ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV1 and further decreased sweat chloride compared to TRIKAFTA® BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug...Read more
Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with...Read more
CRENESSITY, a First-in-Class Treatment for Classic Congenital Adrenal Hyperplasia (CAH), is now commercially available in the U.S. CAH-trained pharmacists are available 24/7 to support patients with prescriptions exclusively through PANTHERx Rare, a specialty pharmacy Neurocrine Access Support is available to provide free, comprehensive access and support information to patients, caregivers and healthcare providers SAN DIEGO, Dec....Read more
RAHWAY, N.J. / Dec 20, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the closing of the exclusive global license agreement for LM-299, a novel investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd. As previously announced, Merck will develop, manufacture and commercialize LM-299. Merck will record a pre-tax charge relating to the upfront payment of $588...Read more
Investigational REGN7508 (catalytic domain) and REGN9933 (A2 domain) are being evaluated for their potential to control thrombosis while minimizing bleeding risk in a variety of patient populations and clinical settings Evaluated against current standards of care, single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects Phase 3 program to be initiated in...Read more
Trials met efficacy success criteria for non-inferiority of DOR/ISL to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 Safety profiles were generally comparable between DOR/ISL and other therapies in these trials RAHWAY, N.J. / Dec 19, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from two pivotal Phase 3 trials of the...Read more
Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) Placebo arm showed similar within-group reduction in NPRS Suzetrigine was generally well tolerated Advancement to Phase 3 in painful lumbosacral radiculopathy planned,...Read more
PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints Prasinezumab continues to be well tolerated and no new safety signals were observed Genentech is further evaluating the data and will work together with health authorities to determine next steps SOUTH SAN FRANCISCO, Calif. / Dec 19, 2024 / Business Wire / Genentech, a member of the Roche...Read more
RAHWAY, N.J. / Dec 18, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, today announced that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. “We continue to leverage science-driven business development to augment and complement our robust...Read more
The agreement is a critical step in ensuring paediatric patients living with NF1 PN have public access to Koselugo, the only approved therapy in Canada for this rare disease MISSISSAUGA, ON, Dec. 18, 2024 /CNW/ - Alexion Pharma Canada Corp., AstraZeneca's Rare Disease group, has entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for Koselugo for the treatment of paediatric...Read more
Sarepta anticipates filing for accelerated approval of SRP-9003 in 2025 CAMBRIDGE, Mass. / Dec 18, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that enrollment and dosing is complete in EMERGENE (Study SRP-9003-301), a Phase 3 clinical trial of SRP-9003 (bidridistrogene xeboparvovec). SRP-9003 is an investigational gene therapy for the...Read more
Biomarker data from CARE study characterizing cenerimod's mechanism of action in systemic lupus erythematosus also published in the Annals of the Rheumatic Diseases PITTSBURGH, Dec. 18, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today announced the publication of Phase 2b CARE study results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE). The...Read more
Full-Year 2025 Revenue Guidance(1) Range of $61.0 to $64.0 Billion Full-Year 2025 Adjusted(2) Diluted EPS Guidance Range of $2.80 to $3.00 Expect Full-Year 2025 Adjusted(2) Diluted EPS Operational(3) Growth of 10% to 18% from the Midpoint of 2024 Guidance After Adjusting for 2024 Non-Recurring Items(4) Achieved Goal of $4.0 Billion in Net Cost Savings Through 2024 and Anticipate an Additional $500 Million in Savings in 2025 from...Read more
China is the fourth major market where Kisunla has received approval Kisunla was first approved in the United States in July 2024, approved in Japan in September 2024 and then in Great Britain in October 2024 INDIANAPOLIS, Dec. 17, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the National Medical Products Administration (NMPA) in China has approved Kisunla™...Read more
FOSTER CITY, Calif. / Dec 17, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. The Breakthrough Therapy Designation is...Read more
Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibody Sanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions PARSIPPANY, N.J. and PARIS, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S....Read more
The first living recipient of a UKidney™ is recovering after a successful transplant This transplant builds on two successful UHeart™ transplants completed in 2022 and 2023 and a successful UThymoKidney™ transplant in 2024 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Dec 17, 2024 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the world’s first transplant of a...Read more
Gilead and Terray Will Leverage Terray’s tNova Drug Discovery Platform to Identify Small Molecule Therapeutics Against Targets of Interest Gilead Has Exclusive Option to Develop and Commercialize Products from the Collaboration FOSTER CITY, Calif. & LOS ANGELES / Dec 17, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Terray Therapeutics, Inc. announced today that the companies have entered into a...Read more
EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025 TARRYTOWN, N.Y., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Regeneron...Read more
If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the U.S. in time for the 2025-26 season RAHWAY, N.J. / Dec 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational...Read more
This milestone stems from the companies' collaboration to expand access to affordable insulin to one million people living with diabetes in low- to middle-income countries annually by 2030 INDIANAPOLIS and CAIRO, Dec. 17, 2024 /PRNewswire/ -- The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022,...Read more
RAHWAY, N.J. / Dec 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. Vibostolimab is being evaluated as an investigational fixed-dose combination with pembrolizumab (KEYTRUDA®) in the KeyVibe program. Favezelimab is being evaluated as an...Read more
Bagsværd, Denmark, 16 December 2024 – Today, Novo Nordisk announced plans to invest 8.5 billion Danish kroner to establish a completely new production facility in Odense, Denmark. The investment marks the first time in this century that Novo Nordisk breaks ground in Denmark by establishing a new production site. The new site will feature a state-of-the-art finished production facility and warehouse spanning over 40,000 m2....Read more
This approval marks the fourth non-small cell lung cancer (NSCLC) indication and the first indication in earlier stages of NSCLC for KEYTRUDA in China RAHWAY, N.J. / Dec 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with...Read more
Transaction Expected to Close in the Coming Days SOMERSET, N.J. & COPENHAGEN, Denmark / Dec 14, 2024 / Business Wire / Catalent, Inc. (“Catalent,” NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings A/S (“Novo Holdings”), a global life sciences investment firm, today announced that the companies have fulfilled all regulatory closing conditions for their pending...Read more
CRENESSITY, the first new treatment available in 70 years to the classic congenital adrenal hyperplasia (CAH) community, offers a paradigm-shifting treatment approach FDA approval supported by data from the largest-ever clinical trial program in pediatric and adult patients with classic CAH CRENESSITY is expected to be commercially available in approximately one week Rare Pediatric Disease Priority Review Voucher granted in...Read more
Proposed acquisition adds Nimble's lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for psoriasis, and a pipeline of other novel oral peptide assets across autoimmune diseases where significant unmet needs remain Acquisition also allows AbbVie to utilize Nimble's proprietary peptide synthesis platform to enable the discovery and optimization of oral peptide therapeutics NORTH CHICAGO, Ill. and...Read more
The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without prior biologic failure and was the basis for the positive opinion VIVID-1 was the first pivotal Crohn's disease trial to show benefits in hard-to-treat symptom of bowel urgency using a patient-centric scale Omvoh will be the first treatment for Crohn's disease with results demonstrating improvements of histologic measures of...Read more
If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor available for these patients in the European Union Positive opinion granted based on data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial RAHWAY, N.J. / Dec 13, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines...Read more
Recommendation Based on the RESPONSE Study Which Demonstrated ALP Normalization in 25% of Participants at 12 Months and Statistically Significant Reduction of Pruritus Versus Placebo If Approved by the European Commission, Seladelpar Would Provide an Important Treatment Option for People Living with the Rare Liver Disease in the EU FOSTER CITY, Calif. / Dec 13, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today...Read more
SAN MATEO, Calif. / Dec 12, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it has entered into a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. (“CSPC”) for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid...Read more
Bagsværd, Denmark, 12 December 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events,...Read more
IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy NEW YORK / Dec 12, 2024 / Business Wire / Pfizer Inc. (NYSE:PFE) and Alliance Foundation Trials, LLC (AFT) today announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE® (palbociclib) to current standard-of-care first-line...Read more
MINNEAPOLIS, Dec. 12, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities today announced a partnership with MedSanTek. Under the agreement, MedSanTek becomes the distributor of Bio-Techne's R&D Systems, Novus, Tocris, Protein Simple, Advanced Cell Diagnostics (ACD), and Asuragen brands across...Read more
87.5% of patients treated with LYNPARZA were alive at six years vs. 83.2% in the comparator arm First and only PARP inhibitor to improve survival in early breast cancer WILMINGTON, Del. / Dec 11, 2024 / Business Wire / Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA® (olaparib) demonstrated sustained, clinically meaningful improvements...Read more
As monotherapy, imlunestrant significantly reduced the risk of progression or death by 38% compared to standard endocrine therapy (ET) in patients with ESR1 mutations As combination therapy, imlunestrant plus Verzenio significantly reduced the risk of progression or death by 43%, compared to imlunestrant alone, in all patients, regardless of ESR1 mutation status These data were published simultaneously in the New...Read more
The pivotal Phase 3 inMIND trial met its primary endpoint of progression-free survival (PFS) and key secondary endpoints in patients with relapsed or refractory follicular lymphoma (FL) treated with tafasitamab (Monjuvi®) in combination with lenalidomide and rituximab Positive data featured in a late-breaking oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting support the planned U.S. filing of a...Read more
5-year follow-up from SEQUOIA study demonstrated treatment with BRUKINSA reduced the risk of progression or death by 71% compared to bendamustine-rituximab in patients with treatment-naïve CLL, further solidifying its position as the leader in new patient starts in both frontline and relapsed/refractory (R/R) CLL with the broadest label of any BTK inhibitor At a median follow-up of 1.5 years, promising data from the 320 mg expansion...Read more
Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration...Read more
89 percent of patients evaluable for MRD assessment were MRD negative, with the majority reaching MRD negativity in less than 2 months Results add to the overall survival (OS) benefits recently presented, as the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma SAN DIEGO, Dec. 9, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today new results from the...Read more
Results from BRUIN CLL-321 show Lilly's pirtobrutinib reduced the risk of disease progression or death by 46% compared to idelalisib plus rituximab or bendamustine plus rituximab Pirtobrutinib prolonged the time to next treatment or death by a median of 23.9 months compared to 10.9 months in the control arm BRUIN CLL-321 is the first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK...Read more
ZUMA-5 Analysis Shows Median Progression-Free Survival of 62.2 Months and Median Duration of Response of 60.4 Months After Median Follow-Up of More Than Five Years Over Half of Patients Alive at Time of Analysis, with No Need for Subsequent Therapy and Rare Instances of Late Disease Progression, Indicating Curative Potential SANTA MONICA, Calif. / Dec 09, 2024 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced...Read more
DREAMM-7 trial shows sustained overall survival benefit for belantamab mafodotin combination versus daratumumab combination; benefit seen early and maintained through follow-up Data build on findings from DREAMM-7 and DREAMM-8 and support the potential for belantamab mafodotin combinations to become standard of care Belantamab mafodotin combinations are under regulatory review in seven major markets PHILADELPHIA / Dec 09, 2024 /...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-2 flexible-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 261 Trial also met its key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score at week 261 Positive results across all three Phase 3 TEMPO...Read more
First Breakthrough Therapy Designation for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan Based on TROPION-Lung05 Phase II trial and supported by data from TROPION-Lung01 Phase III trial WILMINGTON, Del. / Dec 09, 2024 / Business Wire / Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth...Read more
KEYTRUDA® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone The study did not reach its secondary endpoint of overall survival RAHWAY, N.J. / Dec 09, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...Read more
Results from Arm 1 of the EPCORE® NHL-2 trial show treatment with epcoritamab combination led to an overall response rate (ORR) of 100 percent and a complete response (CR) rate of 87 percent in high-risk patients with previously untreated diffuse large B-cell lymphoma (DLBCL) Extended follow-up data from EPCORE® NHL-1 trial demonstrates durability of responses and long-term safety of epcoritamab monotherapy for patients with...Read more
Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL) at the 66th Annual Meeting and Exposition of...Read more
New analysis from Phase 3 CEPHEUS study demonstrates 85 percent of patients who achieved MRD negativity (10-6) with DARZALEX FASPRO® were progression free at 4.5 years Subgroup analysis from Phase 3 AURIGA study show higher rates of MRD-negative conversion in patient populations disproportionately impacted by multiple myeloma SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data...Read more
Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate RAHWAY, N.J. / Dec 08, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s investigational antibody drug conjugate (ADC) that targets receptor...Read more
Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week key secondary endpoints1 Scemblix showed a clinically relevant 15.1% higher MMR rate vs. second generation (2G) TKIs (72.0% vs. 56.9%)1 96-week data extend favorable safety and tolerability profile for Scemblix vs. imatinib and 2G TKIs, with...Read more
Data from long-term follow-up of patients in clinical trials further demonstrate durability of the transformative benefits of CASGEVY™ Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant Vertex provides update on progress in bringing CASGEVY to patients BOSTON / Dec 08, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced longer-term data for...Read more
100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance...Read more
Exploratory long-term follow-up analysis of the Phase III POLARIX study indicated a positive trend in overall survival in favor of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL) Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems These encouraging five-year results continue to...Read more
First and only subcutaneous anti-CD38 therapy demonstrating potential to prevent end-organ damage, and extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from the Phase 3 AQUILA study showing that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly delayed progression from...Read more
CALQUENCE plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 58% versus standard of care in this setting CALQUENCE plus venetoclax poised to become first all-oral fixed-duration regimen of a second-generation BTK inhibitor plus venetoclax in 1st-line CLL WILMINGTON, Del. / Dec 08, 2024 / Business Wire / Positive results from the AMPLIFY Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib)...Read more
COPENHAGEN, Denmark / Dec 08, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): Preliminary analyses from the EPCORE® CLL-1 trial demonstrates overall response rate (ORR) of 61 percent and complete response (CR) rate of 39 percent in heavily pretreated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) who received epcoritamab monotherapy In the study, 75 percent of evaluable responders achieved undetectable...Read more
Largest Real-World Evidence (RWE) Analysis of Yescarta in Second-Line Shows 71% Overall Survival Rate, Consistent with Pivotal ZUMA-7 Study, in Broader Patient Population with Relapsed/Refractory Large B-cell Lymphoma (R/R LBCL) RWE Shows Decreasing Trend Over Time of Cytokine Release Syndrome and Related Adverse Events After Yescarta Treatment in Third-Line Plus Setting Findings from ALYCANTE Study Show Stable Long-Term Quality of Life...Read more
Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 7, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with...Read more
COPENHAGEN, Denmark / Dec 07, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): Results show 96 percent overall response rate (ORR), 87 percent complete response (CR), and 80 percent 21-month progression-free survival (PFS) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) following treatment with epcoritamab plus lenalidomide + rituximab (R2) Long-term follow-up results demonstrated strong and durable efficacy,...Read more
Head-to-head exploratory cohort of a Phase 3 trial showed first-in-class poze-cemdi combination treatment helped patients achieve and maintain greater disease control, as measured by lactate dehydrogenase (LDH) levels, compared to standard-of-care ravulizumab Five patients receiving ravulizumab did not achieve meaningful LDH control compared to one patient receiving poze-cemdi; after switching to the combination, four of the five...Read more
Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif., Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of...Read more
Phase 3 POD1UM-304 trial met primary endpoint of overall survival (OS) and all secondary endpoints in patients with previously untreated metastatic non-small cell lung cancer (NSCLC) Data presented at the European Society for Medical Oncology (ESMO) Asia Congress 2024 support the planned 2025 filing of a supplemental Biologics License Application (sBLA) in the U.S. for retifanlimab in NSCLC WILMINGTON, Del. / Dec 07, 2024 / Business...Read more
Transaction Expected to Close Towards the End of Calendar Year 2024 SOMERSET, N.J. & COPENHAGEN, Denmark / Dec 06, 2024 / Business Wire / Catalent, Inc. (“Catalent,” NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings A/S (“Novo Holdings”), a global life sciences investment firm, today announced that the European Commission (EC) has granted unconditional...Read more
Decision based on NIAGARA Phase III trial results which demonstrated a statistically significant and clinically meaningful event-free and overall survival benefit If approved, this will be the first and only perioperative immunotherapy regimen in this curative-intent setting WILMINGTON, Del. / Dec 06, 2024 / Business Wire / AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) has been accepted and...Read more
The investment will benefit millions of patients worldwide, boosting the production of the company's medicines, including those for diabetes and obesity INDIANAPOLIS, Dec. 5, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced a $3 billion expansion of the Kenosha County, Wisconsin, manufacturing facility that the company acquired earlier this year. This investment will extend the company's global parenteral...Read more
Investment Establishes Second Facility in Holly Springs; Builds on Previous $550M Commitment THOUSAND OAKS, Calif., Dec. 5, 2024 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced a $1 billion expansion to establish a second drug substance manufacturing facility in North Carolina. This brings the company's total planned investment in Holly Springs to more than $1.5 billion, building on its previously announced $550 million...Read more
Based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo WILMINGTON, Del. / Dec 05, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted...Read more
MOVe-NOW will build on existing LAGEVRIO data to assess efficacy in the current COVID-19 environment and support applications for licensure RAHWAY, N.J. & MIAMI / Dec 05, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for...Read more
Application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression Improving survival outcomes is needed for...Read more
TOKYO and CAMBRIDGE, Mass., Dec. 4, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody...Read more
Participants using Zepbound lost 50.3 lbs (22.8 kg) and participants on Wegovy lost 33.1 lbs (15.0 kg) SURMOUNT-5 compared Zepbound, a dual GIP and GLP-1 receptor agonist, to Wegovy, a mono GLP-1 receptor agonist in adults living with obesity without diabetes INDIANAPOLIS, Dec. 4, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the SURMOUNT-5 phase 3b open-label randomized...Read more
About 50% of patients with CLL/SLL have high-risk molecular features limiting effectiveness of certain treatments; a blood test can identify these features and help guide which therapy is most likely to be efficacious Campaign highlights national treatment guidelines supporting targeted therapies rather than chemotherapy for improved CLL outcomes BeiGene and CLL Society launch partnership during the American Society of Hematology (ASH)...Read more
AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in pediatric patients aged 6-17 years1 Efficacy consistent with fremanezumab pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed Full data presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam,...Read more
Elritercept is a late-stage, potentially best-in-class activin inhibitor designed to treat anemia associated with certain hematologic cancers, including myelodysplastic syndromes and myelofibrosis Takeda to receive exclusive global license in all territories outside of mainland China, Hong Kong and Macau Transaction builds upon Takeda’s legacy in the treatment of hematologic cancers and advances company’s global oncology...Read more
Single-Asset Focused Collaboration, License, and Option Agreement Combines Tubulis’ Differentiated ADC Platform Technologies with Gilead’s Oncology Research and Development Expertise Agreement Provides Gilead with Exclusive Option to License the Resulting ADC Program for Further Development FOSTER CITY, Calif & MUNICH / Dec 03, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Tubulis today announced that...Read more
First breakthrough therapy designation for investigational sac-TMT in the U.S. RAHWAY, N.J. / Dec 03, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung...Read more
Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis SPRING HOUSE, Pa., Dec. 2, 2024 /PRNewswire/ -- Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older...Read more
TOKYO and CAMBRIDGE, Mass., Nov. 27, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" has been launched in South Korea. LEQEMBI received the Ministry of Food and Drug...Read more
FOSTER CITY, Calif. / Nov 27, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine (NEJM) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. The study found that twice-yearly...Read more
New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients treated with TEVIMBRA in combination with chemotherapy SAN MATEO, Calif. / Nov 27, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines, today announced that the European Commission has approved TEVIMBRA®...Read more
MariTide Demonstrated up to ~20% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau in People Living With Obesity or Overweight MariTide is the First Obesity Treatment With Monthly or Less Frequent Dosing to Demonstrate Safe and Effective Weight Loss in a Phase 2 Study In People With Type 2 Diabetes Living With Obesity or Overweight MariTide Demonstrated up to ~17% Average Weight Loss Without a Weight Loss Plateau and...Read more
Sarepta obtains exclusive worldwide licenses to four clinical-stage and three preclinical-stage programs in muscle, central nervous system, and rare pulmonary disorders, including potential best-in-class siRNA-based treatments for DM1 and FSHD Additionally, Arrowhead and Sarepta have entered into a discovery partnership pursuant to which Sarepta will nominate, and Arrowhead will deliver, IND-ready constructs for six targets across...Read more
Acquisition supports Roche’s Pharma Strategy and allows for a range of potentially first and best-in-class therapies across oncology, immunology, and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapies Roche to acquire Poseida Therapeutics for US $9.00 per share in cash at closing, representing a total equity value of approximately US $1.0 billion Stockholders would also receive a...Read more
SOUTH SAN FRANCISCO, Calif. / Nov 26, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study...Read more
WEST SACRAMENTO, Calif., Nov. 25, 2024 /PRNewswire/ -- Gemini Bioproducts, LLC ("GeminiBio"), a leading supplier of cell culture reagents and process liquids, and a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida-based healthcare private equity firm, today announced the acquisition of selected fetal bovine serum (FBS) product rights and inventory from Bio-Techne (NASDAQ: TECH). GeminiBio has a 39-year...Read more
First and only AKT inhibitor combination to demonstrate benefit in this specific subtype of prostate cancer WILMINGTON, Del. / Nov 25, 2024 / Business Wire / Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s TRUQAP® (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary...Read more
Prescription Drug User Fee Act (PDUFA) Date Set for March 23, 2025 CAMBRIDGE, Mass. / Nov 25, 2024 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental New Drug Application (sNDA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of...Read more
WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality Study to be stopped early and participants will be offered the opportunity to receive WINREVAIR Second positive phase 3 trial adds to growing body of evidence for WINREVAIR, an activin signaling inhibitor therapy that targets an...Read more
The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA. There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis. This approval represents a new indication for Roche's existing PATHWAY HER2 (4B5) test and expands its...Read more
| Company | Change | Last Trade |
|---|---|---|
| Eli Lilly | 10.15 1.34 | $767.69 |
| Alnylam Pharmaceuticals | 6.57 2.75 | $245.44 |
| Amgen | 2.19 0.84 | $263.38 |
| BeiGene | 1.78 1.02 | $176.50 |
| Incyte | 1.78 2.65 | $68.84 |
| Bio-Techne | 1.78 2.49 | $73.17 |
| BioNTech | 1.74 1.56 | $113.08 |
| Gilead Sciences | 1.48 1.62 | $92.57 |
| Insmed | 1.03 1.48 | $70.44 |
| Bristol-Myers Squibb | 1.03 1.83 | $57.33 |
| AstraZeneca | 0.91 1.41 | $65.35 |
| Johnson & Johnson | 0.89 0.62 | $144.47 |
| Teva Pharmaceutical | 0.78 3.66 | $22.09 |
| BioMarin Pharmaceutical | 0.66 1.02 | $65.66 |
| Royalty Pharma | 0.64 2.64 | $24.92 |
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets...
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Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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