Eli Lilly and Company and Sigilon Therapeutics, Inc. announced a definitive agreement for Lilly to acquire Sigilon, a biopharmaceutical company that seeks to develop functional cures for patients with a broad range of acute and chronic diseases. Since 2018, Lilly and Sigilon have worked together to develop encapsulated cell therapies, including SIG-002, for the treatment of type 1 diabetes
Sangamo Therapeutics, Inc., a genomic medicine company, and Voyager Therapeutics, Inc. announced the parties have entered into a definitive license agreement for a potential treatment of prion disease
Cyclo Therapeutics, Inc. announced the publication of positive data from its Phase 1/II clinical trial, which demonstrated promising safety and efficacy results for Trappsol Cyclo in the treatment of Niemann-Pick Disease Type C1, a rare, genetic disease causing cholesterol accumulation in cells, leading to dysfunction of the liver, lung, spleen and brain and premature death
BioXcel Therapeutics, Inc. announced positive topline results for TRANQUILITY II, a Phase III trial of BXC L501, the Company’s proprietary, orally dissolving film formulation of dexmedetomidine under investigation for the acute treatment of Alzheimer’s disease-related agitation
BioMarin Pharmaceutical Inc. announced that the FDA approved Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1%
Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II-III
Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira (adalimumab)
Eton Pharmaceuticals, Inc , an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced that the FDA issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning
Regeneron Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler
Regeneron Pharmaceuticals, Inc. announced top-line, two-year (96 weeks) data for aflibercept 8 mg from the pivotal PHOTON trial in patients with diabetic macular edema (DME)
Bavarian Nordic A/S reported topline results from a Phase III non-inferiority clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate
UCB announced Rystiggo (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control
Pivotal data from the Phase III XTEND-Kids study evaluating efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis in previously treated patients younger than 12 years of age with severe haemophilia A were presented in a late-breaking session at the Annual Meeting of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada
Detailed results from SURMOUNT-2, a phase III clinical trial evaluating the efficacy and safety of Eli Lilly and Company's tirzepatide (10 mg and 15 mg) for chronic weight management in participants with obesity or overweight and type 2 diabetes, showed that tirzepatide led to superior weight reduction versus placebo for both doses
Zenyaku Kogyo has signed an exclusive license agreement to get secure eblasakimab, a monoclonal antibody being developed by Singapore-based biotech ASLAN Pharmaceuticals for the treatment of atopic dermatitis (AD)
Agios Pharmaceuticals, Inc. announced that the Phase II portion of the global RISE UP study of mitapivat in sickle cell disease met its primary endpoint of hemoglobin response for patients in both the 50 mg and 100 mg twice daily (BID) mitapivat arms
Trevena, Inc. announced new topline Olinvyk data from the ARTEMIS study
FibroGen, Inc. announced topline results from its Phase III ZEPHYRUS-1 trial evaluating the safety and efficacy of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF)
Boehringer Ingelheim and Zealand Pharma A/S announced additional data demonstrating superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment
Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus
Novo Nordisk announced data from the phase IIIa ONWARDS 1 and 3 trials evaluating investigative once-weekly basal insulin icodec, which were presented at the 83rd Annual Scientific Sessions of the American Diabetes Association (ADA)
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Refixia.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Soliris. The marketing authorisation holder for this medicinal product is Alexion Europe SAS/AstraZeneca.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera (methoxypolyethylene glycolepoetin beta).
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lonsurf.
Talaris Therapeutics, Inc and Tourmaline Bio, Inc. , a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune diseases, announced that the companies have entered into a definitive agreement under which Tourmaline will combine with Talaris in an all-stock transaction (the “Merger”).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced ; Empagliflozin is currently indicated for the treatment of heart failure and type 2 diabetes in adults.
Amylyx Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the application for conditional marketing authorisation of AMX 0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name Albrioza, for the treatment of adults with amyotrophic lateral sclerosis (ALS) in the European Union (EU).
Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic kidney disease who are on chronic dialysis.
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month.
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Trodelvy (sacituzumab govitecan) as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that it has completed submission of a regulatory application to the FDA for its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 (mRNA-1273.815).
Gilead Sciences, Inc. announced Week 96 results from the pivotal MYR 301 Phase III clinical trial evaluating the first-in-class entry inhibitor Hepcludex (bulevirtide) for the treatment of adults with chronic hepatitis delta (HDV) infection.
Sarepta Therapeutics, Inc. the leader in precision genetic medicine for rare diseases, announced FDA accelerated approval of Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus based gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
Intercept Pharmaceuticals is halting investment its drug development program for nonalcoholic steatohepatitis, or NASH, after receiving negative feedback on its market application for its NASH drug candidate obeticholic acid.
Horizon Therapeutics plc announced positive topline results from its randomized, double-masked, placebo-controlled Phase III clinical trial (OPTIC-J) evaluating Tepezza for the treatment of TED in Japanese patients with higher levels of disease activity, as measured by clinical activity score (CAS).
Bayer announced the initiation of FINE-ONE, a global, multicenter, randomized, placebo-controlled, double blind parallel-group Phase III study to evaluate the efficacy and safety of finerenone versus placebo in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D).
The FDA has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company announced Jardiance is not recommended in patients with type 1 diabetes.
Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two Phase III studies that were submitted.
Aldeyra, a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, announced receipt of a Complete Response Letter from the FDA for the 505(b)(2) New Drug Application (NDA) of ADX 2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).
Eli Lilly and Company and DICE Therapeutics, Inc announced a definitive agreement for Lilly to acquire DICE.
Seagen Inc. announced that the clinical research cooperative German Hodgkin Study Group (GHSG) presented results showing that a phase III trial of Adcetris in combination with chemotherapy
The drug, branded as Vyvgart Hytrulo, is expected to be available in the U.S. next month and will come at a list price of $15,773. The FDA had approved an intravenous version of the drug in 2021 under the brand name Vyvgart, but the company expects an under-the-skin version to offer more convenient dosing than infusion into the veins.
Vera Therapeutics, Inc. announced the Phase IIb ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36.
Surmodics, Inc. announced the receipt of FDA approval for the SurVeil drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (less than 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm.
SK Biopharmaceuticals said that Health Canada granted a Notice of Compliance for Xcopri (ingredient: cenobamate), its epilepsy drug, approving its application for marketing authorization in Canada.
Amneal Pharmaceuticals, Inc. announced the 505(b)(2) New Drug Application (NDA) approval from the FDA for Pemrydi RTU. This product is the first and only ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration.
Horizon Therapeutics plc announced the presentation of a series of analyses demonstrating the risk of hearing-related events among people with Graves’ disease and TED including among those treated with Tepezza.
Santhera Pharmaceuticals announces that it has signed an exclusive license and collaboration agreement for vamorolone in North America (NA) with Catalyst Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on novel medicines for patients living with rare diseases
The FDA has accepted a supplemental new drug application (sNDA) seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection (Onivyde) plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC)
Ipsen announced that the FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS)
Takeda and HUTCHMED (China) Limited announced that results of the Phase III FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in The Lancet
Bristol Myers Squibb announced that the FDA approved the supplemental New Drug Application (sNDA) to add positive data from the Phase III VALOR-HCM study to the U.S. Prescribing Information for Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules)
Bristol Myers Squibb announced the first disclosure of primary analysis results from two pivotal studies, TRANSCEND FL, an open-label, global, multicenter, Phase II, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory follicular lymphoma (FL) and the relapsed or refractory mantle cell lymphoma (MCL) cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi
LivaNova PLC announced the 150th bipolar depression patient has been randomized in the RECOVER clinical study, “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy™ System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression.”
Horizon Therapeutics plc announced the presentation of new data from the randomized, double-masked, placebo-controlled Phase IV clinical trial (NCT04583735) evaluating Tepezza in patients with long disease duration and low Clinical Activity Score (CAS), a measure of disease activity
Coherus BioSciences, Inc. and Surface Oncology, Inc. announced that the companies have entered into a definitive merger agreement providing that, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.
GSK plc announced that the FDA has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data.
Merck Inc.(known as MSD outside of the United States and Canada) announced that the Phase III KEYNOTE-811 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab and chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
AbbVie announced positive top-line results from COMMAND, its Phase III maintenance study, showing risankizumab (Skyrizi 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis.
Verve Therapeutics, Inc. announced an exclusive research collaboration with Eli Lilly and Company focused on advancing Verve’s preclinical stage in vivo gene editing program targeting lipoprotein(a) (Lp(a)). Elevated Lp(a) is an established and genetically validated, independent risk factor for atherosclerotic cardiovascular disease (ASCVD), ischemic stroke, thrombosis, and aortic stenosis.
Eli Lilly and Company announced results of the CHALLENGE-MIG clinical trial of Emgality (galcanezumab-gnlm) and Nurtec ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies.
Roche announced that the FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy
VBI Vaccines Inc. announced that PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the United Kingdom for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults
Tonix Pharmaceuticals Holding Corp. announced that previously disclosed results from the Phase III RELIEF study of TNX 102 SL for the management of fibromyalgia have been published in the peer-reviewed journal Arthritis Care & Research, an official journal of the American College of Rheumatology
IO Biotech a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, announced that it has randomized 225 patients in its global Phase III clinical trial for IO102-IO103, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma
Sandoz, a global leader in generic and biosimilar medicines, announced the launch of a global roadmap to increase patient access to biologic medicines
Bayer and its development partner MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) announced that the first patient has been enrolled in the Phase II/III VALOR trial
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide
Panbela Therapeutics, Inc. a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, announced it has entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in combination with CAR-T cell therapies in preclinical models
AbbVie announced new findings demonstrating sustained long-term safety and efficacy of Venclyxto/ Venclexta (venetoclax)-based combination therapies in patients with previously untreated CLL with co-existing conditions, as well as R/R CLL
Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive
Valneva SE announces that the Company’s pivotal Phase III data for its single-shot chikungunya vaccine candidate, VLA 1553, have been published in The Lancet, the world’s leading peer-reviewed medical journal
Seagen Inc. announced updated efficacy and safety results from Part C of a phase II single-arm trial (SGN35-027) evaluating the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine (AN+AD) for the frontline treatment of patients with early-stage classical Hodgkin lymphoma (cHL)
Actinium Pharmaceuticals announced positive SIERRA trial results in an oral presentation at the European Hematology Association 2023 Congress (EHA)
Horizon Therapeutics announced the publication of a new analysis from the N-MOmentum clinical trial of Uplizna (inebilizumab-cdon) demonstrating the utility of a robust adjudication process that could improve clinical care decision-making in neuromyelitis optica spectrum disorder (NMOSD) through more accurate and consistent assessment of disease-related attacks
Novartis announced that it has entered into an agreement to acquire Chinook Therapeutics, a Seattle, WA, based clinical stage biopharmaceutical company with two high-value, late-stage medicines in development for rare, severe chronic kidney diseases
The MHRA) (UK) has granted approval for a new indication for Merz Therapeutics’ Xeomin (incobotulinumtoxinA) to treat focal spasticity of the lower limbs affecting the ankle joint
Fennec Pharmaceuticals Inc.has announced Pedmarqsi– known as Pedmark in the U.S. – was granted marketing authorization by the European Commission
Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, announced that the FDA approved Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity
AstraZeneca has entered into an exciting collaboration, exclusive option and license agreement with Quell Therapeutics to develop multiple engineered T-regulator (Treg) cell therapies that have the potential to be curative in Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD) indications.
Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that the FDA has accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Eisai Co., Ltd. and Biogen Inc. announced that the FDA's Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase III Clarity AD clinical trial confirms the clinical benefit of Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer’s disease (AD).
The FDA Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously 21 to 0 that AstraZeneca and Sanofi’s nirsevimab has a favourable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.
Genentech, a member of the Roche Group announced that positive results from the global Phase III COMMODORE 1 and 2 studies, evaluating the efficacy and safety of crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, compared to eculizumab, a current standard of care in paroxysmal nocturnal hemoglobinuria (PNH), were presented at the European Hematology Association (EHA) Hybrid Congress, taking place in Frankfurt, Germany on June 8-11, 2023.
Positive results from the pivotal Phase III ALPHA trial showed that investigational, first-in-class oral Factor D inhibitor danicopan as add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) demonstrated a statistically significant and clinically meaningful increase in haemoglobin levels and maintained disease control in patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience clinically significant extravascular haemolysis (EVH), compared to placebo plus established C5 inhibitor therapy.
Acadia Pharmaceuticals announced that Nature Medicine published results from the pivotal Phase III LAVENDER trial, a 12-week randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Daybue (trofinetide) in patients with Rett syndrome five to 20 years of age
FibroGen, Inc.announced topline data from the Phase III LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the FDA has approved Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease
Merck known as MSD outside of the United States and Canada, announced the FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC)
GSK plc announced the FDA accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
GSK announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older
The LAG-3 inhibitor fianlimab plus cemiplimab (Libtayo) produced high and consistent tumor responses and a comparable toxicity profile to that of anti–PD-L1 monotherapies in patients with advanced melanoma who were PD-L1 inhibitor–naïve in the advanced setting, according to data from a phase 1 study (NCT03005782) presented at the 2023 ASCO Annual Meeting
The addition of sintilimab to chemoradiotherapy demonstrated a significant reduction in the risk of disease recurrence or death, distant metastasis and locoregional recurrence compared with chemoradiotherapy alone as frontline therapy in patients with locally advanced nasopharyngeal carcinoma, according to findings from the phase III CONTINUUM trial (NCT03700476) that were presented at the 2023 ASCO Annual Meeting
Paratek Pharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on the development and commercialization of novel therapies for life-threatening diseases and other public health threats, announced it has entered into a definitive agreement to be acquired by Gurnet Point Capital and Novo Holdings A/S in a transaction valued at approximately $462 million, including the assumption of debt and assuming full payment of a Contingent Value Right (CVR)
Treatment with lisocabtagene maraleucel (liso-cel; Breyanzi) elicited encouraging responses regardless of prior progression on BTK inhibition or absence of clinical benefit with venetoclax (Venclexta) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), meeting the primary end point of the phase 1/II TRANSCEND CLL 004 trial (NCT03331198). Primary findings were presented at the 2023 ASCO Annual Meeting
UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorisation for Bimzelx(bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA
Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to conventional systemic HS therapy
The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from an interim analysis of Cohort 1 of the Phase III THOR study, evaluating treatment with Balversa (erdafitinib) versus chemotherapy in patients with metastatic or unresectable urothelial carcinoma (UC) and selected fibroblast growth factor receptor (FGFR) gene alterations who had received prior treatment with an anti-programmed death ligand 1 (PD-[L]1) agent.
Merck Inc. known as MSD outside of the United States and Canada, announced the FDA has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review
BrainStorm Cell Therapeutics Inc. a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the FDA will convene a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (ADCOM) to review the Biologics License Application (BLA) for NurOwn, its investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS)
Zai Lab Limited and Novocure are presenting positive results from the phase III LUNAR clinical trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard therapies for the treatment of non-small cell lung cancer (NSCLC) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
Kite, a Gilead Company announces findings from the largest real-world analysis to date of Tecartus (brexucabtagene autoleucel) in patients with relapsed or refractory mantle cell lymphoma (R/R MCL)
The Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term data from the pivotal Phase 1/II MajesTEC-1 study showing the sustained efficacy and safety of Tecvayli (teclistamab-cqyv) in the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed and previously received treatment with three or more prior lines of therapy
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies
The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase IIIb COSMOS clinical trial showing that treatment with Tremfya (guselkumab) provided sustainable improvements in all minimal disease activity (MDA)a domains through week 48 in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR)
Pfizer Inc. announced the first detailed results from the Phase II PHAROS study, which is evaluating the efficacy and safety of Braftovi (encorafenib) given in combination with Mektovi(binimetinib) to patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC)
Legend Biotech Corp announced that results from the Phase III CARTITUDE-4 study showed that, at a median follow up of 16 months, cilta-cel (ciltacabtagene autoleucel) reduced the risk of disease progression or death by 74 percent compared to standard of care regimens in adult patients with multiple myeloma who have received one to three prior lines of therapy and are refractory to lenalidomide (Hazard ratio [HR]=0.26 (95% CI, 0.18–0.38); P-value [P] <0.0001)
Gilead Sciences announced longer-term overall survival (OS) results from the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) versus comparator chemotherapy (physicians’ choice of chemotherapy, TPC) in patients with HR+/HER2- (IHC0, IHC1+, IHC2+/ISH-) metastatic breast cancer who received endocrine-based therapies and at least two chemotherapies
Kite, a Gilead Company announces detailed results from the overall survival (OS) analysis of the landmark Phase III ZUMA-7 study of Yescarta (axicabtagene ciloleucel [axi-cel]) CAR T-cell therapy compared with historical standard of care (SOC) as initial treatment in the curative setting for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL)
Autolus Therapeutics plc announces the presentation of top-line data from the Pivotal Phase II FELIX study of obe-cel in adult r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
Patients with glioma could soon be treated with an oral targeted drug instead of undergoing more toxic chemotherapy and radiation that could potentially change the treatment landscape
mRNA-4157 (V940) + Keytruda demonstrated a statistically significant and clinically meaningful improvement in distant metastasis-free survival in patients with high-risk stage III/IV melanoma following complete resection
Positive results from an interim analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful and durable responses across a broad range of HER2-expressing advanced solid tumours in previously treated patients
Updated results from the TROPION-Lung02 Phase Ib trial showed that, with additional enrolment and follow-up from the initial presentation, datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum-based chemotherapy demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGAs)
SpringWorks Therapeutics, Inc. announced that the FDA has updated the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for nirogacestat for the treatment of adults with desmoid tumors
Iovance Biotherapeutics, Inc. announced that the FDA accepted its Biologics License Application (BLA) for lifileucel for patients with advanced melanoma
Bristol Myers Squibb announced that the FDA has accepted the New Drug Application (NDA) for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), based on results from the TRIDENT-1 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023
ANNEXA-I, a post-marketing Phase IV trial to assess the efficacy and safety of Andexxa (andexanet alfa) from AstraZeneca in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial haemorrhage, will be stopped early
Merck known as MSD outside of the United States and Canada, announced positive results from the pivotal Phase III KEYNOTE-671 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC)
ImmunoGen Inc. announced detailed results from the Phase III confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRalpha)-positive platinum-resistant ovarian cancer (PROC)
Amgen announced the presentation of new data from the CodeBreaK clinical trial program, the most comprehensive global development program in patients with KRAS G12C-mutated cancers, at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago
Merck known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) announced results from the Phase III CCTG IND.227/KEYNOTE-483 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma
Bristol Myers Squibb announced four-year follow-up results from the Phase III CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer (NSCLC)
Positive results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent
GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and the University of Oxford announced results from the prospective SYMPLIFY study during an oral session on Saturday, June 3, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. SYMPLIFY is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented to primary care and were referred for diagnostic follow-up for suspicion of cancer.
Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations.
Geron Corporation announced a presentation reporting durable continuous transfusion independence with GRN 163L (imetelstat), the Company’s first-in-class telomerase inhibitor, in IMerge Phase III lower risk MDS patients. These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
Pfizer Inc. announced positive results from the Phase III program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of the novel investigational antibiotic combination ATM ATI (aztreonam-avibactam) in treating serious bacterial infections due to Gram-negative bacteria including metallo-beta-lactamase (MBL)-producing multidrug-resistant pathogens for which there are limited or no treatment options.
A poster presentation (Abstract #7514) presented at ASCO will highlight efficacy data with a median survival follow-up time of two years for Jaypirca in relapsed or refractory MCL from the BRUIN Phase 1/II clinical trial.
Neurocrine Biosciences, Inc. presented findings from a meta-analysis of three long-term studies evaluating Ingrezza (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy.
TG Therapeutics announced that the European Commission (EC) has granted approval of Briumvi (ublituximab xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Briumvi was granted approval by the FDA on December 28, 2022, for the treatment of RMS in adults. Briumvi is the first and only anti-CD20 monoclonal antibody approved in the U.S. and now the European Union (EU) for adult patients with RMS that can be administered in a one-hour infusion following the starting dose.
Bayer announced data from three distinct Vitrakvi (larotrectinib) post-hoc subgroup analyses. The data was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023.
Novartis presents positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Eli Lilly and Company announced Verzenio (abemaciclib; CDK4/6 inhibitor) and Jaypirca (pirtobrutinib; non-covalent (reversible) BTK inhibitor) data to be presented at the 2023 ASCO Annual Meeting in Chicago, June 2 – 6, 2023.
Pfizer Inc. announced that the FDA has approved Abrysvo (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older
Horizon Therapeutics plc announced the publication of new data from the Phase III N-MOmentum pivotal trial of Uplizna, which offer insights on serum biomarkers that signal acute attacks and disability worsening associated with NMOSD and illustrate the role of Ulip in reducing these biomarker levels, potentially reducing the frequency and severity of these attacks
Aurinia Pharmaceuticals Inc. announced the results of a post-hoc, pooled analysis of the Phase II AURA-LV (NCT02141672) and Phase III AURORA 1 (NCT03021499) studies, which found that Lupkynis with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high proteinuria across biopsy classes, races, and ethnicities
Biohaven has submitted New Drug Application (NDA) to the FDA for troriluzole for the treatment of spinocerebellar ataxia type 3 (SCA3), an ultra-rare, genetically-defined, neurodegenerative disease associated with progressive disability, frequent falls, loss of ambulation, speech and swallowing impairment, and premature death that is the most common SCA genotype worldwide
Sandoz AG, a global leader in generic and biosimilar medicines, has announced the location of its future permanent headquarters in central Basel
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)
AstraZeneca announced the discontinuation of the brazikumab inflammatory bowel disease (IBD) development programme, an anti-IL-23 monoclonal antibody, being investigated for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC)
Aridis Pharmaceuticals, Inc. announced positive feedback from the FDA on the Company’s proposed single confirmatory Phase III study of investigational monoclonal antibody candidate AR 301, which is being developed as an adjunctive therapy in combination with standard of care (SOC) antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus ( S. aureus ) in mechanically ventilated hospitalized patients
New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate that frexalimab, Sanofi’s novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase II trial of patients with relapsing multiple sclerosis (MS)
Horizon Therapeutics plc announced new analyses from the MIRROR randomized controlled trial of Krystexxa (pegloticase) injection with methotrexate show a multi-faceted impact when treating adults living with chronic gout refractory to oral therapy, or uncontrolled gout
