The two deaths reported following treatment with Novartis’s Zolgensma mark the first fatal cases of acute liver failure associated with the gene therapy. Liver complications […]
Novartis has secured its first approval in Europe for prostate cancer radioligand therapy Pluvicto, getting a green light from the UK Medicines and Healthcare products […]
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
Novartis said this morning that it remains on course to make a decision on the future of its generics business Sandoz by the end of […]
Novartis is partnering with algorithms startup Anumana to develop a new artificial intelligence-based solution for cardiovascular diseases. The goal is to find ways to detect […]
The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the […]
Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer – Gilead’s Trodelvy and Novartis’ Piqray – […]
Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for […]
Novartis is still waiting for FDA approval of its PD-1/PD-L1 inhibitor latecomer tislelizumab in relapsed oesophageal cancer, but is already planning a move the drug […]
A Swiss newspaper has said Novartis’ previously announced restructuring programme could lead to 8,000 axed jobs, including up to 1,400 at its home base in […]
GSK will invest around £1 billion ($1.2 billion) over a 10-year period to speed up R&D on infectious diseases that mainly impact lower-income countries. The […]
Novartis’ two-drug regimen of Tafinlar and Mekinist has been approved by the FDA as the first therapy for solid tumours that have a BRAF V600E […]
Novartis has shouldered its way into the in vivo gene editing category via a deal with US biotech Precision BioSciences, focused on a therapy for […]
Novartis is paying Precision Bio $75 million up front to begin a partnership aiming to develop in vivo gene-editing therapies for serious genetic blood disorders, […]
Novartis could lose years of patent protection in the US for its blockbuster multiple sclerosis therapy Gilenya, after a federal appeals verdict went against the […]
Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial […]
Amgen is planning to push its olpasiran candidate for reducing lipoprotein(a) into phase 3 as quickly as possible as it tries to catch up with […]
Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its […]
People who trust pharma are more interested in using the industry’s services – making building confidence in the sector key to realising the potential of […]
For life science companies around the world, enabling faster access to innovative drugs and therapies is a complicated challenge. As this issue’s contributors discuss, changes […]
Novartis has shut down production of its radioligand therapies – one of its key growth areas – at facilities in Europe and the US after […]
Novartis’ CAR-T Kymriah has become the first therapy in the category to be approved for the treatment of relapsed/refractory follicular lymphoma, ahead of Gilead Sciences’ […]
Novartis has confirmed it is planning to reduce its headcount as part of a restructuring initiative announced last week, but has declined to put a […]
Novartis has joined the select cadre of drugmakers developing KRAS inhibitors for cancer, opening its account with phase 1b data on JDQ443 showing efficacy in […]
The UK regulator has said eligible patients with prostate cancer will get early access to a radioligand therapy developed by Novartis’ Advanced Accelerator Applications (AAA) […]
A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by […]
The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of […]
Novartis unveiled a corporate restructuring that is consolidating some operations in cash-saving moves expected to lead to $1 billion in annual savings. The shakeup means […]
Novartis chief executive Vas Narasimhan, already eyeing a possible divestment of generics business Sandoz, has now turned his attention to the rest of the company. […]
Ann Aerts, head of the Novartis Foundation, tells us about AI4Leprosy, a diagnostic assistant researchers developed that helps healthcare workers detect leprosy with over 90% […]
Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval […]
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition […]
Novartis may be planning to sell off its generics business Sandoz, but that hasn’t stopped it investing in the unit ahead of a decision on […]
Novartis is paying Voyager Therapeutics $53 million up front to begin a partnership focused on the discovery of capsids for central nervous system disorder gene […]
Voyager Therapeutics has signed another big pharma partner for its TRACER adeno-associated virus (AAV) vector technology, designed to improve the safety of gene therapies, with […]
Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance has become the first drug in the class to be approved in the EU for all adults […]
Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only […]
Novartis chief executive Vas Narasimhan has downplayed any chances of swift decision on the future of its generics business Sandoz, saying that a decision on […]
Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal […]
GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 […]
Prospects for Aldeyra’s dry eye disease candidate reproxalap were hit last month after the drug failed to hit its primary objective in a phase 3 […]
There are still licensing deals to be done in the COVID-19 category it seems, after Novartis paid around $163 million to license rights to an […]
Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company […]
Novartis has blocked an attempt by Chinese drugmaker HEC Pharma to launch a generic version of its big-selling multiple sclerosis drug Gilenya in the US […]
Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the […]
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. […]
Novartis is acquiring gene therapy developer Gyroscope Therapeutics and its lead program, a potential treatment for the vision loss disorder geographic atrophy. It’s the latest […]
Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not […]
Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. […]
Novartis is partnering with BeiGene on the development of a drug that addresses TIGIT, a hot cancer immunotherapy target. The Swiss pharma giant is committing […]
Novartis’ big-selling IgE inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but with biosimilars looming the company […]
This episode of the pharmaphorum podcast is the second in a limited series focused on patient engagement that’s being led by clinician, consultant and patient […]
Novartis as opted out of a collaboration with Mesoblast to develop its stem cell-based therapy remestemcel-L as a treatment for COVID-19, prompting a slump in […]
Novartis has licensed a potential drug for Parkinson’s from Belgium’s UCB that it thinks could be the first oral, disease-modifying drug for the disease – […]
Novartis is paying UCB $150 million up front to share in the development of two clinical-stage Parkinson’s disease drugs that offer new approaches to treating […]
Just a few weeks after Novartis revealed it was considering a sale of its generics business Sandoz, there are reports that a potential buyer has […]
With drug pricing controls back on the legislative table in the US, the influential Institute for Clinical and Economic Review (ICER) has published its third […]
Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with […]
Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: […]
Switzerland’s Social Democratic Party has argued that the government should step in and acquire Novartis’ generics unit Sandoz if the company decides to sell it, […]
Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing […]
Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated […]
Novartis’s equity stake in Roche, shares acquired 20 years ago in a strategy to build up to a potential mega-merger, will be sold back to […]
After more than 20 years, Novartis has finally decided to sell its substantial share in fellow Swiss pharma group Roche for $20.7 billion, a decent […]
The development of digital medicine requires valid endpoints that can be used in clinical trials, and a consortium of pharma companies has just identified a […]
Shots: Dunad to receive $24M up front, equity investment, research funding & is eligible to receive ~$1.3B milestones along with royalties & will also be […]
In only its second year of operations, Cambridge, UK startup Dunad Therapeutics has already attracted a big pharma partner for its protein degradation platform. Swiss […]
Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid […]
ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, […]
Shots: The submissions are based on the P-II ELARA trial evaluates the efficacy and safety of Kymriah in adult patients with r/r FL after at […]
Novartis revealed today that it may consider divesting its generic medicines subsidiary Sandoz – amongst other options – which would further narrow its focus to […]
Shots: The P-III CANOPY-1 trial evaluates canakinumab (ACZ885) + pembrolizumab + platinum-based doublet CT vs PBO + pembrolizumab + CT in patients with LA or […]
Expectations for Novartis’ canakinumab as a therapy for cancer have taken another dive, after a second phase 3 trial in non-small cell lung cancer (NSCLC) […]
Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to […]
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 […]
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: […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular […]
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 […]
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 […]
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, […]
Roche has highlighted new data with its oral treatment for spinal muscular atrophy (SMA) – Evrysdi – showing its benefits when given to pre-symptomatic babies […]
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. […]
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 […]
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 […]
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 […]
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, […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
Shots: The company reported 2yrs. & 1 yrs. results from P-III KITE & KINGFISHER studies evaluating Beovu (6mg, q4w) vs aflibercept (2mg) in 926 patients […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and […]
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 […]
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 | […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: […]
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 […]
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 […]
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: […]
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 […]
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 […]
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 […]
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 […]
Shots: The P- III MERLIN study involves assessing the efficacy & safety of Beovu (6 mg, q4w) vs aflibercept (2 mg, q4w) following the loading […]
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 […]
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, […]
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, […]
The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – […]
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 […]
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 […]
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, […]
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 […]
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, […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
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 […]
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 […]
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
EMD Serono’s Tepmetko is one of a number of targeted cancer therapies that have passed FDA muster in the past year. The decision sets up […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
“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 […]
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 […]
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 […]
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 […]
What You Should Know: – H1, the largest database of information on every doctor in the world raises $58M in Series B funding, just six […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Shots: The P-lll RUXCOVID study involves assessing Ruxolitinib (5mg, bid) + SoC therapy vs PBO + SoC therapy in 432 patients aged ≥12 yrs. in […]
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 […]
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, […]
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 […]
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 […]
What You Should Know: – Pear Therapeutics today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund […]
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 […]
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 […]
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, […]
Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps […]
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. […]
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 […]
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 […]
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/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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach […]
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 […]
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. […]
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 […]
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 […]
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, […]
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 […]
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 […]
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. […]
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 […]
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 […]
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, […]
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 […]
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 […]
In a HLTH session Tuesday, an executive at the pharma company offered an update on its efforts to become a digital and data powerhouse.
Shots: Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold […]
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 […]
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 […]
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 | […]
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 […]
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 […]
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 […]
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 […]
Shots: The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients […]
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