In SURPASS-PEDS, Mounjaro met the primary and all key secondary endpoints at 30 weeks and showed sustained improvement in glycemic control and continued BMI reduction through the study's 52-week extension The safety and tolerability profile of Mounjaro was generally consistent with previous adult studies INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from...Read more
For the primary endpoint, orforglipron lowered A1C by 2.2% vs. 1.4% with oral semaglutide at the highest doses Participants taking the highest dose of orforglipron lost an average of 19.7 lbs (9.2%) vs. 11.0 lbs (5.3%) with oral semaglutide, a 73.6% relative improvement, in a key secondary endpoint The safety and tolerability of orforglipron were consistent with previous trials INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli...Read more
Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study Robust findings continue to demonstrate the potential of icotrokinra to disrupt the treatment paradigm to set a new...Read more
Subcutaneous administration of first-in-class biologic SAPHNELO demonstrates statistically significant and clinically meaningful reduction in disease activity WILMINGTON, Del. / Sep 17, 2025 / Business Wire / Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca’s SAPHNELO®...Read more
Oral semaglutide 25 mg (the once-daily pill formulation of Wegovy®) achieved significant weight loss, with one in three study participants losing 20% or more body weight1** Oral semaglutide 25 mg also demonstrated improvements in the ability to perform everyday physical activities such as bending, standing, walking, being physically active, and improvements in cardiovascular risk factors1 Oral semaglutide 25 mg is the first oral GLP-1...Read more
Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11 The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPD The EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from...Read more
New site in Virginia's Goochland County will develop active pharmaceutical ingredients (API) in the U.S. for cancer, autoimmune and other advanced therapies Company will create 2,450 high-wage manufacturing and construction jobs This marks the first of four new U.S. manufacturing sites that Lilly plans to announce this year INDIANAPOLIS, Sept. 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that it plans...Read more
The investigational once-daily oral pill led to an average weight loss of 27.3 lbs (12.4%) at the highest dose at week 72 in the Phase 3 study Orforglipron demonstrated significant improvements across key cardiometabolic risk factors, supporting its potential as a treatment option for millions living with obesity INDIANAPOLIS, Sept. 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results...Read more
The integration of Accu-Chek SmartGuide's AI-enabled predictive CGM with the popular mySugr app delivers a simple, intuitive solution for people to manage their diabetes with greater ease. Accu-Chek SmartGuide is now available in 13 countries, with plans to accelerate access to over 30 countries across Europe, Latin America and Asia-Pacific by year-end. Real-world evidence from rollout and clinical perspectives presented at the...Read more
Positive results show that the average weight loss was 12.5 kg (11.8% body weight reduction) with cagrilintide compared to 2.5 kg (2.3%) with placebo, after 68 weeks*1,2 Cagrilintide was well-tolerated, with the most common side effects being gastrointestinal; these were mainly transient and mild to moderate in severity1 Based on these results, Novo Nordisk will advance cagrilintide into the dedicated RENEW phase 3 clinical programme...Read more
VELA to operate the world’s first sailing cargo trimaran powered by 100 percent wind when at sea1 to sail between Europe and the U.S. Takeda to become the first biopharmaceutical company to ship its products on VELA’s wind-powered trimaran, starting a new era of sustainable shipping in pharma OSAKA, Japan & CAMBRIDGE, Mass. / Sep 16, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) and VELA Transport today announced their...Read more
TEL AVIV, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced plans to present data from the completed phase 3 SOLARIS trial at the 2025 Psych Congress Annual Meeting, taking place from September 17 – 21, 2025, in San Diego, California. Teva will also host a conference call for analysts and investors on Monday, September 22, 2025, at 11:00 a.m. ET to discuss these data. In...Read more
MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD MIAMI, FLORIDA / ACCESS Newswire / September 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive results demonstrating...Read more
Arbli™ is the first and only ready-to-use liquid formulation of losartan, eliminating the need for compounding while offering reduced dosing volume and extended room-temperature shelf life COMMACK, NY, Sept. 16, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through...Read more
All 172 patients have now entered the 12-month follow-up phase Trial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatment Study results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026 WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a...Read more
21 abstracts from across the Company's portfolio highlight clinical and real-world data on major depressive disorder, treatment-resistant depression and schizophrenia New Phase 3 data demonstrate the safety and efficacy of adjunctive seltorexant compared to quetiapine XR in major depressive disorder with insomnia symptoms TITUSVILLE, N.J., Sept. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 21...Read more
First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s raludotatug deruxtecan based on phase 1 trial and REJOICE-Ovarian01 phase 2/3 trial Second Breakthrough Therapy Designation since the start of the Daiichi Sankyo and Merck collaboration Fifteenth Breakthrough Therapy Designation granted by FDA across the oncology portfolio of Daiichi Sankyo BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 15, 2025 / Business Wire /...Read more
Results from a real-world survey suggest that semaglutide for weight management (Wegovy®) helped suppress food noise – unwanted and intrusive thoughts about food – in addition to its established effect on weight loss1 The number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy®1 The majority of respondents reported improved mental health (64%) and...Read more
Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1 This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1 In addition, new results from SOUL...Read more
GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received a $17 million contract modification from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to supply TEMBEXA® (brincidofovir) oral...Read more
New data show how Sympazan is being used in daily clinical practice to treat patients with Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy Study addresses lack of awareness and real-world data with oral film formulation of clobazam New data presented during poster session at 150th Annual Meeting of the American Neurological Association SYMPAZAN is the only FDA-approved oral film formulation of clobazam for...Read more
PARSIPPANY, N.J. / Sep 12, 2025 / Business Wire / Zoetis Inc. today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for Portela® (relfovetmab), a new monoclonal antibody (mAb) therapy intended for the alleviation of pain associated with osteoarthritis (OA) in cats. Portela Will Be First...Read more
MONTREAL, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that its shareholders have approved the previously announced plan of arrangement (the “Arrangement”) under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC...Read more
SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies. MIAMI, FL / ACCESS Newswire / September 12, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic...Read more
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...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...Read more
Expands Amneal’s Affordable Medicines portfolio and broadens patient access BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an...Read more
The transaction adds larsucosterol, an FDA Breakthrough Therapy for alcohol-associated hepatitis with a registrational Phase 3 clinical trial in development, to Bausch Health's hepatology pipeline LAVAL, QC, AND CUPERTINO, CA / ACCESS Newswire / September 11, 2025 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) ("Bausch Health"), a global, diversified pharmaceutical company, today announced the successful completion of its...Read more
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. (“Cosmos Health” or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today announced that its wholly owned subsidiary, Sky Pharm SA, signed a distribution agreement (the “Agreement”) with Scientific Pharmacy LLC (“Scientific Pharmacy”) for its Sky Premium Life food supplement products in Oman. Scientific Pharmacy, 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...Read more
Poster presentation will feature new data for SYMPAZAN, the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older Abstract is now available on ANA2025 website LAKE FOREST, Ill., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with...Read more
Agreement strengthens Canadian veterinarians' access to Zomedica's advanced therapeutic and monitoring solutions ANN ARBOR, MI / ACCESS Newswire / September 10, 2025 / Zomedica Corp. (OTCQB:ZOMDF), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, announced today that it has expanded its distribution agreement with UXR Inc., a leading Canadian animal health...Read more
BEIJING, Sept. 10, 2025 /PRNewswire/ -- Shineco Inc. (NASDAQ: SISI) ("Shineco" or the "Company"), a leading developer of induced pluripotent stem cell (iPSC) technology platforms, today announced that its subsidiary, Fuzhou Meidashan Biotechnology Co., Ltd., has successfully achieved large-scale production of high-purity, highly active free-form soybean phospholipids. This breakthrough was made possible through its proprietary...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...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 &...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...Read more
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis. BiPASS™ (Biopsy of the Prostate Avoidance Stratification...Read more
VANCOUVER, B.C. / ACCESS Newswire / September 9, 2025 / Lobe Sciences Ltd. ("Lobe" or the "Company") (CSE:LOBE)(OTCQB:LOBEF)(FWB:LOBE.F) a clinical stage biopharmaceutical company focused on developing products to treat diseases with significant unmet medical needs is pleased to announce its participation in the upcoming Clusterbusters 20th Annual U.S. Patient Conference taking place September 11-14, 2025, in Grapevine, Texas (near...Read more
VANCOUVER, BC / ACCESS Newswire / September 8, 2025 / Lobe Sciences Ltd. ("Lobe Sciences" or the "Company") (CSE:LOBE) (OTCQB:LOBEF) (FWB:LOBE.F) a clinical stage biopharmaceutical company focused on developing products to treat diseases with significant unmet medical needs is pleased to announce the appointment of Mr. Marco Mastrodonato to the Company's Board of Directors. Mr. Mastrodonato brings extensive leadership and international...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...Read more
NEW BRUNSWICK, N.J. / Sep 08, 2025 / Business Wire / Johnson & Johnson (NYSE: JNJ) announced today that John Morikis, retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, has been elected to its Board of Directors. “We are pleased to welcome John to our Company’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “He is a proven leader of a large...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...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...Read more
Takeda is the Leader in Orexin Science and is on Track to Submit Global Regulatory Applications Starting in Fiscal Year 2025 Four Orexin Oral Presentations from Phase 3 Pivotal Studies Highlight Statistically Significant and Clinically Meaningful Improvement in Narcolepsy Type 1 Symptoms Demonstrating the Potential for a New Era of Care Oveporexton was Generally Well-Tolerated with Safety Profile Consistent with Previous Clinical...Read more
Announces Commitment for New $40 Million Revolving Credit Facility Issues Conditional Notice of Redemption of 11.875% Senior Notes due 2027 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has commenced a private offering (the “Offering”) of $250.0 million aggregate principal amount of...Read more
Vancouver, British Columbia--(Newsfile Corp. - September 8, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company") a Canadian drug manufacturer of MDMA and naturally-derived psilocybin announces that it has publicly filed a registration statement with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its common shares in the United States. The...Read more
CorMedix is making a strategic investment in Talphera as the lead investor, supported by existing stockholders Nantahala, Rosalind and Rock Springs with several new institutional investors $17 million in proceeds at first closing with the potential to receive an additional $12 million across one additional tranche upon the achievement of the primary endpoint in the NEPHRO clinical study The completion of this financing is expected to...Read more
Chemotherapy-free combination regimen ushers in new era for first-line treatment, with overall survival projected to exceed four years, surpassing monotherapy TKI osimertinib by more than one year RARITAN, N.J., Sept. 7, 2025 /PR Newswire/ – Johnson & Johnson (NYSE: JNJ) today announced The New England Journal of Medicine (NEJM) published results from the Phase 3 MARIPOSA study, which showed RYBREVANT® (amivantamab-vmjw)...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...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...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...Read more
In AVONELLE-X, the largest long-term extension trial in wet AMD, disease control and durability were maintained over 4 years, with nearly 80% of patients on extended dosing by study end Over 60% of people with a difficult-to-treat form of wet AMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observed Vabysmo was well tolerated with a consistent long-term safety profile in...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...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...Read more
17 abstracts accepted, including one oral presentation Data from the REFRESH real-world study highlight efficacy of once-nightly sodium oxybate when switching from twice-nightly oxybates REFRESH study also highlights efficacy in those who were new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate DUBLIN, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical...Read more
EGRIFTA WR™ offers convenience of weekly reconstitution and reduced daily injection volume, compared to EGRIFTA SV® Specialty pharmacies are now ordering EGRIFTA WR™ to fill prescriptions MONTREAL, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced the availability of EGRIFTA WR™ (tesamorelin) for...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...Read more
THOUSAND OAKS, Calif., Sept. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 9:15 a.m. ET on September 9, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Kave Niksefat, senior vice president of Global Marketing and Access at Amgen, will present at the conference. The webcast will be...Read more
PALO ALTO, Calif, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Semnur Pharmaceuticals, Inc. (“Semnur”), a majority-owned subsidiary of Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced that the...Read more
Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2025 World Conference on Lung Cancer (“WCLC”) taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology (“CSCO”) Annual...Read more
Oral presentation will feature data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistance Additional poster presentations highlight SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus species Company anticipates reporting Phase 1 Single Ascending...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,...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,...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...Read more
Expands Avadel’s pipeline with salt-free, artificial sweetener-free, once-at-bedtime oxybate for treatment of narcolepsy and idiopathic hypersomnia Initial pharmacokinetic (PK) and comparative bioavailability study to initiate in fourth quarter 2025 with pivotal PK trial planned for second half 2026 XWPharma to receive $20 million upfront; potential for development, regulatory and sales milestone payments in addition to...Read more
LAKE FOREST, Ill., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT) announced that members of its management team will host investor meetings at two investor conferences in New York City during September 2025. Company management will host investor meetings at the HC Wainwright Conference on Wednesday, September 10, 2025, taking place at the Lotte New York Palace Hotel. Investors can...Read more
Strategic partnership with Pioneer Veterinary Products Limited expands Zomedica's presence in the UK veterinary market through distribution of its leading point-of-care solutions ANN ARBOR, MI / ACCESS Newswire / September 3, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, today announced a new...Read more
Export of 1,000 natural psilocybin capsules for prescription use under Australia's Authorised Prescriber Scheme follows the Company's successful launch of MDMA sales in 2024 Vancouver, British Columbia--(Newsfile Corp. - September 3, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP psychedelic medicines, is pleased to announce the commercial launch of its...Read more
VARIPURE demonstrated strong safety outcomes with no incidence of stroke and 99.7% acute effectiveness of the VARIPULSE™ Platform in nearly 800 enrolled patientsi IRVINE, Calif., Sept. 2, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced acute safety and effectiveness results from the VARIPURE substudy of SECURE, evaluating...Read more
Health Canada has approved ELAHERE®, the first novel therapy to demonstrate statistically significant and clinically meaningful improvements in overall survival (OS) compared to chemotherapy alone for patients with platinum-resistant ovarian cancer (PROC).1 ELAHERE® received approval through Health Canada's Priority Review process, based on data from the pivotal MIRASOL Phase 3 trial, establishing it as a potential new standard of care...Read more
NORTH CHICAGO, Ill., Sept. 2, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9, 2025. Management will participate in a fireside chat at 9:00 a.m. Central time. A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the session will be...Read more
Enlicitide is the first oral PCSK9 inhibitor to demonstrate statistically significant and clinically meaningful reductions in LDL-C compared to placebo in Phase 3 trials Enlicitide had a favorable safety profile, with comparable rates of discontinuation between treatment groups RAHWAY, N.J. / Sep 02, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results...Read more
Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension studies Substantial increase in seizure-free days and continuous improvements in quality of life demonstrated in patients already taking standard of care anti-seizure medicines Zorevunersen generally well tolerated across all studies Data...Read more
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO:...Read more
TEL AVIV, Israel, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, will present at two upcoming investor conferences in September as follows: Morgan Stanley 23rd Annual Global Healthcare ConferenceTuesday, September 9, 2025, at 8:30 A.M. ET BofA Global Healthcare Conference 2025 (London)Wednesday, September 24, 2025, at 9:00...Read more
SHANGHAI & JERSEY CITY, N.J. / Sep 02, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2 “The FDA...Read more
GAITHERSBURG, Md., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received a $30 million contract modification from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to supply CYFENDUS® (Anthrax Vaccine Adsorbed,...Read more
MADRID, Aug. 31, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Late breaking clinical science data, presented at the European Society of Cardiology (ESC) Congress today and simultaneously published in the New England Journal of Medicine (NEJM), finds at up to 10 years, when compared to standard care, routine use of Impella CP® in patients who have had a heart attack with cardiogenic shock leads to an absolute mortality...Read more
Compared with tirzepatide, Wegovy® (semaglutide 2.4 mg) showed a significant 57% greater reduction in the risk of heart attack, stroke or death from any cause, in people with overweight or obesity and cardiovascular disease (CVD) who stayed on treatment1 Similarly, the study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy® users compared with tirzepatide users in...Read more
Baxdrostat 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline, and was generally well tolerated with no unanticipated safety findings Full results presented at the European Society of Cardiology Congress 2025 and published in the New England Journal of Medicine WILMINGTON, Del. / Aug 30, 2025 / Business Wire / Positive full results from the BaxHTN Phase III trial showed baxdrostat demonstrated...Read more
Phase III trial informed by comprehensive KARDIA data set generated through three Phase II studies: KARDIA-1, KARDIA-2 and KARDIA-3 In the Phase II KARDIA-3 study, presented today as a late breaker at the European Society of Cardiology Congress 2025, zilebesiran demonstrated clinically meaningful reductions in office systolic blood pressure at month three with continuous control through month six Zilebesiran, a potential best-in-disease...Read more
Results from the Phase 3 VICTOR trial and a pooled analysis of the VICTOR and VICTORIA trials were presented today at the ESC Congress 2025 and simultaneously published in The Lancet RAHWAY, N.J. / Aug 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results evaluating VERQUVO® (vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction...Read more
THOUSAND OAKS, Calif., Aug. 29, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2025 Wells Fargo Healthcare Conference at 10:15 a.m. ET on Wednesday, Sept. 3, 2025. Paul Burton, M.D., Ph.D, senior vice president and chief medical officer 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...Read more
Findings from COLLIGO-HCM reinforce Camzyos’ efficacy and safety profile in reducing left ventricular outflow tract (LVOT) obstruction and improving symptom burden in a racially diverse, global patient population COLLIGO-HCM is a part of the WAYFARER-HCM global data program aimed at providing insights into use of Camzyos in real-world clinical practice PRINCETON, N.J. / Aug 29, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY)...Read more
LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq:...Read more
DUBLIN, Aug. 29, 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 the following upcoming investor conferences: 2025 Wells Fargo Healthcare Conference: Fireside chat on Friday, September 5 at 11:00 a.m. ET. Morgan Stanley 23rd Annual Global Healthcare Conference: Fireside...Read more
TORONTO, Aug. 28, 2025 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that FRUZAQLATM (fruquintinib capsules) will now be reimbursed by Régie de l'assurance maladie (RAMQ) for people in Quebec, under certain criteria, as a treatment for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates, for available standard therapies.1 FRUZAQLA received...Read more
Generic Saxenda® is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the U.S. market. This approval and launch add to Teva’s continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy. Liraglutide injection is indicated for adults with obesity or overweight (excess weight) who also have weight related medical problems, and...Read more
LONDON, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that management will participate in fireside chats at the following investor conferences in September: Citi 2025 Biopharma Back to School Summit on Wednesday, September 3 at 9:00 a.m. Eastern Time 2025 Wells Fargo Healthcare Conference on Thursday, September 4 at 9:30 a.m. Eastern Time A live webcast of Kiniksa’s...Read more
| Company | Change | Last Trade |
|---|---|---|
| AbbVie | 4.53 2.09 | $220.79 |
| Scilex | 2.40 10.64 | $24.96 |
| Harrow | 1.64 3.82 | $44.53 |
| Amgen | 1.63 0.60 | $274.71 |
| Gilead Sciences | 1.40 1.26 | $112.26 |
| Novo Nordisk | 1.30 2.27 | $58.50 |
| Regencell Bioscience | 1.29 9.01 | $15.60 |
| Biogen | 1.15 0.80 | $144.87 |
| PTC Therapeutics | 0.96 1.61 | $60.65 |
| Shuttle Pharmaceuticals | 0.86 24.02 | $4.44 |
| Supernus Pharmaceuticals | 0.81 1.84 | $44.80 |
| Johnson & Johnson | 0.74 0.42 | $177.20 |
| GSK | 0.31 0.77 | $40.36 |
| Avadel Pharmaceuticals | 0.25 1.62 | $15.66 |
| Universe Pharmaceuticals | 0.22 5.33 | $4.35 |
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. The company's lead cell therapy asset is NXC-201 in multiple myeloma...
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Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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