Daiichi Sankyo and Merck’s patritumab deruxtecan demonstrates a statistically significant progression-free survival improvement in this EGFR-mutated non-small cell lung cancer population with high unmet need following prior EGFR TKI treatment Discussions with global regulatory authorities to be initiated BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 17, 2024 / Business Wire / The HERTHENA-Lung02 phase 3 trial evaluating patritumab...Read more
Company planning for every eligible baby in the US to have access to BEYFORTUS New BEYFORTUS filling line approved by the U.S. Food and Drug Administration (FDA) to expand manufacturing capacity and help meet demand 2 out of 3 babies get respiratory syncytial virus (RSV) disease1 BRIDGEWATER, N.J., Sept. 16, 2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private...Read more
Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, Del. / Sep 16, 2024 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not...Read more
ST. PAUL, Minn., Sept. 16, 2024 /PRNewswire/ -- ScaleReady and Bio-Techne Corporation (NASDAQ: TECH) today announced the launch of the G-Rex optimized ProPakTM GMP Cytokines, ideally tailored to high efficiency closed system cell and gene-modified cell therapy (CGT) manufacturing. The ProPakTM GMP Cytokine product consists of a weldable bag filled with liquid formulated GMP-grade cytokines, specifically interleukin-7 (IL-7) or...Read more
TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the...Read more
Vatroslav Mateljic's innovative approach and commitment to transforming the lives of patients will strengthen Takeda's leadership position in the Canadian biopharmaceutical sector TORONTO, Sept. 16, 2024 /CNW/ - Takeda Canada Inc. ("Takeda Canada") is pleased to announce the appointment of Vatroslav (Vatro) Mateljic as its new General Manager to lead the Canadian operations of Japan's largest pharmaceutical...Read more
Veteran biopharmaceutical executive from GSK and Eli Lilly brings more than 30 years of experience to Sarepta’s Board CAMBRIDGE, Mass. / Sep 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointment of Deirdre P. Connelly to its Board of Directors. Ms. Connelly is a well-regarded executive with more than 30 years of experience in the...Read more
Late-breaking results selected for presentation during a Presidential Symposium session and an official Press Briefing at the European Society for Medical Oncology Congress 2024 and simultaneous publication in the New England Journal of Medicine KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival as pre-operative (neoadjuvant) treatment...Read more
These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial; data selected for official ESMO press conference At ten years, more than 40% (43%) of patients treated with Opdivo plus Yervoy were alive; a decade ago, this patient population faced a survival rate of around 25% after only one year Data to be presented today as a mini oral and simultaneously published in The New England Journal of...Read more
Treatment with rinatabart sesutecan (Rina-S) showed encouraging response rate in heavily pretreated patients with ovarian cancer in dose expansion cohort Responses with Rina-S were observed across FRα expression levels Phase 3 trial will further evaluate the safety and efficacy of Rina-S at 120 mg/m2 in patients with advanced ovarian cancer COPENHAGEN, Denmark / Sep 15, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today...Read more
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab RAHWAY, N.J. / Sep 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA® (pembrolizumab), Merck’s...Read more
Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive BARCELONA, Spain, Sept. 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200...Read more
Study met primary endpoint of change from baseline in body weight for ponsegromab compared to placebo across all ponsegromab doses tested, reaching 5.6% mean increase at the highest dose evaluated at 12 weeks; ponsegromab was generally considered safe and well-tolerated at all dose levelsi At the highest dose evaluated, improvements were seen from baseline in appetite and cachexia symptoms, physical activity, and muscle massi Based on...Read more
In the Phase 3 LEAP-012 trial, KEYTRUDA plus LENVIMA in combination with TACE reduced the risk of disease progression or death by 34% compared to TACE alone Late-breaking first interim analysis results are being presented during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 RAHWAY, N.J. & NUTLEY, N.J. / Sep 14, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
Phase 3 POD1UM-303/InterAACT2 trial met primary endpoint of progression-free survival and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) taking retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) Late-breaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024 support the planned U.S. filing of a supplemental...Read more
KEYNOTE-A18 is the first Phase 3 study of an immunotherapy in combination with CRT to demonstrate a statistically significant and clinically meaningful improvement in overall survival versus CRT alone in these patients Results were selected for the official press briefing and presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 and published simultaneously in The...Read more
KEYTRUDA is the first anti-PD-1/L1 therapy in combination with trastuzumab and chemotherapy to demonstrate a statistically significant improvement in OS in this patient population Results from the final analysis of KEYNOTE-811 are being presented during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2024 and published simultaneously in the New England Journal of Medicine In the U.S., KEYTRUDA, in...Read more
Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease New results show potential of RYBREVANT® beyond lung cancer BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI)...Read more
Post-progression outcomes showed significant and sustained improvement for RYBREVANT® plus standard of care versus chemotherapy alone BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with...Read more
BRAFTOVI + MEKTOVI continued to show substantial antitumor activity after a minimum follow up of approximately three years, corresponding to the longest duration of response and progression-free survival in treatment-naïve patients compared to historical outcomes Results support BRAFTOVI + MEKTOVI as a standard of care option for this population NEW YORK / Sep 14, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced...Read more
New antitumor response data from a range of doses and regimens unveiled today at Incyte investor event These results build upon safety and tolerability data presented earlier today during a mini-oral presentation at the European Society of Medical Oncology (ESMO) Congress 2024 Findings support the initiation of a pivotal trial in ovarian cancer, expected to begin in 2025; additional plans to evaluate INCB123667 in combination with other...Read more
EBGLYSS provides a new first-line biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topicals Patients treated with EBGLYSS experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks EBGLYSS delivers long-lasting efficacy for patients through one year of treatment with a monthly maintenance dose INDIANAPOLIS, Sept. 13, 2024 /PRNewswire/ --...Read more
Ocrevus Zunovo™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor's office This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally Ocrevus Zunovo™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs SOUTH SAN FRANCISCO, Calif. / Sep...Read more
Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron...Read more
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq New subcutaneous (SC) option reduces treatment time to approximately 7 minutes, compared with 30-60 minutes for IV infusion SOUTH SAN FRANCISCO, Calif. / Sep 12, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced...Read more
Second Phase 2 Study for Luvadaxistat Fails to Meet Primary Endpoint as Potential Treatment for Cognitive Impairment Associated with Schizophrenia Results Confounded by Variability in Cognition Measures Across Population Studied and Potential Imbalance in Baseline Characteristics of Enrolled Subjects Neurocrine Biosciences to Focus Resources on Phase 3 Clinical Development of NBI-1117568 for Schizophrenia and NBI-1065845 for Major...Read more
99.9% of Participants Did Not Acquire HIV Infection in the Lenacapavir Group, with 2 Incident Cases Among 2,180 Participants PURPOSE 2 Trial Results for Cisgender Men and Gender-Diverse People Add to the Body of Evidence for the Investigational Use of Lenacapavir for HIV Prevention Gilead Stopped the Blinded Phase of the Trial at Interim Analysis and Will Offer Open-Label Lenacapavir to All Participants FOSTER CITY,...Read more
KIRKLAND, QC, Sept. 12, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a...Read more
Company ups manufacturing investment in Limerick by $1 billion; unveils new $800 million Kinsale facility New investment will enhance global medicine production, benefiting millions of patients worldwide INDIANAPOLIS, Sept. 12, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced a $1 billion expansion of its Limerick, Ireland, manufacturing site to increase production of biologic active ingredients,...Read more
CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- The Biogen Inc. (Nasdaq: BIIB) Board of Directors (the “Board”) today announced the appointments of two new independent directors, Lloyd B. Minor, M.D., effective October 1, 2024, and Sir Menelas (Mene) Pangalos, Ph.D., effective January 1, 2025. Dr. Minor is currently the Dean of the Stanford University School of Medicine and Vice President for Medical Affairs at Stanford University,...Read more
The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5 TREMFYA® is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis HORSHAM, Pa., Sept. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ)...Read more
BOTOX® Cosmetic is the first neurotoxin approved in China for the treatment of masseter muscle prominence (MMP), the largest global market for MMP. Approval supported by well-established safety profile and robust clinical trials demonstrating BOTOX® Cosmetic is effective in reducing the prominence of the masseter muscle. Allergan Aesthetics intends to develop onabotulinumtoxinA treatment for MMP in additional global markets and expand...Read more
Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect comparison evaluates disease control of EYLEA HD and faricimab across different pivotal Phase 3 trials in wAMD TARRYTOWN, N.Y., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new...Read more
More than 10 oral and mini-oral presentations span Pfizer’s extensive Oncology portfolio of approved and investigational therapies Two late-breaking presentations include longer-term results from BRAFTOVI® + MEKTOVI® PHAROS study in BRAF V600E-mutant metastatic NSCLC and new Phase 2 ponsegromab data in cancer cachexia Encouraging early results for PD-L1 vedotin ADC, disitamab vedotin and the novel combination of CDK4 + CDK2 inhibitors...Read more
RAHWAY, N.J. / Sep 11, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years. The trial met its primary and secondary endpoints demonstrating that...Read more
Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines Data will support regulatory resubmission in the U.S. by year-end; if...Read more
Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union TARRYTOWN,...Read more
Pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous RYBREVANT®, a three-fold reduction from 67.4 percent historically seen with standard IRR management SAN DIEGO, Sept. 10, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related...Read more
Gilead and Genesis Will Leverage the GEMS AI Platform to Generate and Jointly Optimize Molecules Against Selected Targets Gilead Receives Exclusive Rights to Develop and Commercialize Products from the Collaboration FOSTER CITY, Calif. & BURLINGAME, Calif. / Sep 10, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic...Read more
CONSTELLA is the first and only Health Canada-approved prescription therapy for functional constipation in this patient population Submission is based on positive Phase 3 study data demonstrating linaclotide (72mcg) resulted in increases in frequency of spontaneous bowel movements (SBM) in children and adolescents aged 6 to 17 years MONTREAL, Sept. 10, 2024 /CNW/ - AbbVie (NYSE: ABBV), today announced that Health Canada has approved...Read more
Late-breaking data at WCLC show Libtayo monotherapy nearly doubled median overall survival and reduced the risks of death and disease progression by 41% and 50%, respectively, compared to chemotherapy WCLC presentation also reviews data on overall survival, progression-free survival and response rate among patients who added chemotherapy to Libtayo following disease progression TARRYTOWN, N.Y., Sept. 09, 2024 (GLOBE NEWSWIRE) --...Read more
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population Presidential Symposium for NeoCOAST-2 demonstrates potential for datopotamab deruxtecan plus IMFINZI® (durvalumab) and chemotherapy in neoadjuvant early-stage non-small cell lung cancer WILMINGTON, Del. / Sep 09, 2024 / Business...Read more
DeLLphi-303 Study Results Show Potential for IMDELLTRA in Combination with a PD-L1 Inhibitor as First-Line Maintenance Therapy in ES-SCLC DeLLphi-301 Long-Term Follow-up Data Demonstrate Sustained Safety and Efficacy for IMDELLTRA THOUSAND OAKS, Calif., Sept. 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data showcasing IMDELLTRATM (tarlatamab-dlle), a first-in-class delta-like ligand 3...Read more
Milestone marks a significant step toward producing mRNA vaccines in Canada by 2025 CAMBRIDGE, MA / ACCESSWIRE / September 9, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that its manufacturing facility in Laval, Quebec, has been granted a Drug Establishment License (DEL) from Health Canada. This certification affirms the facility's compliance with rigorous safety and quality standards, authorizing it to produce drug substance....Read more
The Roche Digital Pathology Open Environment brings together a wide array of innovative AI-based pathology tools to help clinicians improve patient care and expand personalised healthcare. Roche is now integrating more than 20 artificial intelligence (AI) algorithms from eight new collaborators into its digital pathology open environment. AI technology helps enhance pathology with high value insights, which can benefit cancer patients...Read more
New longer-term data from the MARIPOSA study confirm superior outcomes of chemotherapy-free RYBREVANT® plus LAZCLUZE™ regimen compared to osimertinib monotherapy as first-line therapy Results from an interim analysis featured in late-breaker oral presentation at WCLC SAN DIEGO, Sept. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced longer follow-up data from the landmark Phase 3 MARIPOSA study which...Read more
AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan demonstrated meaningfully greater magnitude of progression-free survival benefit in patients with this biomarker AstraZeneca and Roche Tissue Diagnostics are collaborating to co-develop and commercialize the TROP2-QCS biomarker companion diagnostic WILMINGTON, Del. / Sep 08, 2024 / Business Wire / Results from an exploratory analysis of the TROPION-Lung01 Phase III trial showed...Read more
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients 12 mg/kg selected as optimal dose for extension part of IDeate-Lung01 phase 2 trial and recently initiated IDeate-Lung02 phase 3 study BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2024 / Business Wire / Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2...Read more
Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European Commission authorization decision CAMBRIDGE, MA / ACCESSWIRE / September 5, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of...Read more
Approved indications include the treatment of adult patients with von Hippel-Lindau (VHL) disease for associated non-metastatic renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or non-metastatic pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery KIRKLAND, QC, Sept. 5, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that it has...Read more
In the phase 3 study, QWINT-1, efsitora was administered via four fixed doses once weekly in a single-use autoinjector in people with type 2 diabetes using basal insulin for the first time In a second phase 3 study, QWINT-3, efsitora also delivered non-inferior A1C reduction compared to daily insulin in people with type 2 diabetes switching from daily basal injections INDIANAPOLIS, Sept. 5, 2024 /PRNewswire/ -- Eli Lilly and Company...Read more
KIRKLAND, QC, Sept. 4, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that WINREVAIR® (sotatercept) is now authorized for use in Canada in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III. Sotatercept is the first activin signaling inhibitor therapy...Read more
VRAYLAR, an atypical antipsychotic medication, received its Notice of Compliance from Health Canada on April 22, 2022. Following the positive recommendation from INESSS issued in October 2022, VRAYLAR completed negotiations at pCPA and has an active letter of intent (LOI). Québec and the federal plans (NIHB, CSC and VAC) have subsequently listed VRAYLAR, for the treatment of schizophrenia, as a result of this completed negotiation and...Read more
Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational dose regimen Higher dose nusinersen regimen showed statistically significant improvement compared to a prespecified matched sham control group Among key measures of clinical efficacy, higher dose regimen showed positive trends compared to...Read more
RAHWAY, N.J. / Sep 04, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent,...Read more
Lilly will license certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply treatment for various immunological diseases across 49 low- to middle-income countries in Africa INDIANAPOLIS and CAIRO, Sept. 4, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and EVA Pharma announced today that the companies have entered into an agreement to expand access to baricitinib to an estimated...Read more
NEW YORK and COPENHAGEN, Denmark, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Ascendis Pharma A/S (Nasdaq: ASND) today announced that Royalty Pharma and Ascendis Pharma Bone Diseases A/S, a wholly-owned subsidiary of Ascendis Pharma A/S, has entered into a $150 million capped synthetic royalty funding agreement based on U.S. net sales of Yorvipath. “We are pleased to again partner with Royalty Pharma, a...Read more
VLA15-221 Phase 2 study: strong immune response shown one month after a second booster dose (month 31) in pediatric and adult populations Significant anamnestic antibody response observed across all six serotypes, consistent with previous results Favorable safety profile of VLA15 observed in all age groups and for all vaccinations Saint-Herblain (France) and New York, NY, September 3, 2024 – Valneva SE (Nasdaq: VALN;...Read more
Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines At present, the JN.1 group of subvariants remain dominant in the UK The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today...Read more
Approval of KEYTRUDA plus enfortumab vedotin brings a potential new first-line standard of care to these patients in the European Union RAHWAY, N.J. / Sep 03, 2024 / 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® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an...Read more
CAMBRIDGE, MA / ACCESSWIRE / September 2, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Taiwan Food & Drug Administration (FDA) has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1., for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. In April 2024, the World Health Organization (WHO) Technical Advisory...Read more
Cumulative analysis of data up to 3.5 years from EXPLORER-LTE showed consistent and sustained improvements in echocardiographic measures and symptoms, with no new safety signals observed CAMZYOS is the first and only approved cardiac myosin inhibitor that targets the source of symptomatic obstructive hypertrophic cardiomyopathy PRINCETON, N.J. / Sep 01, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced new...Read more
In the Overall Population, Achieved 28% Reduction in Primary Composite of All-Cause Mortality and Recurrent Cardiovascular Events, and 31% and 36% Reductions in All-Cause Mortality During the 33-36-Month Double-Blind Period and up to Month 42, Respectively In the Monotherapy Population, Reduced Composite Primary Endpoint by 33% and All-Cause Mortality up to Month 42 by 35% Strong Trends of Additive Efficacy on Top of Tafamidis Across...Read more
Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ SPRING HOUSE, Pa., Aug. 29, 2024...Read more
Q4'24 net revenue of $1.30 billion increased 23% as reported, or 24% in constant currency, compared to Q4'23. Organic, constant-currency net revenue increased 24%, compared to Q4'23. Q4'24 net revenue, excluding COVID-related revenue of ~$70 million in Q4’23 and ~$30 million in Q4’24, increased 29% compared to Q4'23. Fiscal 2024 net revenue of $4.38 billion increased 3% as reported, or 2% in constant currency, compared to fiscal...Read more
RAHWAY, N.J. / Aug 29, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630. Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II (stage IIB N0, M0)...Read more
The Once-Daily 20 mg Dose Met the Primary Endpoint, Demonstrating a Statistically Significant 7.5-Point Improvement (p=0.011, 0.61 Effect Size) in the PANSS Total Score Compared to Placebo at Week 6 with an 18.2-Point PANSS Total Score Improvement from Baseline The Once-Daily 20 mg Dose Met Additional Endpoints, Demonstrating Statistically Significant Improvements in Clinical Global Impression of Severity Scale and Marder Factor Score...Read more
Novartis secures exclusive global rights across multiple biologic targets to Lindy Biosciences' microglassification technology Collaboration aims to enable high-concentration self-administered drug treatments, improving patient outcomes and compliance Lindy Biosciences to receive an upfront payment of US$20 million and eligible to receive up to US$934 million in milestone payments plus tiered royalties RALEIGH, N.C. / Aug 28, 2024 /...Read more
Distributed through LillyDirect®'s self-pay channel, Zepbound single-dose vials are at least 50% less than the list price of all other incretin medicines for obesity INDIANAPOLIS, Aug. 27, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced Zepbound® (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay for patients with an on-label prescription, significantly expanding the...Read more
PfizerForAll makes managing everyday health quicker and more convenient for millions of Americans Platform is designed for patients with migraine, COVID-19 or flu, and adults seeking vaccines for preventable diseases, including COVID-19, flu, RSV and pneumococcal pneumonia End-to-end offering gives people an easier way to connect with a qualified healthcare professional the same day, find and book vaccines, receive tests and medications...Read more
The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs) RAHWAY, N.J. / Aug 27, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of Shorespan-007, a pivotal Phase 3 clinical trial evaluating bomedemstat, an investigational orally available lysine-specific...Read more
SkinMedica®, by the makers of BOTOX® Cosmetic (onabotulinumtoxinA) launches the first and only product to use a proprietary complex of five forms of Hyaluronic Acid (HA) and Hydra Collagen, plus Advanced VITISENSCE® Technology for deeper hydration IRVINE, Calif., Aug. 27, 2024 /PRNewswire/ -- For 25 years, SkinMedica® has been at the forefront of science-based skincare solutions, and today, Allergan Aesthetics, an AbbVie company...Read more
Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, including in the post-CAR-T setting Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission TARRYTOWN, N.Y., Aug. 26, 2024 (GLOBE NEWSWIRE) --...Read more
WINREVAIR is the first activin signaling inhibitor therapy for PAH approved in Europe RAHWAY, N.J. / Aug 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health...Read more
Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) SAN MATEO, Calif. / Aug 26, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track...Read more
CAMBRIDGE, MA / ACCESSWIRE / August 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The marketing authorization follows the Positive Opinion from the European Medicines Agency's (EMA)...Read more
CAMBRIDGE, MA / ACCESSWIRE / August 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1. "We appreciate the Ministry of Health, Labour and Welfare approval decision for our updated COVID-19 mRNA vaccine,"...Read more
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older The KP.2 adaptation is based on FDA guidance, which stated that KP.2 is the preferred strain for COVID-19 vaccines for the US 2024-2025 fall and winter season, if feasible Shipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in...Read more
Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval CAMBRIDGE, MA / ACCESSWIRE / AUGUST 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. Emergency Use...Read more
Approval is based on the Phase 3 KEYNOTE-A39 Trial KIRKLAND, QC, Aug. 22, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with enfortumab vedotin, an antibody-drug conjugate, for the treatment of adult patients with unresectable locally advanced or metastatic...Read more
In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd....Read more
Acceptance based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of lenvatinib or sorafenib in this patient population The U.S. Food and Drug Administration assigned a target action date of April 21, 2025 PRINCETON, N.J. / Aug 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more
TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This anticipated outcome was previously disclosed during...Read more
First and Only Pill for Children and Adolescents Ages 6-17 with Moderate to Severe Plaque Psoriasis THOUSAND OAKS, Calif., Aug. 20, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced Otezla® (apremilast) is now available in the U.S. for pediatric use. Earlier this year, the U.S. Food and Drug Administration (FDA) approved Otezla for the treatment of moderate to severe plaque psoriasis in children and adolescents ages 6 and...Read more
V-Wave’s Novel and Minimally Invasive Interatrial Shunt is Designed to Treat Heart Failure and Addresses Significant Treatment Gap Device Further Strengthens Johnson & Johnson MedTech’s Position in Cardiovascular NEW BRUNSWICK, N.J. / Aug 20, 2024 / Business Wire / Johnson & Johnson1 (NYSE: JNJ) today announced that it has entered into a definitive agreement to acquire V-Wave Ltd., a privately-held company focused on...Read more
RYBREVANT® plus LAZCLUZE™ is the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib Following Priority Review, approval is based on Phase 3 MARIPOSA results showing RYBREVANT® plus LAZCLUZE™ reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine-month-longer median duration of response RARITAN, N.J., Aug. 20, 2024 /PRNewswire/ -- Johnson...Read more
176-week SURMOUNT-1 Phase 3 study in adults with pre-diabetes is the longest completed trial of tirzepatide to date Tirzepatide resulted in sustained weight loss through the treatment period, averaging a 22.9% decrease in body weight with the 15 mg dose at end of treatment Results are consistent with the combined pharmacology of GIP and GLP-1 receptor agonism INDIANAPOLIS, Aug. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
TEPKINLY (epcoritamab) is the first and only subcutaneous bispecific antibody conditionally approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of prior therapy FL is an incurable form of non-Hodgkin's lymphoma (NHL), with about 13,000 estimated cases in Western Europe alone each year1 NORTH...Read more
Company Announcement TEPKINLY is the first and only subcutaneous bispecific antibody approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy COPENHAGEN, Denmark / Aug 19, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) today announced that the European Commission (EC) has granted...Read more
Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile Breyanzi also received approval in Japan for the treatment of relapsed or refractory follicular lymphoma (FL) after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy, making it the first and only CAR T treatment approved for this...Read more
| Company | Change | Last Trade |
|---|---|---|
| Alnylam Pharmaceuticals | 2.89 1.07 | $273.26 |
| Moderna | 2.82 4.08 | $71.99 |
| BioNTech | 0.63 0.51 | $124.10 |
| Sarepta Therapeutics | 0.56 0.45 | $124.90 |
| BioMarin Pharmaceutical | 0.54 0.77 | $70.40 |
| BeiGene | 0.51 0.26 | $196.96 |
| Bio-Techne | 0.51 0.68 | $75.27 |
| Merck | 0.34 0.29 | $118.30 |
| Catalent | 0.20 0.33 | $60.36 |
| Bayer | 0.15 2.01 | $7.61 |
| Roche | 0.15 0.38 | $39.36 |
| Insmed | 0.10 0.14 | $73.33 |
| Johnson & Johnson | 0.08 0.05 | $167.07 |
| Takeda | 0.04 0.27 | $14.85 |
| Incyte | 0.02 0.03 | $66.43 |
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
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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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