HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its final results for the year ended December 31, 2024 on Wednesday, March 19, 2025 at 7:00 am Eastern Daylight Time (EDT) / 11:00 am Greenwich Mean Time (GMT) / 7:00 pm Hong Kong Time (HKT). Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted... Read more
TEL AVIV, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will conduct a conference call and live webcast at 8 am E.T. on Monday, February 24, 2025. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (anti-TL1A) positive Phase 2b results at... Read more
Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo
SPN-820 was well-tolerated with few adverse events, consistent with previously reported studies ROCKVILLE, Md., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central... Read more
Calgary, Alberta, Canada – February 18, 2025 – TheNewswire - Voyageur Pharmaceuticals Ltd. (TSX.V:VM) (OTC Pink:VYYRF) ("Voyageur" or the "Company") is pleased to announce the launch of its next generation MRI contrast agent development program in collaboration with Applied Pharmaceutical Innovations (API) and Rain Cage Carbon Inc (RC). This program aims to create novel, high performance MRI contrast drug formulations utilizing advanced nanotechnology.
Under this... Read more
WINNIPEG, MB / ACCESS Newswire / February 18, 2025 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today announced that through its wholly-owned U.S. subsidiary, Medicure Pharma Inc., it has signed a definitive agreement on February 14, 2025 to acquire 100% of Gateway Medical Pharmacy Inc.... Read more
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
DeepSolar brings new customer base in creation, including major utility-scale solar operators and independent power producers, while breaking into the residential solar market
The Company remains committed to advancing its drug delivery technologies while broadening its growth potential TEL AVIV, Israel, Feb. 18, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the... 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
Vibativ® is a life-saving antibiotic for pneumonia and serious skin infections
Approval in China paves the way for launch in world's second-largest market NASHVILLE, Tenn. and SHANGHAI, Feb. 18, 2025 /PRNewswire/ -- Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals" or "SciClone") today announced the NMPA (National Medical Products Administration) approval of... 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
GARDEN CITY, NY, Feb. 18, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase” or the “Company”), a next-generation biotech, genomics, and consumer products company, today announced the appointment of Stu Hollenshead as Chief Operating Officer, marking a pivotal step in the company’s expansion into consumer-centered health and wellness products. As COO, Hollenshead will focus on accelerating ProPhase Labs’ consumer-facing strategy, leveraging... 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
PARSIPPANY, N.J. / Feb 14, 2025 / Business Wire / Zoetis today announced that the U.S. Department of Agriculture (USDA), Center for Veterinary Biologics (CVB) has issued the company a conditional license for its Avian Influenza Vaccine, H5N2 Subtype, Killed Virus. The vaccine is labelled for use in chickens. The conditional license was granted on the demonstration of safety, purity, and reasonable expectation of efficacy based on serology data.
Zoetis is committed to supporting... 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
Richard A. Gonzalez to retire from the board of directors effective July 1, 2025 NORTH CHICAGO, Ill., Feb. 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its board of directors has unanimously elected chief executive officer (CEO) Robert A. Michael to assume the additional position of chairman, effective July 1, 2025. He will succeed Richard A. Gonzalez, who formerly served as AbbVie's CEO and has been chairman since the Company's formation... Read more
Positive IHL-42X PK findings for the treatment of Obstructive Sleep Apnea (OSA) support future 505(b)(2) New Drug Application (NDA) submission
New OSA Clinical Advisory Board Announced; Appoints Dr. Alison Wimms, Representing ResMed NEW YORK and MELBOURNE, Australia, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today reported... Read more
MONTREAL, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today announced that it has resumed distribution of EGRIFTA SV® (tesamorelin for injection), following correspondence from the U.S. Food and Drug Administration (FDA) that allows the... Read more
Conference Call Scheduled for Friday, February 14 at 11:30 AM EST Northvale, New Jersey--(Newsfile Corp. - February 13, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, announced results for the three months ended December 31, 2024, which is the third quarter of the Company's fiscal year ending on March 31, 2025 ("Third... Read more
First Major Technological Breakthrough in Hyaluronic Acid Dermal Fillers in a Decade; U.S. Launch Planned in Q2 2025
Launch Establishes Evolus as a Multi-Product Performance Beauty Company and Expands Addressable Market by 78% NEWPORT BEACH, Calif. / Feb 13, 2025 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse™... 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
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
Full year 2024 revenue of $6.4 billion, up 2% as-reported and 3% at constant currency
Full year 2024 diluted earnings per share of $3.33 and non-GAAP Adjusted diluted earnings per share of $4.11
Full year 2024 Adjusted EBITDA of $1.96 billion inclusive of $81 million of IPR&D, representing a 30.6% Adjusted EBITDA margin
Full year 2025 financial guidance ranges provided Full year revenue range of $6.125 billion - $6.325 billion, inclusive of an approximate $200... Read more
Reports Revenue of $2.3 Billion, Growing 5%, and Net Income of $581 Million, or $1.29 per Diluted Share, Increasing 11% and 13%, Respectively, on a Reported Basis for Fourth Quarter 2024 Delivers 6% Operational Growth in Revenue and 9% Operational Growth in Adjusted Net Income for Fourth Quarter 2024
Delivers 9% Organic Operational Growth in Revenue for Fourth Quarter 2024 After Accounting for the Divestiture of the Medicated Feed Additive Product Portfolio, Certain... Read more
MELBOURNE, Australia and INDIANAPOLIS, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces presentations featuring the Company’s late-stage and next generation therapeutic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2025) to be held in San Francisco, CA (US) from 13 – 15 February 2025.
Dr. David N. Cade, Telix Group Chief Medical... Read more
Company reported positive Phase 2b QUALITY study topline results for enobosarm + semaglutide (Wegovy®) with study meeting prespecified primary endpoint of preservation of lean mass as well as greater fat loss and improvement of physical function
The Independent Data Monitoring Committee met this week on February 10, 2025 to evaluate the unblinded safety Phase 2b QUALITY data and recommended to continue the QUALITY extension study as designed
Topline results of the... Read more
MELBOURNE, Australia, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).
Illuccix is indicated in the UK for the detection and localization... 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
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
Finalizing scale-up production phase Engaging with Contract Research Organizations to complete the technical dossier Clinical trials expected to complete in late 2025 or early 2026 Potential classification as a Class III medical device Product launch expected in the first or second quarter of 2026 Further updates on progress to follow in the coming months CHICAGO, IL / ACCESS Newswire / February 11, 2025 / Cosmos Health Inc. ("Cosmos Health"... Read more
Accomplished Consumer Goods and Health Care Leader Would Bring Decades of Leadership Experience to Role EAGLE, Idaho, Feb. 11, 2025 (GLOBE NEWSWIRE) -- PetIQ, Inc. (“PetIQ” or the “Company”), a leading pet medication, health and wellness company and portfolio company of Bansk Group, is pleased to announce that Camillo Pane would join PetIQ as Chief Executive Officer, effective February 17, 2025. Mr. Pane would succeed Cord Christensen.
Mr. Pane’s passion... 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
CHICAGO, IL / ACCESS Newswire / February 10, 2025 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today the filing of two new patent applications, covering groundbreaking developments in the treatment... 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
CHICAGO, IL / ACCESS Newswire / February 10, 2025 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today the appointment of Dimitris Moraitis as Vice President of Strategy & Operations.
Mr.... 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
CHICAGO, IL / ACCESS Newswire / February 7, 2025 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that its wholly owned subsidiary, Cana Laboratories ("Cana"), has entered into a new long-term... Read more
First data in NPC1 on treatment in this age group over a period of 48 weeks
At 24 weeks of the sub-study, 7 of 8 patients (87%) and at 48 weeks of the sub-study, 6 of 7 patients (86%) show stabilization or improvement in Clinical Global Impression – Change (CGI-C) Scale
Data presented at the 21st Annual WORLDSymposium™ 2025
Company on track for topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ in H1 2025 GAINESVILLE, Fla.... 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
THOUSAND OAKS, Calif., Feb. 7, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) will present at the 35th Annual Oppenheimer Healthcare Life Sciences Conference at 11:20 a.m. ET on Wednesday, Feb. 12, 2025. Narimon Honarpour, senior vice president of global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as... Read more
Dr. Reddy’s gets exclusive rights to commercialize the subcutaneous as well as intravenous formulations of HLX15 in the U.S. and Europe HYDERABAD, India / Feb 06, 2025 / Business Wire / Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy’s”), today announced that it has entered into a license agreement... 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