND filing on track for mid-year and phase 1 clinical trial expected third-quarter 2020…”

 

spesolimab (BI 655130) / Boehringer Ingelheim
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis (clinicaltrials.gov) – Jul 1, 2020 – P2; N=79; Recruiting; Sponsor: Boehringer Ingelheim; N=535 –> 79

 

EUPHORIA: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (clinicaltrials.gov) – Jul 2, 2020 – P; N=504; Not yet recruiting; Sponsor: iThera Medical GmbH

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Weekly Top News – Psoriasis – July 6, 2020

July 6, 2020

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis (clinicaltrials.gov) – Jun 30, 2020 – P3; N=116; Not yet recruiting; Sponsor: AbbVie

 

Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin
Efficacy and safety of brodalumab in adolescents from 12 to 17 years of age with moderate-to-severe plaque psoriasis (clinicaltrialsregister.eu) – Jun 30, 2020 – P3; N=120; Sponsor: LEO Pharma A/S

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharmaceutical Industries receives Japan MHLW approval for Ilumya (Business Standard) – Jun 29, 2020 – “Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries has received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for Ilumya (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

AVT02 (adalimumab biosimilar) / Cipla, Alvotech
Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=448; Not yet recruiting; Sponsor: Alvotech Swiss AG

 

bimekizumab (UCB4940) / UCB; Humira (adalimumab) / Eisai, AbbVie
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=840; Recruiting; Sponsor: UCB Biopharma SRL; Suspended –> Recruiting

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Suspended –> Recruiting

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Daily Top News – July 3, 2020

July 3, 2020

remdesivir / Generic mfg.
European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury (remdesivir) for the Treatment of COVID-19 (Businesswire) – Jul 3, 2020 – “Gilead Sciences, Inc….today announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection….The conditional marketing authorization was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020. Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.”

 

MIV-818 / Medivir
The European Commission has Granted Orphan Medicinal Product Designation in the EU for MIV-818 (PRNewswire) – Jul 3, 2020 – “Medivir…today announced that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC)…”

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Daily Top News – July 2, 2020

July 2, 2020

Sarconeos (BIO101) / Biophytis
Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure (Reuters) – Jul 2, 2020 – “Biophytis SA…today announces that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to proceed with its clinical development program COVA. This Phase 2/3 program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19….’We have already initiated the work to start this key Phase 2/3 trial as soon as possible in the US, and in the European countries where we received approval, and will update the market shortly on our planned timelines.'”

 

Sylvant (siltuximab) / BeiGene, Jazz
EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (Businesswire) – Jul 2, 2020 – “EUSA Pharma…today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS)….The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6.”

 

Erbitux (cetuximab) / Eli Lilly, EMD Serono; MEN1611 / Menarini
Menarini Ricerche announces C-PRECISE-01, a new phase Ib / II study with MEN1611 in colorectal cancer (PRNewswire) – Jul 2, 2020 – “Menarini Ricerche…announced today that the company will launch a new Phase Ib / II trial with MEN1611 in the second half of 2020…The new study, called C-PRECISE-01, will evaluate MEN1611 and cetuximab in patients with PIK3CA mutant, RAS and RAF wild-type metastatic colorectal cancer (mCRC)….The design of the study will be presented on the virtual ESMO World Congress 2020 for gastrointestinal cancer from July 1st to 4th…The primary goal of the C-PRECISE-01 study is to determine the combination RP2D and to evaluate the anti-tumor activity of MEN1611…”

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