Results from the Phase 3 STRIDE-13 trial presented at the 6th ESCMID Conference on Vaccines
Merck to share STRIDE-13 results with global regulatory authorities RAHWAY, N.J. / Sep 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society of Clinical Microbiology and Infectious... Read more
Rhonda Pacheco to Succeed Julie Kim, Who Was Appointed to Be Takeda’s Next CEO CAMBRIDGE, Mass. / Sep 11, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that Rhonda Pacheco, most recently group vice president of U.S. Cardiometabolic Health at Eli Lilly, will join Takeda, effective September 29, as president of Takeda’s U.S. Business Unit and will be a member of the Takeda Executive Team. Pacheco will succeed Julie Kim, who was appointed by the... Read more
Transformation to increase speed and redirect resources to growth opportunities within diabetes and obesity, aiming at reaching millions of untreated patients
Intention to reduce ~9,000 roles globally with the expectation to deliver DKK 8bn of annualised savings by the end of 2026
One-off restructuring costs of DKK 8bn leading to an updated full-year 2025 operating profit growth outlook of 4–10% at CER Bagsværd, Denmark, 10 September 2025 – Novo Nordisk today... Read more
First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1
Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal RARITAN, N.J., Sept. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today... Read more
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.
New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression.
Emrusolmin is a small molecule that targets the alpha synuclein protein, which is... Read more
Program provides access to Lilly-trained artificial intelligence to help accelerate breakthrough medicines
New offering expands Lilly Catalyze360's support for early-stage drug development INDIANAPOLIS, Sept. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug discovery models trained on years of Lilly's... Read more
Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone
In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months TARRYTOWN, N.Y., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,... Read more
THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD).
The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate... Read more
CAMBRIDGE, Mass. / Sep 08, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (“Alnylam”) (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has commenced a private offering of $500 million aggregate principal amount of convertible senior notes due 2028 (the “notes”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). In connection... Read more
PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer (”ES-SCLC”), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond
Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression free survival (mPFS) of 6.8 months... Read more
In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study
BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program in CLL
Results from BRUIN CLL-313... Read more
Phase 3 clinical trial cohort of adults 65+ and 18-64 with at least one underlying risk condition shows at least a 4-fold increase in LP.8.1-neutralizing antibody titers after receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula
First LP.8.1 sublineage clinical findings reinforce pre-clinical data supporting recent FDA approval of 2025-2026 Formula of Pfizer-BioNTech COVID-19 Vaccine
Companies have submitted these data to the FDA NEW YORK & MAINZ, Germany... Read more
In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo
Data from these trials will support further Phase 3 development TARRYTOWN, N.Y., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge Phase 3 trials in adults... Read more
An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients
Discussions with global regulatory authorities underway BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2025 / Business Wire / Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These... Read more
FLAURA2 final overall survival analysis reinforces the favorable benefit-risk profile of this combination
Results underscore TAGRISSO as 1st-line standard of care and backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Sep 07, 2025 / Business Wire / Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy... Read more
New data from Phase 3 PEGASUS study demonstrates a 49.7% decrease in mean blood Phe levels in adolescents aged 12-17 treated with PALYNZIQ
BioMarin's planned submission to global health authorities on track for second half of 2025 SAN RAFAEL, Calif., Sept. 6, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced new data characterizing the efficacy and safety of PALYNZIQ® (pegvaliase-pqpz) for the treatment of adolescents with phe... Read more
RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment BARCELONA, Spain, Sept. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly reduces the development of epidermal growth factor receptor (EGFR)-... Read more
Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1
VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in Adults and Children with VWD1
VWD, the Most Common Bleeding Disorder, Impacts More Than 3 Million People in the U.... Read more
The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU.
The VENTANA HER2 (4B5) test is also now approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.
Roche continues to break ground as the leader in breast cancer... Read more
The Breakthrough Therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial
Updated efficacy and safety data for olomorasib will be presented at the IASLC 2025 World Conference on Lung Cancer INDIANAPOLIS, Sept. 4, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination... Read more
New Bay Area Building Marks Significant Progress as Part of $32 Billion U.S. Investment Projected to Create $43 Billion in Economic Value FOSTER CITY, Calif. / Sep 03, 2025 / Business Wire / Gilead Sciences (Nasdaq: GILD) today celebrates the groundbreaking of its new Pharmaceutical Development and Manufacturing (PDM) Technical Development Center (NTDC) at the company’s Foster City headquarters. This milestone marks continued momentum in Gilead’s multi-year strategy... Read more
New awareness campaign features authentic, often misunderstood, stories from people living with hidradenitis suppurativa (HS), highlighting the emotional and physical impact of the condition WILMINGTON, Del. / Sep 03, 2025 / Business Wire / Incyte (Nasdaq:INCY) announced the launch of HS TRUTHS, a new educational campaign aimed at revealing the authentic and often hidden realities of living with hidradenitis suppurativa (HS), a chronic inflammatory skin condition. This... Read more
Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapse... Read more
Trial demonstrated the feasibility of treating and monitoring adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in an outpatient setting
Results showed that 92% of patients with R/R DLBCL received the first full dose of epcoritamab monotherapy in an outpatient setting
Adverse event profile and efficacy were consistent with previously reported studies in R/R DLBCL patients
Data also demonstrated 64.3% overall response rate with a complete... Read more
Agreement to explore Argo's Phase 2 ANGPTL3 in a combination trial in dyslipidemia with an option to license second-generation molecules in the pipeline
License to an additional Argo siRNA candidate currently in IND-enabling studies
Argo will receive an upfront payment of $160 million, an option for Profit & Loss split across multiple geographies and potential near-term equity; Argo is also eligible to receive option payment, development, sales milestones and royalties... Read more
