Eisai Co., Ltd. and Biogen Inc.: announced that Eisai presented new analyses on amyloid-related imaging abnormalities (ARIA) with the use of antiplatelet and anticoagulant medications, isolated ARIA-H, and caregiver burden and health-related quality of life (QOL), from the results of Eisai’s Phase III Clarity AD study of lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (A beta) protofibril antibody, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases annual meeting AD/PD
Trevena, Inc. announced initial topline Olinvyk data from two related real-world outcomes studies: VOLITION and ARTEMIS
Takeda confirmed that the New England Journal of Medicine (NEJM) has published positive data from the Phase IV EARNEST study of Entyvio (vedolizumab) for the treatment of chronic pouchitis
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine
Bristol Myers Squibb announced three-year follow-up results from the Phase III CheckMate -816 trial, demonstrating sustained clinical benefits with three cycles of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC)
TNX 102 SL from Tonix Pharmaceuticals met its pre-specified primary endpoint in the Phase III RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia
FDA converts to full approval indication for Keytruda for certain adult and pediatric patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
Emergent BioSolutions Inc. announced that the FDA has approved Narcan Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose
The Janssen Pharmaceutical Companies of Johnson & Johnson announced new long-term data from the CHRYSALIS study evaluating Rybrevant (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy. Data from the study showed long-term response and safety in this population and were presented in an oral presentation at the 2023 European Lung Cancer Congress (ELCC)
Bristol Myers Squibb announced that the European Commission has approved Sotyktu (deucravacitinib), a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease
Regeneron Pharmaceuticals announced that the European Commission (EC) approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with at least 1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation
GSK plc has announced interim results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer
Vanda Pharmaceuticals Inc. announced a win in its jet lag FOIA litigation against the FDA. On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records created by the FDA during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz (tasimelteon).
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.The indication is for patients with HER2-low disease defined as immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization.
Merck Inc., known as MSD outside of the United States and Canada, announced results from the Phase III NRG GY018 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR).
Monopar Therapeutics Inc. announced completion of a pre-specified interim analysis for its Validive Phase IIb/III VOICE trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC). This is an indication for which there is currently no FDA-approved preventative or treatment.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced further findings for Spravato (esketamine nasal spray [NS]) from the ESCAPE-TRD study.
Positive high-level results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed eplontersen met its co-primary endpoints through 66 weeks. The results were consistent with the positive 35-week findings announced in June 2022.
Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at risk of recurrence.
Iovance Biotherapeutics, Inc. announced it has completed its rolling Biologics License Application (BLA) submission to the FDA for lifileucel. Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.
Pharming Group N.V. announces that the FDA has approved Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adult and pediatric patients 12 years of age and older. Joenja, an oral, selective PI3K delta inhibitor, is the first and only treatment approved in the US for APDS, a rare and progressive primary immunodeficiency.
Novo Nordisk announced headline results from the PIONEER PLUS trial, a phase IIIb, 68-week, efficacy and safety trial with once-daily oral semaglutide 25 mg and 50 mg versus 14 mg as add-on to a stable dose of 1–3 oral antidiabetic medicines in people with type 2 diabetes in need of treatment intensification .
Incyte announced that the FDA has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
AbbVie announced topline results from a Phase II study of upadacitinib (Rinvoq, 30 mg) given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once daily in patients with moderately to severely active systemic lupus erythematosus (SLE)
Alkermes plc announced the publication of results from its phase III ENLIGHTEN-Early study of Lybalvi (olanzapine and samidorphan) in the peer-reviewed publication, the Journal of Clinical Psychiatry.
Bayer further expands the global clinical development program for the oral androgen receptor inhibitor (ARi) darolutamide in prostate cancer. The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.
Biogen Inc. announced the outcome of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
Regeneron Pharmaceuticals, Inc. and Sanofi announced the primary and all key secondary endpoints were met in a Phase III trial evaluating the investigational use of Dupixent (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation
AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Astellas Pharma will present detailed results from the Phase III GLOW trial evaluating first-line treatment with IMAB 362 (zolbetuximab), an investigational first-in-class Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) versus placebo plus CAPOX in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
Cidara Therapeutics and Melinta Therapeutics announced that the FDA approved Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options
Vistagen announced positive data from its Phase III open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of PH 94B (fasedienol) over time in adults with social anxiety disorder (SAD).
Incyte announced that the FDA has approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
Regeneron Pharmaceuticals, Inc. announced the FDA has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH)
Evofem Biosciences, Inc., announced it has implemented measures to lower its operating expenses, with the goal of reaching cash flow break even by year-end 2023.
Roche announced that it has entered into a collaboration with Eli Lilly and Company to support the development of Roche’s Elecsys Amyloid Plasma Panel (EAPP). The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease.
Selecta Biosciences and Sobi announced positive topline results from the Phase III DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL 212 (rapamycin + pegsiticase) in adult patients with chronic refractory gout.
Kite/Gilead Sciences announced the primary overall survival (OS) analysis results of the Phase III ZUMA-7 study.
Sandoz, announced that the FDA approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection.
Mirum Pharmaceuticals, Inc. announced that the FDA has approved a reduction in age from one year to three months for Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Graybug Vision, Inc.announced that it has changed its name to CalciMedica, Inc. which will become effective at 4:02 pm ET.
Telix Pharmaceuticals announces that the FDA has approved a supplementary New Drug Application (sNDA) for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated.
argenx a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with gMG who are AChR antibody positive.
Regeneron Pharmaceuticals, Inc.and Sanofi announced that the European Commission (EC) has approved Dupixent (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy . With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the U.S.
Karuna Therapeutics, Inc. announced positive topline results from its Phase III EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults with schizophrenia.
Genentech, a member of the Roche Group announced new long-term data for Evrysdi (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study.
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Novartis presented new data which underscore the transformational and sustained benefit of Zolgensma (onasemnogene abeparvovec), an essential one-time gene therapy for the treatment of spinal muscular atrophy (SMA).
Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the Phase III EMBARK trial evaluating Xtandi (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).
Concert Pharmaceuticals announced the presentation of data from its Phase III clinical trial, THRIVE-AA2 evaluating the oral investigational medicine CTP 543 (deuruxolitinib) in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss.
Regeneron Pharmaceuticals, Inc. and Sanofi presented positive results from the clinical trial assessing Dupixent (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis.
AbbVie announced new 52-week data from an open-label, single-arm study demonstrating improved plaque psoriasis signs and symptoms among a difficult-to-treat patient population who received Skyrizi (risankizumab), an IL-23 inhibitor.
Oculis S.A., announces the completion of enrollment for stage 1 of its Phase III DIAMOND (DIAbetic Macular edema patients ON a Drop) study evaluating the efficacy and safety of OCS 01 in ppatients with diabetic macular edema (DME)
UCB, a global biopharmaceutical company, announced detailed positive results from two Phase III studies (BE HEARD I and BE HEARD II) evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).
Galderma premiered the positive phase III results from the OLYMPIA 2 trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of CIM 331 (nemolizumab) compared with placebo in adult patients with prurigo nodularis.
LEO Pharma presented positive results from the phase III DELTA 1 trial with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).
Arcutis Biotherapeutics presented new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase III studies of Zoryve (roflumilast cream 0.15%) in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
LEO Pharma presented new clinical data from the ECZTRA 6 and ECZTEND trials of Adbry (tralokinumab-ldrm), marketed outside of the US under the tradename Adtralza, in adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD). New data from the ECZTRA 6 trial showed that Adbry significantly reduced the abundance of Staphylococcus aureus in the lesional and non-lesional skin of adolescents with AD after 16 weeks.
Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) has approved BAT 1806, a biosimilar of Actemra (tocilizumab), in China. BAT 1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS).
Acer Therapeutics Inc. announced that topline results from its Phase IIa proof of concept clinical trial to evaluate ACER 801 (osanetant) as a potential treatment for moderate to severe Vasomotor Symptoms (VMS) associated with menopause showed that ACER 801 was safe and well-tolerated but did not achieve statistical significance when evaluating ACER 801’s ability to decrease the frequency or severity of hot flashes in postmenopausal women.
Sarepta Therapeutics, Inc. announced that at its late cycle meeting for the SRP 9001 (delandistrogene moxeparvovec) biologics license application (BLA), the U.S. Food and Drug Administration’s Office of Therapeutics (OTP) has determined that an advisory committee meeting will be held for SRP 9001 in advance of the May 29, 2023 regulatory action date. SRP 9001 is Sarepta’s investigational gene therapy for the treatment of Duchenne muscular dystrophy.
Merck Inc., provided an update on the open-label arm of the non-registrational Phase II KeyVibe-002 trial. KeyVibe-002 is evaluating MK 7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (Keytruda), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy
Vertex Pharmaceuticals Incorporated announced publication in the New England Journal of Medicine (NEJM) of results from preclinical studies and a Phase II study evaluating the efficacy and safety of inaxaplin (VX 147) on top of standard-of-care in people with focal segmental glomerulosclerosis (FSGS) and two APOL1 variants , a severe, rapidly progressive form of chronic kidney disease also known as APOL1-mediated kidney disease (AMKD). AMKD is caused by variants of the APOL1 gene and affects approximately 100,000 people in the U.S. and Europe. Inaxaplin is an APOL1 inhibitor aimed at treating the underlying cause of AMKD.
Ipsen announced that the FDA Prescription Drug User Fee Act (PDUFA) goal date, for the resubmitted New Drug Application (NDA) for investigational Sohonos (palovarotene) as a potential treatment for fibrodysplasia ossificans progressiva (FOP), is 16 August 2023.
Novartis announced the FDA granted approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
Pfizer announced that the FDA Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.
-BD (Becton, Dickinson and Company) announced that it has received 510(k) clearance from the FDA for the BD Vaginal Panel on the BD COR System, a comprehensive diagnostic test that directly detects the three most common infectious causes of vaginitis using BD's high-throughput molecular diagnostic platform for large laboratories.
Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results of the BIOMAG-I clinical study at the Cardiovascular Research Technologies (CRT) meeting.
Dermavant Sciences, announced positive results from ADORING 2, one of two double-blind, randomized, vehicle-controlled Phase III studies to evaluate the efficacy and safety of topical Vtama (tapinarof) cream, 1% in pediatric subjects down to 2 years old and adult subjects with atopic dermatitis (AD).
The Board of Directors of Jounce Therapeutics, Inc. a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, confirmed that Concentra Biosciences, LLC , of which Tang Capital Partners, LP is the controlling shareholder, has made an unsolicited and non-binding proposal to acquire 100% of the equity of Jounce. According to the Schedule 13D filed with the U.S. Securities and Exchange Commission (“SEC”) disclosing the Proposal, Tang Capital is currently approximately a 10.2% shareholder of Jounce.
Medtronic announced that it has received CE (Conformité Européenne) Mark for the Affera Mapping and Ablation System, which includes the Sphere-9 Catheter and the Affera Prism-1 Mapping Software.
GSK announced positive headline results from the phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years.
Servier announced that the Phase III INDIGO clinical trial investigating AG 881 (vorasidenib) in monotherapy for patients with residual or recurrent IDH mutant low-grade glioma met its primary endpoint of progression free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis were both statistically significant and clinically meaningful.
Calliditas Therapeutics AB announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase III clinical trial NefIgArd, which investigated the effect of Nefecon (Tarpeyo/Kinpeygo (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN).
Horizon Therapeutics plc announced the presentation of new MRI imaging data from the Phase III clinical trial showing Uplizna reduced the formation of subclinical (asymptomatic) optic nerve lesions in people with NMOSD. These findings are being presented during the 49th annual meeting of the North American Neuro-Ophthalmology Society (NANOS) March 11-16, 2023, in Orlando, Florida.
Atea Pharmaceuticals, Inc. has announced the presentation of new Phase 1, in vitro and in vivo data that demonstrate key profile attributes of Atea’s lead drug candidate, bemnifosbuvir, for the treatment of COVID-19 and hepatitis C (HCV). Additionally, new data for AT-752 for dengue and a nucleotide analogue are being presented. These results are being presented at the 36th International Conference on Antiviral Research (ICAR 2023) taking place March 13-17, 2023 in Lyon, France.
BioMarin Pharmaceutical Inc. will present updated data demonstrating the long-term benefit of treatment with Voxzogo (vosoritide) and new observational data on disease burden in children with achondroplasia. These data will be shared this week in an oral presentation and five posters at the 2023 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in Salt Lake City, Utah.
Acadia Pharmaceuticals Inc. announced that the FDA has approved Dayblue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Dayblue is the first and only drug approved for the treatment of Rett syndrome.
Pfizer has agreed to buy Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical company with a biotechnology company that pioneered a new type of tumor-killing medicine. The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.
Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.
GenSight Biologics reported topline efficacy and safety results at 3 years of post-treatment administration in the REFLECT Phase III clinical trial with Lumevoq (lenadogene nolparvovec).
Horizon Therapeutics plc announced results of an analysis of real-world treatment with Tepezza in Thyroid Eye Disease (TED) patients with DON (Dysthyroid Optic Neuropathy), the majority of whom had not previously responded to other treatments.
Aldeyra Therapeutics, Inc. announced that the FDA accepted for Priority Review the New Drug Application (NDA) for ADX 2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023. The FDA noted that no potential filing review issues have been identified.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced data from a new prespecified analysis from the Phase III VOYAGER PAD clinical trial reinforcing the benefits of the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase III A DUE study (NCT03904693), which showed an investigational once-daily, single tablet combination therapy, also known as fixed dose combination, of macitentan 10 mg and tadalafil 40 mg (M/T STCT), significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in pulmonary arterial hypertension (PAH) patients with World Health Organization (WHO) functional class (FC) II or III.[1] The data were presented as a Late-Breaking Clinical Trial presentation during the American College of Cardiology’s 72nd Annual Scientific Session & Expo Together With World Heart Federation’s World Congress of Cardiology.
invoX Pharma Limited a U.K.-based wholly-owned subsidiary of Sino Biopharmaceutical Limited with an advancing pipeline of innovative products, announces that it has successfully completed the acquisition of F-star Therapeutics, Inc.,a clinical-stage biopharmaceutical company pioneering bispecific antibodies in immunotherapy, for an aggregate cash consideration of approximately $161 million (or $7.12 per share).
Intercept Pharmaceuticals, Inc. announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA will discuss Intercept’s new drug application (NDA) for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH) on May 19, 2023. The Advisory Committee Meeting will be hosted as a virtual meeting.
Galera Therapeutics announced the presentation of a net treatment benefit analysis of Phase III ROMAN results for GC 4419 (avasopasem manganese) at the 10th European Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal.
Pfizer announced the FDA has approved Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.
Astellas Pharma Inc. and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) announced topline results from the Phase III MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (HSCT) for patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML).
Merck Inc. known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) announced that the Phase II/III CCTG IND.227/KEYNOTE-483 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
LivaNova PLC a market-leading medical technology and innovation company, announced it received FDA 510(k) clearance for its Essenz Heart-Lung Machine (HLM). With FDA clearance, LivaNova initiates the commercial launch of Essenz in the U.S.
Astellas Pharma Inc. and Seagen Inc. announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
InVivo Therapeutics Holdings Corp. a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries (SCI),announced topline results from the company's INSPIRE 2.0 tudy, which was designed to evaluate the safety and probable benefit of InVivo's investigational Neuro-Spinal Scaffold, a bioresorbable scaffold-based device in development for patients with acute SCI.
Genentech, a member of the Roche Group announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).
GenSight Biologics announced the publication of a peer-reviewed article in the renowned American Journal of Ophthalmology focusing on pooled safety data from the 5 clinical studies with Lumevoq (lenadogene nolparvovec) in Leber’s Hereditary Optic Neuropathy (ND4-LHON).
Covis Pharma Group announced it has submitted a response to the Presiding Officer’s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research’s (CDER) proposal to withdrawal approval for Makena (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
Positive high-level results from a planned interim analysis of the AEGEAN Phase III, placebo- controlled trial showed that treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC)
Positive high-level results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint, 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
Ionis Pharmaceuticals announced that the FDA has accepted for review a New Drug Application (NDA) for IONIS-TTR-LRx (eplontersen), an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).
In the prospective observational XARENO study , after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K antagonists (VKA).
Boehringer Ingelheim and Eli Lilly and Company announced that the FDA accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes.
Eli Lilly and Company has announced that solanezumab did not slow the progression of cognitive decline due to Alzheimer's disease (AD) pathology when initiated in individuals with amyloid plaque but no clinical symptoms of the disease, known as the preclinical stage of AD1. Solanezumab only targets soluble amyloid beta.
Virax Biolabs Group Limited an innovative diagnostics company focused on the prevention, detection, and diagnosis of viral diseases, announced that it has entered into an agreement for the distribution of an Avian Influenza A Virus ("AIV") real-time PCR test kit to markets accepting the CE mark, namely the European Union.
Esperion announced the full results from the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial , which were presented at the American College of Cardiology’s Annual Scientific Session & Expo together with the World Congress of Cardiology and simultaneously published in the New England Journal of Medicine. CLEAR Outcomes was a global study of nearly 14,000 patients with or at risk for cardiovascular disease who were unable to maximize or tolerate a statin.
-BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the FDA has accepted the company's supplemental New Drug Application (sNDA) for Voxzogo (vosoritide) for injection to expand treatment in the United States to include children with achondroplasia under the age of 5.
HanAll Biopharma announced that its licensed partner Harbour BioMed in Greater China reported positive top-line results from its pivotal Phase III clinical trial of HBM 9161 (batoclimab) in generalized myasthenia gravis (gMG) patients.
Regeneron Pharmaceuticals, In and Sanofi announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023.
Incyte announced that it will discontinue the Phase III LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. The recommendation to stop the study was not due to safety.
Novan, Inc. announced that the FDA accepted for filing Novan’s New Drug Application (“NDA”) seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum .The Company also received its Prescription Drug User Fee (“PDUFA”) goal date of January 5, 2024.
Merck Inc., known as MSD outside of the United States and Canada, announced full results from the Phase III STELLAR trial, which evaluated sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study’s primary endpoint.></0.001)>
Medtronic plc announced that its PulseSelect Pulsed Field Ablation (PFA) System exceeded its safety performance goal, with an adverse event rate of 0.7%, one of the lowest adverse event rates of any prior FDA Investigational Device Exemption (IDE) trial for atrial fibrillation (AF) ablation or any multi-center PFA study
Edwards Lifesciences highlighted new important data examining mortality rates and cardiac damage of early-stage aortic stenosis (AS) sufferers, along with data examining 10-year transcatheter aortic valve replacement (TAVR) re-intervention rates using real-world Medicare data .
Abbott announced that the FDA has cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors for integration with automated insulin delivery (AID) systems. Abbott modified the sensors to enable integration with AID systems.
Eisai Co., Ltd. and Biogen Inc. announced that the FDA has accepted Eisai’s supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of Leqembi to a traditional approval.
Positive high-level results from an analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients
Cytokinetics, Incorporated announced that positive results from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK 274 in Obstructive Outflow Disease in HCM), a Phase II clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM), were presented at the American College of Cardiology 72nd Annual Scientific Session (ACC.23).
Abbott announced late-breaking data for MitraClip, the leading therapy to treat leaky valves in people with mitral regurgitation (MR), that demonstrate long-term benefits of the device in patients battling heart failure.
Abbott has announced late-breaking data for the TriClip transcatheter edge-to-edge repair (TEER) system, a first-of-its-kind minimally invasive device designed specifically for tricuspid heart valve repair.
Ayala Pharmaceuticals announced that the Independent Data Monitoring Committee (IDMC) for its Phase II/III RINGSIDE study evaluating investigational new drug AL 102 in desmoid tumors conducted a prespecified periodic review of data from the study and recommended that the study continue without modifications.
Neurocrine Biosciences, Inc. announced it will present data analyzing the long-term outcomes of treating tardive dyskinesia (TD) with Ingrezza (valbenazine) capsules in older ( greater than 55 years) and elderly ( greater than 65 years) patients from two studies (KINECT 3-extension and KINECT 4).
Altamira Therapeutics Ltd.reported that data from a recent peer-reviewed clinical study involving Bentrio nasal spray's residence time and other rheological properties demonstrated superiority vs. a saline control.
Eli Lilly and Company announced that the FDA approved an expanded indication for Verzenio (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence.
Bristol Myers Squibb announced that the European Commission (EC) has granted full Marketing Authorization for Reblozyl (luspatercept), a first-in-class therapeutic option, for treatment in adult patients of anaemia associated with non-transfusion-dependent (NTD) beta thalassemia.
Veru Inc. announced that the FDA has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).
In 2023, Novavax intends to focus the organization to align our investments and activities with our top priority of delivering an updated Covid-19 vaccine consistent with public health recommendations for strain composition for the 2023 fall vaccination season
Exelixis, Inc. announced that the phase III CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS)
Santhera Pharmaceuticals announced that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for VBP 15 (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD)
The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi) from Bayer and Orion Corp, plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Merck Inc. announced that the Phase III KEYNOTE-671 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, met one of its dual primary endpoints, event-free survival (EFS), as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC)
Ambrx Biopharma announced that it has been informed by its partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex), that an interim analysis for ACE-Breast-02, a randomized Phase III breast cancer clinical trial investigating Ambrx’s ARX 788, an anti-HER2 antibody drug conjugate (ADC), has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control
AstraZeneca and MSD announced that the FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC)
Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen) announced the launch of the Phase III Librexia program studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic)
Aldeyra Therapeutics, Inc. announced that the FDA accepted for Priority Review the New Drug Application (NDA) for ADX 2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma
In parallel to the MAA submission to the UK MHRA, Santhera is currently preparing an application to include vamorolone for the treatment of DMD in the Early Access to Medicines Scheme (EAMS) in the UK
Sobi and Sanofi announced that the XTEND-Kids phase III pivotal study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa as once-weekly prophylaxis in previously treated patients under 12 years of age with severe haemophilia A met its primary endpoint
ReCor Medical, Inc.and its parent company, Otsuka Medical Devices Co., Ltd. announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA)
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper
-Bayer has submitted an application to the Japanese Ministry of Health, Labor, and Welfare (MHLW) seeking approval of aflibercept 8 mg for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Cytokinetics, Incorporated announced that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF)
Reata Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the FDA has approved Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older
Abbott announced late-breaking data for its next-generation Navitor transcatheter aortic valve implantation (TAVI) system
23 February 2023- - Merck Inc., (known as MSD outside of the United States and Canada), provided updates on two Phase III trials, KEYNOTE-641 and KEYNOTE-789
Merck Inc,. announced that the Phase III KEYNOTE-789 trial evaluating Keytruda in combination with pemetrexed plus platinum-based chemotherapy did not meet its dual primary endpoint of OS for the treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with epidermal growth factor receptor (EGFR)-genomic tumor mutations, who have previously progressed on a tyrosine kinase inhibitor (TKI), including osimertinib
Aldeyra Therapeutics, Inc. announced top-line results from a 12-month, vehicle-controlled, multicenter, parallel-group safety clinical trial of reproxalap, an investigational new drug, in dry eye disease patients
