Articles

Kelun-Biotech Secures Investigational New Drug Approval for SKB118

Kelun-Biotech has received Investigational New Drug approval from CDE for SKB118, a promising PD-1 x VEGF bispecific antibody. This approval marks a significant milestone for the company and the broader pharmaceutical landscape.

Merck’s Billion-Dollar Bet on TROP2: Regulatory Updates and Implications

Merck's strategic investment in Kelun-Biotech's TROP2 shows promising survival benefits in endometrial cancer. This analysis covers the regulatory updates and their implications for investors.

LogiPharma Asia 2026: What to Expect from the Event

LogiPharma Asia 2026 is set to be a pivotal event for the pharmaceutical logistics sector. Attendees can expect insights into emerging trends and key players in the industry.

BeOne's 'One Save Changes Everything' Campaign: A New Era in Pharma Marketing

BeOne launches a transformative campaign with Tim Howard, aiming to reshape pharma marketing. Discover its potential impact on the industry.

Roche's Alecensa Expansion: Implications for Pharma Stakeholders

Roche's Alecensa has received approval for the treatment of all ALK tumor types in Japan, marking a significant regulatory milestone. This article explores the implications for pharma stakeholders.

Takeda's $885M Verdict: Implications for Pharma Business Strategies

Takeda faces an $885M verdict in a pay-for-delay antitrust case, raising significant questions for pharmaceutical business strategies and market dynamics.

Doceree Launches Daily Command: Transforming Pharma Brand Strategies

Doceree has unveiled Daily Command, an AI platform designed for pharma brand teams. This innovation promises to reshape how pharmaceutical companies strategize and execute their marketing efforts.

SCOTUS Restores Telehealth Access to Mifepristone: Implications for Pharma

The recent SCOTUS ruling temporarily restores telehealth access to mifepristone, impacting pharmaceutical strategies and market dynamics. This article explores the implications for pharma teams.

Rusan Pharma Secures GMP Clearance from Japan's PMDA

Rusan Pharma has achieved a significant milestone by securing GMP clearance from Japan's PMDA, marking a pivotal moment for the company. This article explores the implications of this regulatory update for the pharmaceutical industry.

Reckitt Benckiser Layoffs: Mucinex Maker Cuts Jobs in NJ

Reckitt Benckiser, the company behind Mucinex, has announced further layoffs in New Jersey. This move signals ongoing strategic adjustments within the pharmaceutical giant.

SAKIGAKE Designation Japan: Bispecific Antibodies for Leukemia Status 2026

This article delves into the SAKIGAKE Designation in Japan for bispecific antibodies, focusing on their potential to transform leukemia treatment by 2026.

Harmonization of Clinical Trial Regulations: PMDA, TGA & CDSCO Compared

This article compares the clinical trial regulations of PMDA, TGA, and CDSCO, focusing on their impact on drug development and patient safety.

Saudi Arabian Pharmaceutical Market: Impact of SFDA's Accelerated Drug Approval

The Saudi Arabian pharmaceutical market is evolving rapidly due to the SFDA's accelerated drug approval process, enhancing access to essential medications.

Biosimilar Approval Pathways: ANVISA vs COFEPRIS Insights 2026

This article delves into the 2026 biosimilar approval pathways of ANVISA and COFEPRIS, focusing on their implications for monoclonal antibody therapies.

ANVISA Approves Enhertu: Transforming HER2-Positive Breast Cancer Care in Brazil

Enhertu has received ANVISA approval, marking a significant advancement in the treatment landscape for HER2-positive breast cancer in Brazil.

NMPA Approval Lung Cancer Immunotherapy: PD-1/PD-L1 Combo Trends 2025

This article delves into the NMPA's approval landscape for lung cancer immunotherapy, highlighting the emerging trends of PD-1/PD-L1 combination therapies by 2025.

NMPA Conditional Approval Pathway: Impact on Innovative Oncology Drug Access

The NMPA Conditional Approval Pathway significantly enhances access to innovative oncology drugs, facilitating timely treatment options for cancer patients.

African Medicines Agency Implementation: Transforming Regulatory Harmonization & Market Access

The African Medicines Agency is set to revolutionize regulatory processes, ensuring faster market access for vital medicines across the continent.

SAHPRA Approval Trastuzumab Deruxtecan: Access & Affordability Insights

Explore the implications of SAHPRA's approval of Trastuzumab Deruxtecan for breast cancer, highlighting key insights on access and affordability.

COFEPRIS Generic Drug Approval: Market Impact & Competitive Shift 2025

This article analyzes the implications of COFEPRIS's generic drug approval for hypertension treatments, highlighting market dynamics and competitive shifts expected in 2025.