Novartis

Novartis-backed project mobilises patient power against heart disease

Novartis has joined forces with a group representing cardiovascular disease patients organisations to push for changes in how health systems handle the world’s number one killer. The Invisible Nation partnership with Global Heart Hub aims to reduce 15 million deaths that occur each year due to atherosclerotic cardiovascular disease (ASCVD), according to the Swiss pharma …

Novartis-backed project mobilises patient power against heart disease Read More »

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …

PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »

Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema

Shots: The US FDA has accepted the sBLA and EMA has validated the type-II variation application for Beovu (brolucizumab, 6mg) for the treatment of DME. Additionally, the PMDA has accepted an application for Beovu for the same indication The application is based on P-III KESTREL and KITE studies, which met their 1EPs of non-inferiority in …

Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema Read More »

Consternation as NICE rejects Janssen MS drug Ponvory

NICE has delivered its first verdict on NHS funding of Janssen’s oral multiple sclerosis drug Ponvory, and it’s not good news for patients with the disease waiting for new treatment options. In a provisional decision, NICE has said Ponvory (ponesimod) should not be available routinely on the NHS in England and Wales for relapsing forms …

Consternation as NICE rejects Janssen MS drug Ponvory Read More »

Novartis’s Adakveo (crizanlizumab) Receives NICE Recommendation as a New Therapy for Sickle Cell Disease

Shots: The NICE has recommended Novartis’ Adakveo (crizanlizumab) as a new treatment option to prevent recurrent sickle cell crises in patients aged ≥16 Additionally, patients will now have access to this treatment option on the NHS. The clinical evidence demonstrated that the people treated with crizanlizumab have significantly fewer sickle cell crises in a year …

Novartis’s Adakveo (crizanlizumab) Receives NICE Recommendation as a New Therapy for Sickle Cell Disease Read More »

Joy as sickle cell patients get access to Novartis’ Adakveo after NICE ruling

People living with sickle cell disease (SCD) in England and Wales will be able to get access to treatment with Novartis’ Adakveo, thanks to a special arrangement between the drugmaker and NICE. The decision makes Adakveo (crizanlizumab) the first new treatment for SCD available via the NHS for 20 years, according to the cost-effectiveness agency, …

Joy as sickle cell patients get access to Novartis’ Adakveo after NICE ruling Read More »

Novartis’ Amit Nastik on COVID’s supply chain impact: the pharmaphorum podcast

Episode 41 of the pharmaphorum podcast heard from Amit Nastik about the impact of COVID-19 on pharma supply chains and how he and his team mitigated disruption to Novartis’ own operations. Amit’s the global head strategy and operations and local markets manufacturing at Novartis Technical Operations and discussed how his company ensured an uninterrupted supply …

Novartis’ Amit Nastik on COVID’s supply chain impact: the pharmaphorum podcast Read More »

Kite claims a first for CAR-T Tecartus in adult leukaemia

The FDA has approved Kite Pharma’s Tecartus as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), making CAR-T therapy an option for an entirely new group of patients. The regulator cleared Tecartus (brexucabtagene autoleucel) for the new indication after a swift review that focused on the ZUMA-3 trial, which …

Kite claims a first for CAR-T Tecartus in adult leukaemia Read More »

Novartis tightens up its COVID-19 vaccine policy for staff

Novartis has joined a growing number of companies insisting that its workforce is double vaccinated against COVID-19 if they want to work at one of its sites. The Swiss pharma group had earlier said it would require staff to either be vaccinated or have a negative COVID-19 test result within the last 14 days before …

Novartis tightens up its COVID-19 vaccine policy for staff Read More »

PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …

PharmaShots Weekly Snapshots (September 27 – October 01, 2021) Read More »

Novartis Presented Results of Remibrutinib (LOU064) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria at EADV

Shots: The P-IIb study evaluates the efficacy & safety of remibrutinib vs PBO in 311 patients with CSU inadequately controlled by H1-antihistamines for 12wks. The results showed an improvement in UAS7 related to CFB @4 & 12wks. & rapid improvement as of 1wks., patients achieved UAS7=0 (complete absence of hives & itch) and UAS7≤6 (well-controlled …

Novartis Presented Results of Remibrutinib (LOU064) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria at EADV Read More »

PharmaShots’ Key Highlights of Third Quarter 2021

The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, …

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Novartis drug raises hope of tackling malaria drug resistance

More than two decades ago , Novartis made a big contribution to the fight against malaria when it won approval for Coartem, the first artemisinin-based combination therapy (ACT), which has transformed care for people with the parasitic infection. Now – over a billion doses of Coartem (artemether-lumefantrine) later – the drugmaker thinks it may have …

Novartis drug raises hope of tackling malaria drug resistance Read More »

Novartis Reports Results of ligelizumab (QGE031) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria

Shots: The P-IIb study evaluates ligelizumab (72/240mg) vs Xolair or PBO in patients with CSU with an inadequate control on antihistamines The results showed that proportion of patients achieved complete control of CSU symptoms @12 & 20wks. (44.1%/40.0% vs 23.5% & 0.0%) & (33.3%/34.1% vs 25.9% & 4.7%); CSU-free patients (38.1%/35.3% vs 18.8% & 0.0%) …

Novartis Reports Results of ligelizumab (QGE031) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria Read More »

PharmaShots Weekly Snapshots (September 20 – 24, 2021)

Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

Roche builds evidence for Evrysdi’s benefits younger SMA patients

Roche has highlighted new data with its oral treatment for spinal muscular atrophy (SMA) – Evrysdi – showing its benefits when given to pre-symptomatic babies with the rare disease. The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet …

Roche builds evidence for Evrysdi’s benefits younger SMA patients Read More »

EFPIA: Partnership is the key to healthcare’s biggest challenges

The European pharma body’s new Health Collaboration Guide hopes to inspire greater partnership working across healthcare, showcasing award-winning collaborations involving Pfizer, Janssen, Novartis and more. Partnership is the key to unlocking the solutions to our major healthcare challenges, and “no player has a monopoly on good ideas”. That’s according to the European Federation of Pharmaceutical …

EFPIA: Partnership is the key to healthcare’s biggest challenges Read More »

First FDA filing for Novartis’ latecomer PD-1 drug tislelizumab

Novartis has filed for FDA approval of tislelizumab – a PD-1 inhibitor licensed from Chinese biotech BeiGene earlier this year – as a second-line treatment for oesophageal cancer. The Swiss pharma giant licensed ex-China rights to tislelizumab in February for $650 million upfront ad up to $1.55 billion in milestones, shortly after its own PD-1 …

First FDA filing for Novartis’ latecomer PD-1 drug tislelizumab Read More »

Novartis to Discontinue CIRRUS-1 Study of CFZ533 (iscalimab) in Kidney Transplant Patients

Shots: The discontinuation is based on the interim analysis of data from the CIRRUS-1 study demonstrating that CFZ533 (iscalimab)-based treatment is less efficacious compared to tacrolimus-based treatment in the prevention of organ rejection in patients receiving a kidney transplant In the study, both CFZ533 and tacrolimus were used in combination with other immunosuppressive therapies (induction …

Novartis to Discontinue CIRRUS-1 Study of CFZ533 (iscalimab) in Kidney Transplant Patients Read More »

Novartis “one transplant for life” drug flunks test in kidney transplant patients

A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis

Shots: NICE has recommended Cosentyx as a cost-effective option for the treatment of mod. to sev. PsO in patients aged 6-17 yrs. who have not responded to other forms of systemic treatment & for whom these options were contraindicated or not tolerated Additionally, patients will now have access to this treatment option on the NHS. …

Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Read More »

NICE backs Cosentyx’ use in thousands of children with psoriasis

NICE has recommended broadening NHS use of Novartis’ IL-17 inhibitor Cosentyx to include children aged six to 17 with severe plaque psoriasis. The cost-effectiveness agency says in draft guidance that Cosentyx (secukinumab) should be offered as an option to patients in this age bracket who either don’t respond to or cannot tolerate other systemic treatments. …

NICE backs Cosentyx’ use in thousands of children with psoriasis Read More »

Novartis’ transplant drug hope iscalimab flunks mid-stage trial

Novartis hopes of improving on tacrolimus as the standard drug for preventing organ rejection in transplant patients have been dashed after its iscalimab candidate failed a mid-phase trial. An interim analysis of data from the CIRRUS-1 trial suggested that iscalimab (CFZ533) was less effective than tacrolimus at preventing rejection in kidney transplant patients when both …

Novartis’ transplant drug hope iscalimab flunks mid-stage trial Read More »

NICE backs NHS use of Novartis’ cholesterol drug Leqvio

Novartis’ cholesterol-lowering drug Leqvio will be made available on the NHS in England and Wales, and could help to prevent up to 30,000 deaths, according to NICE. The PCSK9-targeting oligonucleotide – which is already available in Scotland – requires dosing just twice a year and has been approved by the health technology assessment (HTA) agency …

NICE backs NHS use of Novartis’ cholesterol drug Leqvio Read More »

Novartis Signs an Agreement with NHS to Commercialize Leqvio (inclisiran) for the Treatment of Cardiovascular Disease

Shots: The agreement follows the NICE recommendation to deliver Leqvio via a population health management approach for high-risk cardiovascular patients across England The NICE recommendation was based on Novartis’s ORION clinical research program including P- III trials ORION-9/10/11 evaluating the safety, efficacy, and tolerability of inclisiran in 3,600 patients with CVD which showed that the …

Novartis Signs an Agreement with NHS to Commercialize Leqvio (inclisiran) for the Treatment of Cardiovascular Disease Read More »

Versanis Bio unveils $70M and a Novartis drug ready for Phase 2 test in obesity

Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio licensed rights to the antibody and plans to use its Series A financing for clinical trials testing the drug in obese patients.

PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) Read More »

Top 7 Pharma Industry Leaders in 2020 By the Numbers

Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic …

Top 7 Pharma Industry Leaders in 2020 By the Numbers Read More »

Novartis’ bid to extend Kymriah into earlier use hits a roadblock

Novartis’ CAR-T therapy Kymriah racked up back-to-back approvals in acute lymphoblastic leukaemia and large B-cell lymphoma a few years ago, but hasn’t added to its label since. Now, a bid to move it onto earlier-stage use in lymphoma has ended in failure. In the phase 3 BELINDA trial, Kymriah (tisagenlecleucel) was unable to extend event-free …

Novartis’ bid to extend Kymriah into earlier use hits a roadblock Read More »

Novartis’ Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma

Shots: The P-III BELINDA study evaluates the efficacy, safety, & tolerability of Kymriah vs SOC in patients with aggressive B-cell NHL who had primary refractory disease or relapsed within 12mos. of 1L treatment in 73 sites across 18 countries globally The study did not meet its 1EPs of EFS while the safety profile was consistent …

Novartis’ Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma Read More »

IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis

UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including Novartis’ big-selling Cosentyx. The European Commission has cleared the drug as Bimzelx for the treatment of moderate to severe plaque psoriasis …

IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis Read More »

Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Byooviz (ranibizumab, also known as SB11) has been cleared for the same indications as Lucentis – including namely wet age-related macular degeneration (AMD) and diabetic macular oedema (DMO – and will …

Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz Read More »

PharmaShots Weekly Snapshots (August 16 – 20, 2021)

Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 …

PharmaShots Weekly Snapshots (August 16 – 20, 2021) Read More »

NICE says yes to Novartis’ Rydapt for rare blood disorder

Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for  treatment with oral, twice-daily drug, …

NICE says yes to Novartis’ Rydapt for rare blood disorder Read More »

Novartis Reports Results of Beovu (brolucizumab) in P-III KITE & KINGFISHER Trials for the Treatment of Diabetic Macular Edema

Shots: The company reported 2yrs. & 1 yrs. results from P-III KITE & KINGFISHER studies evaluating Beovu (6mg, q4w) vs aflibercept (2mg) in 926 patients with DME across 36 countries The results showed non-inferiority to aflibercept in a change in BCVA from baseline @100wks. in KITE & 52wks. in KINGFISHER studies. The therapy also demonstrated …

Novartis Reports Results of Beovu (brolucizumab) in P-III KITE & KINGFISHER Trials for the Treatment of Diabetic Macular Edema Read More »

Novartis’ Cosentyx (secukinumab) Receives the NMPA’s Approval for the Treatment of Pediatric Psoriasis in China

Shots: The approval is based on two P-III international studies that evaluate cosentyx in pediatric patients aged 6 to <18 yrs. with mod. to sev. PsO who are candidates for systemic therapy or phototherapy The results showed that the therapy is safe and effective for children and adults with PsO. Additionally, therapy has supported the …

Novartis’ Cosentyx (secukinumab) Receives the NMPA’s Approval for the Treatment of Pediatric Psoriasis in China Read More »

Novartis says trials back Beovu safety in diabetic eye disease

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on …

Novartis says trials back Beovu safety in diabetic eye disease Read More »

Novartis says trials back Beovu safety in diabetic eye disease

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on …

Novartis says trials back Beovu safety in diabetic eye disease Read More »

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the …

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

Novartis cleared to restart trials of new Zolgensma delivery route

The FDA has relaxed a clinical hold on clinical trials of Novartis’ intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get underway. Zolgensma (onasemnogene abeparvovec) is already approved as an intravenous treatment in babies and very young children for the rare muscle-wasting disease, but the new …

Novartis cleared to restart trials of new Zolgensma delivery route Read More »

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy …

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict Read More »

Allergen builds case for first drug therapy for presbyopia

If you are in middle aged and find you have to hold your phone at arm’s length to read, you may have presbyopia – a difficulty focusing on close objects that is usually corrected using glasses, contact lenses or laser eye surgery. Now, there could be another alternative, in the form of eye drops administered …

Allergen builds case for first drug therapy for presbyopia Read More »

Novartis eyes New Year verdict from FDA on delayed Leqvio

Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date of 1 January 2022. The drugmaker refiled its application for Leqvio (inclisiran) earlier this month, trying to get the programme back on track in …

Novartis eyes New Year verdict from FDA on delayed Leqvio Read More »

Crowdsourced science refines AI prediction of clinical trial outcomes

Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market. In 2019, a team at Massachusetts Institute of Technology (MIT) in the US came up with just such a …

Crowdsourced science refines AI prediction of clinical trial outcomes Read More »

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe …

PharmaShots Weekly Snapshots (July 12 – 16, 2021) Read More »

Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure

Boehringer Ingelheim and Eli Lilly have the results they were hoping for in a large-scale study of Jardiance therapy in heart failure with preserved ejection fraction (HFpEF), a form of chronic heart failure associated with high hospitalisation rates, poor quality of life and increased mortality. The results of the much-anticipated EMPEROR-Preserved trial found that SGLT2 …

Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure Read More »

Novartis tries to rescue stalled inclisiran filing with FDA

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at …

Novartis tries to rescue stalled inclisiran filing with FDA Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

NICE backs Novartis’ Cosentyx for underdiagnosed back condition

NICE has extended the range of indications that Novartis’ Cosentyx can be prescribed for by the NHS in England, giving a green light for its use in non-radiographic axial spondyloarthritis (nr-axSpA), a form of arthritis affecting the joints of the spine. IL-17 inhibitor Cosentyx (secukinumab) is already approved by NICE to treat ankylosing spondylitis or …

NICE backs Novartis’ Cosentyx for underdiagnosed back condition Read More »

Blueprint’s latest approval for Ayvakit sets up clash with Novartis

Blueprint Medicines has claimed its second FDA approval for Ayvakit, getting the nod for advanced systemic mastocytosis (SM), a group of rare blood cancers currently treated mainly by Novartis’ Rydapt.  The FDA has cleared Ayvakit (avapritinib) for adults with SM, including the three major subtypes – aggressive disease with or without an associated haematological neoplasm, …

Blueprint’s latest approval for Ayvakit sets up clash with Novartis Read More »

EHA21: Novartis trumpets iptacopan as oral alternative to antibodies in PNH

The mainstay of therapy for the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) is Alexion’s infusion therapy Soliris, but Novartis’ iptacopan could provide an oral option after positive phase 2 trial results. The first-in-class therapy – a targeted factor B inhibitor – was able to “substantially” reduce the destruction of red blood cells (haemolysis) that …

EHA21: Novartis trumpets iptacopan as oral alternative to antibodies in PNH Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing …

ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data Read More »

Novartis Presents Results of Iptacopan in P-II Study for IgA Nephropathy at ERA-EDTA Congress

Shots: The P-II study involves evaluating the iptacopan vs PBO in 112 patients with IgAN. The new interim results of the P- II study in C3G will also be presented at ERA-EDTA Congress The study met its 1EP i.e @ 90days, reduction in proteinuria as measured by 24hrs. UPCR, 23% reduction in proteinuria at the …

Novartis Presents Results of Iptacopan in P-II Study for IgA Nephropathy at ERA-EDTA Congress Read More »

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: …

PharmaShots Weekly Snapshots (May 31 – June 4, 2021) Read More »

ASCO21: Novartis’ prostate cancer radiotherapy extends survival

Novartis’ big investment in radiopharmaceuticals for cancer seems to have paid off, after lead candidate 177Lu-PSMA-617 helped men with advanced prostate cancer and few treatment options live longer in a phase 3 trial. New data from the VISION study showed that 177Lu-PSMA-617 on top of standard care reduced the risk of death by 38% compared …

ASCO21: Novartis’ prostate cancer radiotherapy extends survival Read More »

Novartis radiopharmaceutical improves survival in key prostate cancer study

Novartis reported Phase 3 study results for a targeted radiation therapy showing that treatment helped patients with advanced prostate cancer live longer. The company will present data from this pivotal study during the annual meeting of the American Society of Clinical Oncology.

Novartis’ Cosentyx (secukinumab) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Plaque Psoriasis

Shots: The approval is based on two P-III studies evaluating Cosentyx (75 mg/ 150 mg) vs PBO in children aged 6 to <18 yrs with plaque psoriasis The first study demonstrates reduction in psoriasis severity @12 wks., PASI 75 response for 75mg and 150mg (55%, 86% vs 10%, 19%), achieved clear or almost clear skin …

Novartis’ Cosentyx (secukinumab) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Plaque Psoriasis Read More »

Novartis halts three trials of Beovu eye drug on safety concerns

Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related macular degeneration (AMD). On the plus side, Beovu (brolucizumab) met its efficacy objectives in the MERLIN study, but that was offset by higher rates of inflammatory reactions in the eyes …

Novartis halts three trials of Beovu eye drug on safety concerns Read More »

Novartis Reports One Year Results of Beovu (brolucizumabin) in P- III MERLIN Study to Treat Wet Age-Related Macular Degeneration

Shots: The P- III MERLIN study involves assessing the efficacy & safety of Beovu (6 mg, q4w) vs aflibercept (2 mg, q4w) following the loading phase in patients with wet AMD who have persistent retinal fluid despite anti-VEGF therapy Results: met its 1EPs i.e. non-inferiority in mean change in BCVA from baseline and superiority on …

Novartis Reports One Year Results of Beovu (brolucizumabin) in P- III MERLIN Study to Treat Wet Age-Related Macular Degeneration Read More »

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

Novartis and Molecular Partners Initiate P-II/III EMPATHY Study to Evaluate Ensovibep (MP0420) for the Treatment of COVID-19

Shots: The P-II/II EMPATHY study will evaluate the safety & efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization. The P-II study will enroll 400 patients in the P-II part to identify dose, with anticipated results in Aug’2021 P-III part will be conducted …

Novartis and Molecular Partners Initiate P-II/III EMPATHY Study to Evaluate Ensovibep (MP0420) for the Treatment of COVID-19 Read More »

Novartis and Molecular Partners Initiate P-II/III EMPATHY Study to Evaluate Ensovibep (MP0420) for the Treatment of COVID-19

Shots: The P-II/II EMPATHY study will evaluate the safety & efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization. The P-II study will enroll 400 patients in the P-II part to identify dose, with anticipated results in Aug’2021 P-III part will be conducted …

Novartis and Molecular Partners Initiate P-II/III EMPATHY Study to Evaluate Ensovibep (MP0420) for the Treatment of COVID-19 Read More »

New Cell & Gene Therapy Collective seeks to boost UK adoption

The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – but there are still many barriers to wider adoption. These challenges often arise because these therapies go through the same value assessment processes as less complex medicines, and the infrastructure …

New Cell & Gene Therapy Collective seeks to boost UK adoption Read More »

Novartis Presents Results of Beovu (brolucizumab -dbll) in P-III KESTREL and KITE Studies for Diabetic Macular Edema at ARVO2021

Shots: The company reported the 1yrs. results from the P-III KESTREL & KITE studies assessing Beovu (6mg) vs aflibercept (2mg) in 926 patients with DME across 36 countries Results: met its 1EPs i.e. non-inferiority in mean change BCVA from baseline @48wks., patients treated with Beovu (6mg) experienced fluid (IRF/SRF) resolution and achieved CSFT levels below …

Novartis Presents Results of Beovu (brolucizumab -dbll) in P-III KESTREL and KITE Studies for Diabetic Macular Edema at ARVO2021 Read More »

Alcon to Acquire Exclusive US Commercialization Rights to Novartis’ Simbrinza

Shots: Novartis to receive $355M following the closure of acquisition, which is expected to occur in Q2’21. The acquisition expands existing Alcon’s ophthalmic portfolio and strengthens its footprints in the US The companies will initiate a transition period where Novartis will continue to sell Simbrinza and transfer the profit to Alcon. Following the transition period, …

Alcon to Acquire Exclusive US Commercialization Rights to Novartis’ Simbrinza Read More »

PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, …

PharmaShots Weekly Snapshots (Apr 19 – 23, 2021) Read More »

PharmaShots’ Key Highlights of First Quarter 2021

The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter …

PharmaShots’ Key Highlights of First Quarter 2021 Read More »

Novartis Reports Results of Kesimpta (ofatumumab) in P- III ASCLEPIOS Trials for Newly Diagnosed Patients with RMS

Shots: The company reported new post hoc data from the P- III ASCLEPIOS trials assessing Kesimpta (ofatumumab) vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with RMS The results showed a 60% reduction in the risk of disability progression independent of relapse activity @3 and 6 mos., thus supporting Kesimpta as a 1L …

Novartis Reports Results of Kesimpta (ofatumumab) in P- III ASCLEPIOS Trials for Newly Diagnosed Patients with RMS Read More »

PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)

ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of …

PharmaShots Weekly Snapshots (Apr 12 – 16, 2021) Read More »

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

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, CIU, and nasal polyps, supported with a clinical development program, …

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

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)

Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab …

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021) Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to combat this global crisis. The top 20 companies on the …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

Novartis expands in radio-oncology again with $1.3bn Artios alliance

In its second licensing deal in the radio-oncology area in consecutive weeks, Novartis has agreed a $1.3 billion-plus alliance with UK biotech Artios Pharma to develop precision medicines for cancer. The collaboration will focus on combining Artios’ DNA damage response (DDR) drug candidates with Novartis’ radioligand therapies, which consist of tumour-targeting molecules carrying radioactive isotopes …

Novartis expands in radio-oncology again with $1.3bn Artios alliance Read More »

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »

Novartis builds radio-oncology pipeline with iTheranostics deal

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body.  The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is …

Novartis builds radio-oncology pipeline with iTheranostics deal Read More »

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

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 50% and achieved >30% relative risk reduction of 3mos. confirmed …

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

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

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

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 will enroll an additional 700 patients. Ensovibep is currently being …

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

Novartis says £1.8m Zolgensma is model for gene therapy pricing

Novartis has said its gene therapy pricing model, involving a steep one-off payment, could be a template for the hundreds of similar treatments that could follow its Zolgensma for Spinal Muscular Atrophy (SMA).  Zolgensma (onasemnogene abeparvovec) has a list price of £1,795,000 excluding VAT in the UK, but Novartis says the price is justified by …

Novartis says £1.8m Zolgensma is model for gene therapy pricing Read More »

PharmaShots Weekly Snapshots (Mar 08 – 12, 2021)

PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, BioVectra, Support,  Development, Commercialization, Bentracimab Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Published: Mar 12, 2021 | Tags: …

PharmaShots Weekly Snapshots (Mar 08 – 12, 2021) Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

Novartis’ Canakinumab Fails to Meet its Primary Endpoint in P-III CANOPY-2 Study

Shots: The P-III CANOPY-2 study involves assessing canakinumab (ACZ885) + CT (docetaxel) in 237 adults with LA/m-NSCLC, prior treatment with PD-L1 inhibitors and Pt-based CT. The study did not meet its 1EPs of OS The company will continue to evaluate the therapy in ongoing P-III CANOPY-1 and CANOPY-A studies evaluating canakinumab in 1L and adjuvant …

Novartis’ Canakinumab Fails to Meet its Primary Endpoint in P-III CANOPY-2 Study Read More »

Novartis’ canakinumab falls short in phase 3 lung cancer trial

Novartis’ attempt to treat cancer with the anti-inflammatory drug canakinumab was always a long shot, but it’s nevertheless a disappointing feeling when things don’t work out. Already approved for auto-inflammatory diseases such as active systemic juvenile idiopathic arthritis under the brand name Ilaris, Novartis is testing canakinumab to see if inhibiting the IL-1beta pathway can …

Novartis’ canakinumab falls short in phase 3 lung cancer trial Read More »

Double first for Scotland as it backs Roche’s Rozlytrek, Novartis’ Zolgensma

The Scottish Medicines Consortium (SMC) has said Roche’s Rozlytrek can be used by NHS Scotland for the treatment of solid tumours with NTRK gene fusion mutations, regardless of where they occur in the body.  This is the second approval by the SMC for Rozlytrek (entrectinib), coming after the drug was cleared for use in ROS1-positive, …

Double first for Scotland as it backs Roche’s Rozlytrek, Novartis’ Zolgensma Read More »

NICE says NHS should fund Novartis’ £1.79m SMA gene therapy

The NHS should pay for Novartis’ £1.79 million one-off gene therapy for Spinal Muscular Atrophy (SMA) NICE has said, the most expensive treatment ever approved for funding. In first draft guidance NICE said Zolgensma (onasemnogene abeparvovec) should be made available for babies up to 12 months with type 1 SMA, although the age restriction is …

NICE says NHS should fund Novartis’ £1.79m SMA gene therapy Read More »

Two biotechs target dry eye disease after Novartis’ Xiidra problems

The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis. Novartis paid Takeda $3.4 billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this …

Two biotechs target dry eye disease after Novartis’ Xiidra problems Read More »

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

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. The current treatment options are minimal. Most of the disorders …

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

FDA to quickly review Incyte’s Jakafi in chronic GVHD

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. The US pharma, which has partnered with Novartis to develop this first-in-class JAK1/JAK2 inhibitor, said the FDA will review data from the phase 3 REACH 3 study comparing Jakafi to …

FDA to quickly review Incyte’s Jakafi in chronic GVHD Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

PharmaShots Weekly Snapshots (Feb 15- 19, 2021) Read More »

No cooling off for pharma digital transformation in 2021

COVID-19 has already proved to be a digital accelerant for the pharmaceutical industry, sparking new ideas into life and lighting a fire underneath existing plans that had, in retrospect, yet to burn brightly. After a year in which the need for digital transformation in pharma reached white heat levels, the sector mustn’t cool off in …

No cooling off for pharma digital transformation in 2021 Read More »

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

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 and to prioritize populations and regions bearing the greatest burden …

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

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

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 Entresto is the 1st and only therapy approved in the …

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

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

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 pen over other autoinjectors for current treatment (84% vs 16%). …

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

The Paradox of Rare: Chalking out Challenges in the Rare Disease Market

How is a Rare disease defined? Well, it depends on the geography in question, since there is no universal definition, even so, the definition revolves around the point of prevalence or incidence of rare disease. However, despite the changing attributes in the definition, there is one common ground every country faces‒challenges in mapping the patient …

The Paradox of Rare: Chalking out Challenges in the Rare Disease Market Read More »

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene …

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021) Read More »

Novartis antibiotic retreat doesn’t stop Sandoz buying GSK drugs

Novartis exited novel antibiotics R&D three years ago, but is clearly still interested in the category – its Sandoz unit has just spent $350 million buying GlaxoSmithKline’s cephalosporin franchise.  The deal covers global rights to three brands – Zinnat (cefuroxime axetil), Zinacef (cefuroxime) and Fortum (ceftazidime) – which are sold in more than 100 markets …

Novartis antibiotic retreat doesn’t stop Sandoz buying GSK drugs Read More »

UK patient group warns COVID could limit access to Novartis’ new eye drug

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular …

UK patient group warns COVID could limit access to Novartis’ new eye drug Read More »

CHMP clears way for EU approval of Novartis’ MS drug

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks. Kesimpta (ofatumumab) started life as an oncology drug and was first developed by Genmab and licensed to GlaxoSmithKline who marketed under the brand name Arzerra to …

CHMP clears way for EU approval of Novartis’ MS drug Read More »

Novartis hails digital strategy as profits hold up during pandemic

Novartis has said that its investment in digital technology has helped it to ride out the worst of the pandemic, although sales of some of its newly-launched products have been affected by a fall in prescriptions and hospital visits. The big Swiss pharma still managed to grow sales in Q4 compared with the same period …

Novartis hails digital strategy as profits hold up during pandemic Read More »

Insights+: Key Deals of JP Morgan Healthcare Conference 2021

This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference Our PharmaShots …

Insights+: Key Deals of JP Morgan Healthcare Conference 2021 Read More »

Roche targets wet AMD with faricimab and its 16-week regimen

Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from Novartis and Bayer strengthens. With faricimab Roche is aiming to outperform rivals in a highly competitive market by doubling the time taken between doses compared with standard care to 16 …

Roche targets wet AMD with faricimab and its 16-week regimen Read More »

Sobi gets EU nod for Doptelet in rare blood disorder ITP

Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the drug. Doptelet (avatrombopag) – an oral thrombopoietin receptor agonist – has been cleared to boost depleted levels of platelets in the blood of patients with ITP, an autoimmune clotting disorder …

Sobi gets EU nod for Doptelet in rare blood disorder ITP 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 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 Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, …

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) Read More »

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

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 ~2000 patients across the globe with its anticipated results in …

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

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …

PharmaShots’ Key Highlights of Fourth Quarter 2020 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

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 binding to them, ultimately leading to cell death in tumor …

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 Read More »

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Shots: BieGene to receive $650M as up front along with milestones and royalties and will retain rights to Tislelizumab in China and other countries Novartis to get the development & commercialization rights to tislelizumab in the US, Canada, Mexico, EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, & Japan. Additionally, the companies have identified multiple tislelizumab …

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio Read More »

Armed with $270M in capital, Scorpion Therapeutics aims to broaden the reach of precision oncology

Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.

Top 20 Biopharma M&A of 2020 by Total Deal Value

Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% …

Top 20 Biopharma M&A of 2020 by Total Deal Value Read More »

Roche set to file ophthalmology drug faricimab in DME

Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema (DME) but with half the injections, in twin phase 3 studies. While Eylea (aflibercept) is taken in doses eight weeks apart, results from the YOSEMITE and RHINE studies showed faricimab …

Roche set to file ophthalmology drug faricimab in DME Read More »

PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020. 1. …

PharmaShots’ Most Read News of 2020 Read More »

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

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.

FDA rejects Novartis’ cholesterol drug after factory inspection issue

Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected. Matters appear to have been complicated by the pandemic and the travel disruption that it has caused, which is preventing an FDA team from visiting the plant in …

FDA rejects Novartis’ cholesterol drug after factory inspection issue Read More »

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, …

PharmaShots Weekly Snapshots (Dec 14-18, 2020) Read More »

H1 Secures $58M to Expand Global Healthcare Data Platform

What You Should Know: – H1, the largest database of information on every doctor in the world raises $58M in Series B funding, just six months after raising its Series A round during the pandemic. – H1 is the largest database in the world connecting that provides comprehensive in-depth profiles of more than 9 million …

H1 Secures $58M to Expand Global Healthcare Data Platform Read More »

Hospitals sue drug companies over discount program

The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.

Novartis to Acquire Cadent Therapeutics for ~$770M

Shots: Novartis to acquire all outstanding shares of Cadent for a total value of ~$770M. Cadent to receive $210M up front and is eligible for ~$560M as milestones. The transaction is expected to be close in Q1’21 Novartis gains full rights to Cadent’s NMDAr program which consist of two clinical programs: CAD-9303 and MIJ-821, an …

Novartis to Acquire Cadent Therapeutics for ~$770M 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

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 designed oral inhibitors, which could target mitochondrial DNA (mtDNA). In …

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

Novartis buys neurology biotech Cadent for up to $770m

Novartis is to buy neuroscience drugs firm Cadent Therapeutics in a deal worth up to $770 million. The big Swiss pharma already has a presence in neurology with its multiple sclerosis drug Gilenya (fingolimod) and the more recently approved Aimovig (erenumab). With the acquisition of Cambridge, Massachusetts-based Cadent, Novartis gains rights to a portfolio of …

Novartis buys neurology biotech Cadent for up to $770m Read More »

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

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 from completed and ongoing studies in patients with SMA and …

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

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

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 additional evidence from PARAMOUNT (P-II trial in HFpEF), as well …

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

Entresto set for big sales hike after FDA panel endorsement

Novartis’ Entresto is on course to become the first drug to be approved in the US for a form of heart failure that is notoriously hard to treat effectively, despite missing the mark in a phase 3 trial. An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with …

Entresto set for big sales hike after FDA panel endorsement Read More »

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Shots: The P-lll RUXCOVID study involves assessing Ruxolitinib (5mg, bid) + SoC therapy vs PBO + SoC therapy in 432 patients aged ≥12 yrs. in a ratio (2:1) hospitalized for COVID-19 and not intubated or receiving ICU care prior to randomization The study did not meet its 1EPS of reducing the number of hospitalized COVID-19 …

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19 Read More »

Novartis/Incyte draw blank with Jakafi in COVID-19

Novartis/Incyte’s Jakafi (ruxolitinib) looks unlikely to be added to the list of therapies that can be used against COVID-19, after it failed to cut complications or death in a phase 3 trial. Data from the phase 3 RUXCOVID study showed that there was no significant reduction in the proportion of COVID-19 patients on ruxolitinib plus …

Novartis/Incyte draw blank with Jakafi in COVID-19 Read More »

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, …

PharmaShots Weekly Snapshots (Dec 7-11, 2020) Read More »

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

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 mos.) observed in IIT population; @ 42 mos. follow-up, estimated …

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

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

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 rate (25.5% vs 13.2%) tCCyR rate (40.8% vs 24.2%); DMR …

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

Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics

What You Should Know: – Pear Therapeutics today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund 2. –  Pear is the leader in prescription digital therapeutics and the first company to receive FDA authorization for a prescription digital therapeutic (PDT) to treat disease. – Pear currently …

Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics Read More »

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

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. The study is designed to investigate the influence of OCT …

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology Read More »

Novartis signs ophthalmology AI deal with RetinAI

Novartis has signed a multi-year agreement with RetinAI, which will see the companies work together to use artificial intelligence (AI) tools to support ophthalmology and digital health projects. Both companies have already worked on pilot projects in this area. The first project under a new master agreement will involve a multi-centre international clinical study involving …

Novartis signs ophthalmology AI deal with RetinAI Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) Read More »

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

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 -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs …

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

Novartis set to overcome $14 billion patent cliff say analysts

Novartis’ pipeline is strong enough to overcome a $14 billion patent cliff as blockbuster drugs face generic competition in the coming years, analysts have said. Following a briefing with management, a team of analysts led by Peter Welford said that the big Swiss pharma will be propped up by its psoriasis and infectious diseases blockbuster …

Novartis set to overcome $14 billion patent cliff say analysts Read More »

Novartis taps smartpatient for app to support wet AMD patients

German digital health company smartpatient is adding a new section of its MyTherapy app providing information on wet age-related macular degeneration (AMD), a leading cause of blindness. The Munich-based company is launching the educational See What’s Next app in collaboration with Novartis, which sells the wet AMD medicines Beovu (brolucizumab) and Lucentis (ranibizumab), and has …

Novartis taps smartpatient for app to support wet AMD patients Read More »

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, …

PharmaShots Weekly Snapshot (Nov 16-20, 2020) Read More »

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

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 based platform with WW rights to a range of potential …

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

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival. Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration …

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar Read More »

NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival

UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the CGRP inhibitor class to achieve that milestone. The decision means that with two CGRP antibodies now cleared for migraine prevention, the first drug in the class to be approved in …

NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival Read More »

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of …

PharmaShots Weekly Snapshots (Nov 09-13, 2020) Read More »

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

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 survival without the need for mechanical ventilation up to day29 …

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

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, …

PharmaShots Weekly Snapshot (Nov 02-06, 2020) Read More »

Novartis’ Ilaris fails in late-stage COVID-19 trial

Novartis’ Ilaris (canakinumab) has failed to produce results in a phase 3 trial, which tested whether it could improve COVID-19 patients’ survival chances without need for mechanical ventilation. The company is trying to repurpose the drug used in rare inflammatory diseases such as juvenile arthritis for COVID-19, to see if it could relieve the extreme …

Novartis’ Ilaris fails in late-stage COVID-19 trial Read More »

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

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. with an early improvement observed as 1wk., ACR20 (68% vs …

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

Novartis’ Aimovig tops topiramate in migraine face-off

Novartis’ injectable migraine prevention antibody Aimovig has been shown to be more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial. The HER-MES trial found that Aimovig (erenumab) was more effective at preventing migraine attacks and also better tolerated than topiramate, a generic epilepsy drug which …

Novartis’ Aimovig tops topiramate in migraine face-off Read More »

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

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 population & across exploratory subgroups, m-OS was not reached while …

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

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

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 The study met its 1EPs & 2EPs and had superior …

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

Novartis keeps a close eye on gene therapy with Vedere Bio buy

Already a major player in gene therapy, Novartis has swooped on US startup Vedere Bio in a $280 million deal that builds its position in inherited eye diseases that can lead to blindness. Incubated by Atlas Ventures, Cambridge, Massachusetts Vedere has been flying under the radar since it was founded in 2019 to develop adeno-associated …

Novartis keeps a close eye on gene therapy with Vedere Bio buy Read More »

Novartis Acquires Vedere Bio for $280M

Shots: Vedere Bio received $150M as upfront payments and is eligible to receive up to $130M as milestones making a total deal value of $280M. The transaction closed in Sept’2020 The acquisition will strengthen Novartis’ footprints with the addition of lead preclinical intravitreally injected AAV gene therapy programs focused on pan-genotypic vision restoration in patients with …

Novartis Acquires Vedere Bio for $280M Read More »

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

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 the option period, Molecular Partners will conduct a P-I study …

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

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

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 (49%) as measured by 24hrs. UPCR assessment; improvement in plasma …

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

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 …

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020) Read More »

Novartis launches digital health hub in Canada

Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers. The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019. Canada is the latest country …

Novartis launches digital health hub in Canada Read More »

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or …

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »

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

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 branaplam in HD patients in 2021 Branaplam (qw, PO) is …

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

Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug

Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma is now a step closer to getting a return on its investment. Inclisiran – now give the trade name Leqvio – has been recommended for approval by the CHMP as …

Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug Read More »

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

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 adults with ASCVD, ASCVD risk equivalent or HeFH6 80% of …

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

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …

PharmaShots Weekly Snapshot (Oct 12-16, 2020) Read More »

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

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 to provide functioning copies of the RPE65 gene to act …

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

NICE changes its mind on Novartis’ progressive MS drug Mayzent

UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance. The change of heart means Mayzent (siponimod) becomes the first oral disease-modifying therapy to be recommended for NHS use in SPMS patients with active disease, defined as relapses or evidence of …

NICE changes its mind on Novartis’ progressive MS drug Mayzent Read More »

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

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 in healthy volunteers demonstrated safety and tolerability and reduction of …

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

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

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%), defined as the presence of intra-retinal fluid or subretinal fluid …

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

Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1

Shots:   The P-III STR1VE-EU study involves assessing Zolgensma (IV) in patients with SMA Type 1 aged <6mos. at the time of gene therapy, with 1 or 2 copies of the SMN2 backup gene and have bi-allelic SMN1 gene deletion or point mutations Results: 65.6% achieved motor milestones not observed in the natural history of SMA …

Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1 Read More »

PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis 2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic …

PharmaShots Weekly Snapshot (Aug 24 -28, 2020) Read More »

FDA starts quick review of Merck’s MET-targeting lung cancer drug

Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator started a priority review of the drug, but could still be beaten to market by a rival drug. Tepotinib has been developed to treat non-small cell lung cancer (NSCLC) with …

FDA starts quick review of Merck’s MET-targeting lung cancer drug Read More »

Novartis eyes filings for leukaemia drug asciminib after phase 3 win

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 previously been treated with two or more tyrosine kinase inhibitors …

Novartis eyes filings for leukaemia drug asciminib after phase 3 win Read More »

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

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 targeting the ABL myristoyl pocket (STAMP), being evaluated in multiple …

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

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

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 metastatic BRAF V600 mutation-positive melanoma compared to Tafinlar and Mekinist …

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

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

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 part 3 of the trial. The study did not meet …

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

Blow for Novartis as PD-1 drug spartalizumab flunks trial

Novartis’ hopes of catching up with other companies in immuno-oncology have been dented after PD-1 inhibitor spartalizumab failed a phase 3 trial in skin cancer. Novartis had hoped the COMBI-i trial would allow it to file for approval of the ‘me-too’ PD-1 inhibitor before the end of this year as part of a triple therapy …

Blow for Novartis as PD-1 drug spartalizumab flunks trial Read More »

Mission successful for Novartis after FDA approves ofatumumab in MS

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis. Kesimpta will have a list price of around $83,000 a year, which the …

Mission successful for Novartis after FDA approves ofatumumab in MS Read More »

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

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 of subcutaneous delivery of Kesimpta via a prefilled syringe and …

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

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children 2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Published: Aug 07, …

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Roche takes on pricey rivals as FDA approves SMA drug

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene abeparvovec). But Spinraza costs $750,000 in the …

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

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, maternity care, and surgery preparation. – Cerner and LRVHealth have …

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

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 ASCLEPIOS I & II: 51% & 58% reduction in ARR …

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Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma

Shots: The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the …

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PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease  Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium …

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Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

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

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 by Novartis Novartis to get exclusive license rights of ZFP-TFs …

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Novartis, company culture and COVID-19: the pharmaphorum podcast

Novartis’ Steven Baert joined the pharmaphorum podcast for episode 22 to discuss how COVID-19 will change the face of company culture, now and in the future. We also looked at how Novartis’ own operations had to change in response to the coronavirus pandemic and the considerable challenges that presented him as its chief people and …

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PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis  Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis 2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Published: Jul 24, 2020 | Tags: Synaffix, Expands, …

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UCB’s IL-17 latecomer bimekizumab beats Cosentyx in psoriasis trial

Belgian biopharma company UCB is bringing up the rear of the IL-17 inhibitor category with its bimekizumab drug, so is celebrating new late-stage data showing superiority to the class leader. The BE RADIANT trial pitted bimekizumab against Novartis’ Cosentyx (secukinumab) in the treatment of adults with moderate-to-severe psoriasis, and according to UCB is the first …

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Novartis takes $485m hit after axing eczema drug from pipeline

Novartis has axed development of its mid-stage eczema drug ZPL389, taking a $485 million hit in the process. Buried deep in the Swiss company’s Q2 results statement, the company said it had discontinued development of the oral H4 receptor antagonist. Novartis added ZPL389, also known as adriforant, to its pipeline with a buyout of UK …

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

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) costs $2.1 million, while Spinraza (nusinersen) costs $750,000 in its …

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Biogen to launch Phase IV study of spinal muscular atrophy drug in post-gene therapy patients

The company plans to enroll 60 patients who have received its drug, Spinraza, following suboptimal response to Novartis’ Zolgensma, which was approved last year. The trial, RESPOND, is anticipated to start enrolling in the first quarter of 2021, pending regulatory approval.

Pandemic hits sales at Novartis after strong launch for SMA gene therapy

The COVID-19 pandemic has bit into sales at Novartis, the big Swiss pharma said in second quarter results, after orders fell back following a period of stockpiling earlier in the year. Figures for the quarter showed reported sales fell by 4% to $11.3 billion compared with the corresponding period last year, although favourable currency fluctuations …

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Lilly’s mirikizumab tops Novartis’ blockbuster Cosentyx in psoriasis

Eli Lilly is a latecomer in the new generation of biologic therapies for psoriasis with its mirikizumab candidate, but a win in a head-to-head trial against Novartis’ big-selling Cosentyx could help close the gap. The pivotal trial with anti-IL-23 antibody mirikizumab – OASIS-2 – delivered a significant improvement over placebo at 16 weeks, achieving its …

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PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid …

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Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Shots: Novartis will offer a portfolio of 15 generic and OTC medicines addressing the need of low- and lower-middle-income countries to treat patients with COVID-19 symptoms. The medicines will available governments, NGOs, and other institutional customers in up to 79 countries at zero-profit to support financially strained healthcare systems The Novartis’ COVID-19 portfolio aid to …

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Propeller Health, Novartis Co-Package Asthma Medication in Europe for Prescription

What You Should Know: – Propeller Health announced it will co-package a new asthma medication from Novartis, which was approved by the European Commission this week for use in the EU. – Enerzair® Breezhaler® plus Propeller Health sensor is the first asthma medication to be co-packaged and co-prescribed with a digital health platform. – Propeller’s …

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Novartis looking for Scientific Writer | Ph.D, M.Pharm, M.Sc

Novartis looking for Scientific Writer | Ph.D, M.Pharm, M.Sc Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field. Post : Scientific Writer II …

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