BioVie Inc., announced positive analysis of unblinded, topline efficacy data from its Phase III clinical trial ( NCT04669028 ) of NE 3107 in the treatment of mild to moderate Alzheimer’s Disease (AD)
Vivos Therapeutics, Inc. announced that it has been granted 510(k) clearance from the FDA for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances
argenx SE announced topline results from the ADVANCE-SC study evaluating Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with primary immune thrombocytopenia (ITP)
Ascendis Pharma A/S has announced that the European Commission (EC) has granted marketing authorization for Yorvipath (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism
Avidity Biosciences, Inc., a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), announced a global licensing and research collaboration with Bristol Myers Squibb focused on the discovery, development and commercialization of multiple cardiovascular targets with potential cumulative payments of up to $2.3 billion
Spexis AG, a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, announced that it is in discussions with SPRIM Global Investments (“SGI”) to restructure its current financing agreements with SGI, and to seek new financing from SGI, with a view to supporting the advancement of the COPILOT trial, the first part of the ColiFin Phase III program
The European Commission has expanded the approval of Takhzyro (lanadelumab) to include children with hereditary angioedema (HAE) as young as 2 years of age
Medtronic announced the United States launch of the Penditure left atrial appendage (LAA) exclusion system, an implantable clip preloaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures
GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma
Merck Inc., known as MSD outside of the United States and Canada, announced results from STRIDE-3, a Phase III trial evaluating V 116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
SpringWorks Therapeutics, Inc. announced that the FDA has approved Ogsiveo (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment
Protagonist Therapeutics, Inc. announced two additional Phase III studies, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, evaluating JNJ 2113 (formerly PN 235) in head-to-head comparisons against deucravacitinib, an oral TYK2 inhibitor, in patients with moderate-to-severe psoriasis
Biotronik announced the presentation of two-year results from the investigator-initiated BIOPACT RCT by Principal Investigator Dr. Koen Deloose at the Paris Vascular Insights 2023 congress
Roche announced the launch of Elecsys HBeAg quant, an immunoassay that is able to determine both the presence and quantity (qualitative and quantitative) of the hepatitis B e antigen (HBeAg) in human serum and plasma
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the second Dupixent (dupilumab) investigational Phase III chronic obstructive pulmonary disease (COPD) trial (NOTUS) showed that Dupixent significantly reduced (34%) exacerbations, confirming positive results from the landmark Phase III BOREAS trial
The European Commission (EC) has approved rucaparib (Rubraca) as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy
Genentech, a member of the Roche Group has announced a multi-year strategic research collaboration with NVIDIA that couples Genentech’s artificial intelligence (AI) capabilities, extensive biological and molecular datasets, and research expertise with NVIDIA’s world-leading accelerated computing capabilities and AI to speed up drug discovery and development.
AstraZeneca launches Evinova, set to be a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators and patients.
Medtronic has received CE (Conformité Européenne) Mark for the PulseSelect Pulsed Field Ablation (PFA) System and the Nitron CryoConsole.
Sumitomo Pharma Chinese subsidiary received a notification from local regulators that Xenleta (lefamulin) was approved in China for the treatment of community-acquired pneumonia in adults.
Junshi Biosciences has revealed the final results for its Covid-19 pill VV 116 (mindeudesivir hydrobromide), indicating its efficacy.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking the approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or after osimertinib.
Aldeyra Therapeutics, Inc announced that it has entered into an exclusive option agreement with AbbVie Inc.(AbbVie).
Evelo Biosciences, a biotechnology company launched by Flagship Pioneering to develop microbiome drugs, is shutting down, according to a regulatory filing
Freeline Therapeutics Holdings plc announced that it has entered into a definitive agreement with a newly established portfolio company of Syncona Ltd, a leading life science investor focused on creating, building and scaling global leaders in life science, to acquire Freeline in an all-cash transaction. Under the agreement, the newly established portfolio company will acquire all shares of Freeline not currently owned by Syncona for $6.50 per American Depositary Share (ADS)
BeiGene, Ltd., a global biotechnology company, and Ensem Therapeutics, Inc, a biotechnology company focusing on high-value and difficult-to-drug oncology targets, announced an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor
InDex Pharmaceuticals Holding AB announces that an independent DMC has completed the planned dose selection analysis including safety review and assessment for futility in Induction Study 1 of the phase III program CONCLUDE
Innovent Biologics, Inc. announces that the New Drug Application (NDA) for IBI 351 (KRAS G12C inhibitor) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and granted Priority Review designation for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy
Janssen Pharmaceutical has filed a new drug application in Japan for its oral fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor erdafitinib for the treatment of certain patients with urothelial cancer
Vertex Pharmaceuticals Incorporated announced that the European Commission has granted approval for the label expansion of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for the treatment of children with cystic fibrosis (CF) ages 2 through 5 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
3M has announced Solventum will be the name of the planned, independent health care company following its spin-off
Boehringer Ingelheim announced the acquisition of privately-held T3 Pharmaceuticals AG, a clinical stage Swiss biotech company, for an amount of up to 450 million CHF
Bristol Myers Squibb and 2seventy bio, Inc. announced the FDA's Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase III KarMMa-3 study
The Ministry of Health, Labor and Welfare (MHLW) on November 21 ordered label revisions for five anticoagulants to newly advise the risk of acute kidney injury, including Bristol Myers Squibb’s Eliquis (apixaban)
Ipsen and Medison Pharma, a global pharma company focused on providing access to highly innovative therapies to patients in international markets, are pleased to announce the Health Canada approval for Bylvay (odevixibat) for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease
Argenx SE announced that the European Commission (EC) approved SC injectable Vyvgart (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
Disappointing data from a trial of the last remaining drug in its pipeline means that Oxurion (formerly known as ThromboGenics) is closing its doors after more than 30 years
Merck Inc., known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments
GSK plc announced it will start Phase III trials of a low carbon version of its metered dose inhaler (MDI), Ventolin (salbutamol), using a next generation propellant, in 2024
Amgen announced new data reinforcing the safety and efficacy of Repatha (evolocumab) from the FOURIER Open Label Extension (OLE) [FOURIER-OLE] trial at the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia
Janssen Pharmaceutical has made a Japan submission for its bispecific antibody amivantamab to be used in combination with chemotherapy for certain types of non-small cell lung cancer (NSCLC)
Santen Pharmaceutical Co., Ltd. announced the European Commission (EC) has approved the Marketing Authorization Application (MAA) for Catiolanze (cationic emulsion of latanoprost 50ug/mL, STN1013001) for lowering of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension
Sandoz, announces the launch of Hyrimoz (adalimumab) citrate-free high concentration formulation (HCF; 100 mg/mL) in Europe
MorphoSys AG announced strong topline results from the Phase III MANIFEST-2 study investigating pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib compared with placebo plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis
The Medical Board of the National Psoriasis Foundation has issued a new consensus statement to provide standardized guidance on the management of generalized pustular psoriasis, or GPP
Bristol Myers Squibb and 2seventy bio, Inc. announced the FDA 's Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase III KarMMa-3 study
OCEANIC-AF, a phase III study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke is being stopped early
AbbVie announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of Ubrelvy (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack
Altamira Therapeutics Ltd. announced that it has entered into a binding agreement for the sale of a 51% stake in its subsidiary Altamira Medica AG (“Medica”) to a Swiss private equity investor as part of its strategic repositioning around its RNA delivery technology.
Dermata Therapeutics, Inc. a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, announces agreement with the FDA on the DMT 310 Phase III clinical protocols for the treatment of acne.
Astellas Pharma Inc. and Propella Therapeutics, Inc announced that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella.
CorMedix Inc. announced that the FDA has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).
Medtronic plc announced that the FDA has approved the Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.
BeiGene, Ltd. announced that the European Commission (EC) has granted marketing authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.
Boston Scientific Corporation announced the close of its acquisition of Relievant Medsystems Inc., a company that offers the only FDA -cleared Intracept Intraosseous Nerve Ablation System, a therapy to treat vertebrogenic pain that is a form of chronic low back pain.
Alkermes plc announced that it has completed the separation of its oncology business into Mural Oncology plc , a new, independent, publicly traded company
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN)
Valneva SE announced that the FDA has approved Ixchiq, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV
Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)
Bristol Myers Squibb announced that the FDA approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1 positive non-small cell lung cancer (NSCLC)
As part of its longstanding commitment to patients in rheumatology, UCB, a global biopharmaceutical company, is sponsoring an expert-led, multi-stakeholder programme called Rheumacensus. The programme aims to identify key challenges in the current care pathways of psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) across Europe, and reach consensus on potential improvements
Pacira BioSciences, Inc. announced that the FDA has approved its supplemental new drug application (sNDA) to expand the Exparel (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa
Mallinckrodt plc announced that it has completed its financial restructuring, emerged from Chapter 11 following an expedited court-supervised process and completed the Irish Examinership Proceedings
Selecta Biosciences, Inc. announced that it has merged with Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases
Alvotech and JAMP Pharma Group, a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced that Health Canada has granted JAMP Pharma marketing authorization for AVT 04, a biosimilar to Stelara (ustekinumab) developed by Alvotech. AVT04 will be marketed under the brand name Jamteki
Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin)
AstraZeneca’s Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin)
The PACIFIC-2 Phase III trial for Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival (PFS) versus CRT alone for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending aflibercept 8 mg with extended treatment intervals in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) for approval
Health Canada approved avatrombopag (doptelet, Sobi) to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) and in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure
Aurinia Pharmaceuticals Inc.announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN)
KalVista has achieved the targeted number of on-treatment attacks required to complete the phase III KONFIDENT trial
Eli Lilly’s Mounjaro is recommended for use in Europe for the treatment of obesity
Bristol Myers Squibb announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for Breyanzi (lisocabtagene maraleucel) to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received a prior Bruton tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i)
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 Talzenna
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Rimmyrah, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularisation. The applicant for this medicinal product is Qilu Pharma.
Merck Inc., known as MSD outside of the United States and Canada, has announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
Mirati Therapeutics, Inc. announced that following a re-examination procedure, the Company has received a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Krazati (adagrasib) as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.
Novo Nordisk announced the primary results of SELECT, its landmark phase III cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4 mg (Wegovy) in adults with established cardiovascular disease (CVD) and overweight or obesity without diabetes at the American Heart Association (AHA) annual Scientific Sessions in Philadelphia. The data were simultaneously published in the New England Journal of Medicine (NEJM).
Blueprint Medicines Corporation announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Ayvakyt (avapritinib) for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment. Pending European Commission (EC) approval, Ayvakyt will become the first and only therapy for people living with ISM in Europe.
UCB, will present a post hoc analysis of the EXXELERATE trial examining the efficacy of certolizumab pegol and adalimumab in patients with rheumatoid arthritis (RA) with high rheumatoid factor (RF) levels . The data are being presented at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, U.S., November 10–15.
UCB has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for rozanolixizumab as an add-on to standard therapy 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
Partners STADA and Alvotech announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab).
On 9 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Omjjara from GSK, intended for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.
UCB announced that the Comittee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for rozanolixizumab as an add-on to standard therapy 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.
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine Sirturo (bedaquiline)
- Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, announced new data from the CorEvitas Psoriatic Arthritis (PsA) and Spondyloarthritis Registry
Positive high-level results from the EMERALD-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolisation
The FDA approved Eli Lilly and Company's Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors
Neurocrine Biosciences, Inc. announced the availability of DISCOVER TD , an interactive digital tool designed to help healthcare providers learn about and identify tardive dyskinesia
Gilead Sciences Inc. and Arcus Biosciences Inc. announced that domvanalimab plus zimberelimab and chemotherapy showed encouraging overall response rate (ORR) and 6-month progression-free survival (PFS) rate results in a preliminary analysis from Arm A1 of the EDGE-Gastric study
Merck Inc. known as MSD outside of the United States and Canada, announced that the Phase III KEYNOTE-564 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
Jazz Pharmaceuticals plc and The University of Texas MD Anderson Cancer Center announced a five-year strategic research collaboration agreement to evaluate zanidatamab, Jazz's investigational HER2-targeted bispecific antibody, in multiple HER2-expressing cancers
GSK plc announced positive headline results from a planned analysis of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab as a single agent, compared to placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer
GSK plc has announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products Administration (NMPA) of China has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with the Janssen Pharmaceutical Companies of Johnson & Johnson's Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection
Aurinia Pharmaceuticals Inc. announced the presentation of five studies (one oral and four posters) at the annual American College of Rheumatology Convergence 2023 taking place in San Diego, CA, November 10-15
Health Canada has approved the gene therapy Hemgenix (etranacogene dezaparvovec) for treating adults with hemophilia B who rely on routine prophylactic therapies to prevent or reduce bleeding episodes
Phathom Pharmaceuticals, Inc. announced the FDA has approved Voqenza (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults for the healing of all grades of Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), maintenance of healing of all grades of Erosive GERD, and relief of heartburn associated with Erosive GERD
Gedeon Richter Plc. together with Sumitomo Pharma America, Inc. and Sumitomo Pharma Switzerland, GmbH has announce that the European Commission (‘EC’) has granted approval of a Type II Variation application for Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis
Results from the real-world ZORA observational multi-country study presented at the American Society of Nephrology (ASN) 2023 shows that treating hyperkalaemia (HK) with the potassium binder Lokelma (sodium zirconium cyclosilicate) can allow patients with chronic kidney disease (CKD) or heart failure (HF) to maintain their lifesaving renin-angiotensin-aldosterone system inhibitor (RAASi) therapy
Combination of zibotentan with dapagliflozin showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), used to assess albuminuria, at 12 weeks compared with dapagliflozin alone
Bayer expands its Phase III OCEANIC clinical development program for the investigational drug asundexian (BAY2433334) by initiating a third clinical study, OCEANIC-AFINA
OPKO Health, Inc. presented late-breaking clinical data on Rayaldee extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia
The European Medicines Agency had validated the submission of a marketing authorization application (MAA) seeking the approval of the combination of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer (NSCLC) who are treatment naïve or have received prior therapy
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC)
Boehringer Ingelheim announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).
Boehringer Ingelheim and Carelon Research have conducted a validation study of the Klinrisk model, a machine-learning tool developed to predict the risk of chronic kidney disease (CKD) progression at all stages of the disease.
In alignment with its 5-year strategic plan, Cook Medical announced that Cooper Companies has acquired select products from Cook’s Maternal Fetal Medicine portfolio, as well as gynecological surgery products, and Doppler monitor technology.
Amgen announced new data for Krystexxa (pegloticase) showing a decrease in blood pressure during treatment of adults living with chronic gout refractory to oral urate-lowering treatment; uncontrolled gout, both with and without chronic kidney disease (CKD).
Penumbra, Inc. announced the latest STRIKE-PE data evaluating Penumbra’s Indigo Aspiration System with Lightning.
Mirati Therapeutics, Inc. a commercial stage biotechnology company, announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for Krazati (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRASG12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.
Neurocrine Biosciences, Inc. announced interim results from the ongoing open-label KINECT -HD2 study about Ingrezza (valbenazine) capsules when used for the long-term treatment of adults with chorea associated with Huntington's disease (HD)
Tonix’s once-daily formulation of tianeptine, widely used to treat depression in Europe, failed to improve depression severity in a Phase II study and will be discontinued
AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases
Otsuka Pharmaceutical has filed its antipsychotic agent Rexulti (brexpiprazole) in Japan for a label expansion into agitation associated with dementia due to Alzheimer’s disease
Protagonist Therapeutics, Inc. announced the achievement of a $50 million milestone event under its license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company
CRISPR Therapeutics announced the completion of the FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting for exagamglogene autotemcel (exa-cel) for the treatment of SCD in people ages 12 and older with recurrent vaso-occlusive crises (VOCs)
Kite, a Gilead Company and Epicrispr Biotechnologies announced the companies have entered into a research collaboration and license agreement using Epic Bio’s proprietary gene regulation platform to develop next-generation cancer cell therapies
SeaStar Medical Holding Corporation, a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces that the FDA's Center for Biologics Evaluation and Research (CBER) has issued an Approvable Letter for the company’s proprietary Selective Cytopheretic Device Pediatric (SCD-PED)
Novartis, a global leader in immuno-dermatology and rheumatology, announced that the FDA has approved Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults
