The Digest

Pharma news roundup and Larvol updates

Contact Us
Month: June 2020

Daily Top News – June 30, 2020

June 30, 2020

ATH434 / Alterity Therap
Alterity Therapeutics up big on advancement of ATH434 for Parkinsonian disorder (SeekingAlpha) – Jun 30, 2020 – “Alterity Therapeutics…is up 71% premarket after receiving FDA guidance on a development pathway for ATH434…including feedback on the design of a Phase 2 trial. Alterity reached agreement with the agency on the non-clinical investigations required to support the mid-stage study, along with patient population, safety monitoring plan, and strategy for evaluating drug exposure during the trial.”

 

Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex; Kalydeco (ivacaftor) / Vertex
Vertex Announces Expansion of Reimbursement Agreement With NHS England to Include KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO (ivacaftor) (Vertex Press Release) – Jun 30, 2020 – “Vertex…today announced that it has expanded its reimbursement agreement with NHS England for Vertex’s cystic fibrosis medicines to include KAFTRIO® (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with KALYDECO® (ivacaftor) 150 mg, ahead of the medicine’s anticipated approval by the European Commission.”

 

Zygel (cannabidiol gel) / Zynerba
Zynerba Pharmaceuticals Announces Top Line Results from Pivotal CONNECT-FX Trial of Zygel (CBD Gel) in Fragile X Syndrome (GlobeNewswire) – Jun 30, 2020 – P2/3, N=204; CONNECT-FX (NCT03614663) ; Sposnor: Zynerba Pharmaceuticals; “Zynerba Pharmaceuticals, Inc….today announced top line results from the 14-week pivotal CONNECT-FX….Zygel did not achieve statistical significance versus placebo in the primary endpoint of improvement in the Social Avoidance subscale….Zygel also did not demonstrate statistical significance versus placebo in the three key secondary endpoints….A pre-planned ad hoc analysis…demonstrated that patients receiving Zygel achieved statistical significance in the primary endpoint of improvement at 12 weeks….Upcoming Corporate Milestones: Fragile X syndrome: Meet with the FDA to discuss CONNECT-FX results as soon as possible; Zynerba intends to meet with FDA to discuss the positive Phase 2 BRIGHT trial results and clinical path forward in 2H2020.”

 

Melflufen (melphalan flufenamide) / Oncopeptides; dexamethasone / Generic mfg.
Oncopeptides submits a New Drug Application to the FDA for accelerated approval of melflufen in triple-class refractory multiple myeloma patients (Oncopeptides Press Release) – Jun 30, 2020 – “Oncopeptides…today announces that the Company submits a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen (INN melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with multiple myeloma…The submission is based on the results from the pivotal phase 2 study HORIZON….Following the submission to the FDA Oncopeptides will initiate an Expanded Access Program (EAP) in the U.S. to enable melflufen treatment for patients with a significant unmet medical need.”

Read More …

COVID-19 Top News – June 29, 2020

June 29, 2020

stannous protoporphyrin (RBT-9) / Renibus Therap
Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19 (GlobeNewswire) – Jun 23, 2020 – “Renibus Therapeutics, Inc….announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19….RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19.”

 

losmapimod (FTX-1821) / Fulcrum Therap
Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients (GlobeNewswire) – Jun 24, 2020 – “Fulcrum Therapeutics, Inc….today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod…..LOSVID trial is…in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness….An interim analysis will be conducted in the fourth quarter of 2020 for futility and sample size re-estimation….Topline data is expected to be reported in the first quarter of 2021.”

 

hydroxychloroquine / Generic mfg.
It’s the end of road for hydroxychloroquine in COVID-19 as Novartis, NIH and WHO pull out of trials (Fierce Pharma) – Jun 22, 2020 – P=NA, N=470; “…the World Health Organization (WHO), generic hydroxychloroquine (HCQ) maker Novartis and the U.S. National Institutes of Health (NIH) have all ended their HCQ COVID-19 studies….Sanofi previously put a temporary halt to its own study based on safety….Novartis said it would discontinue its sponsored HCQ trial for COVID-19….NIH also decided that its Orchid study of HCQ would no longer continue after a fourth interim analysis by an independent data monitoring panel found the drug provided no additional benefit over placebo control.”

 

EDP1815 / Evelo Biosci
Evelo Biosciences Announces EDP1815 to Advance into Phase 2/3 TACTIC-E COVID-19 Trial (GlobeNewswire) – Jun 22, 2020 – “Evelo Biosciences, Inc….announced today that EDP1815 will be included in the TACTIC-E clinical trial. The trial will evaluate the safety and efficacy of certain experimental therapies….Interim data from the trial are anticipated during the fourth quarter of 2020. If the Phase 2/3 data are positive, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration.”

 

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19 (GlobeNewswire) – Jun 24, 2020 – “NeuroRx, Inc….today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19….As part of NeuroRx’s enrollment in the Fast Track program, the FDA has requested NeuroRx to submit a publicly-available expanded access policy…”

 

EMD Serono Initiates First Clinical Trial of TLR7 and 8 Inhibitor as a Potential Treatment for Severe Symptoms of Covid-19 Infection (EMD Serono Press Release) – Jun 25, 2020 – “EMD Serono…today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. The Company will initiate a Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population….M5049 will be investigated in a randomized, placebo-controlled study at sites in the United States and Brazil….In addition to the FDA, Merck KGaA, Darmstadt, Germany is working with other global health authorities and investigators to accelerate clinical development to meet the critical need presented by the current global pandemic and expects results from the Phase II study around the end of 2020.”

 

Celltex-AdMSCs / Celltex
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19 (Businesswire) – Jun 26, 2020 – “Celltex…today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).”

 

VP01 / Vicore Pharma
Battling the cytokine storm (PharmaTimes) – Jun 25, 2020 – “Researchers have recently identified part of the cytokine storm known as a ‘burning point’….The research shows that this occurs five days before what the authors describe as a ‘composite end point event’ or CEPE….Another marker identified by researchers is a deficiency of vitamin D….At Vicore we have been researching the RAS for nearly 20 years….We are trialling VP01, (sic) an experimental first in class low molecular weight angiotensin II receptor type 2 (AT2R) agonist, as a potential COVID-19 treatment.”

 

remdesivir / Generic mfg.
Gilead to Test Inhaled Form of Remdesivir in COVID-19 Starting in August (BioSpace) – Jun 22, 2020 – “‘From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of COVID-19, in parallel with emerging knowledge about the disease,’ said Merdad Parsey…’While the novel coronavirus appears to disproportionally affect adults-especially the elderly and those with underlying health conditions-concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms.'”

 

Hopeful for a COVID-19 vaccine by late 2020, early 2021: Dr Anthony Fauci (Financialexpress) – Jun 23, 2020 – “The government’s top infectious disease expert said Tuesday he is cautiously optimistic that there will be a COVID-19 vaccine by the end of the year or early 2021, but warned that the next few weeks will be critical to tamping down coronavirus hot spots around the country….’We will be doing more testing,’ Fauci told a House committee.”

Read More …

Weekly Top News – Ovarian Cancer – June 29, 2020

June 29, 2020

Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Samsung Bioepis Receives Positive CHMP Opinion for AYBINTIO (Bevacizumab) (GlobeNewswire) – Jun 26, 2020 – “Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO®, a biosimilar candidate referencing Avastin®i (bevacizumab). AYBINTIO® has been recommended for approval for the treatment of the same types of cancer as reference bevacizumab in the European Union (EU) including metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer.”

Read More …

Weekly Top News – IBD – June 29, 2020

June 29, 2020

BMS-986165 / BMS
BMS-986165: Data from P2 trial (NCT03934216) for moderate-to-severe ulcerative colitis in 2021 (Bristol-Myers Squibb) – Jun 27, 2020 – Investor Series Immunology and Cardiovascular: Data from P2 trial (NCT03599622) for moderate-to-severe Crohn’s disease in 2022 or later

 

 

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….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.”

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Diversigen, Inc. and Alimentiv Inc. Announce Collaboration Agreement for Ulcerative Colitis Research Study (GlobeNewswire) – Jun 25, 2020 – “Diversigen, Inc….today announced they have signed a collaboration agreement for a research study on patients with Acute Severe Ulcerative Colitis (ASUC)….The study, titled: ‘Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis (PROTOS Study),’ is designed to provide new insights into the molecular determinants of response to infliximab (IFX) in patients with ASUC….The results will be jointly owned by Diversigen and Alimentiv, and the data will be co-published upon completion of the study.”

 

Entyvio (vedolizumab) / Takeda
BRIEF—FDA nod of for Takeda’s US Entyvio facility (The Pharma Letter) – Jun 24, 2020 – “…Takeda Pharmaceutical says the US Food and Drug Administration has approved the company’s submission for its biologics manufacturing facility located in Brooklyn Park, Minnesota for the production of Entyvio (vedolizumab) drug substance. The facility also has capabilities beyond production of Entyvio drug substance to support the study and development of future biologic products.”

 

Zeposia (ozanimod) / BMS
Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jun 23, 2020 – P3; N=869; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting

Read More …

Weekly Top News – Psoriasis – June 29, 2020

June 29, 2020

bimekizumab (UCB4940) / UCB; Stelara (ustekinumab) / J&J
First Presentations of Bimekizumab Phase 3 Data Demonstrate Superior Skin Clearance Over Placebo and Stelara at Week 16 in Adults with Moderate-to-Severe Plaque Psoriasis (Canada Newswire) – Jun 22, 2020 – P3, N=435; BE READY (NCT03410992); P3, N=570; BE VIVID (NCT03370133); Sponsor: UCB Biopharma S.P.R.L.; “UCB Canada Inc., today shared the first presentations of data from the Phase 3 clinical development program of bimekizumab, its investigational IL-17A and IL-17F inhibitor, as part of a virtual session for the American Academy of Dermatology (AAD) 2020 Annual Meeting held on June 12, 2020. Patients treated with bimekizumab achieved superior skin clearance in both the BE VIVID and BE READY Phase 3 studies, compared to those who received placebo or Stelara (ustekinumab)….The two late-breaking presentations cited in this release are…Kim A. Papp, Andrew Blauvelt, Richard Langley…Kenneth Gordon…Mark Lebwohl.”

 

Skilarence (dimethyl fumarate) / Almirall; Fumaderm (dimethyl fumarate) / Biogen
To evaluate the long-term efficacy and tolerability of treatment with dimethyl fumarate in adults with chronic plaque psoriasis. Valutare l’efficacia e la tollerabilità a lungo termine del trattamento con dimetilfumarato in adulti affetti da psoriasi cronica a placche . (clinicaltrialsregister.eu) – Jun 25, 2020 – P3; N=300; Ongoing; Sponsor: ALMIRALL SPA

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Israel approves new psoriasis treatment (The Jerusalem Post) – Jun 25, 2020 – “Skyrizi – A new treatment for psoriasis that has been recently approved is now being available to treat Israeli psoriasis patients and it has demonstrated therapeutic success, even in severe cases.”

 

BMS-986165 / BMS
BMS-986165: Data from P2 trial (NCT03881059) for psoriatic arthritis in H2 2020 (Bristol-Myers Squibb) – Jun 27, 2020 – Investor Series Immunology and Cardiovascular: Data from P2 trial (NCT03252587) for systemic lupus erythematosus in 2021

 

 

Novartis Cosentyx gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile (Novartis Press Release) – Jun 26, 2020 – “Novartis…today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to

 

bimekizumab (UCB4940) / UCB
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) (clinicaltrials.gov) – Jun 23, 2020 – P3; N=38; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; N=255 –> 38

Read More …

Daily Top News – June 29, 2020

June 29, 2020

Translarna (ataluren) / PTC Therap, Sanofi
PTC Therapeutics Announces CHMP Recommendation of Translarna (ataluren) Label Update for Non-Ambulatory Patients with Duchenne Muscular Dystrophy (PRNewswire) – Jun 29, 2020 – “PTC Therapeutics…today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended by a majority of votes to remove the statement ‘efficacy has not been demonstrated in non-ambulatory patients’ from the SmPC for Translarna™ (ataluren)…The change also should support reimbursement agencies granting continued access to Translarna for patients who become non-ambulatory during the course of their treatment. The CHMP’s positive opinion is subject to final approval by the European Commission, which is normally granted in a two-month time frame.”

 

cetuximab sarotalocan (ASP-1929) / Rakuten Medical
Rakuten Medical Receives Conditional Early Approval Designation from Japanese Health Ministry for its Lead Drug, ASP-1929, to Treat Recurrent Head & Neck Cancer (PRNewswire) – Jun 29, 2020 – “Rakuten Medical, Inc…announced that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has notified Rakuten Medical that its lead drug ASP-1929 will be reviewed under the Conditional Early Approval System (CEAS)….Rakuten Medical submitted a Japanese Biological License Application (JBLA) for this drug on March 26, 2020 – based on results of Phase I / II clinical trials. In addition – on March 19, 2020 – the company applied for Japan approval of the laser illumination system which is utilized in conjunction with ASP-1929.”

 

Vafseo (vadadustat) / Akebia Therap, Otsuka, Mitsubishi Tanabe
Akebia Therapeutics Announces Approval of Vadadustat in Japan for the Treatment of Anemia Due to Chronic Kidney Disease in Dialysis-Dependent and Non-Dialysis Dependent Adult Patients (PRNewswire) – Jun 29, 2020 – “Akebia Therapeutics…announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD). Mitsubishi Tanabe…has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020. Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO™.”

 

Duvroq (daprodustat) / GSK, Kyowa Hakko Kirin
GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease (GSK Press Release) – Jun 29, 2020 – “GlaxoSmithKline…announced the approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare for Duvroq (daprodustat) tablets, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anaemia due to chronic kidney disease (CKD).”

 

Enspryng (satralizumab) / Roche
Chugai’s Enspryng (Satraliazumab) Subcutaneous Injection 120 mg Syringe Approved in Japan for Neuromyelitis Optica Spectrum Disorder (Chugai Press Release) – Jun 29, 2020 – “Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the new drug application was approved by the Ministry of Health, Labour and Welfare (MHLW) for…Enspryng® Subcutaneous Injection 120 mg Syringe (generic name: satralizumab) (hereafter, Enspryng) for the prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica)….’In addition, Enspryng, which was the first to apply our proprietary recycling antibody technology, can be subcutaneously administered every four weeks for convenience.’…This approval is based on the results from 2 global phase III clinical studies in patients with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279).”

Read More …

Daily Top News – June 26, 2020

June 26, 2020

Reblozyl (luspatercept-aamt) / Acceleron, BMS
European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia (Businesswire) – Jun 26, 2020 – “Bristol Myers Squibb…and Acceleron Pharma Inc…announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of…Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy….This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.”

 

casimersen (SRP-4045) / Sarepta Therap
Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45 (Sarepta Therap Press Release) – Jun 26, 2020 – “Sarepta Therapeutics…today announced the Company has completed the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for casimersen (SRP-4045)….The completion of the rolling submission includes data from the casimersen arm of the ESSENCE study (also known as study 4045-301)…Phase 3 study evaluating efficacy and safety in patients amenable to skipping exons 45 and 53…If the casimersen NDA is accepted and granted accelerated approval, the completed ESSENCE study will serve as a post-marketing confirmatory study.”

 

 

Cosentyx (secukinumab) / Novartis
Novartis Cosentyx gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile (Novartis Press Release) – Jun 26, 2020 – “Novartis…today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to

 

Kalydeco (ivacaftor) / Vertex; Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex
CHMP Grants Positive Opinion for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO (ivacaftor) in People Ages 12 and Older With Cystic Fibrosis With the Most Common Genotypes (Businesswire) – Jun 26, 2020 – “Vertex Pharmaceuticals…today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with KALYDECO® (ivacaftor) 150 mg to treat people with cystic fibrosis (CF) ages 12 and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene….The CHMP positive opinion was based on the results of two global Phase 3 studies in people with CF…”

 

COSMO RECEIVES POSITIVE EMA CHMP OPINION RECOMMENDING APPROVAL OF METHYLENE BLUE MMX FOR THE VISUALIZATION OF COLORECTAL LESIONS DURING COLONOSCOPIES (Cosmo Press Release) – Jun 26, 2020 – “Cosmo Pharmaceuticals…today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Methilthioninium Chloride Cosmo (Methylene Blue MMX), its drug for the visualization of colorectal lesions during colonoscopies…The final decision on the Marketing Authorisation Application for Methylene Blue MMX is expected in the next couple of months…”

Read More …

Daily Top News – June 24, 2020

June 24, 2020

lacutamab (IPH4102) / Innate
U.S. FOOD AND DRUG ADMINISTRATION LIFTS PARTIAL CLINICAL HOLD ON LACUTAMAB TELLOMAK TRIAL IN ADVANCED T-CELL LYMPHOMAS (Innate Pharma Press Release) – Jun 24, 2020 – “Innate Pharma SA…announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas…The Company can now resume recruitment of new patients in the US with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies….The Company expects to start sharing data from the TELLOMAK trial for mycosis fungoides in 2021 and Sézary syndrome in 2022.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi; Coronavirus Vaccine / Sanofi, GSK; Coronavirus Vaccine / Sanofi, Translate Bio
Sanofi’s virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients (GlobeNewswire) – Jun 24, 2020 – “Sanofi transforms R&D to drive productivity….This includes an integrated development organization…resulted in rapid initiation of clinical trials such as the studies evaluating Kevzara® (sarilumab) as a potential COVID-19 therapeutic….A recombinant protein-based​ vaccine approach (baculovirus), in collaboration with GSK….Sanofi expects a Phase 1/2 study to start in September and at the earliest, full approval by the first half of 2021….A messenger RNA (mRNA) candidate in collaboration with Translate Bio….Sanofi expects a Phase 1 study to start by the end of the year, and, if data is positive, an approval at the earliest in the second half of 2021​.”

 

Nidlegy (darleukin/fibromun) / Philogen
Philogen Received Combination Pack Approval for Nidlegy (PRNewswire) – Jun 24, 2020 – “EMA’s CHMP expressed a favorable opinion to the request of a combination pack for the to-be-marketed pharmaceutical form of NidlegyTM, a combination of the active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). NidlegyTM is being developed as a neoadjuvant intralesional treatment for resectable Stage III melanoma patients and in locally advanced, not metastatic nonmelanoma skin cancers. NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) – Indent 1 – Biotech medicinal product of Regulation (EC) No 726/2004.”

Read More …

Daily Top News – June 23, 2020

June 23, 2020

PL8177 / Palatin Technologies
Palatin Technologies to Develop PL8177 as a Potential Treatment for COVID-19 and Associated Lung Complications (PRNewswire) – Jun 23, 2020 – “Palatin Technologies, Inc….announced it is developing PL8177 as a treatment for patients with COVID-19….Palatin submitted a preliminary proposal to the Biomedical Advanced Research and Development Authority…and submitted a pre-Investigational New Drug (pre-IND) package….Company is planning to submit an IND in the third quarter of calendar year 2020 and planning a Phase 2 clinical trial initiation in the fourth quarter of calendar year 2020. Required preclinical and Phase 1 safety studies are complete and support the safe use of PL8177 in a Phase 2 clinical study….PL8177 will be delivered as a sterile subcutaneous injection.”

 

stannous protoporphyrin (RBT-9) / Renibus Therap
Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19 (GlobeNewswire) – Jun 23, 2020 – “Renibus Therapeutics, Inc….announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19….RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19.”

 

Imbruvica (ibrutinib) / AbbVie, J&J
IMBRUVICA (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström’s Macroglobulinemia (WM) (PRNewswire) – Jun 23, 2020 – “AbbVie…announced that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). The application seeks to update the IMBRUVICA U.S. Prescribing Information based on analysis of more than five years of data from the Phase 3 iNNOVATE clinical trial.”

 

xanomeline/trospium (KarXT) / PureTech
Karuna Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for KarXT for the Treatment of Acute Psychosis in Patients with Schizophrenia (Businesswire) – Jun 23, 2020 – “The Company and FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) filing…The Company plans to initiate two five-week inpatient trials evaluating the efficacy and safety of KarXT for the treatment of acute psychosis in adults with schizophrenia….The first Phase 3 trial is expected to commence by the end of 2020….Details of the second efficacy trial will be finalized by the end of 2020, with initiation expected in the first half of 2021….The Company currently plans to also conduct a separate 52-week open-label trial evaluating the long-term safety of KarXT in adults with schizophrenia who have not been enrolled in the inpatient trials. This trial is expected to begin the first half of 2021….Additional details regarding the development plan, including anticipated completion timelines, will be shared in the second half of 2020.”

 

seviprotimut-L (POL-103A) / Polynoma
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L (PRNewswire) – Jun 23, 2020 – “Polynoma LLC…announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine for the adjuvant treatment of stage IIB/IIC melanoma patients post-resection to improve recurrence-free survival.”

Read More …

Daily Top News – June 22, 2020

June 22, 2020

Xpovio (selinexor) / Ono Pharma, Karyopharm, Antengene
Karyopharm announces FDA approval of Xpovio (selinexor) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (GlobeNewswire) – Jun 22, 2020 – “Karyopharm Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIO® (selinexor)…for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy….XPOVIO will be commercially available immediately in this new indication in the U.S. and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication. A Marketing Authorization Application for selinexor for relapsed or refractory DLBCL is planned for submission to the European Medicines Agency in 2021.”

 

Relumina (relugolix) / Gedeon Richter, Roivant, Takeda, ASKA Pharma
Myovant Sciences Announces Priority Review and FDA Acceptance of New Drug Application for Once-Daily, Oral Relugolix for Advanced Prostate Cancer (GlobeNewswire) – Jun 22, 2020 – “Myovant Sciences…announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA)…The FDA has set a target action date of December 20, 2020 under the Prescription Drug User Fee Act (PDUFA)….Data from an additional key secondary endpoint, castration resistance-free survival, are expected in the third quarter of 2020.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) approved in China for second-line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (CPS ≥10) (Merck (MSD) Press Release) – Jun 22, 2020 – “Merck…announced that KEYTRUDA…has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy. This new indication was granted full approval based on the overall survival (OS) findings from the global Phase 3 KEYNOTE-181 trial, including data from an extension of the global study in Chinese patients.”

 

 

Qinlock (ripretinib) / Deciphera
Deciphera announces Health Canada’s authorization of Qinlock (ripretinib) for the treatment of fourth-line gastrointestinal stromal tumor (Businesswire) – Jun 22, 2020 – “Deciphera Pharmaceuticals…announced that Health Canada has authorized QINLOCK™ (ripretinib)…for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib. The QINLOCK New Drug Submission was approved by Health Canada under Project Orbis, an initiative of the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence designed to provide a framework for concurrent submission and review of oncology products among international partners….Health Canada’s authorization was based on efficacy results from the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK.”

 

Bavencio (avelumab) / EMD Serono, Pfizer
European Medicines Agency Validates Application for BAVENCIO (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma (Merck (MSD) Press Release) – Jun 22, 2020 – “Merck and Pfizer Inc….today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). With this validation, the application is complete, and the EMA will now begin the review procedure. The application is based on results from the Phase III JAVELIN Bladder 100 study…The data were presented at the ASCO 2020 Virtual Scientific Meeting.”

Read More …
« Older Entries