If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV Prevention Choice FDA to Review Applications Under Priority Review, with a PDUFA Date of June 19, 2025 Gilead Also Recently Submitted Applications for Lenacapavir for PrEP to the European Medicines Agency That Will Be Reviewed Under Accelerated Assessment Review Timeline FOSTER CITY, Calif. / Feb 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that... Read more
Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights Collaboration broadens Biogen’s rare disease pipeline and leverages global expertise commercializing high-value, disease-modifying medicines for rare genetic diseases Pivotal Phase 3 EMPEROR study of zorevunersen on track to initiate in Q2 2025 with an anticipated readout in 2H 2027 Stoke to receive $165M upfront,... Read more
MINNEAPOLIS, Feb. 18, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a leading provider of innovative life science research tools, is pleased to announce the official release of GMP Transposase mRNA for the TcBuster™ non-viral genome engineering system, supporting the development and manufacture of immune cell- and stem cell-based therapies. The TcBuster System has been widely used by researchers to introduce large cargo genetic modifications in a range... Read more
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union RAHWAY, N.J. / Feb 18, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has conditionally approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: The treatment of adult patients with von Hippel-Lindau... Read more
REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s... Read more
If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results demonstrating significant improvements in sustained disease remission with Dupixent compared to placebo BP is a chronic, debilitating and relapsing skin disease with underlying type 2 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesi... Read more
Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y) Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults PHILADELPHIA / Feb 17, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) for... Read more
No new safety signals observed at Year 5 in the POETYK PSO long-term extension trial, consistent with the established Sotyktu safety profile Following five years of continuous Sotyktu treatment, clinical response was maintained in nearly half of patients for Psoriasis Area and Severity Index (PASI) 90 in the POETYK PSO long-term extension trial PRINCETON, N.J. / Feb 16, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today announced new five-year results from... Read more
IMFINZI reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Feb 14, 2025 / Business Wire / Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free survival (EFS) and overall survival (OS) versus neoadjuvant... Read more
Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizing Reports full-year revenues of $3.2 billion, GAAP net loss of $(3.6) billion and GAAP diluted EPS of $(9.28) Expects 2025 revenue range of $1.5 to 2.5 billion andending cash balance of approximately $6 billion Submitted three investigational mRNA products for regulatory... Read more
TALZENNA + XTANDI is the first PARP inhibitor plus ARPI combination to demonstrate statistically significant and clinically meaningful improvement in overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of HRR mutation status TALZENNA + XTANDI improved median OS by almost 9 months in unselected patients (Cohort 1) and by 14 months in patients selected for HRR mutations (Cohort 2) versus standard of care XTANDI NEW... Read more
PRINCETON, N.J. / Feb 13, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 RELATIVITY-098 trial evaluating Opdualag™ (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab. “We are... Read more
Achieved Fourth Quarter and Full Year 2024 Global Net Product Revenues of $451 Million and $1,646 Million, Respectively, Representing 30% and 33% Growth Compared to Same Periods in 2023 Supplemental NDA for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy Accepted by FDA, with March 23, 2025 PDUFA Date Reiterates Product Sales and Profitability Guidance and Provides Additional 2025 Financial Guidance Company to Host and Webcast R&D... Read more
Published results reinforce the high-affinity binding and immunoselective properties of nipocalimab, which has been shown to reduce IgG levels by >75%, including autoantibodies, potentially without affecting other immune functions SPRING HOUSE, Pa., Feb. 13, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the publication of data detailing the differentiated molecular properties of nipocalimab, an investigational neonatal Fc receptor (FcRn)... Read more
Approval is based on positive data from the Phase 3 ECHELON-3 trial, which demonstrated ADCETRIS regimen reduced the risk of death by 37%, a statistically significant, clinically meaningful improvement in overall survival (OS), compared to lenalidomide and rituximab plus placebo ECHELON-3 is the first Phase 3 trial to demonstrate OS advantage over lenalidomide and rituximab plus placebo for patients with at least 2 prior lines of therapy with R/R diffuse large B-cell... Read more
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration SOUTH SAN FRANCISCO, Calif. / Feb 12, 2025 / Business Wire / Genentech, a member of the Roche... Read more
Collaboration will combine AbbVie's oncology expertise and Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers Xilio to host investor conference call and webcast today at 8:30 am EST NORTH CHICAGO, Ill. and WALTHAM, Mass., Feb. 12, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immu... Read more
NEW YORK, Feb. 12, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has entered into an agreement with Biogen to provide research and development (R&D) funding of up to $250 million for litifilimab, a first-in-class investigational drug candidate in Phase 3 with demonstrated proof-of-concept in both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). “We are excited to collaborate with Biogen on litifilimab,”... Read more
Product Sales Excluding Veklury Increased 8% Year-Over-Year to $26.8 billion for Full Year 2024 Biktarvy Sales Increased 13% Year-Over-Year to $13.4 billion for Full Year 2024 Oncology Sales Increased 12% Year-Over-Year to $3.3 billion for Full Year 2024 FOSTER CITY, Calif. / Feb 11, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024. “Gilead delivered another exceptionally... Read more
Anthos Therapeutics is a clinical-stage biopharmaceutical company developing abelacimab, a potential first-in-class monoclonal antibody targeting the FXI inhibition pathway Abelacimab is currently in Phase 3 development, with the lead indication for prevention of stroke and systemic embolism in patients with atrial fibrillation Acquisition adds a late-stage asset and is aligned with Novartis strategic focus, strength and expertise in the cardiovascular therapeutic ar... Read more
Approval is based on the Phase 3 KEYNOTE-671 Trial KIRKLAND, QC, Feb. 11, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a treatment for adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment,... Read more
Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma... Read more
Portfolio Receipts of $742 million in Q4 2024 and $2,801 million for FY 2024 Royalty Receipts growth of 12% in Q4 2024 and 13% for FY 2024 Net cash provided by operating activities of $743 million in Q4 2024 and $2,769 million for FY 2024 Full year 2025 guidance: Portfolio Receipts expected to be $2,900 to $3,050 million excluding future transactions NEW YORK, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for... Read more
Enfortumab vedotin plus pembrolizumab continues to demonstrate superior efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/mUC At nearly 30 months of follow-up in the Phase 3 EV-302 trial, the combination doubled median overall survival and progression-free survival compared to chemotherapy, with no new safety signals identified NEW YORK & TOKYO / Feb 10, 2025 / Business Wire / Pfizer... Read more
Full year product revenue of $11.02 billion, a 12% increase compared to full year 2023 Company provides full year 2025 total revenue guidance of $11.75 to $12.0 billion ALYFTREK™ approved in the U.S. for patients ages 6+ with cystic fibrosis; JOURNAVX™ approved in the U.S. for moderate-to-severe acute pain Diverse late-stage clinical pipeline accelerates with four programs in pivotal development Stuart Arbuckle, Chief Operating Officer, announces... Read more
Total revenues of $1.2 billion (+16% Y/Y) in the fourth quarter 2024 and $4.2 billion (+15% Y/Y) for the full year 2024 Jakafi® (ruxolitinib) net revenues of $773 million (+11% Y/Y) in the fourth quarter 2024 and $2.8 billion (+8% Y/Y) for the full year 2024; Jakafi net revenues guidance range of $2,925 - $2,975 million for the full year 2025 Opzelura® (ruxolitinib) cream net revenues of $162 million (+48% Y/Y) in the fourth quarter 2024 and $508 million (+50% Y/Y)... Read more
Trial met primary endpoint of overall response rate and key secondary endpoint of complete response rate With these data, Breyanzi demonstrates efficacy and manageable safety in a fifth cancer type, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Feb 10, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult patients with relapsed or refractory... Read more
At three years of EYLEA HD treatment, the vast majority of patients maintained visual and anatomic improvements while achieving extended dosing regimens, including those of just twice a year: 77%, 58%, 40% and 24% achieved last assigned dosing intervals of ≥3, ≥4, ≥5 and 6 months, respectively At three years, the vast majority of patients who switched to EYLEA HD from a fixed 2-month dosing regimen with EYLEA® (aflibercept) Injection 2 mg maintained visual and... Read more
EMBLAVEOTM is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the U.S. FDA to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria Gram-negative bacterial infections represent a significant public health threat due to their ability to develop resistance to antimicrobial therapies Antimicrobial resistance (AMR) could lead to over 39 million deaths worldwide by 2050, and new treatments... Read more
More than 90% of Omvoh-treated patients who were in clinical remission at one year sustained it with two years of continuous treatment Nearly 90% of patients who achieved endoscopic response at one year sustained it at two years Omvoh is the first IL-23p19 antagonist to demonstrate multi-year, sustained efficacy and safety for both Crohn's disease and ulcerative colitis INDIANAPOLIS, Feb. 7, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced... Read more
Nearly half of patients on Gazyva plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone Analysis showed consistent CRR benefit across patient subgroups highlighting potential to treat a broad patient population with high unmet need Gazyva is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with... Read more
INGREZZA® (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of $615 Million and $2.3 Billion, Representing Year-Over-Year Growth of 23% and 26% Respectively INGREZZA® (valbenazine) Full Year 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion CRENESSITYTM (crinecerfont), a First-in-Class Treatment for Children and Adults with Classic Congenital Adrenal Hyperplasia, Approved and Launched in the United States Phase 3 Programs for Osavampator in Major... Read more
Performance Reflects Progress Toward Delivering Sustained, Top-Tier Growth Fourth Quarter Revenues were $12.3 Billion, Increasing 8% (+9% Adjusting for Foreign Exchange); GAAP Earnings Per Share (EPS) was $0.04 and Non-GAAP EPS was $1.67 Growth Portfolio Revenues were $6.4 Billion, Increasing 21% (+23% Adjusting for Foreign Exchange) Full-Year Revenues were $48.3 Billion, Increasing 7% (+9% Adjusting for Foreign Exchange); GAAP Loss Per Share was $(4.41) and Non-GAAP... Read more
Revenue in Q4 2024 increased 45% to $13.53 billion driven by volume growth from Mounjaro and Zepbound. Non-incretin revenue(i) grew by 20% compared to Q4 2023. Pipeline progress included the approval of Zepbound in the U.S. for moderate-to-severe obstructive sleep apnea in adults with obesity and the approval of Omvoh in the U.S. for moderately to severely active Crohn's disease. Notable recent events include the pending acquisition of Scorpion Therapeutics, Inc's... Read more
Strong momentum in FY 2024 with Total Revenue and Core EPS up 21% and 19% respectively CAMBRIDGE, England / Feb 06, 2025 / Business Wire / AstraZeneca: Revenue and EPS summary FY 2024 % Change Q4 2024 % Change $m Actual CERi $m Actual CER - Product Sales 50,938 16 19 13,362 18... Read more
Expansion of the waveLINE clinical development program demonstrates company’s progress in advancing research in hematologic malignancies RAHWAY, N.J. / Feb 06, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to... Read more
Brensocatib Would be the First and Only Available Treatment for Bronchiectasis and First DPP1 Inhibitor, if Approved BRIDGEWATER, N.J., Feb. 6, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application... Read more
Operating profit increased by 25% in Danish kroner and by 26% at constant exchange rates (CER) to DKK 128.3 billion. Operating profit was positively impacted by gross-to-net sales adjustments in the US and negatively impacted by impairment losses. Sales in North America Operations increased by 30% in Danish kroner (30% at CER). Sales in International Operations increased by 17% in Danish kroner (19% at CER). Sales within Diabetes and Obesity care increased by 26% in Danish... Read more
MINNEAPOLIS, Feb. 5, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today reported its financial results for the second quarter ending December 31, 2024. Second Quarter FY2025 Highlights Second quarter organic revenue increased by 9% (9% reported) to $297.0 million. GAAP earnings per share (EPS) was $0.22 versus $0.17 one year ago. Delivered adjusted EPS of $0.42 compared to $0.40 one year ago. Improving biopharma end-market conditions combined with continued... Read more
THOUSAND OAKS, Calif., Feb. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023. "Robust growth in sales and earnings throughout 2024 reflects the momentum of our business. With strong performance globally, we are investing heavily in our rapidly advancing pipeline to deliver innovative therapies across our four therapeutic areas," said Robert A. Bradway, chairman and... Read more
Fourth-Quarter Worldwide Sales Were $15.6 Billion, an Increase of 7% From Fourth Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 9% Fourth-Quarter GAAP EPS Was $1.48; Non-GAAP EPS Was $1.72; GAAP and Non-GAAP EPS Include a Charge of $0.23 per Share Related to Certain Business Development Transactions Full-Year Worldwide Sales Were $64.2 Billion, an Increase of 7% From Full Year 2023; Excluding the Impact of Foreign Exchange, Growth Was 10% KEYTRUDA... Read more
Full-Year 2024 Revenues of $63.6 Billion, Reflecting 7% Year-over-Year Operational Growth Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 12% Operationally Full-Year 2024 Reported(2) Diluted EPS of $1.41 and Adjusted(3) Diluted EPS of $3.11 Fourth-Quarter 2024 Revenues of $17.8 Billion, Reflecting 21% Year-over-Year Operational Growth Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 11% Operationally Fourth-Quarter... Read more
Fourth quarter 2024 revenues increased 10% to $3.79 billion versus fourth quarter 2023 Full year 2024 revenues increased 8% to $14.20 billion versus 2023; excluding RonapreveTM(a)(b), revenues increased 10% Fourth quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 15% to $3.70 billion versus fourth quarter 2023; full year 2024 Dupixent global net sales increased 22% to $14.15 billion versus 2023 Fourth quarter 2024 U.S. net... Read more
Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) With as few as two treatments per year, Susvimo may help people with DME maintain their vision Approval marks the second indication for Susvimo in addition to wet, or neovascular age-related macular degeneration (AMD) SOUTH SAN FRANCISCO, Calif. / Feb 04, 2025 / Business Wire / Genentech, a member of the Roche Group... Read more
Over 100,000 patients in the United States have IPF, with only two approved therapies available that only slow the course of disease progression Top line data expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Feb 04, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 1 study evaluating the use of Tyvaso® (treprostinil) inhalation solution... Read more
MINNEAPOLIS, Feb. 4, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced the appointment of Amy E. Herr, Ph.D. to serve as an independent director on the Company's Board of Directors beginning on February 1, 2025. Dr. Herr will serve on the Science & Technology Committee of the Board of Directors. Dr. Herr is a Chancellor's Professor of Bioengineering at the University of California, Berkeley. Dr. Herr also currently serves as the Vice President... Read more
First-ever human clinical trial of a xeno-organ intended to allow for potential registration through the submission of a Biologics License Application to the U.S. FDA First xenotransplant is expected to occur around mid-year 2025 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Feb 03, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared... Read more
BRAFTOVI in combination with cetuximab and mFOLFOX6 showed statistically significant and clinically meaningful improvement in progression-free survival and overall survival in patients with metastatic colorectal cancer with a BRAF V600E mutation BRAFTOVI combination regimen received accelerated approval for treatment-naïve patients in December 2024 Results to be shared with the U.S. FDA to support potential conversion to full approval NEW YORK / Feb 03, 2025 / Business... Read more
Acquisition to strengthen key pillar of BioNTech’s oncology strategy aimed at establishing BNT327 as a pan-tumor technology platform for the treatment of advanced cancers With the closing of the transaction, BioNTech will expand its capabilities to develop, manufacture and commercialize novel BNT327 combinations and next-generation bispecific antibodies Biotheus will become a new indirect Chinese subsidiary of BioNTech, adding a local research and development hub... Read more
RAHWAY, N.J. / Jan 31, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The... Read more