Novartis

Novartis’s Xolair (omalizumab) Prefilled Syringe for Self-Injection Receives the US FDA’s Approval Across All Indications

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Shots: The US FDA has approved the sBLA for a new self-administration option for Xolair in patients across all approved indications in the US The use of the therapy across multiple indications is based on the efficacy and safety profile of Xolair in allergic asthma,… Read More »Novartis’s Xolair (omalizumab) Prefilled Syringe for Self-Injection Receives the US FDA’s Approval Across All Indications

Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis

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Shots: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in 1,882 adults aged 18-55yrs. with a confirmed diagnosis of RMS The study demonstrated a reduction of annual relapses by over… Read More »Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis

Novartis and Molecular Partners Report Inclusion of Ensovibep (MP0420) in NIH-Sponsored ACTIV-3 Trial for the Treatment of COVID 19

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Shots: The P-III ACTIV-3 trial plan to evaluate the safety & efficacy of Ensovibep (MP0420) vs PBO in 300 patients hospitalized with mild to moderate COVID-19. The first patient dosing is anticipated in Q2’21 If the ensovibep treatment has a positive benefit/risk profile, the trial… Read More »Novartis and Molecular Partners Report Inclusion of Ensovibep (MP0420) in NIH-Sponsored ACTIV-3 Trial for the Treatment of COVID 19

Gene and Cell Therapies in CNS Disorders: Miracle Cure? Opportunities Galore!

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CNS disorders are a wide-ranging set of disorders in which the brain loses its normal functioning, limiting everyday ability to function. These may arise from various reasons-some are inherited, some result from damage, and some from infections. It contributes to the highest disability-adjusted life years.… Read More »Gene and Cell Therapies in CNS Disorders: Miracle Cure? Opportunities Galore!

Novartis Collaborates with Bill & Melinda Gates Foundation to Discover and Develop Gene Therapy for Sickle Cell Disease

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Shots: The Gates Foundation will provide funding support to discover and develop in vivo gene therapy for SCD. The alliance brings together Novartis drug discovery and gene therapy expertise with Gates’ funding’s The focus of the agreement to address the disparity in access to treatments… Read More »Novartis Collaborates with Bill & Melinda Gates Foundation to Discover and Develop Gene Therapy for Sickle Cell Disease

Novartis’s Entresto Receives US FDA’s Approval for Chronic Heart Failure

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Shots: The approval is based on P-III PARAGON-HF study involves assessing of Entresto (sacubitril/valsartan) in the treatment of patients with preserved ejection fraction HFpEF The expanded indication enables potential treatment of adults with left ventricular ejection fraction (LVEF) below normal, benefits are most clearly evident… Read More »Novartis’s Entresto Receives US FDA’s Approval for Chronic Heart Failure

Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

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Shots: The multicenter survey involves assessing Kesimpta Sensoready autoinjector pen in 80 MS patients and 50 MS nurses, with RMS who received a disease modifying treatment through a subcutaneous/intramuscular injection via an autoinjector The result shows MS patients and nurses prefer the Kesimpta Sensoready autoinjector… Read More »Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

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Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment… Read More »PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

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Shots: The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in… Read More »Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off

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Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by… Read More »Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

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Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.

Mitochondria destruction for Cancer Treatment; Atsena raises USD 55 Million financings; Novartis and Cadent Therapeutics collaboration; Neuron23’s strategy to tackle CNS disorders

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Mitochondria destruction can help in Cancer Treatment  Human cells require structures known as mitochondria for the generation of energy for their biochemical activities. Researchers at the Karolinska Institutet in Sweden thought that destroying these could be a strategy for cancer treatment.  Following that hypothesis, scientists… Read More »Mitochondria destruction for Cancer Treatment; Atsena raises USD 55 Million financings; Novartis and Cadent Therapeutics collaboration; Neuron23’s strategy to tackle CNS disorders

Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

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Shots The Health Canada has approved Zolgensma (onasemnogene abeparvovec) for pediatric patients with 5q SMA with bi-allelic mutations in the SMN1 gene and 3 or fewer copies of SMN2 gene or infantile-onset SMA The efficacy and safety data supporting the approval of Zolgensma are derived… Read More »Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

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Shots: The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF The decision was based on efficacy & safety analyses, including findings from a pre-specified subgroup analysis of PARAGON-HF (P-III study in HFpEF) and… Read More »Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

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Shots: The P-III MONALEESA-7 trial involves assessing Kisqali + endocrine therapy (goserelin + either an aromatase inhibitor or tamoxifen) as initial treatment vs endocrine therapy alone in patients with HR+/HER2- m-BC Result: @53.5 mos. follow-up, m-OS (58.7 vs 48.0 mos.); similar m-OS (58.7 vs 47.7… Read More »Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

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Shots: The P-lll ASCEMBL study involves assessing Asciminib (40mg, bid) vs Bosulif (bosutinib, 500mg, qd) in 223 patients with Ph+ CML-CP prior treated with two or more TKIs and the data were presented at 62nd (ASH) Annual Meeting & Exposition Results: @ 24 wks. MMR… Read More »Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

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Shots: RetinAI signs a multi-year collaboration with Novartis under which RetinAI’s IT solutions and AI tools will be employed to support multiple projects in ophthalmology and digital health The first project under the agreement will support a multi-center international clinical study involving patients with nAMD.… Read More »RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

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Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs… Read More »Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

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Shots: Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy… Read More »Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

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Shots: The P-lll CAN-COVID trial involves assessing Ilaris (canakinumab) + SOC vs PBO + SoC in 454 patients aged 18-98yrs. with COVID-19 pneumonia and cytokine release syndrome CRS, with its expected full results in early 2021 Result: The trial fails to meet its 1EPs of… Read More »Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

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Shots: The P-IIIb ULTIMATE study involves assessing Cosentyx (300/150mg) vs PBO weekly for a mos. with treatment starting @4wks., followed by a once-a-month dose for the next 11mos. in 166 biologic-naïve patients in a ratio (1:1) with active PsA The study reduction of synovitis @12wks.… Read More »Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

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Shots: The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI… Read More »Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

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Shots: The P-IV HER-MES study involves assessing Aimovig (erenumab 70mg and 140mg) vs topiramate in 777 patients in a ratio (1:1) with episodic or chronic migraine (≥4 migraine days/month) prior not treated with migraine prevention treatment or previously failed up to three prophylactic migraine treatments… Read More »Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

To avoid crisis, pharma must address costs

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Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.

Novartis Signs an Option and License Agreement with Molecular Partners to Develop Two DARPin Therapies for COVID-19

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Shots: Molecular Partners to receive $65.8M as up front, including equity, and will receive $164.7M as an option payment for both MP0420 and MP0423 along with royalties on sales of therapies. Novartis to get an option to in-license global rights of MP0420 and MP0423 During… Read More »Novartis Signs an Option and License Agreement with Molecular Partners to Develop Two DARPin Therapies for COVID-19

Novartis Presents Results of Iptacopan (LNP023) in P-ll Study for C3 Glomerulopathy at ASN Annual Meeting 2020

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Shots: The P-II study involves assessing the efficacy, safety and PK of Iptacopan (LNP023) in patients with C3G (Cohort A) and patients who have undergone a kidney transplant and have C3G recurrence (Cohort B), interim results presented at ASN 2020 Result: @12wks., reduction in proteinuria… Read More »Novartis Presents Results of Iptacopan (LNP023) in P-ll Study for C3 Glomerulopathy at ASN Annual Meeting 2020

Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

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Shots: The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a reduction in huntingtin mRNA in SMA patients Novartis expects to initiate the P-IIb study for… Read More »Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

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Shots: The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52% with 2doses/yr, after an initial dose and one @3mos., in… Read More »Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

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Shots: Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells Luxturna is designed… Read More »Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

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Shots: Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold full responsibility for the development and commercialization of the M6495 program Two P-I studies were completed with M6495 where NCT03224702… Read More »Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

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Shots: The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%),… Read More »Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

Novartis eyes filings for leukaemia drug asciminib after phase 3 win

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A first-in-class STAMP inhibitor developed by Novartis – asciminib – has outperformed a current drug for chronic myeloid leukaemia (CML) in a head-to-head trial, setting up regulatory filings. The ASCEMBL trial compared asciminib (ABL001) to Pfizer’s Bosulif (bosutinib) in Philadelphia chromosome-positive CML patients who had… Read More »Novartis eyes filings for leukaemia drug asciminib after phase 3 win

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

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Shots: The P-III ASCEMBL study involves assessing of Asciminib (ABL001) vs bosutinib in patients with Ph+ CML-CP, prior treated with two or more TKIs The study met its 1EPs of superiority in major molecular response (MMR) rate @24wks. Asciminib (ABL001) is an investigational treatment specifically… Read More »Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

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Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial  Novartis recently declared the results of its Phase III COMBI-I trial evaluating its experimental checkpoint inhibitor spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) for patients, previously untreated, with unresectable or… Read More »Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

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Shots: The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma The study was conducted in three parts while today’s results are from… Read More »Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

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Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence… Read More »Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Court approves Otsuka’s bid to buy Proteus for $15M

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A bankruptcy court in Delaware approved a stalking-horse bid from Otsuka to acquire Proteus Digital Health for $15 million. The company, which makes sensor that can be embedded in pills to track medication adherence, filed for bankruptcy in June.

Cerner Invests in Xealth to Jointly Develop Digital Health Solutions for Clinicians

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What You Should Know: – Cerner and Xealth announce a collaboration to foster tighter physician-patient relationships by giving patients easier access to digital health tools. – These assets will be prescribed directly within the physician’s EHR workflow to manage conditions including chronic diseases, behavioral health,… Read More »Cerner Invests in Xealth to Jointly Develop Digital Health Solutions for Clinicians

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

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Shots: The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites  Results of… Read More »Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

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Shots: Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M in commercial milestones plus royalties on sales of the product. Additionally, Sangamo to take care of certain research and manufacturing activities funded… Read More »Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Biogen plans trial of Spinraza in patients not responding to SMA gene therapy

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Biogen is planning to trial its Spinraza spinal muscular atrophy (SMA) drug in patients who have not responded properly to Novartis’ gene therapy Zolgensma, combining the two ultra-expensive therapies to treat the rare muscle-wasting disease. In the US, a single shot of Zolgensma (onasemnogene abeparvovec)… Read More »Biogen plans trial of Spinraza in patients not responding to SMA gene therapy