Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial ELREXFIO is an off-the-shelf (ready-to-use), fixed-dose, subcutaneous BCMA-directed bispecific antibody immunotherapy with reduced dosing after 24 weeks for responding patients NEW YORK / Dec 08, 2023 / Business Wire / Pfizer Inc. (NYSE:PFE) today announced the European...Read more
Alignment reached on key elements of the NASH development strategy, including accelerated approval pathway for both F4 and F2-F3 NASH patients using histology Outcomes trial in F4 cirrhotic NASH patients expected to support full approval across F2-F4 NASH; potential to accelerate timeline to outcomes readout based on agreement with FDA on modified definition of some events Safety database will be inclusive of data from the...Read more
Boca Raton, Florida, Nov. 27, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments that leverage the patient’s innate immune system to combat disease, announced today it has received European Medicines Agency’s (EMA) Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) in France and the Agencia...Read more
U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation (BTD) for epcoritamab-bysp for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy European Medicines Agency (EMA) validates regulatory application for epcoritamab for the same indication The regulatory actions are supported by data from the phase 1/2 EPCORE™ NHL-1 trial COPENHAGEN, Denmark /...Read more
Updates are supported by data from the Phase 1/2 EPCORE™ NHL-1 clinical trial NORTH CHICAGO, Ill., Nov. 27, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL). The FDA has...Read more
If approved, ~3,000 people with DEB in the European Union could receive VYJUVEK to treat the underlying cause of the disease for the first time VYJUVEK received Orphan Drug Designation and PRIME designation from the EMA PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of...Read more
More than 1,200 children are newly eligible for a medicine that could treat the underlying cause of their disease BOSTON / Nov 23, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today 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)...Read more
YORVIPATH (developed as TransCon PTH) is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism Ascendis plans its first EU launch of YORVIPATH in Germany in January 2024 COPENHAGEN, Denmark, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH®...Read more
NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that representatives of Anavex met with team members of the European Medicines Agency (EMA). These meetings discussed the debilitating pathology of...Read more
BRUKINSA is the first and only BTK inhibitor approved for follicular lymphoma in the European Union Approval was based on results from the ROSEWOOD trial in which BRUKINSA plus the anti-CD20 monoclonal antibody obinutuzumab achieved higher overall response rate compared to obinutuzumab alone BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Nov 17, 2023 / Business Wire / BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235),...Read more
VYVGART® SC Now Approved for Subcutaneous Administration, Adding to the Already Approved IV Administration SAN DIEGO, Nov. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received European Commission (EC) approval of VYVGART® SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of generalized myasthenia gravis (gMG) in adult...Read more
BOSTON, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that the European Medical Agency (EMA) has awarded its Priority Medicines (PRIME) designation for elsunersen (PRAX-222) for the...Read more
VYVGART® is now approved for both intravenous (IV) and self-administered subcutaneous (SC) use in Europe argenx is committed to continued collaboration with local authorities across the region to enable broad access to VYVGART SC for eligible patients Amsterdam, The Netherlands— November 16, 2023 — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from...Read more
CAMBRIDGE, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative single-dose therapeutics leveraging CRISPR-based technologies, today announced that the European Commission (EC) has granted orphan drug designation to NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is an in vivo CRISPR-based...Read more
YAVNE, Israel, Nov. 13, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all...Read more
Recommendation by Committee for Medicinal Products for Human Use (CHMP) based on positive results from PULSAR clinical trial in neovascular (wet) age-related macular degeneration (nAMD) and PHOTON trial in diabetic macular edema (DME) If approved by European Commission, aflibercept 8 mg will be the only drug providing extended treatment intervals of up to 5 months for patients with nAMD and DME Extended treatment intervals with...Read more
Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE‑966 trial RAHWAY, N.J. / Nov 10, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today 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...Read more
SAN DIEGO, Calif. and ZUG, Switzerland, Nov. 10, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today 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...Read more
For the first time, the estimated 40,000 patients with indolent SM in the EU1,2* would have a medicine that treats the primary disease driver3,4 Opinion based on the positive PIONEER trial, in which once-daily AYVAKYT achieved significant improvements across a broad range of symptoms with a comparable safety profile to placebo3,4 CAMBRIDGE, Mass., Nov. 10, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (Nasdaq:...Read more
CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within gastroenterology, dermatology and rheumatology Positive CHMP opinion for Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including AVT04-GL-301 study for pharmacokinetic similarity in healthy subjects and confirmatory comparative efficacy and safety...Read more
Novavax's updated COVID-19 vaccine is the only updated protein-based non-mRNA COVID-19 vaccine available in the European Union for individuals aged 12 and older Novavax is working closely with EU member states to bring its updated COVID-19 vaccine to those that have requested doses through the advance purchase agreement GAITHERSBURG, Md., Oct. 31, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing...Read more
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment of untreated, unresectable or metastatic urothelial carcinoma in the European Union Application based on CheckMate -901 trial, the first Phase 3 trial with an immunotherapy-based combination to show statistically significant and clinically meaningful survival benefit over standard-of-care cisplatin-based...Read more
WALTHAM, Mass. / Oct 27, 2023 / Business Wire / ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian,...Read more
PRIME Designation Granted Based on Phase 2 ARCHER Trial Results, which Showed Meaningful Preservation of Visual Function in Patients with Geographic Atrophy ANX007 is the First Therapeutic Candidate to Receive PRIME Designation by the EMA for the Indication of Geographic Atrophy Company Engaging with U.S. and EU Regulatory Authorities to Determine the Optimal Global Pivotal Phase 3 Program for ANX007 BRISBANE, Calif., Oct. 24, 2023...Read more
The European Medicines Agency’s priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four VEGF pathway targets (VEGF A, B, C, and PlGF) in wet age-related macular degeneration (wet AMD) and diabetic macular...Read more
NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced the creation by the European Commission’s DG HERA (Health Emergency Preparedness and Response Authority) of a joint procurement mechanism under which 13 participating countries from the European Union (EU) and the European Free Trade Association (EFTA)...Read more
Approval Based on Updated Positive Overall Survival Results from the Phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma First Significant Improvement in Overall Survival in Two Decades in Stage III & IV Hodgkin Lymphoma Approval Expands on Six Current Indications for ADCETRIS in the European Union OSAKA, Japan & CAMBRIDGE, Mass. / Oct 18, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the...Read more
RAHWAY, N.J. / Oct 17, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PREVYMIS® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative...Read more
BASKING RIDGE, N.J., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products has granted orphan drug designation to LSTA1, the Company’s lead...Read more
REDWOOD CITY, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI). PRIME eligibility is...Read more
Decision marks fifth approval for KEYTRUDA in lung cancer in the EU RAHWAY, N.J. / Oct 16, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete...Read more
Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial If approved, a KEYTRUDA combination would become an option in the EU for the treatment of both HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma in tumors expressing PD-L1 (CPS ≥1) RAHWAY, N.J. / Oct 13, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that...Read more
PHOENIX Phase 3 trial topline results on track for mid-2024 and will inform regulatory next steps in the EU Final decision from the European Commission expected by the end of 2023 CAMBRIDGE, Mass. / Oct 13, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its...Read more
CAMBRIDGE, Mass., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, today announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is an in vivo...Read more
CHMP recommends approval for BRUKINSA plus obinutuzumab as a treatment for adult patients who have received at least two prior lines of therapy If approved, BRUKINSA will be the first and only BTK inhibitor approved for follicular lymphoma BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Oct 13, 2023 / Business Wire / BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the...Read more
The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.2,3 If approved by the European Medicines Agency, rezafungin could be the first new treatment option in over 10 years for patients with invasive candidiasis.4 SAN DIEGO and CAMBRIDGE, England, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Cidara...Read more
ANX005 Granted Orphan Drug Designation by the European Medicines Agency for the Treatment of GBS Target Enrollment Achieved in Phase 3 Pivotal Study of ANX005 in GBS Representing the Company’s Third Successfully Executed Clinical Study in GBS Company on Track to Report Pivotal Data in the First Half of 2024 BRISBANE, Calif., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX) a clinical-stage biopharmaceutical company...Read more
STOCKHOLM, Oct. 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the company's application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome. The COMP opinion will now go to the European Commission, which is...Read more
FOSTER CITY, Calif. / Sep 29, 2023 / Business Wire / Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for imetelstat, a first-in-class investigational telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS). The MAA...Read more
Request submitted by STADA to EMA to convert conditional marketing authorization to standard marketing authorization for Kinpeygo treatment for primary IgA nephropathy Submission to the CHMP for full approval is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet ...Read more
Europe has 150,000 new head & neck cancer cases each year, more than twice the incidence in the U.S. VIENNA, Va. / Sep 26, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the...Read more
WATERTOWN, Mass., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Company’s application for orphan drug designation for VGL101 for...Read more
TEPKINLY® (epcoritamab) is the first and only subcutaneous bispecific antibody approved as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy Conditional marketing authorization approval from the European Commission is supported by data from the pivotal Phase 1/2 EPCORE™ NHL-1 clinical trial TEPKINLY represents AbbVie's second approved hematological...Read more
DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission (EC) has granted marketing authorization for Enrylaze® (JZP458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and...Read more
SME status offers regulatory guidance and engagement in dialogue with EMA NeuroSense to open an EU office in Ulm, Germany Company plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC CAMBRIDGE, Mass., Sept. 20, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, announced today...Read more
NEW YORK / Sep 19, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. LITFULO is also the...Read more
This Positive Opinion Reinforces Veklury’s Strong Safety Profile FOSTER CITY, Calif. / Sep 19, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury® (remdesivir) to treat people with COVID-19 with mild to severe hepatic impairment. The European Commission (EC)...Read more
European Commission approves TEVIMBRA for previously treated advanced or metastatic esophageal squamous cell carcinoma (ESCC) U.S. FDA accepts Biologics License Application in first-line advanced ESCC BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Sep 19, 2023 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has...Read more
BOSTON, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company’s orphan drug designation request...Read more
FLORHAM PARK, N.J., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to iopofosine I 131, the company’s lead small-molecule drug candidate, for...Read more
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial RAHWAY, N.J. / Sep 15, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that 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, for the adjuvant...Read more
If approved, more than 1,200 children would be newly eligible for a medicine that could treat the underlying cause of their disease BOSTON / Sep 15, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a...Read more
European Commission Approval Decision Expected Q4 2023 Opinion Based on Positive Results from Global Phase 2 and Ongoing Extension Study U.S. Food and Drug Administration PDUFA Target Action Date for Supplemental New Drug Application for VOXZOGO for Children Under 5 is Oct. 21, 2023 SAN RAFAEL, Calif., Sept. 15, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to...Read more
Conference call to be held at 8:45 am EDT SOUTH PLAINFIELD, N.J., Sept. 15, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna™ (ataluren) for the treatment of...Read more
Positive opinion based on Phase 3 ADAPT-SC study demonstrating noninferior total IgG reduction at day 29 with subcutaneously (SC) administered efgartigimod, compared to intravenous (IV) administration European Commission (EC) decision on marketing authorization application (MAA) expected within approximately 60 days Amsterdam, The Netherlands—September 15, 2023—argenx SE (Euronext & Nasdaq: ARGX), a global immunology company...Read more
Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union launch planned in Germany in early 2024 COPENHAGEN, Denmark, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended the approval of TransCon PTH...Read more
The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for autumn/winter 2023 vaccination campaigns Clinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants CAMBRIDGE, MA /...Read more
Application based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58% TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic...Read more
Milestone signifies ongoing effort to help prepare for outbreaks of Zaire ebolavirus RAHWAY, N.J. / Sep 07, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. The...Read more
BridgeBio completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), and a scientific advice engagement with the European Union (EU) European Medicines Agency (EMA) FDA and EMA alignment was reached on the adequacy of a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial for infigratinib to support a marketing application for the treatment of children with achondroplasia The primary endpoint...Read more
EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met An additional Phase 3 booster study demonstrating non-inferiority of immune response compared to Comirnaty® and superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was shown as a key secondary endpoint SAN DIEGO / Sep 05, 2023 / Business Wire / Arcturus Therapeutics Holdings...Read more
The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older Recommendation is based on pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which continue to dominate globally1 Doses...Read more
MAA for vilobelimab was submitted in July MAA has been validated by EMA and is now under review Regulatory submission based on pivotal data from PANAMO Phase III trial Company announces attendance at upcoming scientific and investor events JENA, Germany, Aug. 30, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced...Read more
Approval based on progression-free survival benefit demonstrated in Phase 3 KEYNOTE-811 trial KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population RAHWAY, N.J. / Aug 29, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination...Read more
XORTX’s Proprietary Formulation of Oxypurinol – XORLO™ – to Treat Progressive Kidney Disease Associated with Autosomal Dominant Polycystic Kidney Disease (ADPKD) CALGARY, Alberta, Aug. 29, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive...Read more
Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2 Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed1,2 Risankizumab is an IL-23 inhibitor being evaluated as a treatment for...Read more
ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for both older adults and for immunization of pregnant individuals to help protect their infants immediately from birth through six months of age NEW YORK / Aug 24, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company’s bivalent respiratory syncytial...Read more
SANTA CLARA, Calif. / Aug 24, 2023 / Business Wire / Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR). PD-L1 IHC 22C3 pharmDx, Code SK006,...Read more
Approval based on results from the Phase 3 CheckMate -76K trial in patients with stage IIB or IIC melanoma, in which Opdivo reduced the risk of recurrence or death by 58% versus placebo Opdivo is the only PD-1 inhibitor that is indicated as an adjuvant treatment for patients within stages IIB, IIC, III, as well as stage IV resected melanoma PRINCETON, N.J. / Aug 22, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more
HOLLISTON, Mass., Aug. 21, 2023 /PRNewswire/ -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) ("Harvard Apparatus Regenerative Technology" or the "Company"), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today announced the Approval of an Orphan Disease Application for its lead product, the Cellspan Esophageal Implant by the...Read more
AQUIPTA® (atogepant) is the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) in the European Union (EU) approved for the prophylaxis of migraine in adults who have four or more migraine days per month Approval is based on two pivotal Phase 3 studies that demonstrated statistically significant reduction in mean monthly migraine days with AQUIPTA compared to placebo in adult patients with...Read more
TARRYTOWN, N.Y., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The EMA...Read more
SYDNEY, AUSTRALIA, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the continued development of eftilagimod...Read more
Taldefgrobep alfa, in Phase 3 global clinical development for Spinal Muscular Atrophy, granted EU Orphan Drug Designation in addition to previously receiving Fast Track and Orphan Drug Designation in the US NEW HAVEN, Conn., July 31, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN; "Biohaven") announced today that it received orphan medicinal product designation from the European Commission (EC) for taldefgrobep alfa, a novel...Read more
ZTALMY is the first treatment approved by the European Commission for seizures associated with CDKL5 deficiency disorder in children and adolescents RADNOR, Pa. / Jul 31, 2023 / Business Wire / Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the European Commission (EC) has granted approval of ZTALMY®...Read more
Approval Based on Clinically Meaningful Overall Survival Benefit Demonstrated in the TROPiCS-02 Study in Pre-Treated HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) Metastatic Breast Cancer vs. Physician’s Choice of Chemotherapy Trodelvy Now Indicated in Both Pre-Treated HR+/HER2- Metastatic Breast Cancer and Second-Line Metastatic Triple-Negative Breast Cancer in Europe FOSTER CITY, Calif. / Jul 27, 2023 / Business Wire / Gilead Sciences,...Read more
NEW YORK and LONDON, July 27, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the European Commission granted orphan drug designation to nomacopan as a treatment in hematopoietic stem cell transplantation following the European Medicines Agency positive opinion in June. Akari is currently...Read more
Opinion granted based on positive progression-free survival results from the Phase 3 KEYNOTE-811 trial If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1) in the EU RAHWAY, N.J. / Jul 21, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European...Read more
RAHWAY, N.J. / Jul 21, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The...Read more
If approved, epcoritamab (TEPKINLY®) will become the first and only subcutaneous bispecific antibody conditionally approved as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) DLBCL after two or more lines of systemic therapy The positive CHMP opinion is supported by results from the EPCORE™ NHL-1 Phase 1/2 trial evaluating the preliminary efficacy and safety of epcoritamab in patients with...Read more
Company Announcement The positive CHMP opinion is supported by results from the EPCORE™ NHL-1 phase 1/2 trial evaluating the preliminary efficacy and safety of epcoritamab in patients with non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) DLBCL is an aggressive subtype of NHL and accounts for approximately 30 percent of all global cases If approved, epcoritamab (TEPKINLY®) would become the first and only...Read more
Recommendation based on results from the Phase 3 CheckMate -76K trial in patients with stage IIB or IIC melanoma, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival versus placebo If approved, this would build upon the 2018 European Commission approval based on data from the CheckMate -238 trial of Opdivo for the adjuvant treatment of adult patients with melanoma with...Read more
DUBLIN, July 21, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization of JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic...Read more
Following ratification by the European Commission, Evrysdi will be available to treat all spinal muscular atrophy patients, including babies from birth SOUTH PLAINFIELD, N.J., July 21, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi® (risdiplam) marketing authorization to include...Read more
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Jul 21, 2023 / Business Wire / BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced...Read more
SAN DIEGO and ZUG, Switzerland, July 21, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the Conditional Marketing Authorisation Application (MAA) for KRAZATI® (adagrasib) for treatment of patients with KRASG12C -mutated advanced non-small cell...Read more
LOS GATOS, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the European Medicines Agency (EMA) on the Company’s proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301, which is being developed as an adjunctive therapy in combination with standard of care (SOC) antibiotics for the treatment of pneumonia caused by...Read more
HOUSTON, July 10, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, announced that zedenoleucel, its multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, was granted Orphan Drug Designation by the Committee...Read more
Cholesterol Efflux Mediator™ VAR 200 is in phase 2a development to reduce renal cholesterol and lipid accumulation that damages the kidneys' filtration system in patients with glomerular diseases, including diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome WESTON, Fla., July 07, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty...Read more
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU Marketing Authorization includes use of Nuvaxovid™ as a primary series in individuals aged 12 and older and booster in adults Marketing Authorization provides regulatory foundation for future vaccine updates, including Fall vaccination campaign GAITHERSBURG, Md., July 6, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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