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Published on 02:56 GMT

OBI Pharma reçoit l’approbation de la FDA à la suite de sa demande d’étude clinique de la Phase I/II pour OBI-902, un ...

TAIPEI, Taïwan, 02 mai 2025 (GLOBE NEWSWIRE) -- OBI Pharma, Inc. (« OBI »), un laboratoire d’oncologie au stade clinique (4174.TWO), annonce ce jour que l’Agence américaine des produits alimentaires et médicamenteux, la Food and Drug Administration, ou « …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on 02:56 GMT

OBI Pharma gibt bekannt, dass die US-Arzneimittelbehörde FDA den IND-Antrag für eine Phase-1/2-Studie mit OBI-902, einem ...

TAIPEI, Taiwan, May 02, 2025 (GLOBE NEWSWIRE) -- OBI Pharma, Inc. („OBI“), ein Onkologieunternehmen in der klinischen Phase (4174.TWO), hat heute bekannt gegeben, dass die US-amerikanische Arzneimittelbehörde FDA (Food and Drug Administration) den Antrag …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 1, 2025

OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-902, a Trop-2 Targeting ADC

TAIPEI, Taiwan, May 01, 2025 (GLOBE NEWSWIRE) -- OBI Pharma, Inc. (“OBI”), a clinical stage oncology company（4174.TWO), today announced that the U.S. Food and Drug Administration (FDA） has cleared an investigational new drug （IND） application for OBI-902, …

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Published on May 1, 2025

浩鼎ADC OBI-902临床试验获美国FDA核准将启动Trop-2靶向ADC 1/2期临床研究

台湾, May 01, 2025 (GLOBE NEWSWIRE) -- 致力于癌症创新疗法研发的台湾浩鼎生技（4174.TWO）今（5/1）日（美国时间4/30）宣布，旗下新药OBI-902已获美国食品药物管理局（FDA）核准临床试验申请（IND），将展开一期/二期临床试验。这项试验预计招募晚期实体肿瘤患者。浩鼎视此次通过IND，为开发进程的重要里程碑，代表此一新世代Trop-2 ADC，将为未被满足医疗需求的患者提供新的治疗希望。浩鼎执行长王慧君博士表示，即将开展的OBI-902-001 …

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Published on May 1, 2025

浩鼎ADC OBI-902臨床試驗獲美國FDA核准將啟動Trop-2靶向ADC 1/2期臨床研究

台灣, May 01, 2025 (GLOBE NEWSWIRE) -- 致力於癌症創新療法研發的台灣浩鼎生技（4174.TWO）今（5/1）日（美國時間4/30）宣布，旗下新藥OBI-902已獲美國食品藥物管理局（FDA）核准臨床試驗申請（IND），將展開一期/二期臨床試驗。這項試驗預計招募晚期實體腫瘤患者。浩鼎視此次通過IND，為開發進程的重要里程碑，代表此一新世代Trop-2 ADC，將為未被滿足醫療需求的患者提供新的治療希望。浩鼎執行長王慧君博士表示，即將開展的OBI-902-001 …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 1, 2025

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for …

Source: JD Supra - California - Neutral
Published on Apr 30, 2025

CHMP Recommends Approval of At-Home, Subcutaneous Trastuzumab/Pertuzumab in HER2+ Breast Cancer

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for a fixed-dose subcutaneous combination of pertuzumab (Perjeta), trastuzumab …

Source: OncLive - Pending
Published on Apr 30, 2025

Clinical Insights Into Treatment Approach for Metastatic HER+ mBC Patient Case

Clinical Brief: Emerging Options for HER2+ mBC Key Themes: Efficacy of Second-Line T-DXd: Trastuzumab deruxtecan (T-DXd) is becoming standard in the second-line setting, supported by National Comprehensive Cancer Network guidelines PATINA Trial Results: …

Source: OncLive - Pending
Published on Apr 30, 2025

Er-Kim Announces Exclusive Distribution Agreement with Puma Biotechnology to Commercialize NERLYNX® (neratinib) for ...

ATHENS, Greece and LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies in the EMEA region, today announced that it has signed an agreement with Puma …

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Published on Apr 30, 2025

Runimotamab Plus Trastuzumab Shows Encouraging Activity and Tolerability in HER2-Positive Breast Cancer

The combination of runimotamab, a T-cell engaging bispecific antibody, and trastuzumab (Herceptin) resulted in encouraging clinical activity and improved tolerability compared with runimotamab monotherapy in patients with HER2-positive breast cancer, …

Source: Targeted Oncology - Pending
Published on Apr 29, 2025

Boehringer’s HER2-mutated lung cancer drug shows sustained benefit for 14 months

Boehringer Ingelheim’s drug candidate for human epidermal growth factor receptor 2 (HER2)-mutated non-small cell lung cancer (NSCLC) has demonstrated a durable response of more than 14 months while maintaining a manageable safety profile. In the Phase Ib …

Source: Clinical Trials Arena - Pending
Published on May 1, 2025

KN026/Chemo Meets PFS End Point in HER2+ Gastric Cancer in 2L Setting

KN026, an anti-HER2 bispecific antibody, administered with chemotherapy met the pre-specified primary end point of progression-free survival (PFS) with statistical significance and clinical relevance in the second-line or above treatment of patients with …

Source: Cancer Network - New Jersey - Pending
Published on May 1, 2025

Samsung Bioepis Report Signals Turning Point for US Biosimilars

The US biosimilar market continued its upward trajectory in the first quarter of 2025, driven by a potent combination of regulatory reform and competitive pricing strategies. According to Samsung Bioepis’ Q2 Biosimilar Market Report,1 the FDA's …

Source: The Center for Biosimilars - Pending
Published on Apr 28, 2025

Targeted drug zongertinib shows strong results for HER2-mutant lung cancer in clinical trial

The HER2-targeted therapy zongertinib demonstrated clinical benefits for previously treated patients with advanced HER2-mutant non-small cell lung cancer – particularly those with specific HER2 mutations – with manageable side effects, according to results …

Source: Medical News - Neutral
Published on May 1, 2025

KN026 Plus Chemo Improves PFS in Pretreated HER2+ Gastric/GEJ Cancer

The addition of the anti-HER2 bispecific antibody KN026 to chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with placebo plus chemotherapy in patients with HER2-positive …

Source: OncLive - Pending
Published on Apr 30, 2025

AZ backs up threat of manufacturing shift from Europe

AstraZeneca has said it is considering a shift in the production of some medicines from Europe to the US in order to sidestep potential tariffs on imports introduced by the new US administration. Chief executive Pascal Soriot said that the company, which …

Source: pharmaphorum - Neutral
Published on 12:06 GMT

CHMP endorses Roche’s breast cancer therapy for administration out of clinical settings

Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo. This fixed-dose combo of Perjeta (pertuzumab) and Herceptin ( …

Source: Pharmaceutical Business Review - Pending
Published on 11:41 GMT

ZMYND8 Boosts HER2 Antibody Resistance via Lipid-IL-27

In a groundbreaking study poised to shift paradigms in breast cancer therapy, researchers have uncovered a pivotal molecular mechanism driving resistance to HER2-targeted antibody treatments. The work, recently published in Nature Communications, …

Source: Bioengineer.org - Pending
Published on 06:53 GMT

Roche announces EMA committee recommends EU label update for its Phesgo to allow administration outside of clinical ...

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo, a subcutaneous (SC) fixed-dose combination of …

Source: Pharmabiz.com - Neutral

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Published on May 2, 2025 - 15:48 GMT

Adial Pharmaceuticals Announces a Warrant Inducement Transaction for $2.75 Million in Gross Proceeds

GLEN ALLEN, Va., May 02, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related …

Distribution channels: Banking, Finance & Investment Industry, Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 10:52 GMT

Omega-3 Market Poised for Robust Growth with Expanding Applications Across Nutrition, Pharmaceuticals & Personal Care

Omega 3 Market Research Report By Source, By Form, By Application, By End Use and By Regional-Forecast to 2035 NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The global Omega-3 Market is experiencing significant momentum, driven …

Distribution channels: Food & Beverage Industry ...

Published on May 2, 2025 - 17:48 GMT

Class Action Filed Against Actinium Pharmaceuticals, Inc. (ATNM) Seeking Recovery for Investors – Contact Levi & ...

NEW YORK, May 02, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Actinium Pharmaceuticals, Inc. ("Actinium" or the "Company") (NYSE: ATNM) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit …

Distribution channels: Consumer Goods, Law ...
Published on May 2, 2025 - 14:54 GMT

Zinc Chloride Market Poised for 5.0% CAGR Growth: Increasing Demand in Batteries, Water Treatment, and Pharmaceuticals

The global zinc chloride market is set to grow from USD 341.3 million in 2025 to USD 556.0 million by 2035, expanding at a CAGR of 5.0%. NEWARK, DE, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The global zinc chloride market is projected to …

Distribution channels: Chemical Industry ...

Published on May 2, 2025 - 12:00 GMT

ARS Pharmaceuticals Announces Co-Promotion Agreement with Partner and Global Allergy Leader ALK-Abelló A/S to Expand ...

Agreement builds on landmark licensing deal between ARS Pharma and ALK-Abelló A/S, which provided ARS Pharma with $145 million upfront and ALK with commercialization rights to neffy in Canada, United Kingdom, European Union and certain other countries …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 10:03 GMT

Rosuvastatin Calcium Market CAGR 5.11 % with Growth USD 940.6 Billion by 2033

Rosuvastatin Calcium market size in 2025 is estimated to be 631.33 million, with projections to grow to 940.6 million by 2033 at a CAGR of 5.11%. PUNE, MAHARASHTRA, INDIA, May 2, 2025 /⁨EINPresswire.com⁩/ -- "Rosuvastatin Calcium Market" …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 06:30 GMT

Nxera Pharma Operational Highlights and Consolidated Results for the First Quarter 2025

Tokyo, Japan and Cambridge, UK, 2 May 2025 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the first quarter ended 31 March 2025. The full report can be found here. …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on May 2, 2025 - 14:11 GMT

NBCI Honors Dr. James H. Powell and Past and Present Black Clinicians Who Have Promoted Diversity in Clinical Trials

Passing the Baton to the National Clinical Trials Strategies Plan (NCTSP) WASHINGTON, DC, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The National Black Church Initiative (NBCI), a coalition of 150,000 African American churches and 27.7 …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...

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Published on May 2, 2025 - 19:38 GMT

The Springs of Ballentine to Open New Memory Care Community in Fuquay-Varina, NC

A new chapter in compassionate care is set to begin as The Springs of Ballentine, a thoughtfully designed memory care community, opens its doors on May 8, 2025 FUQUAY-VARINA, NC, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The Springs of Ballentine …

Distribution channels: Building & Construction Industry, Companies ...
Published on May 2, 2025 - 19:22 GMT

Global IT Signs Managed Services Agreement with Alzheimer’s Los Angeles

Partnership Aims to Enhance Operational Efficiency and Support Mission-Driven Technology Solutions for Alzheimer’s Los Angeles LOS ANGELES, CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Global IT, a top-tier provider of Managed IT …

Distribution channels: Emergency Services, Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 19:14 GMT

Groundbreaking Ceremony for School-Based Health Center in Piketon, Ohio

New Facility To Serve Students, Community PIKETON, OH, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The Scioto Valley Local School District, alongside Valley View Health Centers, recently held a groundbreaking ceremony for a transformative $ …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 19:00 GMT

AST Announces the Return of the IP3 for 2025 – A Unique Patent Purchase and Licensing Opportunity for Patent Owners

AST announces its tenth annual Industry Patent Purchase and Licensing Program - IP3 2025, connecting patent owners with major global technology firms. PRINCETON, NJ, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Allied Security Trust (AST) is …

Distribution channels: Automotive Industry, Banking, Finance & Investment Industry ...
Published on May 2, 2025 - 18:38 GMT

Capy Launches Ponytail Cap: A Stylish & Secure Solution for Healthcare Professionals with Longer Hair

Seattle's Capy launches Ponytail Cap, a comfortable & stylish solution for healthcare pros with voluminous hair. SEATTLE, WA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Capy (yourcapy.com), the beloved direct-to-consumer brand known for …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 18:13 GMT

Pennsylvania Dental Association Installs Dr. Theodore Rockwell as President

HARRISBURG, PA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The Pennsylvania Dental Association (PDA) recently installed Dr. Theodore J. Rockwell of Clarion as its 2025-2026 president, during its annual business meeting on April 26 at The …

Distribution channels: Healthcare & Pharmaceuticals Industry, International Organizations ...
Published on May 2, 2025 - 18:08 GMT

ACHS Leadership Shares Insights on Innovation, Institutional Storytelling, and AI at WASC ARC 2025

ACHS leaders shared strategies on AI, innovation, and storytelling in higher ed at WASC ARC 2025, highlighting their commitment to academic excellence. PORTLAND, OR, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- American College of Healthcare …

Distribution channels: Business & Economy, Conferences & Trade Fairs ...
Published on May 2, 2025 - 18:02 GMT

Mexico Bariatric Center® Introduces Innovative SASI-S Procedure: Get Sassy with SASI

Mexico Bariatric Center now offers the advanced Single Anastomosis Sleeve Ileal (SASI) bypass for powerful, lasting weight loss and improved metabolic health. SACRAMENTO, CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Mexico Bariatric …

Distribution channels: Beauty & Hair Care, Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 17:57 GMT

Fremont Pediatric Dental: Celebrating 50+ Years of 5-Star Pediatric Dentistry in Fremont, CA

FREMONT, CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- For more than 50 years, Fremont Pediatric Dental has been a pillar of excellence in children’s oral health across Bay Area. Today, Fremont Pediatric Dentistry proudly continues to …

Distribution channels: Culture, Society & Lifestyle, Emergency Services ...
Published on May 2, 2025 - 17:37 GMT

American Behavioral Clinics Launches SPRAVATO® Treatment for Depression at Oak Creek Location

American Behavioral Clinics (ABC) is proud to announce the launch of SPRAVATO® (esketamine) treatment at its Oak Creek clinic. OAK CREEK, WI, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- American Behavioral Clinics (ABC), a trusted provider …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 17:35 GMT

World Fellowship Ride Charity Promotes the Franki Moscato Foundation

American Idol Winner's Suicide Prevention Cause Chosen by World Motorcycle Movement OSHKOSH, WI, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- In its second year in the United States, the (May 10th) Fellowship Ride will gift all its event …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 2, 2025 - 17:30 GMT

PINYA XP f/k/a Pineapple Express Cannabis Company, Announces Engagement of Independent Auditor for Fiscal Year 2025

"PINYA XP engages Aloba, Awomolo & Partners to audit FY 2025 financials, reinforcing commitment to transparency and governance" Pineapple Express Cannabis Company (OTCMKTS:PNXP) ATLANTA, GA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com …

Distribution channels: Agriculture, Farming & Forestry Industry, Banking, Finance & Investment Industry ...
Published on May 2, 2025 - 17:09 GMT

Understanding How ADD Manifests Across Childhood, Adolescence, and Adulthood

GULFPORT, MS, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Attention Deficit Disorder (ADD), a neurodevelopmental condition affecting focus, organization, and impulse control, manifests differently across various stages of life. Recognizing …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 17:00 GMT

EIN Presswire’s Debut Edition of ‘Heard on the Streets': PR Expert Clears Up Important PR Misconception

Sherrie Handrinos discusses how to earn media coverage and the key differences between earned PR and paid placement WASHINGTON, DC, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- In the debut edition of “Heard on the Streets,” a new series on …

Distribution channels: Agriculture, Farming & Forestry Industry, Amusement, Gaming & Casino ...
Published on May 2, 2025 - 16:42 GMT

Ascend, Inc. Celebrates a Decade of Great With Great Place To Work®

Ascend Joins Special Event Honoring 10+ Years of Great Place To Work Certification in 2025 BOULDER, CO, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Ascend, Inc., a Great Place To Work® Certified™ workplace, recently received a special …

Distribution channels: Building & Construction Industry, Companies ...
Published on May 2, 2025 - 16:33 GMT

USGrants.org Tracks Over $683 Million in Federal Funding for Higher Education Programs

USGrants.org Tracks Over $683 Million in Federal Funding for Higher Education Programs SACRAMENTO, CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- USGrants.org, an online resource for federal grant information in the United States, has …

Distribution channels: Agriculture, Farming & Forestry Industry, Banking, Finance & Investment Industry ...
Published on May 2, 2025 - 16:08 GMT

Etech's QEval Wins the Spring 2025 Top Performer Award from SourceForge

Etech's QEval is proud to be a winner of the Top Performer award from SourceForge, the world's largest software reviews and comparison website. NACOGDOCHES, TX, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Etech Global Services, a …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on May 2, 2025 - 15:41 GMT

Hypnosis Business Virtual Summit to Take Place June 21-22, 2025, Sponsored by HypnoBiz-in-a-Box™

The Hypnosis Business Virtual Summit is a 2-day event with expert insights for hypnosis business owners, featuring presentations from top industry leaders. TAMPA, FL, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The Hypnosis Education …

Distribution channels: Business & Economy, Conferences & Trade Fairs ...
Published on May 2, 2025 - 15:00 GMT

The Brookbush Institute Publishes NEW Course and Glossary Updates: 'Taut Band'

The Brookbush Institute continues to enhance education with new courses, a modern glossary, an AI Tutor, and a client program generator. NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Excerpt from the glossary term: Taut Band …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on May 2, 2025 - 14:43 GMT

Iylon Precision Oncology, LLC Introduces Its Visionary Executive Team Revolutionizing Cancer Care

Meet the Iylon Precision Oncology, LLC Executive Team, who are passionate about making a positive difference in cancer patients' lives. PROVIDENCE, RI, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Precision oncology is more effective …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...