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Roche’s BTK inhibitor fenebrutinib delivers strong efficacy in relapsing multiple sclerosis, opening up a potential multi‑billion‑dollar revenue opportunity for the company Roche’s BTK inhibitor fenebrutinib has generated a third consecutive Phase III success in multiple sclerosis, strengthening its positioning as a potential first-in-class option across both relapsing and progressive forms of the disease. What clinical benefits fenebrutinib show in clinical trials? In the la

The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for the first licensed treatment for vitiligo to be used in the NHS, providing a new option for more than 80,000 people in England living with the condition. Vitiligo is a chronic autoimmune disorder in which the immune system attacks melanocytes, the cells responsible for skin pigmentation. This leads to pale or white patches on the skin, which can have a considerable effect on

Keytruda and Welireg Combination Cuts Risk of RCC Recurrence by 28% in Adjuvant Setting Merck reported new Phase 3 results from the LITESPARK-022 trial showing that adding Welireg (belzutifan) to Keytruda (pembrolizumab) as adjuvant therapy significantly reduced the likelihood of recurrence or death in certain patients with clear cell renal cell carcinoma (RCC) following nephrectomy. The study demonstrated a 28% lower risk of disease recurrence or death compared with Keytruda

Novo Nordisk Semaglutide Price Cut 2027: Wegovy & Ozempic List Price Drops to $675 Amid Eli Lilly Zepbound Competition Novo Nordisk announced that it will cut the U.S. list price of its leading semaglutide‑based medicines, Wegovy, Ozempic, and Rybelsus, to $675 per month starting January 2027, marking a significant step to improve affordability and access to GLP‑1 therapies for obesity and type 2 diabetes The price reduction, representing up to 50% off for Wegovy and 35% for

Top pharmaceutical companies by revenues in 2025. The revenues are captured from the official websites of pharmaceutical companies

CagriSema produced large absolute weight loss in REDEFINE 4 but failed its main goal of matching Eli Lilly’s tirzepatide, raising questions about its competitive positioning in obesity. CagriSema delivers strong weight loss, but not enough vs tirzepatideIn the open‑label phase 3 REDEFINE 4 trial, adults with obesity and at least one comorbidity were randomized to once‑weekly CagriSema (fixed‑dose cagrilintide 2.4 mg plus semaglutide 2.4 mg) or tirzepatide 15 mg, both given su

Does Novartis remibrutinib work for chronic inducible urticaria? Yes, first Phase III success in 3 CIndU types Oral remibrutinib hit primary endpoint vs. placebo at week 12 in RemIND trial, with complete responses in symptomatic dermographism, cold urticaria, and cholinergic urticaria. Rhapsido CIndU approval status Novartis seeks FDA approval for dermographism (most common form of CIndU).   Why This Matters First targeted therapy for CIndU, affecting ~29M adults worldwide Sa

Eli Lilly shared encouraging early findings from the innovative TOGETHER-PsO trial, testing ixekizumab (Taltz) alongside tirzepatide (Zepbound) against ixekizumab solo in patients facing moderate-to-severe plaque psoriasis plus obesity or excess weight and related health issues. Trial Achieves Dual Goals After 36 weeks, those getting both drugs saw far better outcomes on the main goal, full skin clearing (PASI 100 score) paired with 10%+ body weight drop, outpacing the ixekiz

Amgen has secured European Commission clearance for Uplizna (inebilizumab) as an add‑on therapy for adults with generalized myasthenia gravis (gMG) who test positive for anti‑acetylcholine receptor (AChR) or anti‑muscle‑specific tyrosine kinase (MuSK) antibodies. The decision introduces a targeted B‑cell–depleting option that can be given as two loading infusions followed by maintenance dosing twice a year, with the aim of providing sustained disease control alongside existin

Exdensur (depemokimab), GSK’s new ultra‑long‑acting anti‑IL‑5 biologic, has been granted marketing authorisation by the European Commission for two respiratory indications: severe asthma driven by type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). It is the first biologic in the EU that can be used across respiratory diseases with a twice‑yearly dosing schedule, and the approval is supported by four phase III studies – SWIFT‑1, SWIFT‑2, ANCHOR‑1 and AN

Get the definitive ranking of the top-selling pharmaceutical drugs by global revenue in 2025. See which blockbusters—from Keytruda to the GLP-1 therapies like Ozempic and Mounjaro—are leading the market and driving record sales in Oncology and Immunology.

Eli Lilly has entered into a definitive agreement to acquire Orna Therapeutics, a biotechnology firm pioneering the development of immune cell therapies engineered directly within the body. The transaction is valued at up to $2.4 billion, including an upfront payment and milestone-based potential payouts.   Also read: UCB presented long-term BE HEARD trial in patients with Hidradenitis Suppurativa Advancing In Vivo CAR-T and Genetic Medicine Orna Therapeutics is building a pi

UCB has released long-term BE HEARD trial data showing that bimekizumab (Bimzelx) delivered deep and durable improvements in hidradenitis suppurativa over three years, with results showcased at the European Hidradenitis Suppurativa Foundation (EHSF) 2026 meeting. The new analyses highlight bimekizumab’s capacity not only to clear inflammatory lesions but also to remodel disease severity categories and reduce structurally destructive draining tunnels over time. Long-term HS re

Roche has released new late-breaking Phase III data demonstrating that its experimental Bruton’s tyrosine kinase (BTK) inhibitor, fenebrutinib showing potential in patients with primary progressive multiple sclerosis (PPMS). Findings from the pivotal FENtrepid trial, presented at the ACTRIMS forum, indicate that fenebrutinib met its primary endpoint of non-inferiority to the current standard therapy, OCREVUS (ocrelizumab), in delaying disability progression among people with

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for AstraZeneca’s Biologics License Application (BLA) seeking approval of Saphnelo (anifrolumab) for subcutaneous administration in adults with systemic lupus erythematosus (SLE). This is despite Saphnelo SC meeting primary endpoint in clinical trial. AstraZeneca has provided the additional information requested and stated its commitment to working closely with the FDA to advance the appli

From 1 January 2026, Australians will pay less for many prescription medicines listed on the Pharmaceutical Benefits Scheme (PBS), with the maximum co-payment for Medicare card holders reduced from $31.60 to $25 per prescription. The concessional co-payment remains capped at $7.70 per script until 1 January 2030, helping to ease cost-of-living pressures for people on lower incomes. About the PBS and Co-payments The PBS, funded by the Australian Government, subsidises the cost

CDSCO Clears Durvalumab AstraZeneca received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for the use of durvalumab in combination with FLOT chemotherapy, a regimen including fluorouracil, leucovorin, oxaliplatin, and docetaxel, as a perioperative treatment for adults with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma. This marks the first and only immunotherapy-based perioperative regimen to demonstrate a survival a

The American Hospital Association (AHA) has called on the Health Resources and Services Administration (HRSA) to stop a new Eli Lilly and Company policy that would expand claims‑data reporting requirements for 340B hospitals, warning that the change is unlawful, unworkable, and threatens patient access to discounted medicines.   Also read: Top 10 pharmaceutical companies by revenues On January 15, 2026, Lilly notified 340B covered entities that, effective February 1, all enti

Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity. A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) vs. 13% in the placebo group. CT-388 demonstrated a safety and tol

The UK's National Institute for Health and Care Excellence (NICE) issued final draft guidance on January 26, 2026, recommending Dupixent (dupilumab ; Sanofi/Regeneron) for adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) that remains uncontrolled despite maximal inhaled therapy. Eligible patients must show elevated blood eosinophils (≥300 cells/μL), indicating type 2 inflammation, and have had ≥1 severe or ≥2 moderate exacerbations in the prior year

Sanofi has reported new phase 3 and phase 2 data indicating that amlitelimab continues to build its profile as a potential treatment option for adolescents and adults with moderate-to-severe atopic dermatitis. Amlitelimab: Phase 3 program overview Amlitelimab is a fully human, non–T‑cell–depleting monoclonal antibody that selectively targets OX40 ligand, designed to modulate immune pathways involved in atopic dermatitis. The late-stage program includes three global studies, C

Saudi Food and Drug Authority (SFDA) has approved the registration of Anktiva (nogapendekin alfa inbakicept) for selected bladder and lung cancer indications, introducing a new immunotherapy option for patients with limited treatment choices. Under the new authorization, Anktiva may be used for adult patients with metastatic non‑small cell lung cancer whose disease has progressed after standard systemic therapies, in combination with immune checkpoint inhibitors. SFDA has als

The US Food and Drug Administration has authorised a new under‑the‑skin version of the CD20xCD3 bispecific antibody mosunetuzumab for adults with relapsed or refractory follicular lymphoma after two or more previous systemic treatments. This subcutaneous regimen, known as Lunsumio VELO, received accelerated approval based on phase I/II data from the GO29781 trial, with continued approval potentially dependent on confirmation of clinical benefit in a follow‑up study. iPharmaCe

China’s National Medical Products Administration has authorised two innovative therapies licensed by Sanofi, strengthening treatment options in serious cardiovascular and lipid disorders. Myqorzo (aficamten) has been approved for adults with obstructive hypertrophic cardiomyopathy, while Redemplo (plozasiran) has been cleared to reduce triglyceride levels in adults with familial chylomicronaemia syndrome who require dietary management. iPharmaCenter Consulting: Find services

Lilly has disclosed that the U.S. Food and Drug Administration has granted Breakthrough Therapy status to sofetabart mipitecan (LY4170156) for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer whose disease has already been treated with bevacizumab and, where appropriate, mirvetuximab soravtansine. iPharmaCenter Consulting: Find services here The investigational therapy is an antibody-drug conjugate directed against folate receptor

Aspect Biosystems and Novo Nordisk have agreed to expand and reshape their existing collaboration to accelerate the development of cell‑based therapies intended to transform the treatment of diabetes. The updated agreement marks a move into a new phase of the partnership, with Aspect assuming broader control of core programmes and Novo Nordisk contributing additional technologies, capabilities and funding. Also read: Top selling drugs | 2026 The companies have been working to

Moderna and Merck have released updated results from the phase 2b KEYNOTE‑942/mRNA‑4157‑P201 trial, providing the first median five‑year follow‑up for the personalised mRNA neoantigen therapy intismeran autogene given with pembrolizumab in patients with completely resected stage III/IV melanoma at high risk of relapse. Also read: Top selling drugs | 2026 The adjuvant combination continued to deliver a sustained and clinically meaningful improvement in recurrence‑free survival

GSK has entered into a definitive agreement to acquire RAPT Therapeutics, expanding its Respiratory, Immunology & Inflammation pipeline with a late-stage, long-acting anti-IgE antibody for food allergies. iPharmaCenter Consulting: Find services here The transaction is valued at approximately 2.2 billion dollars in equity and is expected to close in the first quarter of 2026, subject to customary regulatory approvals. Also read: Top selling drugs | 2026 Through this acquisitio

Novartis has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational medicine ianalumab for the treatment of Sjögren’s disease, a systemic rheumatic autoimmune condition that ranks among the most common in its class. About ianalumab and its mechanism of action Ianalumab is a fully human monoclonal antibody engineered with a dual mechanism that both depletes B cells and blocks their activation and survival th

BMG has launched two substantial research funding lines to strengthen women’s health services research in Germany, targeting patient-centered care, junior research groups, and structural capacity building in this field. Germany’s Federal Ministry of Health (BMG) has opened a new women’s health research funding programs to improve healthcare for women across the country. The call targets projects on patient-centered care, sex-specific disease patterns, and the impact of social

Eli Lilly Highlights Expansive Pipeline at JPM 2026, Targeting 1 Billion Patients in High-Volume Diseases Eli Lilly showcased its strategy to address massive patient populations across obesity, diabetes, obstructive sleep apnea, pain, cardiovascular, renal, and hepatic diseases at the 44th Annual J.P. Morgan Healthcare Conference. Also read: Top selling drugs of 2026 Key Pipeline Molecules of Eli Lilly Lilly's key pipeline includes tirzepatide (blockbuster GLP-1/GIP agonist f

President Donald J. Trump has formally urged Congress to pass the Great Healthcare Plan, a sweeping package designed to cut prescription drug prices, lower health insurance premiums, rein in powerful insurers and pharmacy benefit managers, and expand price transparency across the U.S. healthcare system. iPharmaCenter Consulting: Find services here The White House frames the proposal as a way to send money “directly to the American people” instead of funneling extra taxpayer s

Sun Pharmaceutical Industries has introduced UNLOXCYT (cosibelimab) in the United States for adult patients diagnosed with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are ineligible for curative surgery or radiation therapy. iPharmaCenter Consulting: Find services here   Updated FDA Label Reflects Long-Term Efficacy The U.S. FDA recently approved an updated label for UNLOXCYT following the release of extended follow-up data from

Pfizer Braftovi -Based Combination Regimen With Enhanced Chemotherapy Backbone Boosts Response Rates in Select Patients With Metastatic Colorectal Cancer Pfizer has announced new Phase 3 data from the BREAKWATER trial showing that an Braftovi ( encorafenib) based combination can substantially improve response rates in certain patients with advanced colorectal cancer carrying a BRAF V600E mutation. iPharmaCenter Consulting: Find services here In a randomized cohort of previous

Top-Selling Drugs of 2026: Oncology, Diabetes, and Immunology Take the Lead The pharmaceutical market in 2026 continues to be shaped by powerful forces across oncology, metabolic disorders, and immunology. Driven by expanding therapeutic indications, label extensions, and surging patient demand, the world’s largest drugmakers have seen record-breaking revenues from a handful of blockbuster agents. iPharmaCenter Consulting: Find services here Keytruda: The Unchallenged Leader

The Federal Cabinet has approved a draft legislation known as the Pharmacy Services Development Act (ApoVWG) on December 17, 2025. This new framework is designed to modernize and enhance the role of pharmacies across Germany, particularly focusing on expanding healthcare access in rural communities and streamlining administrative processes. iPharmaCenter Consulting: Find services here   Strengthening Pharmacy Infrastructure The legislation introduces financial support for par

Eli Lilly has entered a definitive agreement to acquire Ventyx Biosciences in an all‑cash transaction valued at approximately 1.2 billion dollars, aiming to strengthen its position in orally delivered therapies for chronic, inflammation‑mediated diseases. Ventyx contributes a differentiated portfolio of small‑molecule oral candidates targeting autoimmune, inflammatory and neurodegenerative diseases, centered on NLRP3 inhibition and advanced IBD assets. iPharmaCenter Consultin

China’s National Medical Products Administration has officially cleared Nucala (mepolizumab) as a supplemental maintenance therapy for adults suffering from chronic obstructive pulmonary disease (COPD). This authorization specifically targets patients whose condition remains poorly managed and is linked to elevated levels of eosinophils in the blood.   Nucala: A Milestone in Biological Respiratory Care Nucala stands as the inaugural monthly biological treatment in China indic

Japan has officially sanctioned Exdensur (depemokimab) as a pioneering, ultra-long-lasting biological therapy. This medication is now available for individuals struggling with intense bronchial asthma or chronic rhinosinusitis accompanied by nasal polyps (CRSwNP) who haven't found relief through traditional medical approaches. What distinguishes Exdensur from existing options? Developed by GSK, Exdensur biologic targets type 2 inflammation by binding to interleukin-5 (IL-5) w

Enhertu (trastuzumab deruxtecan) has received marketing authorization in China as the first HER2‑targeting therapy for people with HER2‑low or HER2‑ultralow metastatic breast cancer whose disease has worsened after at least one endocrine treatment in the metastatic setting. The decision is supported by phase 3 DESTINY‑Breast06 data showing clinically meaningful improvements in progression‑free survival versus standard chemotherapy.   New indication in China The National Medic

European Commission grants approval to Sanofi's Wayrilz (rilzabrutinib), marking the first Bruton's tyrosine kinase (BTK) inhibitor for adult patients with refractory immune thrombocytopenia (ITP). Wayrilz, an oral and reversible BTK inhibitor, targets immune pathways through multi-immune modulation to tackle ITP's root causes, such as low platelet counts, bleeding risks, and quality-of-life burdens from this rare autoimmune disorder. The approval follows a positive CHMP opin

Boehringer Ingelheim announced US Food and Drug Administration clearance for Jascayd (nerandomilast) tablets to treat progressive pulmonary fibrosis in adults. This marks the second indication for the therapy, following its recent approval for idiopathic pulmonary fibrosis. Jascayd introduces the first selective phosphodiesterase 4B inhibitor with both immune-modulating and anti-scarring properties approved for this serious lung disorder.   FIBRONEER-ILD Trial Supports Approv

Novo Nordisk announced US Food and Drug Administration approval for the once-daily Wegovy pill (oral semaglutide 25 mg). This marks the first oral glucagon-like peptide-1 receptor agonist approved specifically for chronic weight control and cardiovascular risk reduction in adults with obesity or overweight plus comorbidities. The therapy targets excess body weight reduction, long-term weight maintenance, and lowering major adverse cardiovascular events in eligible patients.  

GSK announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma characterized by an eosinophilic phenotype. Exdensur stands out as the first ultra-long-acting biologic therapy for severe asthma, designed for twice-yearly dosing, offering patients a more convenient treatment schedule compared with currently available biologics. Clinical

Six of the world’s largest drugmakers – GSK, Novartis, Merck, Gilead, Bristol Myers Squibb and Amgen – have struck three‑year agreements with the Trump administration to cut US drug prices, expand direct‑to‑patient access and commit tens of billions of dollars to American R&D and manufacturing. Taken together, these deals form the core of a new TrumpRx and “Most Favored Nation” framework that trades tariff relief and policy predictability for visible price cuts on high‑impact

HAS Issues Conditional Reimbursement for JAYPIRCA (Pirtobrutinib) in Relapsed or Refractory Mantle Cell Lymphoma The French Health Authority (HAS) delivered a favorable opinion for reimbursement of JAYPIRCA (pirtobrutinib) only when used as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received a Bruton's tyrosine kinase (BTK) inhibitor and are ineligible for treatment with TECARTUS (brexucabtagene autoleucel). In ot

Zytorvi PBS listing Toripalimab‑based immunotherapy has been added to Australia’s Pharmaceutical Benefits Scheme (PBS) as the first funded immune checkpoint inhibitor for eligible people with nasopharyngeal carcinoma whose disease has recurred or spread.   From 1 December 2025, Zytorvi (toripalimab), a next‑generation PD‑1 inhibitor supplied by Dr. Reddy’s Laboratories under licence from Shanghai Junshi Biosciences, will be reimbursed on the PBS for defined adult nasopharynge

FDA Greenlights Breyanzi: Pioneering CAR T-Cell Therapy for Marginal Zone Lymphoma The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel) for adults battling relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy. This groundbreaking decision positions Breyanzi as the first CAR T-cell therapy approved in the U.S. for this challenging rare B-cell malignancy, offering new hope to patients with limit

The European Commission has granted Marketing Authorisation to Johnson & Johnson for IMAAVY (nipocalimab), a novel FcRn-blocking antibody therapy designed to help people living with generalised myasthenia gravis (gMG). The approval covers both adult and adolescent patients aged 12 years and older who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies. gMG is a chronic autoimmune neuromuscular disorder that impairs communicati

Sun Pharma Launches ILUMYA in India Sun Pharma has unveiled its globally recognized innovative medication, ILUMYA (Tildrakizumab), now available in India for managing moderate-to-severe plaque psoriasis. This advanced biologic therapy has garnered extensive acceptance among dermatologists in the United States and internationally as a reliable and safe option for treating this condition. Also read: Top pharmaceutical companies by revenues in 2025   Long-Term Efficacy of ILUMYA