Lucira Health, Inc. announced that it has filed for protection under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware
CSL presented results from the pivotal placebo-controlled Phase III VANGUARD clinical trial of CSL 312 (garadacimab), an investigational first-in-class monoclonal antibody being developed as a long-term prophylactic treatment for patients with hereditary angioedema (HAE)
Pfizer Japan has filed a new drug application in Japan for its PARP inhibitor talazoparib for the treatment of “BRCA-mutated, HER2-negative, inoperable or recurrent breast cancer” and “castration-resistant prostate cancer (CRPC).”
Rinvoq, a JAK inhibitor, from AbbVie expanded its label in Japan to include non-radiographic axial spondyloarthritis (nr-axSpA) inadequately controlled with existing therapies
The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer
SpringWorks Therapeutics, Inc. announced that the FDA has accepted the Company’s NDA for nirogacestat, an investigational gamma secretase inhibitor, for the treatment of adults with desmoid tumors
The Japanese health ministry on February 24 approved label expansions for a batch of medicines including a pediatric indication for Pfizer’s sedative agent Precedex (dexmedetomidine)
ViiV Healthcare,has announced positive 12-month findings from the SOLAR study
At WORLD Symposium, data from the Phase III COMET study long-term extension showed sustained treatment effect of Nexviazyme (avalglucosidase alfa) over nearly three years in late-onset Pompe disease (LOPD) patients who were treatment-naïve as well as those who switched from long-time standard of care, alglucosidase alfa, during the 96-week extension period
Pfizer Inc. announced that the FDA has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals
Pfizer Inc. announced that the FDA has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM)
Pfizer Inc. and BioNTech SE have announced they have submitted a supplemental Biologics License Application (sBLA) to the FDA for approval of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals 12 years of age and older
AbbVie and Capsida Biotherapeutics Inc. announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. AbbVie's extensive capabilities will be paired with Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs.
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 Rinvoq.
Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo (cemiplimab) in combination with platinum-based chemotherapy.
Akebia Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Amgen has received a positive opinion from the EMA’s CHMP recommending that its Bekemv eculizumab biosimilar become the first Soliris rival to be granted a pan-European marketing authorization and intended for the treatment of adults and children in paroxysmal nocturnal haemoglobinuria (PNH).
Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. a biopharmaceutical company, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX 102 (pegunigalsidase alfa), the first and only pegylated enzyme for the treatment of adult patients with Fabry disease.
Servier, a global pharmaceutical company,announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Tibsovo® (ivosidenib tablets) - an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme - for two indications: i. in combination with azacitidine, for the treatment of adult patients with newly diagnosed IDH1-mutated Acute Myeloid Leukemia and not eligible for standard induction chemotherapy, ii. in monotherapy, for the treatment of adult patients with locally advanced or metastatic IDH1-mutated Cholangiocarcinoma, previously treated by at least one prior line of systemic therapy.
Incyte announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
The CHMP has given a positive opinion for Hyftor (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for Akeega (niraparib and AA), in the form of a DAT,(dual action tablet) given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
MEI Pharma, Inc. a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, and Infinity Pharmaceuticals, Inc. a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming drug candidate, announced that the companies entered into a definitive merger agreement for an all-stock transaction forming a company combining the expertise and resources of MEI and Infinity to advance a robust pipeline of three clinical-stage oncology drug candidates.
Merck Inc., known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for Lagevrio (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
Medtronic plc the global leader in medical technology, announced one-year data from the ADAPT study (n=82), the first multi-national randomized controlled study comparing the performance of the MiniMed 780G advanced hybrid closed loop system1 (AHCL) against multiple daily injections (MDI) of insulin with an intermittently scanned CGM ( continuous glucose monitoring (isCGM).
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
VBL Therapeutics a biotechnology company developing targeted medicines for immune-inflammatory diseases, and Notable Labs, Inc. a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, announced they have entered into a definitive merger agreement
Regeneron Pharmaceuticals, Inc. announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy
Sobi (Swedish Orphan Biovitrivum) announced that the FDA has approved efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], a first-in-class, high-sustained factor VIII replacement therapy for adults and children with haemophilia A.
Merck KGaA, a leading science and technology company, announced updated long-term efficacy and safety data for investigational evobrutinib that continue to show a favorable safety and tolerability profile, consistent with what was seen earlier in the double-blind period (DBP) of the clinical trials
Blueprint Medicines Corporation announced it will regain global commercialization and development rights to Gavreto (pralsetinib), excluding Greater China, following a decision by Roche to discontinue the collaboration agreement between the companies for Gavreto for strategic reasons
Horizon Therapeutics plc announced new data from two post-hoc analyses of the N-MOmentum clinical trial of Uplizna for the treatment of neuromyelitis optica spectrum disorder (NMOSD) will be presented at the eighth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 23-25, 2023, in San Diego
Sorrento Therapeutics, Inc., a biopharmaceutical company dedicated to the development of life-saving therapeutics to treat cancer, intractable pain, and infectious disease, today announced that the U.S. Bankruptcy Court for the Southern District of Texas granted interim approval of Sorrento's $75 million debtor-in-possession financing from JMB Capital Partners, in connection with Sorrento's chapter 11 case, which was filed on February 13, 2023
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck Inc., known as MSD outside of the United States and Canada, announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by the FDA for the adjuvant treatment of patients with high-risk melanoma following complete resection
Roche announced the launch of the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with brain cancer
GSK plc announced the publication of positive phase III trial results for its respiratory syncytial virus (RSV) older adult vaccine candidate in the New England Journal of Medicine
Amgen announced the African American Heart Study, in collaboration with the Association of Black Cardiologists (ABC) and the Morehouse School of Medicine (MSM), which will measure the association between Lipoprotein(a), or Lp(a), and atherosclerotic cardiovascular disease (ASCVD) in 5,000 African American individuals across the United States
AstraZeneca’s tablet formulation of Calquence (acalabrutinib) has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)
AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers
CSL announced that the European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors
Regeneron Pharmaceuticals announced the FDA has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease (also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-losing enteropathy)
Merck Inc., known as MSD outside the United States and Canada, announced that Lagevrio (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19
Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced that the FDA has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis
Arcutis Biotherapeutics, Inc., an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, announced the submission of a New Drug Application (NDA) to the FDA for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis in adults and adolescents. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk
The board of directors of the Shanghai Junishi Biosciences is pleased to announce that recently, a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“TORCHLIGHT Study”, NCT04085276) of the Company’s product toripalimab (trade name: Tuoyi, product code: JS001) in combination with paclitaxel for injection (albumin-bound) in patients with initial diagnosis of stage IV or recurrent metastatic triple-negative breast cancer has finished the pre-specified interim analysis
Takeda announced late-breaking data from the Phase III GRAPHITE study presented at the 2023 Tandem Meetings, demonstrating Entyvio (vedolizumab) achieved a statistically significant and clinically meaningful improvement in lower gastrointestinal (GI) Acute Graft-Versus-Host Disease (aGvHD)-free survival by Day 180 after allo-HSCT (Allogeneic Hematopoietic Stem Cell Transplantation) with no relevant differences in safety profile versus placebo
The primary end point of the phase III PhALLCON study (NCT03589326) was met as first-line ponatinib (Iclusig) ,from Takeda and Incyte, plus reduced-intensity chemotherapy outperformed imatinib (Gleevec) for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL)
Gamida Cell announced that two oral presentations and a poster presentation highlighting Gamida Cell’s investigational product candidate omidubicel at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT).
Actinium Pharmaceuticals, Inc., announced positive results for the primary and secondary endpoints from its pivotal Phase III SIERRA trial. Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission following BMT with a high degree of statistical significance (p<0.0001).></0.0001).>
Pembrolizumab monotherapy led notable antitumor activity with manageable toxicity in patients with Bacillus Calmette-Guérin (BCG)–unresponsive, papillary high-risk non–muscle-invasive bladder cancer (NMIBC), according to findings from cohort B of the phase II Keynote-057 trial (NCT02625961) that were presented at the 2023 Genitourinary Cancers Symposium.
Apellis Pharmaceuticals, Inc.announced that the FDA has approved Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Syfovre is the first and only FDA-approved treatment for GA, a leading cause of blindness that impacts more than one million people in the U.S. and five million people worldwide.
Krystal Biotech, Inc. announced that FDA notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023.
Merck ,known as MSD outside of the United States and Canada, announced the FDA has accepted for review two supplemental new drug applications (sNDA) for Prevymis (letermovir).
Bristol Myers Squibb announced three-year follow-up results from the Phase III CheckMate -274 trial, demonstrating significant sustained clinical benefits with Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
Moderna, Inc. and vaccines, announced that Health Canada has authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (SpikevaxBivalent Original/Omicron) in children and adolescents 6 to 17 years of age.
Travere Therapeutics, Inc. announced that the FDA has granted accelerated approval to Filspari (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) grwater than 1.5 g/g.
Moderna announced interim results from its pivotal Phase III safety and immunogenicity trial of mRNA 1010 (P301), an mRNA-based seasonal influenza (flu) vaccine candidate, in adults.
IVERIC bio announced that the FDA has completed its filing review and accepted the company’s New Drug Application (NDA) for Zimura (avacincaptad pegol or ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici announced that the FDA has approved Lamzede (velmanase alfa-tycv) for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme alpha-mannosidase.
Merck Inc announced results from the pivotal Phase III KEYNOTE-859 trial investigating Keytruda (pembrolizumab) anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Medtronic plc has received CE (Conformité Européenne) Mark for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest.
Sequencing treatment with Lutetium 177 (177Lu) PSMA-617 (177Lu-PSMA-617) after radium-223 was safe and well tolerated and demonstrated similar overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of whether they received 177Lu-PSMA-617 within 6 months or after 6 months of completing radium-223, according to retrospective data from the RALU trial presented at the 2023 Genitourinary Cancers Symposium.
New subgroup data from the Phase III ARASENS trial show overall survival (OS) benefits of darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with high and low-volume, as well as high and low-risk, metastatic hormone-sensitive prostate cancer (mHSPC), compared to ADT with docetaxel
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase III MAGNITUDE study evaluating the investigational use of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations, including BRCA mutations
Pfizer announced positive results from the Phase III TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations
Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone demonstrated median overall survival (OS) of 42.1 months versus 34.7 months for abiraterone plus placebo
Pfizer Inc. announced publication of results in The Lancet Neurology from the Phase III pivotal clinical trial of zavegepant, an investigational calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine
Shanghai Junshi Biosciences and Coherus BioSciences announced positive results of a final analysis of overall survival from the pivotal study JUPITER-02 (NCT03581786), a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating Tuoyi (toripalimab in combination with gemcitabine and cisplatin) as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma
Frequency Therapeutics announced clinical results from the placebo-controlled Phase IIb study of FX 322 in individuals with acquired Sensorineural Hearing Loss (SNHL)
Delcath Systems announced it submitted a new drug application (NDA) resubmission to the FDA for the HEPZATO Kit (melphalan hydrochloride for Injection/Hepatic Delivery System or Melphalan/HDS) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM)
Mirum Pharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) for Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients two months of age and older with progressive familial intrahepatic cholestasis (PFIC)
GlycoMimetics, Inc. announced the independent Data Monitoring Committee (DMC) reviewed the interim utility analysis of its Phase III study of uproleselan in relapsed/refractory (R/R) acute myeloid leukemia (AML) and recommended the study should continue to the originally planned final overall survival event trigger
Bavarian Nordic A/S announced that it has entered into an agreement with Emergent BioSolutions Inc. to acquire two marketed travel vaccines, Vivotif for the prevention of typhoid fever and Vaxchora against cholera as well as a Phase III vaccine candidate for the prevention of Chikungunya virus for a total consideration of up to $ 380 million, including $ 270 million in an upfront payment and up to $ 110 million in future conditional milestone payments
KalVista Pharmaceuticals, Inc. a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, provided multiple clinical trial and regulatory updates for its lead compound sebetralstat, as a potential oral on-demand therapy for HAE attacks
Sorrento Therapeutics, Inc. and its wholly-owned direct subsidiary, Scintilla Pharmaceuticals, Inc. commenced voluntary proceedings under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas (the “Bankruptcy Court”)
Trevena, Inc. announced the publication of Olinvyk data in the peer-reviewed journal Anesthesiology.
Soligenix, Inc. has announced that the FDA has provided the Company with a Refusal to File (RTF) letter for its HyBryte (synthetic hypericin) new drug application (NDA) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S.
Merck KGaA, a leading science and technology company, announced findings of a new analysis of long-term follow-up data from the Phase III JAVELIN Bladder 100 trial
Bristol Myers Squibb and Exelixis, Inc. announced three-year (36.5 months minimum; 44.0 months median) follow-up results from the Phase III CheckMate -9ER trial, demonstrating sustained survival and response rate benefits with the combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC)
Akari Therapeutics announced the Phase III clinical trial of Coversin (nomacopan) in pediatric patients with hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) is moving into Part B sooner than expected and the company is beginning the planning and design for the pivotal study in pediatric patients over 2 years of age.
G1 Therapeutics announced topline results from its pivotal Phase III PRESERVE 1 trial showing that the trial achieved its co-primary endpoints related to severe neutropenia with statistical significance; however, early anti-tumor efficacy data, including overall response rate (ORR) and preliminary measures of survival, favored the placebo arm
Ocuphire Pharma announced that the FDA has accepted the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM)
Japanese regulatory authorities have approved a shelf-life extension for Pfizer’s oral COVID-19 treatment Paxlovid (nirmatrelvir/ritonavir) from 18 months to 24 months.
Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced that positive results from the inspIRE company-sponsored clinical trial were presented as a late breaker, titled “Paroxysmal AF Ablation Using a Variable-Loop Pulsed Field Ablation Catheter Integrated with a 3D Mapping System: One-Year Outcomes from inspIRE,” at the 28th Annual International AF Symposium
Globus Medical a leading musculoskeletal solutions company, and Nuvasive the leader in spine technology innovation, announced they have entered into a definitive agreement to combine in an all-stock transaction.
GSK plc announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 in support of the question posed to the committee regarding whether data from two proposed single-arm trials will be “sufficient to characterize the benefits and risks” of Jemperli (dostarlimab-gxly) in the curative-intent setting for patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
LEO Pharma announced positive results of the DELTA 2 trial. DELTA 2 is the second of two pivotal phase III clinical trials 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).
Pfizer Inc. announced that the FDA approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis (ad) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. cibinqo was previously approved only for the treatment of adults 18 years and older.
GSK reports that the FDA granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Bristol Myers Squibb and 2seventy bio, Inc. announced the first publication and presentation of positive results from KarMMa-3, a pivotal Phase III, open-label, global, randomized, controlled study evaluating Abecma (idecabtagene vicleucel) compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy , including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who were refractory to their last regimen.
The European Commission granted approval for a label extension for Kerendia (finerenone) in the European Union (EU) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study.
The Company’s Board of Directors has determined that it is in the best interests of the Company and its stockholders to re-prioritize Eliem’s pipeline to focus on its high potential preclinical Kv7.2/3 program (“Kv7 Program”) and the development of its lead Kv7.2/3 candidate, ETX 123
Phathom Pharmaceuticals, Inc. announced regulatory updates for its approved products, Voquezna Triple Pak and Voquezna Dual Pak, approved in the U.S. for the treatment of H. pylori infection, and its pending New Drug Application (NDA) for vonoprazan for the treatment of erosive esophagitis
Medtronic announced late-breaking clinical data from the STROKE AF clinical study, which showed large and small vessel disease stroke patients had a 10-fold increase in AF detection with the Reveal LINQ insertable cardiac monitor (ICM) at three years compared to patients randomized to standard of care who did not receive continuous, long-term monitoring
Kite, a Gilead Company announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus (brexucabtagene autoleucel)
Genentech, a member of the Roche Group announced positive new data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks
Cara Therapeutics, Inc. announced the New England Journal of Medicine (NEJM) has published results from the KOMFORT Phase II clinical trial of oral difelikefalin in patients with moderate-to-severe pruritus from notalgia paresthetica
Abbott and Cardiovascular Systems, Inc. announced a definitive agreement for Abbott to acquire CSI, a medical device company with an innovative atherectomy system used in treating peripheral and coronary artery disease
Galapagos NV announced the topline results from DIVERSITY, a global Phase III trial to evaluate the safety and efficacy of filgotinib, 100mg or 200mg once daily, during induction and maintenance treatment of biologic-naïve and biologic-experienced patients with moderate to severe Crohn's disease (CD)
Cassava Sciences, Inc. announced an update on patient enrollment for its on-going Phase III clinical studies of simufilam for the treatment of Alzheimer’s disease dementia
Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Eylea (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP)
UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older
Idorsia Ltd announces the initial findings of REACT, a Phase III study which investigated the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia, in patients following aneurysmal subarachnoid hemorrhage (aSAH)
Lantheus Holdings, Inc. a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it has acquired Knoxville-based Cerveau Technologies, Inc. (“Cerveau”). Cerveau’s asset is MK 6240, a second-generation F 18-labeled positron emission tomography (“PET”) imaging agent that targets Tau tangles in Alzheimer’s disease
Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF)
Roche announced positive results from the global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal haemoglobinuria (PNH) who have not been previously treated with complement inhibitors
Biogen and Sage Therapeutics announced the FDA has accepted the filing of a New Drug Application (NDA) for SAGE 217 (zuranolone) in the treatment of major depressive disorder (MDD) and postpartum depression (PPD)
The Janssen Pharmaceutical Companies of Johnson & Johnson announced positive topline results from the proof-of-concept Phase II open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN)
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the FDA has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.
Mesoblast Limited has resubmitted to the FDA its Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Takeda announced that the FDA has approved the supplemental Biologics License Application (sBLA) for the expanded use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age.
Magenta Therapeutics a clinical-stage biotechnology company focused on improving stem cell transplantation, announced that it has completed a review of its business, including the status of its programs, resources, and capabilities.
MaaT Pharma reported that the FDA has responded to the Company’s Investigational New Drug (IND) Application to initiate in the U.S. an open-label, single arm Phase III pivotal clinical trial evaluating the safety and efficacy of MaaT 013 in patients with steroid-resistant acute Graft-versus-Host Disease (aGvHD).
Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III NRG-GY018 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) for the treatment of patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status.
Gilead Sciences, Inc. has announced the FDA has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Celyad oncology announced a strategic shift in to prioritize discovery research in areas of expertise where it can leverage the differentiated nature of its platforms.
Orexo AB (publ.), announces the submission of a New Drug Application (NDA) to the FDA for its lead pharmaceutical pipeline asset, OX 124, a nasal rescue medication for opioid overdose.
Biophytis SA a clinical- stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, released the final results from its phase II-III COVA clinical study evaluating Sarconeos (BIO 101) in the treatment of COVID-19-related respiratory failure.
GSK plc announced that the FDA has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is the first innovative medicine for anaemia treatment in over 30 years and the only HIF-PHI approved in the US, providing a new oral, convenient option for patients in the US with anaemia of CKD on dialysis.
AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.
Ionis Pharmaceuticals announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase III studies evaluating the safety and efficacy of GSK 3228836 (bepirovirsen) (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB)
Nippon Boehringer Ingelheim and Eli Lilly Japan said on January 31 that their SGLT2 inhibitor Jardiance (empagliflozin) was filed with Japanese regulatory authorities for an additional indication of chronic kidney disease (CKD)
Hillstream BioPharma, Inc, a biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death for drug resistant and devastating cancers, today announced signing an exclusive option agreement with Dana-Farber Cancer Institute to license technology targeting the MUC1-C oncoprotein
Roche announced that the European Commission approved the expansion of the Hemlibra (emicizumab) European Union (EU) marketing authorisation. The label will now include the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII greater than 1% and less than 5%) with a severe bleeding phenotype. Haemophilia A affects around 900,000 people worldwide, approximately 14% of whom have a moderate form of the disease
Idorsia announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for ACT 132577 (aprocitentan), Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with resistant hypertension
TheracosBio announced that the FDA has approved Brenzavvy(bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor
ODACTRA is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites or by positive skin testing to licensed house dust mite allergen extracts.
Evolus, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva (prabotulinumtoxinA), a neurotoxin dedicated exclusively to aesthetics
