Findings from Part B and Part C of the DEVOTE study support the clinical benefits of a higher dose regimen of nusinersen (50/28 mg) in both individuals previously treated and treatment-naïve to nusinersen Investigational regimen also shows more rapid slowing of neurodegeneration, as measured by neurofilament Biogen plans to submit regulatory applications around the world for approval of the nusinersen higher dose regimen CAMBRIDGE, Mass., Oct. 08, 2024 (GLOBE NEWSWIRE)... Read more
GSK’s RSV vaccine is the only RSV vaccine with efficacy and safety data available through three full seasons, including in people at increased risk Safety and reactogenicity data are consistent with previous results from the phase III program GSK will continue to provide data on longer-term follow-up to help recommending bodies determine future revaccination schedules PHILADELPHIA / Oct 08, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced new data from... Read more
Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine Anticipated decision by both agencies... Read more
KEYNOTE-689 is the first Phase 3 trial to demonstrate statistically significant and clinically meaningful improvement in EFS in the intent-to-treat population in the neoadjuvant and adjuvant setting for an anti-PD-1 therapy in earlier stages of head and neck squamous cell carcinoma RAHWAY, N.J. / Oct 08, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA®... Read more
Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a Geographically Diverse Population of Cisgender Men and Gender-Diverse People Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by End of 2024 Gilead Recently Announced Voluntary Licensing Partners to Expand Future Access in High-Incidence, Resource-Limited Countries FOSTER CITY, Calif. / Oct 07, 2024 / Business Wire / Gilead... Read more
Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis AstraZeneca’s inhaled anti-inflammatory rescue medication AIRSUPRA demonstrated significant benefit compared to albuterol WILMINGTON, Del. / Oct 07, 2024 / Business Wire / Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met the primary endpoint, demonstrating a statistically... Read more
Approval is based on the CheckMate-77T trial, in which the Opdivo-based regimen demonstrated significantly longer event-free survival compared to the chemotherapy and placebo arm; a high pathologic complete response rate was also observed1 Opdivo is the only approved PD-1 inhibitor for resectable NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen1 This milestone adds to Bristol Myers Squibb’s thoracic portfolio and highlights the... Read more
The expansion of the strategic partnership reinforces the solid foundation of the collaborative efforts that commenced in April 2024 The collaboration supports Teva's Pivot to Growth strategy and adds to the company’s biosimilar portfolio Both companies reaffirm their shared commitment to making high-quality, affordable treatments accessible to patients worldwide TEL AVIV, ISRAEL and MADRID, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International... Read more
Based on ECHO Phase III trial which demonstrated CALQUENCE combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy Submission to be reviewed under Project Orbis WILMINGTON, Del. / Oct 03, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated... Read more
Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months compared to enzalutamide LISBON, Portugal, Oct. 2, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the results of a landmark real-world, head-to-head study showing that ERLEADA® (apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic... Read more
License for Companies to Manufacture and Supply High-Quality, Low-Cost Versions of Lenacapavir for 120 Primarily Low- and Lower-Middle Income Countries Gilead Plans to Price Product at No Profit to the Company and Supply Lenacapavir Until Generic Manufacturers Fully Support Demand Agreements Also Cover Lenacapavir for HIV Treatment in Heavily Treatment-Experienced Adults with Multi-Drug Resistant HIV FOSTER CITY, Calif. / Oct 02, 2024 / Business Wire... Read more
This first-to-market launch showcases Teva’s proven strengths in complex generic formulations and enhances Teva’s strategic goal of sustaining a generic powerhouse. Octreotide acetate for injectable suspension is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. PARSIPPANY, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch... Read more
Based on DESTINY-Breast06 Phase III trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for ENHERTU If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU will be the first HER2 directed therapy and ADC for patients prior to receiving chemotherapy for metastatic breast cancer ENHERTU also granted Breakthrough Therapy Designation in the US for this patient population WILMINGTON, Del. / Oct 01, 2024 / Business... Read more
Addition of CN201, a next generation CD3xCD19 bispecific antibody with potential applications in B-cell malignancies and autoimmune diseases, broadens and fortifies Merck’s pipeline RAHWAY, N.J. / Oct 01, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment... Read more
CAMBRIDGE, MA and TAIPEI, TAIWAN / ACCESSWIRE / September 30, 2024 / Moderna, Inc. (Nasdaq:MRNA) and Cenra Healthcare, the sales and marketing arm of Cenra Inc., today announced that the companies have entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Taiwan, including Moderna's COVID-19 vaccine, Spikevax®. Under the agreement, Moderna will manufacture and distribute its mRNA respiratory vaccines. Cenra Healthcare... Read more
Results from CEPHEUS study highlight DARZALEX FASPRO® quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint RARITAN, N.J., Sept. 30, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental Biologics... Read more
KINECT®-HD2 Is the First Prospective Clinical Trial to Include Patients Taking Antipsychotic Medication in a Study Evaluating a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor for the Treatment of Huntington's Disease Chorea Findings Presented at the 2024 MDS International Congress of Parkinson's Disease and Movement Disorders® SAN DIEGO, Sept. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced interim results... Read more
The new full visual range IOL*1 delivers exceptional distance vision2 and 14% smaller readable print size vs PanOptix3 †. 93% of patients become free from glasses at all distances.#4 ‡ TECNIS Odyssey IOL offers higher tolerance to residual refractive errors, enabling surgeons to deliver consistent and reliable patient outcomes.5¶ JACKSONVILLE, Fla., Sept. 30, 2024 /PRNewswire/ -- Johnson & Johnson§, a global leader in eye health, has announced... Read more
CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first participant in the U.S. has been dosed in the Nova 301 Trial, a pivotal Phase 3 randomized clinical trial evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403. Global recruitment for the Nova 301 trial has also begun. "Norovirus is a significant public health concern that affects millions of people worldwide each... Read more
After 25 years of the Viagra® brand in Canada, Viagra ODF (orodispersible film) offers a new option for those who value convenience and discretion Erectile dysfunction (ED) affects over 50% of men aged 40 and older, resulting in pervasive impact on men's sexual health.1 Emerging research and market trends suggest a potential role for discreet ED treatments, underscoring the importance of patients' privacy, comfort and convenience.2 ETOBICOKE, ON, Sept. 30, 2024... Read more
Echocardiographic and Cardiac Biomarker Data From the HELIOS-B Study Presented Today Support the Potential of Vutrisiran in ATTR-CM Vutrisiran Significantly Improved Echocardiographic Assessments of Cardiac Structure, Systolic Function and Diastolic Function Relative to Placebo Over 30 Months Vutrisiran Demonstrated Relative Stability of Cardiac Biomarkers NT-proBNP and Troponin-I Relative to Placebo Over 30 Months CAMBRIDGE, Mass. / Sep 29, 2024... Read more
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. Biologics License Application (BLA) submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial (M14-239). Review of the BLA will be conducted under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program. There are currently... Read more
In the Phase 3b/4 PSORIATYK SCALP trial Sotyktu was superior to placebo across all primary and secondary endpoints at Week 16, with patients reporting significantly greater improvement in symptoms Safety profile in PSORIATYK SCALP was consistent with the established safety profile of Sotyktu In the real-world RePhlect registry of patients, six months of Sotyktu treatment was consistent with the efficacy outcomes observed in the POETYK clinical studies for psoriasis... Read more
Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo... Read more
Minimal residual disease (MRD)-negativity rate of 10-5 more than doubled by 12 months with DARZALEX FASPRO® in maintenance therapy compared to lenalidomide alone, resulting in improvement in 30-month progression-free survival RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from three studies highlighting clinical efficacy of DARZALEX® (daratumumab) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fi... Read more
Study of the first and only subcutaneous quadruplet regimen demonstrates 60.9 percent improvement in minimal residual disease (MRD)-negativity and 43 percent reduction in the risk of progression or death Phase 3 CEPHEUS study results presented in late-breaking oral presentation at the International Myeloma Society (IMS) Annual Meeting RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today results from the Phase 3 CEPHEUS... Read more
Updated data show 100 percent overall response rate with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody Safety profile, including infection rates, similar to TALVEY® and DARZALEX FASPRO® monotherapies RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating... Read more
Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory... Read more
COBENFY represents the first new pharmacological approach to treat schizophrenia in decades, with a mechanism of action distinct from current therapies Approval is supported by data from the EMERGENT clinical program demonstrating statistically significant reductions of schizophrenia symptoms The safety and tolerability profile of COBENFY has been established across acute and long-term trials in schizophrenia PRINCETON, N.J. / Sep 26, 2024 / Business Wire / Bristol... Read more
Vote recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors in advanced esophageal squamous cell carcinoma and gastric/gastroesophageal junction cancers Biologics License Applications for TEVIMBRA in these indications are under review with the FDA SAN MATEO, Calif. / Sep 26, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs... Read more
Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26 Trial also met key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score Results from the Phase 3 TEMPO-2 trial, studying tavapadon as a flexible-dose monotherapy, are expected... Read more
Phase 3 data on investigational vanza triple demonstrates non-inferiority to TRIKAFTA® in ppFEV1 and further improvement of CFTR function as measured by sweat chloride Real-world evidence and clinical studies of TRIKAFTA® continue to show sustained long-term benefits including improvement in pancreatic function in young patients BOSTON / Sep 26, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the first accepted... Read more
MINNEAPOLIS , Sept. 26, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that one of its spatial biology brands, Lunaphore, is partnering with Discovery Life Sciences (Discovery) to add Lunaphore COMET™, a best-in-class spatial biology platform, to Discovery's global suite of biospecimen products and specialty lab services supporting customers with clinical research. The strategic partnership leverages Lunaphore's COMET technology, the... Read more
Based on LAURA Phase III trial results which showed TAGRISSO extended median progression-free survival by more than three years WILMINGTON, Del. / Sep 26, 2024 / Business Wire / AstraZeneca’s TAGRISSO® (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential... Read more
TORONTO, Sept. 26, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has accepted for review its New Drug Submission (NDS) for vanzacaftor/tezacaftor/deutivacaftor, a once-daily triple combination therapy for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. "Vanzacaftor... Read more
SAN MATEO, Calif. / Sep 26, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the appointment of Shalini Sharp to its Board of Directors and as a member of the Board’s Audit Committee, effective September 27, 2024. “We are fortunate to welcome Shalini to the Board of Directors at this pivotal moment of growth,” said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. “The Board is looking... Read more
The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis Gazyva is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease affecting 1.7 million people worldwide, primarily women; up to one-third of people... Read more
First regulatory authorization of a CRISPR-based gene-editing therapy in Canada TORONTO, Sept. 25, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced Health Canada has granted Marketing Authorization for PrCASGEVY® (exagamglogene autotemcel), an autologous genome edited hematopoietic stem cell-based therapy, for the treatment of patients 12 years of age and older with sickle cell disease (SCD) with recurrent vaso-occlusive... Read more
New post-hoc analysis demonstrated efficacy of RINVOQ® (upadacitinib) in moderate-to-severe atopic dermatitis patients with varying degrees of severity in head and neck involvement, with results in skin clearance, itch resolution and impact on quality of life at 16 weeks1 Atopic dermatitis in the head and neck regions can have a significant impact on the quality of life for patients and is highly prevalent based on real-world observational studies2-4 New... Read more
Monthly EGBLYSS maintenance dosing sustained clear or almost-clear skin for up to three years in the vast majority of ADvocate 1 and 2 responders Nearly 87 percent of patients taking EBGLYSS did not require either high-potency topical corticosteroids or systemic treatments during the three-year study The safety profile at three years was consistent with the previously published two-year results INDIANAPOLIS, Sept. 25, 2024 /PRNewswire/ -- More than 80 percent... Read more
RAHWAY, N.J. / Sep 25, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, did not meet its primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable... Read more
New approval in Japan for KEYTRUDA regimen in the perioperative setting for certain patients with NSCLC based on results from KEYNOTE-671 Approval in Japan also demonstrates KEYTRUDA’s important role in combination with other therapies and as monotherapy in certain patients with urothelial carcinoma, based on results from KEYNOTE-A39 and KEYNOTE-052, respectively RAHWAY, N.J. / Sep 25, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States... Read more
THOUSAND OAKS, Calif., Sept. 24, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced TEPEZZA® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare (MHLW). TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision),... Read more
Innovative technology represents a breakthrough scientific achievement for one of the most common feline infectious diseases RAHWAY, N.J. / Sep 24, 2024 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the expansion of the newly USDA-approved NOBIVAC® NXT vaccine platform to include a best in class solution to protect cats against... Read more
Japan is the second major market where Kisunla has received approval Kisunla was first approved in the United States in July 2024 INDIANAPOLIS, Sept. 24, 2024 /PRNewswire/ -- The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Eli Lilly and Company's (NYSE: LLY) Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with... Read more
Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in Japan for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade OSAKA, Japan & CAMBRIDGE, Mass. / Sep 24, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules... Read more
Phase 3 PHOENYCS GO study met the primary endpoint demonstrating clinical improvement in moderate-to-severe systemic lupus erythematosus; Clinical improvements were observed among key secondary endpoints measuring disease activity and flares. UCB and Biogen are advancing dapirolizumab pegol with the objective to address the substantial unmet medical need for people living with SLE, where there are limited treatment options. SLE is a chronic, debilitating autoimmune... Read more
Survival results for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy Trial previously met the dual primary endpoint of progression-free survival WILMINGTON, Del. / Sep 23, 2024 / Business Wire / High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary... Read more
RIM-TD open-label extension (OLE) study showed long-term improvement of Tardive Dyskinesia (TD) symptoms from treatment with deutetrabenazine over three years in European patients1 TD is an involuntary movement disorder that develops in around 15%-25% of patients taking antipsychotic medications for conditions such as schizophrenia, bipolar disorder, and major depressive disorder2,3 Data presented at the European College of Neuropsychopharmacology Congress (ECNP) in... Read more
As a leader in neuroscience, Teva is committed to researching new treatment innovations that may help address unmet needs in treating schizophrenia, including TEV-‘749 Currently, there is no long-acting olanzapine treatment option available for the treatment of schizophrenia that does not contain a boxed warning for Post-Injection Delirium/Sedation Syndrome (PDSS) New Phase 3 SOLARIS and Phase 1 safety data show no incidence of PDSS in study participants receiving... Read more
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