Santhera Pharmaceuticals announces the full divestment of its Raxone/idebenone business worldwide and for all indications to Chiesi Farmaceutici S.p.A., an international research focused healthcare group (Chiesi Group). The transaction replaces the existing license agreement between the two companies entered into in 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more
Regeneron Pharmaceuticals, Inc. announced the first presentation of positive two-year (96 weeks) results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to Eylea (aflibercept) Injection, in patients with diabetic macular edema (DME). The results were presented at the American Society of Retina Specialists (ASRS) annual meeting.
Chinook Therapeutics announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the BEYOND study, a pivotal phase III clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody.
Merck announced that the pivotal Phase III KEYNOTE-756 trial investigating Keytruda (pembrolizumab) Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
Biogen Inc. and Reata Pharmaceuticals, Inc. announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3 billion.
Syndax Pharmaceuticals and Incyte announced positive topline data from the pivotal AGAVE-201 phase II trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy.
The Abbott Amplatzer Steerable Delivery Sheath is a cardiac catheter inserted through the skin that provides a pathway for catheter-based devices to be introduced into the chambers of the heart. It is specifically used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.
Alexion/ AstraZeneca Rare Disease, announced that it has entered a definitive purchase and licence agreement for a portfolio of preclinical gene therapy programmes and enabling technologies from Pfizer Inc. The agreement furthers Alexion and AstraZeneca’s commitment to advancing next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies
Homology Medicines, Inc. a genetic medicines company, announced that it has completed a review of its business, and the Board of Directors has approved a plan to evaluate strategic alternatives to maximize shareholder value
Gilead Sciences, Inc. announced that the European Commission (EC) approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting
AbbVie has launched Vyalev (foslevodopa + foscarbidopa), a continuous subcutaneous infusion for Parkinson’s disease, in Japan on July 26
Merck Inc., known as MSD outside of the United States and Canada, announced positive topline results from two Phase III trials evaluating V 116, the company’s investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals
Eli Lilly and Company announced results of two phase III tirzepatide studies in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes
Soliris (eculizumab) has been approved in the European Union (EU) for expanded use to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+)
Biogen announced a new $1 billion cost savings program that will result in 1,000 job cuts; $300 million of the savings will be reinvested in new drug launches and R&D
AbbVie announced that the first patient has been dosed in the Phase III Step-Up HS study evaluating upadacitinib (Rinvoq) in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have failed anti-tumor necrosis factor (TNF) therapy and/or one approved non-anti-TNF inhibitor therapy for HS
- Merck Inc., known as MSD outside of the United States and Canada, and Moderna, Inc. announced the initiation of the pivotal Phase III randomized V940-001 clinical trial evaluating V 940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda, Merck’s anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma
Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech announced the U.S. launch of the Optrell Mapping Catheter with TRUEref Technology powered by the CARTO 3 System
AbbVie announced the British Journal of Dermatology published results from the head-to-head Phase IV IMMpulse study that evaluated the efficacy and safety of Skyrizi (risankizumab) compared to Otezla (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy1
Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that the FDA approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis
Kodiak Sciences Inc., announced topline results from three Phase III studies of tarcocimab tedromer, a novel antibody biopolymer conjugate
Novartis Pharma’s JAK inhibitor Jakavi (ruxolitinib) passed a review by a key health ministry advisory panel for its label expansion into post-transplant graft-versus-host disease (GVHD)
Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Alvotech announced that they have agreed to expand their existing strategic partnership agreement
ImmunoGen, Inc. a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, announced a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem Corporation, a privately-held biopharmaceutical company focused on the discovery of unique tumor targets and development of novel biological therapeutics
BioCardia, Inc. announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP Cell Therapy Heart Failure Trial (clinicaltrials.gov Identifier: NCT02438306), for which FDA granted Breakthrough Designation
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, announced the label revisions of ViiV Healthcare’s four HIV drugs to update the caution against their administration for patients with renal dysfunctions
Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial
Ipsen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged six months or older
Daiichi Sankyo announced that Vanflyta (quizartinib) has been approved by the FDA in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced it has entered into a strategic agreement with Roche to develop and commercialize zilebesiran, Alnylam’s investigational RNAi therapeutic for the treatment of hypertension, which is currently in Phase II of development
Mirati Therapeutics, Inc. a commercial stage biotechnology company, 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 lung cancer (NSCLC)
Biocon Biologics, a subsidiary of Biocon said that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Yesafili, an aflibercept biosimilar, the company said in an exchange filing. The company in an exchange filing said that Yesafili, an ophthalmology product, is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to renal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for first-of-a-kind biosimilar natalizumab (Tyruko) developed by Polpharma Biologics
Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced that the CHMP has adopted a positive opinion recommending the granting of a marketing authorization for its tocilizumab biosimilar candidate MSB 11456 referencing RoActemra (tocilizumab)
Exelixis, Inc. announced that it has entered into a Settlement and License Agreement (Agreement) with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. This settlement resolves patent litigation brought by Exelixis in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Cabometyx (cabozantinib) tablets prior to the expiration of the applicable patents
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tevimbra (Baizen in China) intended for the treatment of oesophageal squamous cell carcinoma
AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization for epcoritamab (Tepkinly) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
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 conditional marketing authorisation (CMA) for Talvey (talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy
Merck Inc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] of at least 1)
The Menarini Group and Stemline Therapeutics Inc. a wholly-owned subsidiary of the Menarini Group, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of Orserdu (elacestrant) monotherapy, indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)?positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
Bavarian Nordic A/S announced that its Phase III clinical trial of MVA-BN RSV, a respiratory syncytial virus (RSV) vaccine candidate for adults over 60 years of age did not meet all the primary endpoints of preventing lower respiratory tract disease (LRTD) from RSV.
Merck Inc., known as MSD outside the United States and Canada, 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.
Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Litfulo (ritlecitinib), an oral treatment, recommending marketing authorization of once-daily 50 mg for individuals 12 years of age and older with severe alopecia areata.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Inaqovi, intended for the treatment of acute myeloid leukaemia (AML). The applicant for this medicinal product is Otsuka Pharmaceutical Netherlands BV.
Jazz Pharmaceuticals plc 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 JZP 458(Enrylaze) (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 older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
The Committee for Medicinal Products for Human Use (CHMP)has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Apretude, intended for prevention of sexually acquired HIV-1 in combination with safer sex practices. The applicant for this medicinal product is ViiV Healthcare B.V.
Emergent BioSolutions Inc. announced that the FDA has approved Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV 7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV).
Verrica Pharmaceuticals Inc. ,a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, announced FDA approval of Ycanth (cantharidin) topical solution for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients 2 years of age and older.
Gilead Sciences, Inc. announced that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis.
Pfizer Inc. announced data from a Phase II study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS 6, being developed for maternal administration to protect infants against invasive GBS disease.
Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation, which would include infants with genetically confirmed diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies, including from birth to below two months.
Amarin Corporation plc announced that it has initiated an organizational restructuring program to right-size and strengthen the Company to enhance shareholder value
Biophytis announced that it has filed for a pre-submission meeting request with the FDA to discuss filing for Emergency Use Authorization (EUA) in the United States for Sarconeos (BIO101) in the treatment of severe forms of COVID- 19
Novartis announced that the FDA has approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy
The FDA has identified a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.;Recalled Product Product Names: Cobalt XT, Cobalt, Crome ICDs and CRT-Ds Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs
Pieris Pharmaceuticals, Inc.a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases and cancer, provided a strategic update following recent events that have impacted its inhaled respiratory franchise, including AstraZeneca's discontinuation of enrollment of the Phase 2a study for elarekibep
Eisai Co., Ltd. and Biogen Inc. announced that the results of a detailed analysis of the Phase III Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: Leqembi) treatment showed reductions in amyloid-beta (A beta) pathology and downstream biomarker changes
Genentech, a member of the Roche Group announced that data from its ophthalmology portfolio will be highlighted in 25 abstracts at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting, which will be held from July 28 to August 1 in Seattle, WA.
Aurinia Pharmaceuticals Inc. announced that full results from the Phase III, double-blind, placebo-controlled AURORA 2 extension study were published online in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology
The board of directors of Shanghai Junishi Biosciences is pleased to announce that the company has received the Acceptance Notice issued by the National Medical Products Administration
The Janssen Pharmaceutical Companies of Johnson & Johnson announced positive topline results from the Phase III PAPILLON study evaluating Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
Novan, Inc. and its wholly owned subsidiary, EPI Health, LLC (collectively, “the Company” or “Novan”), announced that it has entered into a stalking horse asset purchase agreement (“APA”) with Ligand Pharmaceuticals, Inc. (“Ligand”) prior to filing voluntary petitions for relief under chapter 11 of title 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware
Altamira Therapeutics Ltd. announced the publication of the detailed results from its clinical trial with Bentrio nasal spray in house dust mite (“HDM”) allergic rhinitis
AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season
UCB, a global biopharmaceutical company, announced that the European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS)
Eli Lilly and Company presented full results from the Phase III TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease (AD)
China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel (Fucaso; CT103A) from Innovent Biologics for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
Frontline treatment with the combination of nivolumab (Opdivo) and cisplatin-based chemotherapy, followed by nivolumab monotherapy, led to a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared with standard cisplatin-based chemotherapy regimens alone in previously untreated, cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma, according to data from the phase III CheckMate-901 trial (NCT03036098)
BeiGene Switzerland GmbH , a wholly-owned indirect subsidiary of BeiGene, Ltd. entered into an Option, Collaboration and License Agreement with Novartis Pharma AG , pursuant to which BeiGene Switzerland granted Novartis an exclusive time-based option to receive an exclusive license to develop, manufacture and commercialize the Company’s investigational TIGIT inhibitor ociperlimab in certain territories.
Eli Lilly and Company and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of cardiometabolic diseases.
Astellas Pharma announced the European Medicines Agency (EMA) has accepted for regulatory review the company's marketing authorization application (MAA) for IMAB 362 (zolbetuximab), a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.
Nanobiotix a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, announced a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV (“Janssen”), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTX R3.
Zai Lab Limited announced that the first patient has been treated in the mainland China portion of the global registrational, Phase III FORTITUDE-101 study for bemarituzumab, a potential first-in-class Fc-optimized monoclonal antibody that is designed to block fibroblast growth factors from binding and activating Fibroblast Growth Factor Receptor 2b (FGFR2b), inhibiting several downstream pro-tumor signaling pathways and potentially slowing tumor proliferation.
Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide)
Biotronik announced the one-year subgroup results from the investigator-initiated BIOPACT randomized controlled trial (RCT) BIOPACT randomized controlled trial (RCT), which were presented by principal investigator Dr. Koen Deloose at LINC, the Leipzig Interventional Course 2023
Journey Medical Corporation announced positive topline results from the two Phase III multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg (“DFD 29”) for the treatment of moderate-to-severe papulopustular rosacea in adults
Urotronic, Inc. announced it has received FDA approval of its Optilume BPH Catheter System, a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH
Avrobio a leading clinical-stage gene therapy company working to free people from a lifetime of genetic disease, announced that it has completed a review of its business, including the status of its programs, resources, and capabilities
Dr. Reddy’s Laboratories announced that its Biologics License Application (BLA) for DRL_RI biosimilar rituximab candidate has been accepted for a substantive review by the FDA.
Genentech, a member of the Roche Group announced that the Phase III OCARINA II trial evaluating Ocrevus (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of MS or primary progressive MS (RMS or PPMS)
Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least 2 to <12 years) with atopic dermatitis (ad)
BeiGene announced the FDA has accepted for review the Company’s supplemental new drug application (sNDA) for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy
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-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy
GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.
In a late breaking trial session during EuroPCR 2023 in Paris, on behalf of the HOST-IDEA study investigators, Dr. Hyo-Soo Kim presented the results of a stent level analysis comparing two ultrathin strut drug-eluting stents (DES): Orsiro and Coroflex ISAR . The post-hoc comparison revealed significant differences in efficacy.
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines provided an update on regulatory submissions for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older
Better Therapeutics, Inc. a pioneer in developing software to treat cardiometabolic diseases, announced that the FDA authorized AspyreRx (formerly BT-001), a prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D)
Roche announced that the European Commission (EC) has granted conditional marketing authorisation for Columvi (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG)
Horizon Therapeutics plc announced the publication of the long-term data from the MIRROR randomized controlled clinical trial of Krystexxa (pegloticase) injection with methotrexate, a commonly used immunomodulator, in ACR Open Rheumatology [https://doi.org/10.1002/acr2.11578]
The phase IIa study of abivertinib from Sorrento Therapeutics for r/r Marginal Zone Lymphoma, a rare type of B cell lymphoma, was conducted in China in 27 R/R MZL patients. Abivertinib showed significant treatment benefits in 27 patients who were relapsed or refractory after multiple lines of treatment with an ORR of 59.3% (11.1% CR and 48.2% partial responses).
The FDA has issued a complete response letter (CRL) to Amneal Pharmaceuticals for IPX 203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules designed for the treatment of Parkinson’s disease.
Renalytix plc announces that the FDA has granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease.
Novartis announced that the U.S. District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity.
Incyte Biosciences has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Opzelura cream.
Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for Lytgobi (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA).
Almirall, S.A. announced that Ilumetri (tildrakizumab) significantly improved wellbeing in patients with moderate-to-severe plaque psoriasis achieving a wellbeing status similar to the general population after 16 weeks, which was maintained up to week 28. These first results of the POSITIVE study were presented in a poster at the 25th World Congress of Dermatology, held in Singapore from 3-7 July.
The FDA awarded a full approval to the Alzheimer’s disease treatment Leqembi, a decision expected to significantly increase use of the therapy and, potentially, others that work like it
Biotronik announced FDA approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management
Ultragenyx Pharmaceutical Inc. announced that the first patients have been dosed in both of its late-stage clinical trials evaluating setrusumab in pediatric and young adult patients with OI sub-types I, III and IV
Novavax, Inc. has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid (NVX-CoV2373)
Intercept Pharmaceuticals, Inc. announced a restructuring to strengthen the Company’s focus on rare and serious liver diseases and significantly reduce operating expenses, including discontinuing all nonalcoholic steatohepatitis (NASH)-related investment
Abbott announced that the FDA has approved the Aveir dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms
Allarity Therapeutics, Inc. which is developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, announced initial results from its European Phase II clinical trial evaluating the efficacy of Ixempra in metastatic breast cancer (mBC) patients selected with the DRP-Ixempra companion diagnostic (CDx) candidate
Vertex Pharmaceuticals announced that the European Commission has granted approval for the label extension of Okambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 to less than 2 years old who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common form of the disease
At the 25th World Congress of Dermatology (WCD), Boehringer Ingelheim presented new late-breaking data from the Effisayil 2 trial showing that spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo
Pfizer Inc. has announced that the FDA has approved Litfulo (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata
Pfizer Inc. has announced that the FDA has accepted the company’s BLA for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA)
Sun Pharmaceutical announced that its arm Sun Pharma Canada Inc. has received Health Canada approval for Abscorba LD (isotretinoin capsules) to treat acne
Bristol Myers Squibb announced that the European Commission (EC) has approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients
The FDA approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.
Pfizer Inc and OPKO Health Inc. announced that the FDA has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone
Pfizer Inc.and BioNTech SE announced the companies have submitted regulatory applications to the FDA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older
Shionogi announced that its Chinese license partner Eddingpharm has won regulatory approval for its thrombopoietin receptor agonist Mulpleta (lusutrombopag) in China
Takeda Pharmaceutical on June 30 filed a new drug application in Japan for its recombinant, porcine sequence factor VIII susoctocog alfa for the control of bleeding episodes in patients with acquired hemophilia A (AHA)
Positive high-level results from the TROPION-Lung01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy
The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Novartis’ Luxturna (voretigene neparvovec) for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations
Moderna, Inc. announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2
Alnylam, the leading RNAi therapeutics company, announced that the FDA has set a date of September 13, 2023 for the meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the supplemental New Drug Application for patisiran, an investigational treatment for the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis
UCB, a global biopharmaceutical company,announced that the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis remains under review with the FDA.
Boehringer Ingelheim announced Cyltezo (adalimumab-adbm), a FDA-approved Interchangeable biosimilar to Humira (adalimumab), is now commercially available in the U.S.
JCR Pharmaceuticals Co., Ltd. announced that JCR has received an approval from the Ministry of Health, Labour and Welfare of Japan for an expanded indication of Growject S.C. Injection 6mg and Growject S.C. Injection 12mg (INN?somatropin), a recombinant human growth hormone product, for the treatment of short stature caused by alterations of the Short Stature Homeobox-containing Gene (SHOX).
GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved an updated indication for Shingrix (Recombinant Zoster Vaccine, Adjuvanted - RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over who are at increased risk of the condition.
Genentech, a member of the Roche Group announced new long-term data for Evrysdi (risdiplam) from the open-label extension (n=50) of the pivotal FIREFISH study, reinforcing its sustained efficacy and safety profile in children with Type 1 spinal muscular atrophy (SMA)
Sandoz, a global leader in generic pharmaceuticals and biosimilars, announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection will be available in the United States starting July 1.
Biogen Inc. announced new Spinraza (nusinersen) data aimed at answering critical questions for the spinal muscular atrophy (SMA) community. The data were presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA this week in Orlando, Fla.
Zealand Pharma A/S announced the submission of a NDA to the FDA for dasiglucagon for the prevention and treatment of low blood sugar (hypoglycemia) in pediatric patients 7 days of age or older with congenital hyperinsulinism.
Horizon Therapeutics plc announced the presentation of a new analysis of MRI data from the Phase III clinical trial of Uplizna showing a reduction in the formation of subclinical (asymptomatic) transverse myelitis lesions in people with NMOSD.
Astellas Pharma Inc. announced positive topline results from the Phase IIIb DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause . VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.
Ipsen announced hat the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP).
Novartis announced that it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up to $2.5 billion, including $1.75 billion in upfront cash, plus additional milestone payments.
