Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses The investigational once-daily oral pill reduced weight by an average 16.0 lbs (7.9%) at the highest dose in a key secondary endpoint The overall safety and tolerability profile of orforglipron in ACHIEVE-1 was consistent with injectable GLP-1 therapies INDIANAPOLIS, April 17,...Read more
Label updates include simplified twice-yearly echo monitoring for eligible CAMZYOS patients in the maintenance phase and expanded patient eligibility with reduced contraindications Updated U.S. label is supported by data including long-term clinical and real-world evidence which reinforce the strong safety profile of CAMZYOS PRINCETON, N.J. / Apr 17, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S....Read more
Retrospective analysis reveals no significant differences in comorbidities in narcolepsy patients treated vs. not treated with sodium oxybate One third of patients taking immediate-release, twice-nightly sodium oxybate discontinued treatment, most often due to lack of efficacy; inability to wake up was most common reason for missing second nightly dose DUBLIN, April 17, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals...Read more
Evotec sharpens focus on pioneering drug discovery and charts clear path toward sustainable profitable growth Strategy builds on technology and science leadership, focusing on high-growth, high-value segments, simplifying the business model and fostering operational excellence Strong Q4 2024 revenue and EBITDA results in spite of challenging market conditions. Full year guidance met, with liquidity significantly...Read more
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74 NEW YORK / Apr 16, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years...Read more
Vaccine recommended to help protect persons over 10 years old in the United States (US) against 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 Vaccine doses will be ready for use in the US from Summer 2025 PHILADELPHIA / Apr 16, 2025 / Business Wire / GSK plc...Read more
Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Pericarditis is an inflammation of the pericardium, the sac-like membrane that surrounds and protects the heart. It occurs when the pericardium becomes irritated or infected, leading to swelling and pain. PALO ALTO, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company...Read more
NEWPORT BEACH, Calif. / Apr 16, 2025 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced the commercial launch date for Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse™ collection, scheduled for Friday, April 18th. To support the introduction, Evolus will initiate a comprehensive...Read more
Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago. Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Application. Data from Cardiol's Phase II MAvERIC-Pilot study presented at the American Heart...Read more
MIAMI, FL, April 16, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced that the Company will present at the 2nd Annual GLP-1-Based Therapeutics Summit, taking place April 29 - May 1, 2025, in Boston, Massachusetts. Presentation Title: Phase 2b QUALITY Clinical Study:...Read more
Ketamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced compelling data demonstrating the efficacy of the oral ketamine...Read more
CHICAGO, April 16, 2025 (GLOBE NEWSWIRE) -- 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, today reported financial results for the full year ended December 31, 2024. Full...Read more
2025 First-Quarter reported sales growth of 2.4% to $21.9 Billion with operational growth of 4.2%* and adjusted operational growth of 3.3%* 2025 First-Quarter earnings per share (EPS) increased to $4.54 which includes the reversal of special charges and adjusted EPS increased to $2.77 or 2.2%* Significant new product pipeline progress including approval of TREMFYA in Crohn’s disease, data for RYBREVANT/LAZCLUZE overall survival in...Read more
In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology Lecanemab is the first therapy that targets an underlying cause of the disease to be authorized in the EU for eligible people with...Read more
MELBOURNE, Australia and INDIANAPOLIS, April 16, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study2. IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz...Read more
JERSEY CITY, N.J. / Apr 15, 2025 / Business Wire / Organon (NYSE: OGN) a global healthcare company with a focus on women’s health, today announced the appointment of Ramona A. Sequeira, President of the Global Portfolio Division at Takeda Pharmaceutical Company, to Organon’s Board of Directors, effective July 1, 2025. Ms. Sequeira will serve on the Board’s Talent Committee. In connection with Ms. Sequeira’s appointment, the size of...Read more
ELYXYB® is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1 According to market data from 2018, it was found that migraine was more severe than other types of headaches and it impacted more than 2.7 million Canadians, with the Canadian migraine therapeutics market estimated to reach approximately $400 million by 2025.2 There is strong...Read more
NEW YORK / Apr 14, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. Pfizer’s dose-optimization studies of once-daily formulations of danuglipron (NCT06567327 and NCT06568731) met key pharmacokinetic objectives and confirmed a formulation and...Read more
PRINCETON, N.J. / Apr 14, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy...Read more
Feedback from recent FDA interaction indicates that a confirmatory Phase 3 trial evaluating apraglutide in SBS-IF is needed to seek approval Company has engaged Goldman Sachs & Co. LLC to explore strategic alternatives BOSTON / Apr 14, 2025 / Business Wire / Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with...Read more
Private Placement of US$6 Million to fund additional pre-clinical research, Phase 1 and Phase 2a clinical studies US$20 Million additional option included in Private Placement to fund the Phase 3 clinical program in chronic cluster headache Lobe creates Cynaptec Pharmaceuticals, Inc. which will own and develop Conjugated Psilocin TM VANCOUVER, BC / ACCESS Newswire / April 14, 2025 / Lobe Sciences Ltd. ("Lobe Sciences"...Read more
First Global Phase 3 Trial Showing Substantial Survival Advantage Over Chemotherapy, for Patients With Progression On or After Platinum-Based Chemotherapy THOUSAND OAKS, Calif., April 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the global Phase 3 DeLLphi-304 clinical trial evaluating IMDELLTRA® (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single...Read more
Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator’s choice of lenvatinib or sorafenib1 In the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1 PRINCETON, N.J. / Apr 11, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more
WINNIPEG, MB / ACCESS Newswire / April 11, 2025 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC PINK: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 April 10, 2025 to acquire 100% of...Read more
ICONIC-LEAD is the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis to assess safety and efficacy of a systemic therapy in adolescents and adults simultaneously 84% of adolescents with moderate-to-severe plaque psoriasis treated with investigational icotrokinra achieved clear or almost clear skin (IGA 0/1) at Week 16 SPRING HOUSE, Pa., April 10, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:...Read more
Existing Klarity-C Patients to Have Access to VEVYE for $59 Per Bottle NASHVILLE, Tenn. / Apr 10, 2025 / Business Wire / Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced an expansion of its VEVYE® Access for All (“VAFA”) program to include patients currently prescribed Klarity-C Drops®, a compounded cyclosporine 0.1% product manufactured and distributed by ImprimisRx®, Harrow’s compounding...Read more
Filing provisional patent application with the USPTO entitled “PSMA-Targeted PARP Inhibitor conjugates for Precision Cancer Therapy” key to advancement of Diagnostic and Therapeutic programs Dr. Alan Kozikowski, internationally acclaimed pioneer in the discovery of a critical PSMA targeting ligand for clinical applications is co-inventor Theranostic molecule designed to preferentially target prostate cancer cells to the effects of...Read more
LAVAL, QC / ACCESS Newswire / April 9, 2025 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced that it has signed a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) for Canadian public drug plan coverage for PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, a new triple-combination topical prescription treatment...Read more
FDA Approves EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy Total Revenue $19 million, representing +17% growth year over year FDA Approves Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA Latest from VAMOS study demonstrates excess visceral abdominal fat drives cardiovascular risk MONTREAL, April 09, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies”...Read more
CHICAGO, April 09, 2025 (GLOBE NEWSWIRE) -- 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...Read more
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study 45% of the patients receiving steroids at open-label extension baseline...Read more
RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU) to treat adult patients with giant cell arteritis (GCA) The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete...Read more
Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1 The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date PRINCETON, N.J. / Apr 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more
MELBOURNE, Australia and INDIANAPOLIS, April 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as one of its commercial radiopharmaceutical distributors to supply finished unit doses of Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET...Read more
BRIDGEWATER, N.J. / Apr 08, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its first quarter 2025 financial results on Friday, May 2, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations...Read more
FDA action allows for unrestricted distribution of EGRIFTA SV®, removing uncertainty with respect to all manufactured batches PAS approval follows recent FDA approval of new formulation, EGRIFTA WR™ MONTREAL, April 08, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug...Read more
JERSEY CITY, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria being...Read more
If approved for an expanded pediatric indication, AJOVY would be the first calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients, addressing the high unmet need for effective treatments AJOVY is currently the only anti-CGRP treatment for migraine prevention in adults in the U.S. that is available in both quarterly and monthly dosing options1 These...Read more
EPYSQLI® (eculizumab-aagh) is now available to patients living with difficult-to-treat rare diseases like paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive EPYSQLI will be available at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris® (eculizumab), making it one of the greatest...Read more
Analysis of RISE-PD presented at AAN 2025 showed CREXONT treatment significantly improved patients’ Parkinson’s Disease Sleep Scale-2 (PDSS-2) total and sub-scale scores Treatment with CREXONT also resulted in significantly more patients waking up in an “On” state compared to immediate-release CD/LD patients, as part of separate study analysis Sleep disturbances affect up to 80% of patients with Parkinson’s disease1, highlighting the...Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - April 7, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update on the progress of the commercial launch of GRAFAPEX™ (treosulfan) for Injection in the United States and announce company management's participation in two upcoming investor conferences. Medexus has seen an encouraging market response to GRAFAPEX™ in the weeks since the...Read more
TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis SPRING HOUSE, Pa., April 4, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today...Read more
New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in Phase Ib/IIa Brainshuttle™ AD study Data on the Elecsys® pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease A Phase III program for trontinemab later this year will be initiated based on totality of data SOUTH SAN FRANCISCO, Calif. / Apr 03, 2025 /...Read more
Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo UPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial Advances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen...Read more
MELBOURNE, Australia and INDIANAPOLIS, April 04, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces the appointment of Anne Whitaker as a Non-Executive Director (NED) based in the United States, effective 7 April 20251. Ms. Whitaker is a seasoned healthcare leader and advisor with over 30 years’ global corporate experience spanning large pharmaceutical, biotech and...Read more
CREXONT added to 3 large national formularies: Veterans Administration, UnitedHealthcare and CVS Health Increases insurance coverage to over 50% of covered lives CREXONT was approved by the U.S. FDA to treat Parkinson’s disease in 2024 BRIDGEWATER, N.J. / Apr 03, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that three large...Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / April 3, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO and Dan Dischner, SVP of Corp. Communication, will be participating in an Analyst-Moderated fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9th, 2025, at 1:30 pm ET. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com. This...Read more
Recorded Revenues of $35.2 Million for Q3 Fiscal 2025 Signed Multiple Development Agreements with New and Existing Customers Strengthened Balance Sheet through Sale of Excess Capital Equipment, Raising Approximately $17.0 Million Conference Call Today at 4:30pm ET CHASKA, Minn., April 03, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and...Read more
NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose...Read more
Advances Company’s industry-leading portfolio in mental health with addition of CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive therapy and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, has potential to become a new standard of care...Read more
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1 Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2 IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent...Read more
MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals...Read more
CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious...Read more
FORT LAUDERDALE, FL / ACCESS Newswire / April 2, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) ("We", "Our", the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has completed additional studies on orthotopic human tumor models in mice confirming its K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) product as a novel...Read more
FORT LAUDERDALE, FL / ACCESS Newswire / April 2, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals, today announced that it has entered into definitive agreements in a registered direct offering with institutional investors for the purchase and sale of approximately $2.46 million of shares...Read more
ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49 NEW YORK / Apr 01, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of...Read more
MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR1 trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia. ZOLAR is a first-in-human, proof-of-concept and...Read more
Strengthens and expands U.S. biosimilars immunology portfolio with multi-indication arthritis treatment JERSEY CITY, N.J. / Apr 01, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion. TOFIDENCE, the...Read more
First ready-to-use, subcutaneous formulation of Bortezomib now available Marks Amneal’s fourth 505(b)(2) injectable product launch in the last year BRIDGEWATER, N.J. / Apr 01, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and Shilpa Medicare Limited (“Shilpa”) today announced the U.S. launch of BORUZU™, a new presentation of bortezomib for...Read more
DUBLIN, April 01, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the 24th Annual Needham Healthcare Conference on Tuesday, April 8 at 1:30 p.m. ET. A live webcast of the fireside chat, as well as an archived recording, will be available on Avadel’s...Read more
SCOTTSDALE, Ariz., April 01, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical” or the “Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions, is pleased to announce the promotion of Ramsey Alloush, currently General...Read more
Calgary, Alberta, Canada – April 1, 2025 – TheNewswire - Voyageur Pharmaceuticals Ltd. (TSX.V:VM) (OTC Pink:VYYRF) ("Voyageur" or the "Company") is pleased to announce the successful completion of a key phase in human testing of its Health Canada-licensed barium contrast media product suite. This milestone paves the way for Voyageur’s upcoming product launch across the Candain market. A total of 24 test subjects participated in the phase...Read more
MIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, today announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain. The Phase 1 trial is being conducted at the...Read more
FORT LAUDERDALE, FL / ACCESS Newswire / April 1, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has filed its 2024 annual report on Form 10-K on Tuesday, April 1, 2025. The following are highlights of the report: Revenue in 2024 grew to $34.9 million, a...Read more
New late-breaking clinical trial data presented at ACC and published simultaneously in JACC show benefit of investigational medicine AZD0780 on top of standard of care WILMINGTON, Del. / Mar 31, 2025 / Business Wire / Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care...Read more
Based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Mar 31, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been...Read more
WINREVAIR significantly reduced the risk of major morbidity and mortality events, the primary endpoint, in adults with PAH (Group 1 PH) WHO* functional class (FC) III or IV at high risk of mortality who are on maximum tolerated background PAH therapy ZENITH results presented today at ACC.25 as a late-breaking oral presentation and simultaneously published in the New England Journal of Medicine RAHWAY, N.J. / Mar 31, 2025 / Business...Read more
More than 92% of schizophrenia patients taking TEV-'749 in the SOLARIS survey were satisfied or very satisfied with the initiation regimen, dosing schedule and trial medication1 New data from UZEDY® (risperidone) evaluated predictors of response in schizophrenia with efficacy observed across patient demographic and clinical characteristics in the Phase 3 RISE trial Teva continues its commitment to generating clinical insights that...Read more
PRINCETON, N.J., March 31, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that Nikhil Lalwani, President and Chief Executive Officer, will host a fireside chat at the 2025 RBC Capital Markets Ophthalmology Virtual Conference as follows: Date: Thursday, April 3, 2025 Time: 7:45am ET Webcast: Click here The live and archived webcast will be accessible...Read more
BX211 was safe and well-tolerated BX211 produced sustained and statistically significant1 Percent Area Reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10 Compared to placebo, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at...Read more
The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 patients, of which 6 patients are already enrolled Talphera believes the NEPHRO CRRT study should be completed by the end of 2025 Existing investors, Nantahala Capital and Rosalind Advisors led the capital commitment priced at-the-market as defined by Nasdaq rules $4.925 million in gross proceeds at first...Read more
The U.S. Food and Drug Administration (FDA) agreed to reduce the number of patients in the NEPHRO CRRT study from 166 to 70 Talphera expects the registrational NEPHRO CRRT study to be completed by the end of 2025 Cash and investments at December 31, 2024 of $8.9 million, together with the private placement financing recently announced of up to $14.8 million, expected to provide capital through target completion of the NEPHRO...Read more
Company to Accelerate BE-Smart Commercialization as a Cash-Pay Diagnostic Significantly reduces overhead, improves margins heading into Q2 2025 Company to hold a conference call Monday, March 31, 2025, at 11:00 AM EST GARDEN CITY, NY, March 31, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), (the “Company” or “ProPhase”), a next generation biotech, genomics and consumer products company, today reported its financial...Read more
In Phase 2 ALPACA results, lepodisiran significantly reduced levels of genetically inherited cardiovascular risk factor, with some patients sustaining reductions for nearly 1.5 years These data were presented at the American College of Cardiology 2025 Scientific Sessions and simultaneously published in the New England Journal of Medicine (NEJM) INDIANAPOLIS, March 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
Rybelsus® reduced major adverse cardiovascular events by 14% vs placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease in the SOUL cardiovascular outcomes trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in New England Journal of Medicine2. Rybelsus®, the only approved oral GLP-1...Read more
Ozempic® improved maximum walking distance by 13% vs placebo in adults with type 2 diabetes and peripheral artery disease (PAD) in the phase 3 STRIDE trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in The Lancet2. Approximately 230 million people globally have PAD, a severe form of atherosclerotic cardiovascular...Read more
Recommendation is based primarily on results from the Phase 3 CheckMate -67T trial which demonstrated noninferiority in the co-primary endpoints of Cavgd28 and Cminss and consistent efficacy in the secondary endpoint of overall response rate for the subcutaneous formulation of Opdivo vs. its intravenous formulation A decision on the EU Opdivo extension of marketing authorization is expected by June 2, 2025 PRINCETON, N.J. / Mar 28,...Read more
Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo If approved by the European Commission, the perioperative regimen would be the company’s second Opdivo-based regimen available for the treatment of resectable non-small cell lung cancer in the European Union PRINCETON, N.J. / Mar 28, 2025...Read more
WARREN, N.J., March 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has adopted the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to not renew the authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy. While this action effectively removes the drug's...Read more
SHANGHAI, China & JERSEY CITY, N.J. / Mar 28, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the...Read more
Recognized for contributions to address shortage of epinephrine injection, 0.1 mg/mL syringes RANCHO CUCAMONGA, CA / ACCESS Newswire / March 28, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today announced that International Medication Systems, Ltd. ("IMS"), a subsidiary of Amphastar Pharmaceuticals, Inc. ("Amphastar") received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration ("FDA"). This...Read more
New tools to connect with independent in-person and telehealth providers specializing in Alzheimer's disease are designed to increase capacity and reduce delays in diagnosis INDIANAPOLIS, March 27, 2025 /PRNewswire/ -- Eli Lilly and Company (LLY) has expanded its LillyDirect digital healthcare platform to offer connections to independent in-person and telehealth options for people in the U.S. living with Alzheimer's disease, the...Read more
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy A time and motion descriptive analysis shows nearly 50% reductions in patient chair and treatment room time, and in total active healthcare professional time related to treatment...Read more
GUANGZHOU, China and HYDERABAD, India, March 27, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and 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....Read more
STOUGHTON, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it will present four posters highlighting real-world patient data from its differentiated pain portfolio at PainConnect 2025, the American Academy of Pain Medicine (AAPM)’s Annual Meeting, being held in Austin, TX, from April 3-6, 2025. Among these, the poster titled “Route of Administration and Other Clinical Outcomes Among...Read more
Fourth-Quarter, Full-Year 2024, and Recent Highlights: Record revenues of $66.8 million for Q4 2024, an 84% increase over Q4 2023 Revenues of $199.6 million for FY 2024, a 53% increase over FY 2023 GAAP net income of $6.8 million for Q4 2024, for a GAAP net loss of $(17.5) million for FY 2024 Adjusted EBITDA of $22.5 million for Q4 2024, leading to Adjusted EBITDA of $40.3 million for FY 2024 IHEEZO® unit demand and VEVYE®...Read more
BOCA RATON, Fla. / Mar 27, 2025 / Business Wire / TherapeuticsMD, Inc. (“TherapeuticsMD” or the “Company”) (NASDAQ: TXMD), a company that owns rights to pharmaceutical royalties, today reported financial results for the full year ended December 31, 2024. Full Year 2024 Financial Results Net Loss from Continuing Operations Net loss from continuing operations was $(2.3) million, or $(0.20) per basic and diluted common share, a decrease...Read more
GARDEN CITY, NY, March 27, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs Inc. (NASDAQ: PRPH), (the “Company” or “ProPhase”), a next generation biotech, genomics and consumer products company, today announced that they will be presenting full year 2024 financial results, and a review of current Company strategy, on a virtual conference call hosted by Renmark Financial on March 31, 2025 at 11:00 AM EST. A press release detailing these results will...Read more
Oral presentation features new data from the 24-week pivotal Vivacity-MG3 study which show sustained disease control through treatment with nipocalimab on the clinician-assessed QMGa score in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab data demonstrate longer-term sustained disease control as measured by MG-ADLb and QMG scores from the ongoing open-label extension (OLE) of the Vivacity-MG3 study...Read more
Median overall survival not yet reached with projected improvement of more than one year versus osimertinib RARITAN, N.J., March 26, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™...Read more
| Company | Change | Last Trade |
|---|---|---|
| Eli Lilly | 104.09 14.16 | $838.99 |
| Johnson & Johnson | 3.56 2.31 | $157.47 |
| Biogen | 3.32 2.88 | $118.61 |
| Zoetis | 1.91 1.30 | $148.67 |
| Regencell Bioscience | 1.87 6.86 | $29.12 |
| Merck | 1.54 2.01 | $78.00 |
| Novartis | 1.28 1.17 | $110.86 |
| China SXT Pharmaceuticals | 1.08 109.32 | $2.07 |
| PTC Therapeutics | 0.98 2.11 | $47.39 |
| Evolus | 0.68 6.73 | $10.79 |
| Harrow | 0.64 2.74 | $23.99 |
| Bausch Health | 0.60 13.33 | $5.10 |
| GSK | 0.56 1.58 | $35.93 |
| AstraZeneca | 0.54 0.81 | $67.59 |
| Phibro Animal Health | 0.46 2.73 | $17.29 |
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including a small-molecule GLP-1 receptor...
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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
CLICK TO LEARN MORE